Investigator

Nicolò Bizzarri

Agostino Gemelli University Polyclinic

NBNicolò Bizzarri
Papers(12)
Gliomatosis peritonei…European training req…Surgical timing in ad…Value of frozen secti…Key issues in diagnos…Robotic-assisted vers…Uterine fundus indocy…Uterine transposition…Highlights from the 2…Sentinel-node biopsy …Best original researc…Critical view of safe…
Collaborators(10)
Giovanni ScambiaAnna FagottiFrancesco FanfaniMatteo PavoneDenis QuerleuLuigi Pedone AnchoraStefano RestainoGiuseppe VizzielliJoanna Kacperczyk-Bar…Camilla Fedele
Institutions(4)
Agostino Gemelli Univ…University of Strasbo…University Of PisaMedical University Of…

Papers

Gliomatosis peritonei with ovarian teratoma: an international multicenter case series

Gliomatosis peritonei (GP) is a rare condition characterized by peritoneal implants of mature glial tissue, macroscopically resembling peritoneal carcinomatosis. It is usually associated with ovarian mature or immature teratoma. To describe the clinical characteristics, treatment, and prognosis of cases with GP. Multi-center retrospective study of patients diagnosed with ovarian teratoma and GP between 2000 and 2023. Non-gynecological GP cases were excluded. Overall, 23 patients were included. Median age was 25 years (range; 10-38). Median ovarian tumor size was 19 cm (range; 6-35). The main symptom was abdominal pain (n = 13). Histology was mature teratoma in 13% (n = 3), and immature teratoma in 87% (n = 20) of cases, of which 90% (n = 18) was pure teratomas and 10% (n = 2) was mixed with yolk sac tumor. Overall, 60% were grade 3. Fertility-sparing surgery was performed in 87% (n = 20, of them 18 underwent unilateral salpingo-oophorectomy and 2 cystectomy ± further biopsies) without macroscopic residual disease in 91% (n = 21), and 78% (n = 18) were diagnosed at stage I. Adjuvant chemotherapy was given in 7 cases, only with grade 2 or more. Twelve women relapsed after a median of 43 months. However, only 2 relapses had immature teratoma components. Three patients had a second relapse after a median of 9 months. Over a median follow-up of 81 months (range; 7-270), the entire cohort remained alive and 3 live births were reported. GP is mostly associated with high-grade early-stage immature teratoma in young patients. Resection of peritoneal implants is crucial for the accurate diagnosis and optimal treatment planning. Relapses are mostly mature, therefore, offering fertility-sparing treatment in pre-menopausal cases could be considered.

Surgical timing in advanced ovarian cancer during the TRUST trial era: A systematic review, meta-analysis and study-level meta-regression of randomized controlled trials

The best surgical timing for advanced epithelial ovarian cancer, whether primary debulking surgery or interval debulking surgery, remains debated. Recent data, including the preliminary ones from TRUST trial, necessitates an updated critical evaluation. A systematic search of PubMed identified only randomized controlled trials comparing interval debulking surgery versus primary debulking surgery in patients with newly diagnosed advanced ovarian cancer. Primary outcomes included overall survival (OS) and progression-free survival (PFS). A random-effects meta-analysis, meta-regression, cumulative synthesis, and leave-one-out influence analysis were performed. A total of 2303 patients were included. Compared to primary debulking surgery, interval debulking surgery was associated with lower rates of postoperative complications (OR = 0.37; 95 % CI: 0.18-0.79; P = 0.01) and mortality (OR = 0.23; 95 % CI: 0.09-0.57; P = 0.002). Meta-analysis showed higher rates of complete cytoreduction with interval debulking surgery (OR = 3.84; 95 % CI: 2.14-6.91; P < 0.00001) and lower rates of macroscopic residual disease (OR = 0.20; 95 % CI: 0.13-0.30; P < 0.00001). Pooled data revealed no significant difference in OS (HR = 0.95; 95 % CI: 0.87-1.04; P = 0.26) or PFS (HR = 0.94; 95 % CI: 0.85-1.03; P = 0.16). Subgroup analyses by stage and residual disease confirmed similar survival outcomes. The meta-regression results suggested that even in trials with very high complete cytoreduction rates, no clinically meaningful OS benefit was observed for upfront surgery. In conclusion, interval debulking surgery offers comparable survival outcomes to primary debulking, with reduced perioperative morbidity and mortality, supporting its role as a valid surgical alternative. PROSPERO REGISTRATION NUMBER: CRD420251105308.

Value of frozen section to tailor surgical staging in apparent early-stage epithelial ovarian cancer

Frozen section (FS) has been shown to have high accuracy in determining ovarian malignancy. However, its utility in guiding surgical approaches, particularly, lymph node staging, for early-stage epithelial ovarian cancer remains unclear. This study aimed to evaluate the post-test positive probability of FSs in identifying cases requiring lymph node or peritoneal staging. The secondary aims were sensitivity, specificity, and accuracy assessments. This retrospective study analyzed patients undergoing surgery for early-stage epithelial ovarian cancer with FS performed on ovarian masses between July 2007 and March 2023 at a tertiary center. The FS results were compared with the final histology (gold standard paraffin sections). The FS cases were categorized based on further actions as follows: lymph node staging (type A), peritoneal staging only (type B), or no additional procedures (type C). The patients were divided into group 1 (requiring lymph node and peritoneal staging) and group 2 (requiring only peritoneal staging). A comparison between specialized and general pathology diagnoses was also performed. Incorrect FS assessments were classified as under-diagnosed or over-diagnosed. Of the 715 patients, group 1 had appropriate staging in 425 of 447 cases, with 4.9% over-treatment. In group 2, staging was correct in 109 of 195 cases, with 44.1% under-treatment. For type A FSs, the post-test positive probability was 95% (95% CI 93% to 97%), with sensitivity, specificity, and accuracy rates of 76.4%, 86.1%, and 78.6%, respectively. For type B FSs, the post-test positive probability was 56% (95% CI 50% to 61%), with sensitivity, specificity, and accuracy rates of 68.6%, 84.5%, and 81%, respectively. There was no significant difference in the agreement between the specialized and general pathology groups (p = 0.92). Frozen sections suggestive of a cancer diagnosis requiring peritoneal and lymph node staging in a population with apparent early-stage epithelial ovarian cancer are highly reliable. In the case of FSs suggesting only peritoneal staging, malignancy is frequently underestimated.

Robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: a randomized controlled study (RObese)

Nearly 65% of patients with endometrial cancer who undergo primary hysterectomy have concurrent obesity. Retrospective data show advantages in using robotic surgery in these patients compared with conventional laparoscopy, namely lower conversion rate, increased rate of same-day discharge, and reduced blood loss. Nevertheless, to date no prospective randomized controlled trials have compared laparoscopic surgery versus robotic-assisted surgery in morbidly obese patients. The robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: a randomized controlled study (RObese) trial aims to find the most appropriate minimally invasive surgical approach in morbidly obese patients with endometrial carcinoma. Robotic surgery will reduce conversions to laparotomy in endometrial cancer patients with obesity compared with those who undergo surgery with conventional laparoscopy. This phase III multi-institutional study will randomize consecutive obese women with apparent early-stage endometrial cancer to either laparoscopic or robot-assisted surgery. The RObese trial will include obese (BMI≥30 kg/m Conversion rate to laparotomy between laparoscopic surgery versus robot-assisted surgery. RObese is a superiority trial. The clinical superiority margin for this study is defined as a difference in conversion rate of -6%. Assuming a significance level of 0.05 and a power of 80%, the study plans to randomize 566 patients. Patient recruitment will be completed by 2026, and follow-up will be completed by 2029 with presentation of data shortly thereafter. Two interim analyses are planned: one after the first 188 and the second after 376 randomized patients. NCT05974995.

Sentinel-node biopsy in apparent early stage ovarian cancer: final results of a prospective multicentre study (SELLY)

To evaluate the sensitivity and specificity of sentinel-lymph-node mapping compared with the gold standard of systematic lymphadenectomy in detecting lymph node metastasis in apparent early stage ovarian cancer. Multicenter, prospective, phase II trial, conducted in seven centers from March 2018 to July 2022. Patients with presumed stage I-II epithelial ovarian cancer planned for surgical staging were eligible. Patients received injection of indocyanine green in the infundibulo-pelvic and, when feasible, utero-ovarian ligaments and sentinel lymph node biopsy followed by pelvic and para-aortic lymphadenectomy was performed. Histopathological examination of all nodes was performed including ultra-staging protocol for the sentinel lymph node. 174 patients were enrolled and 169 (97.1 %) received study interventions. 99 (58.6 %) patients had successful mapping of at least one sentinel lymph node and 15 (15.1 %) of them had positive nodes. Of these, 11 of 15 (73.3 %) had a correct identification of the disease in the sentinel lymph node; 7 of 11 (63.6 %) required ultra-staging protocol to detect nodal metastasis. Four (26.7 %) patients with node-positive disease had a negative sentinel-lymph-node (sensitivity 73.3 % and specificity 100.0 %). In a multicenter setting, identifying sentinel-lymph nodes in apparent early stage epithelial ovarian cancer did not reach the expected sensitivity: 1 of 4 patients might have metastatic lymphatic disease unrecognized by sentinel-lymph-node biopsy. Nevertheless, 35.0 % of node positive patients was identified only thanks to ultra-staging protocol on sentinel-lymph-nodes.

Critical view of safety assessment in sentinel node dissection for endometrial and cervical cancer: artificial intelligence to enhance surgical safety and lymph node detection (LYSE study)

This study aims to evaluate the feasibility of video-based assessment rate of Critical Views of Safety criteria for sentinel lymph node dissection in endometrial and cervical cancer. Goal of these Critical Views of Safety is to help standardize the evaluation of surgical quality, improve the precision of sentinel lymph node identification, and lead to better patient outcomes. This international multi-center observational prospective study was conducted from April to September 2024. Surgical videos from patients with cervical and endometrial carcinoma undergoing minimally invasive sentinel lymph node dissection were collected. A total of 3 Critical Views of Safety criteria (lateral pararectal space, lateral paravesical space, internal iliac artery) were proposed based on the anatomical structures defined as mandatory to be identified before sentinel node dissection, according to previously published expert consensus. A total of 3 independent surgeons, blinded to each other's assessments, evaluated whether the proposed criteria were identifiable in the endoscopic surgical video to establish applicability (content validity) and inter-rater agreement (reliability). A total of 80 patients were enrolled, of these, 71 cases (88.8%) had videos suitable for annotation, 64 (90.1%) underwent sentinel lymph node dissection for endometrial cancer, and 7 (9.9%) for cervical cancer; the median age was 52 years (IQR 34-71) and median body mass index was 28.8 kg/m The low assessment rate of the internal iliac artery criteria should raise concerns about missing sentinel lymph nodes in the internal iliac and pre-sacral area. The assessment of such standardized safety criteria could potentially standardize the procedures, thereby improving adherence to guidelines. The introduction of the video assessment of these criteria lays the foundation for exploring the feasibility of artificial intelligence algorithms to automatically assess and document the Critical Views of Safety in surgical videos.

Evaluation of the one-step nucleic acid amplification method for rapid detection of lymph node metastases in endometrial cancer: prospective, multicenter, comparative study

To evaluate the diagnostic performance of the one-step nucleic acid amplification (OSNA) method for the detection of sentinel lymph node (SLN) metastases in women with apparent early-stage endometrial cancer compared with standard ultrastaging. Prospective, multicentric, interventional study. Patients with apparent early-stage endometrial cancer who underwent primary surgical staging with SLN mapping were included. SLNs were serially sectioned with 2 mm slices perpendicular to the longest axis of the node: the odd slices were submitted to ultrastaging, whereas the even slices were submitted to the OSNA analysis. Diagnostic performance was calculated taking ultrastaging as referral standard. Three-hundred and sixteen patients with 668 SLNs were included. OSNA assay detected 22 (3.3%) positive SLNs, of which 17 (2.5%) were micrometastases and 5 (0.7%) macrometastases, whereas ultrastaging detected 24 (3.6%) positive SLNs, of which 15 (2.2%) were micrometastases and 9 (1.3%) macrometastases (p=0.48). Regarding negative SLNs, OSNA detected 646 (96.7%) negative nodes, including 8 (1.2%) isolated tumor cells, while ultrastaging detected 644 (96.4%) negative nodes with 26 (3.9%) isolated tumor cells. Specificity of OSNA was 98.4% (95% CI 97.5 to 99.4), accuracy was 96.7% (95% CI 95.4 to 98.1), sensitivity was 50% (95% CI 30.0 to 70.0), while negative predictive value was 98.1% (95% CI 97.1 to 99.2). Discordant results were found in 22 SLNs (3.3%) corresponding to 20 patients (6.3%). These were 10 (1.5%) false-positive SLNs (all micrometastases): one (0.1%) of these was a benign epithelial inclusion at ultrastaging. There were 12 (1.8%) false-negative SLNs of OSNA, of which 9 (1.3%) were micrometastases and 3 (0.5%) macrometastases. Overall, 17/668 (2.5%) benign epithelial inclusions were detected at ultrastaging. The OSNA method had high specificity and high accuracy in detecting SLN metastasis in apparent early-stage endometrial cancer. The advantage of the OSNA method could be represented as the possibility to analyze the entire lymph node thus eliminating sampling bias.

Comparison of Different Near-Infrared Technologies to Detect Sentinel Lymph Node in Uterine Cancer: A Prospective Comparative Cohort Study

Objectives: Sentinel lymph node biopsy is considered a crucial step in endometrial cancer staging. Cervical injection has become the most favored technique and indocyanine green has been demonstrated to be more accurate than other tracers. Different near-infrared camera systems are currently being used to detect indocyanine green in sentinel lymph nodes and have been compared in different patients. The present study aimed to determine the number and site of sentinel lymph nodes detected in the same patients with two different near-infrared technologies. Methods: This is a prospective, single-center, observational, non-sponsored study. Patients with presumed uterine-confined endometrial cancer were prospectively enrolled. After cervical injection, two different near-infrared cameras were used to detect sentinel lymph nodes at the same time: Olympus, Tokyo, Japan—considered the standard (SNIR); and Medtronic, Minneapolis, MN, USA with VISION SENSE® which is a new laser near-infrared (LNIR) fluorescence laparoscope. The two cameras were alternatively switched on to detect sentinel lymph nodes in the same patients. Results: Seventy-four consecutive patients were included in the study. Most of the patients were diagnosed with endometrioid histology (62, 83.8%), FIGO stage IA (48, 64.9%), grade 2 (43, 58.1%), and underwent surgery with laparoscopic approach (70, 94.0%). The bilateral detection rate was 56/74 (75.7%) with SNIR and 63/74 (85.1%) with LNIR (p = 0.214). The total number of sentinel lymph nodes identified in the left hemipelvis was 65 and 70 with SNIR and LNIR, respectively; while in the right hemipelvis, there were 74 and 76, respectively. The median number of sentinel lymph nodes identified with SNIR and LNIR was 2 (range, 0–4) and 2 (range, 0–4), respectively (p = 0.370). No difference in site of sentinel lymph node detection was evident between the two technologies (p = 0.994). Twelve patients (16.2%) had sentinel lymph node metastasis: in all cases metastatic sentinel lymph nodes were detected both with Olympus and LNIR. Conclusions: No difference in bilateral detection rate and number or site of sentinel lymph node detection was evident comparing two different technologies of near-infrared camera for ICG detection in endometrial cancer patients. No difference in sentinel lymph node metastases identification was detected between the two technologies.

Assessing the Accuracy of Large Language Models on European Guidelines for Cervical Cancer: An In Silico Benchmarking Study

ABSTRACT Objective Although large language models are increasingly used in clinical and research settings, the validity of the information they provide remains uncertain. This study aimed to evaluate the accuracy, consistency, and reliability of three large language models—ChatGPT 4.0, DeepSeek R1, and Gemini 2.0—in answering cervical cancer‐related questions based on the ESGO/ESTRO/ESP guidelines. Design Prospective, comparative in silico benchmarking study. Setting Fondazione Policlinico Universitario A. Gemelli, Rome, Italy. Population or Sample: Fifty questions derived from the ESGO/ESTRO/ESP (European Society of Gynaecologic Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology) Guidelines for Cervical Cancer. Methods Each question was submitted simultaneously to ChatGPT 4.0, DeepSeek R1, and Gemini 2.0, and re‐entered twice to assess response repeatability. Answers were evaluated for accuracy using a Global Quality Score (GQS) from 1 (poor) to 5 (completely accurate). Consistency (intra‐model response stability) and reliability (alignment with guidelines) were assessed using binary classification. Main Outcome Measures: Median GQS, percentage of GQS 5 responses, consistency between repeated answers, and reliability. Results ChatGPT 4.0 achieved the highest performance, with 42% of responses rated GQS 5, followed by Gemini 2.0 (30%) and DeepSeek R1 (28%). DeepSeek R1 and Gemini 2.0 scored lower in median GQS (3.50) compared to ChatGPT 4.0 (4.00). Response consistency varied significantly, with ChatGPT 4.0 and DeepSeek R1 showing differences from Gemini 2.0 ( p  = 0.034 and p  = 0.044, respectively). No significant difference was observed in reliability ( p  = 0.602). Conclusion All models demonstrated suboptimal accuracy in aligning with clinical guidelines. ChatGPT 4.0 was the most accurate and consistent whereas DeepSeek R1 underperformed. Despite similar reliability across models, expert oversight remains essential to ensure safe clinical application and prevent misinformation.

Diagnostic performance of ultrasound-guided biopsy for detecting recurrent or persistent cervical cancer after chemoradiotherapy: a prospective, single-center study

This study aimed to compare the feasibility, diagnostic accuracy, and sample adequacy of trans-vaginal ultrasound-guided biopsy versus per-vagina biopsy for detecting persistent or recurrent pelvic disease after chemoradiotherapy for locally advanced cervical cancer. Procedure-related pain was also evaluated. This prospective, single-center diagnostic study conducted at Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) from November 2019 to September 2024 included consecutive patients with clinical or radiologic suspicion of persistent or recurrent cervical cancer after chemoradiotherapy. Patients undergoing trans-vaginal ultrasound-guided biopsy and per-vagina biopsy (index tests) were analyzed. Histology from pelvic exenteration or follow-up imaging when surgery was not performed served as the reference standard. Accuracy, sensitivity, and specificity were calculated for each index test and compared using the McNemar test. Feasibility was defined as the rate of successfully performed biopsies and adequacy as the proportion of samples yielding a conclusive histologic diagnosis. Fifty-three patients were included. A total of 44 of 53 patients (83.0%) underwent pelvic exenteration, whereas 9 of 53 (17.0%) underwent imaging follow-up. Ultrasound-guided biopsy was feasible in 52 of 53 cases (98.1%) compared with 40 of 53 cases (75.5%) for per-vagina biopsy. All samples obtained from both techniques were adequate. Ultrasound-guided biopsy showed a sensitivity of 0.84, specificity of 1.00, and accuracy of 0.87. Per-vagina biopsy showed a sensitivity of 0.55, specificity of 0.86, and accuracy of 0.60. Among 39 paired feasible cases, specificity did not differ significantly between the 2 techniques (p = .27); however, ultrasound-guided biopsy showed significantly higher sensitivity and accuracy (p = .022 and p = .021, respectively). Ultrasound-guided biopsy appeared to be a feasible method for histologic confirmation in suspected persistent or recurrent cervical cancer after chemoradiotherapy. It demonstrated superior diagnostic accuracy over per-vagina biopsy and holds potential for routine clinical application. Successful integration into clinical practice requires appropriate clinician training and access to specialized equipment.

Tumour budding in pretreatment cervical biopsies: a prognosticator for personalised therapy in the era of precision oncology

Aims Tumour budding (TB) is a noteworthy morphologic indicator for tumour microenvironment (TME) especially because it is detectable with routine haematoxylin and eosin (H&amp;E) staining. Its prognostic relevance has been demonstrated across various cancers, but its significance in pretreatment biopsy specimens of cervical cancer is unknown. This is the first study to investigate the prognostic value of TB in pretreatment cervical biopsy. Additional TME features identifiable with H&amp;E such as cell nest size (CNS) were evaluated. Methods and results A retrospective review was conducted on the 2018 International Federation of Gynaecology and Obstetrics (FIGO) stage IIVA cervical cancer patients ( N  = 182) who had completed standard treatment. In multivariate analysis, TB (hazard ratio [HR], 2.06) and CNS (HR, 2.16) independently predicted overall survival. While TB (AUC, 0.7065) slightly outperformed CNS (AUC, 0.6975) in discriminating overall survival, the combination of TB and CNS demonstrated the highest performance (AUC, 0.7192) in time‐dependent receiver operating characteristic analysis. Conclusions This study is the first to suggest TB in pretreatment biopsy specimens as a reliable morphologic prognosticator in cervical cancer. TME features may enhance precision oncology by offering insights into the individual tumour biology. The fact that these morphologic features are available from routine H&amp;E slides, reserving immunohistochemistry or molecular analysis for indeterminate cases, is of particular value in low‐resource settings where the burden of cervical cancer is most significant.

In-transit metastatic lymph nodes in cervical cancer: A new staging and therapeutic concept

It has been reported that metastatic lymph nodes can be present in the parauterine lymphovascular (PULT) and in lateral paracervical lymphatic tissue as in-transit disease in patients with cervical cancer. This study aimed to clarify the understanding of in-transit positive lymph nodes in PULT and lateral paracervix and its clinical management in patients with cervical cancer, based on insights gathered from an international expert survey. A 29-question survey was emailed to experts identified through a systematic literature search related to sentinel lymph nodes in gynecological cancer. The survey was divided into four sections: 1. Resection of parauterine lymphovascular tissue; 2. Discontinuous lymphatic paracervical involvement; 3. Positive para-uterine or paracervical nodes in fertility-sparing surgery; 4. The impact of positive in-transit nodes on the extent of nodal staging. Consensus was defined as an agreement among at least 70% of the respondents. Responders where only corresponding or last authors of articles addressing sentinel lymph nodes procedures. Results show general agreement on referring to the areas as "para-uterine lymphovascular tissue (PULT)" (84.85 %), with lymph nodes in these regions considered sentinel nodes if stained with indocyanine green (80 %). However, there is no consensus on surgical staging for isolated positive lymph nodes. Most respondents favour adjuvant treatment for in-transit macro or micrometastases (>95 %) but acknowledge the lack of conclusive evidence. In fertility-sparing settings, most would remove PULT while preserving uterine arteries (59 %) and would remove lateral paracervical tissue in low-risk cases (66.7 %). For isolated metastasis, most would recommend chemoradiation over fertility-sparing options (81.8 %). Finally, if a positive in-transit node is found, experts would request additional imaging (80.3 %), though there is no consensus on aortic lymphatic dissection or extended-field radiation without prior aortic staging. The survey highlights expert awareness of the clinical importance of in-transit positive lymph nodes. However, it is essential for the international societies to urgently address the impact of these nodes on staging and treatment guidelines, as current recommendations and evidence are lacking.

Minimally invasive simple hysterectomy in low-risk cervical cancer: a single-arm trial with stopping rules (ENGOT-cx23/MITO/LASH trial)

The oncologic safety of minimally invasive simple hysterectomy in low-risk cervical cancer has not been explored by an adequately powered clinical trial. This study aims to evaluate whether minimally invasive simple hysterectomy affects disease-free survival in low-risk early-stage cervical cancer. Minimally invasive simple hysterectomy represents an oncologically safe approach in selected patients with low-risk cervical cancer. This is a single-arm trial with stopping rules. All patients must undergo cervical conization. Patients with clear conization margins or absence of residual macroscopic disease at imaging after conization (re-conization is mandatory if these criteria are not met) are submitted to minimally invasive (laparoscopy or robot-assisted laparoscopy) simple hysterectomy with sentinel lymph node biopsy algorithm. Adjuvant therapy is given in case of tumor-involved surgical margins, and/or metastatic lymph nodes, and/or substantial lymphovascular space invasion with depth of stromal infiltration >2/3 (or tumor-free distance ≤3 mm). The major inclusion criteria are: squamous cell carcinoma, human papillomavirus-related adenocarcinoma, adenosquamous carcinoma of the uterine cervix; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (≤2 cm) with depth of infiltration ≤10 mm on conization specimen; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (≤2 cm) with depth of infiltration ≤50% at pre-conization magnetic resonance imaging scan or "expert" ultrasound scan. Women are not eligible if they have evidence of metastatic disease, contra-indications to surgery and/or lymph node assessment, or fertility sparing desire. The primary end point is 3-year disease-free survival of patients who undergo minimally invasive simple hysterectomy. A sample size of 974 patients will give a power of 80% at a significance level of 2.5% (1-sided) to reject the null hypothesis of a 3-year recurrence rate of 2.4%, assuming a 3-year recurrence rate of 1.2%. A maximum of 14 recurrences at 3 years should be observed to reject the null hypothesis. A stopping rule based on the number of recurrences observed at different timepoints will be implemented to avoid a higher recurrence rate with the study procedure. The trial will also be stopped if no recurrences are observed in the first 400 patients followed up for 2 years. The enrolment will last 60 months. After the surgery, the follow-up time will be ≥3 years. The trial is registered at ClinicalTrials.gov (NCT06416748) and as ENGOT/MITO trial (ENGOT-cx23).

Factors associated with bilateral sentinel lymph node mapping failure using indocyanine green in patients with apparent early-stage cervical cancer: An Italian retrospective multi-center study

The primary aim of this study was to assess the factors associated with bilateral mapping failure in patients with apparent early-stage cervical cancer undergoing sentinel lymph node (SLN) biopsy using indocyanine green (ICG). Secondary aims were sensitivity, negative predictive value and lymph node recurrence. Retrospective multi-center study. Patients with cervical cancer apparent FIGO stage IA1 to IIA2, treated with primary surgery between 04/2015 and 12/2023 and undergoing SLN mapping attempt with ICG injection, were included. Appropriate statistical analysis was performed to assess study endpoints. Timeframe was divided in first period 04/2015-12/2019 and second period 01/2020-12/2023. 618 patients were included. Bilateral SLN mapping was achieved in 531 (85.9 %) women (36 of them, 5.8 %, underwent cervical re-injection of ICG). SLN unilateral mapping and mapping failure was observed in 71 (11.5 %) and 16 (2.6 %), respectively. The sensitivity, negative predictive value and accuracy were 85.9 %, 98.1 % and 98.3 %, respectively. False negative rate was 4/68 (5.9 %) in patients with unilateral mapping versus 6/316 (1.9 %) in those with bilateral mapping (p = 0.061). BMI>30 (p = 0.001) and pathologic tumor diameter >20 mm (p = 0.023) were the only factors independently associated with bilateral SLN mapping failure. ICG re-injection increased the rate of bilateral SLN detection from 81.3 % to 85.9 %. The rate of bilateral detection was 82.8 % versus 88.3 % in the first versus second study period, respectively (p = 0.061). 3-year DFS and OS in all patients were 89.7 % and 98.2 %, respectively. Seven patients (1.2 %) had lymph node recurrence in the group of any SLN mapping versus 1 (6.3 %) in no mapping group (p = 0.190). High BMI and larger tumors were associated with bilateral SLN mapping failure using ICG. The ICG cervical re-injection increased the rate of bilateral mapping. No lymph node recurrence difference was found in patients undergoing SLN mapping versus patients with mapping failure.

Image-Guided Robotic Surgery for Sentinel Lymph Node Status Assessment in Uterine Cancers Using Ultrasound Drop-in Probe: Surgical Technique in 10 Steps

Abstract Introduction Recent guidelines recommend the sentinel lymph node (SLN) technique in uterine cancers, as it is associated with lower perioperative complications.1 Image-guided surgery can address some limitations of SLN procedures, such as low frozen-section accuracy and risk of empty packets,2–4 by providing real-time lymph node assessment.5,6 This video describes the surgical procedure of intraoperative robotic ultrasound examination for SLN assessment. Materials and Methods The Arietta L43K (2–12 MHz, Hitachi, Japan) drop-in robotic ultrasound probe was used to assist with SLN dissection. The procedure was performed on the da Vinci Xi platform. The probe, introduced through an accessory trocar, was manipulated by robotic instruments, providing real-time ultrasound imaging in split-view mode on the surgeon’s console. Ultrasound images, captured by the surgeon under the guidance of an experienced ultrasound examiner, were analyzed both in vivo and ex vivo.7 Results The procedure involves ten steps, detailed as follows. (1) The procedure begins with the cervical injection of indocyanine green. (2) The pelvic retroperitoneum is opened to allow access to anatomical landmarks. (3) Using near-infrared imaging mode, the lymphatic pathways are highlighted, allowing for the identification of the SLN. (4) Once identified, the drop-in ultrasound probe is introduced. (5) The console is switched to split-view mode, enabling the surgeon to observe ultrasound images alongside the endoscopic view. (6) In vivo imaging is conducted. (7) Both images and videos of the lymph node are captured. (8) The SLN is subsequently dissected. (9) SLN specimens are safely extracted. (10) Ex vivo ultrasound assessment is performed to further evaluate their characteristics. Conclusions Although its accuracy compared with histology as the gold standard is yet to be demonstrated, image-guided robotic lymph node ultrasound is a feasible and promising procedure for real-time SLN assessment. A prospective study is ongoing (R-LYNUS, NCT06621823) to clinically validate this technique.

Prophylactic HPV vaccination in HPV‐related gynecologic cancers: European Society of Gynecological Oncology (ESGO) prevention committee opinion

AbstractMany clinicians recommend that patients diagnosed with HPV‐related gynecologic cancers receive prophylactic HPV vaccination at the time of cancer diagnosis or after cancer treatment. In view of the large use of such practice, we aimed to assess the literature evidence supporting the use of prophylactic HPV vaccines after diagnosis or treatment of HPV‐related gynecologic cancers. Women who develop HPV‐related cervical, vaginal, and vulvar cancers represent a subgroup of patients who may be particularly sensitive to HPV infection and re‐acquire infections. The rationale that the use of prophylactic HPV vaccination at the time or after treatment for cervical, vaginal, and vulvar cancers might reduce the risk of future HPV‐related diseases might be explained by the data coming from the use of HPV vaccination after treatment of pre‐invasive disease; however, the evidence on the use of HPV vaccination in the setting of HPV‐related gynecologic cancers is currently absent. In this context, observational and experimental studies document an important drop in effectiveness of HPV vaccination by age. Physicians should be aware of catch‐up programs in their countries and should be ready to counsel patients about prophylactic HPV vaccine efficacy according to their age. In general, no evidence exists supporting the use of prophylactic HPV vaccine in patients diagnosed with HPV‐related gynecologic cancers; therefore, the European Society of Gynecological Oncology (ESGO) prevention committee opinion is to counsel these patients as any HPV‐related non‐gynecologic cancer (such as anal or oropharyngeal cancer) and non‐cancer patient, suggesting vaccination according to patient's age and prognosis, knowing there is a decrease of efficacy with increasing age. Studies on the use of prophylactic HPV vaccine in patients diagnosed with HPV‐related gynecologic cancers are strongly needed.

The role of diagnostic laparoscopy in locally advanced cervical cancer staging

Peritoneal involvement may be overlooked in patients with locally advanced cervical cancer (LACC). This may lead to underestimation of prognosis and to undertreatment limited to locoregional disease locations. However, staging laparoscopy in LACC is not routinely performed. The primary aim of this study was to determine the proportion of peritoneal metastasis by laparoscopy and the factors associated with peritoneal metastasis in patients with LACC. Secondary aims were to evaluate the performance of staging imaging in detecting peritoneal disease and the prognosis of patients with peritoneal metastasis. Retrospective single-institution study including consecutive patients with newly diagnosed LACC (FIGO 2018 stage IB3 and IIA2-IVA) between 06/2015 and 06/2020. All women underwent PET/CT scan, MRI scan and diagnostic laparoscopy at the time of examination under anesthesia (EUA), as part of cervical cancer staging. Peritoneal metastasis was histologically confirmed in all cases. 251 patients were included. 33 (13.2 %) had peritoneal metastasis. The treatment plan was changed for 28/33 (84.8 %) patients with peritoneal metastasis (11.1 % of the entire LACC cohort). Multivariate analysis demonstrated that grade 3 (OR:1.572, 95%CI:1.021-2.419; p = 0.040) and AJCC stage T3-4 (OR:3.435, 95%CI:1.482-7.960; p = 0.004) were variables associated with increased risk of peritoneal metastasis. Sensitivity of PET/CT-scan and MRI-scan in detecting peritoneal metastasis was 4.5 % (95%CI:0.1-22.8) and 13.8 % (95%CI:3.9-31.7), respectively. Peritoneal metastasis was independently associated with worse PFS and OS (HR:3.008, 95%CI:1.779-5.087, p < 0.001 and HR:4.078, 95%CI:2.232-7.451; p < 0.001, respectively). LACC patients with grade 3 histology and/or AJCC stage T3-4 had high-risk of peritoneal metastasis and diagnostic laparoscopy might be considered as part of cervical cancer staging in these patients. Peritoneal metastasis was an independent factor associated with worse PFS and OS.

Survival associated with the use of one-step nucleic acid amplification (OSNA) to detect sentinel lymph node metastasis in cervical cancer

Sentinel lymph node (SLN) biopsy is part of surgical treatment of apparent early-stage cervical cancer. SLN is routinely analyzed by ultrastaging and immunohistochemistry. The aim of this study was to assess the survival of patients undergoing SLN analyzed by one-step nucleic acid amplification (OSNA) compared with ultrastaging. Single-center, retrospective, cohort study. Patients undergoing primary surgery and SLN mapping ( ±pelvic lymphadenectomy) for apparent early-stage cervical cancer between May 2017 and January 2021 were included. SLN was analyzed exclusively with OSNA or with ultrastaging. Patients with bilateral SLN mapping failure, with SLN analyzed alternatively/serially with OSNA and ultrastaging, and undergoing neo-adjuvant therapy were excluded. Baseline clinic-pathological differences between the two groups were balanced with propensity-match analysis. One-hundred and fifty-seven patients were included, 50 (31.8%) in the OSNA group and 107 (68.2%) in the ultrastaging group. Median follow up time was 41 months (95%CI:37.9-42.2). 5-year DFS in patients undergoing OSNA versus ultrastaging was 87.0% versus 91.0% (p = 0.809) and 5-year overall survival was 97.9% versus 98.6% (p = 0.631), respectively. No difference in the incidence of lymph node recurrence between the two groups was noted (OSNA 20.0% versus ultrastaging 18.2%, p = 0.931). In the group of negative SLN, no 5-year DFS difference was noted between the two groups (p = 0.692). No 5-year DFS and OS difference was noted after propensity-match analysis (87.6% versus 87.0%, p = 0.726 and 97.4% versus 97.9%, p = 0.998, respectively). The use of OSNA as method to exclusively process SLN in cervical cancer was not associated with worse DFS compared to ultrastaging. Incidence of lymph node recurrence in the two groups was not different.

External beam radiotherapy boost versus surgical debulking followed by radiotherapy for the treatment of metastatic lymph nodes in cervical cancer: A systematic review and meta-analysis

We aimed to assess disease-free survival (DFS), overall survival (OS) and treatment-related toxicity of two therapeutic strategies for treating bulky lymph nodes on imaging in patients with locally advanced cervical cancer (LACC): radiotherapy boost versus surgical debulking followed by radiotherapy. We performed a systematic review of studies published up to October 2023. We selected studies including patients with LACC treated by external beam radiotherapy (EBRT) boost or lymph node debulking followed by EBRT (with or without boost). We included two comparative (included in the meta-analysis) and nine non-comparative studies. The estimated 3-year recurrence rate was 28.2% (95%CI:18.3-38.0) in the EBRT group and 39.9% (95%CI:22.1-57.6) in the surgical debulking plus EBRT group. The estimated 3-year DFS was 71.8% and 60.1%, respectively (p = 0.19). The estimated 3-year death rate was 22.2% (95%CI:11.2-33.2) in the EBRT boost group and 31.9% (95%CI:23.3-40.5) in the surgical debulking plus EBRT group. The estimated 3-year OS was 77.8% and 68.1%, respectively (p = 0.04). No difference in lymph node recurrence between the two comparative studies (p = 0.36). The meta-analysis of the two comparative studies showed no DFS difference (p = 0.13) but better OS in the radiotherapy boost group (p = 0.006). The incidence of grade≥3 toxicities (ranging 0-50%) was not different between the two approaches in the two comparative studies (p = 0.31). No DFS and toxicity difference when comparing EBRT boost with surgical debulking of enlarged lymph nodes and EBRT in patients with cervical cancer was evident. Radiotherapy boost had better OS. Further investigation is required to better understand the prognostic role of surgical lymph node debulking in light of radiotherapy developments.

Post-operative pancreatic fistula following splenectomy with or without distal pancreatectomy at cytoreductive surgery in advanced ovarian cancer

Splenectomy with or without distal pancreatectomy may be necessary at time of cytoreductive surgery to achieve complete cytoreduction in advanced ovarian cancer. However, these procedures have been associated with peri-operative morbidity. The aims of this study were to determine the incidence of distal pancreatectomy among patients undergoing splenectomy during cytoreductive surgery for advanced ovarian cancer and to determine the incidence, management, treatment, and prognosis of patients with post-operative pancreatic fistula. Retrospective cohort study of all consecutive patients with FIGO stage IIIC-IVB ovarian, fallopian tube, or primary peritoneal cancer who underwent splenectomy with or without distal pancreatectomy, during primary, interval, or secondary cytoreductive surgery between January 2007 and December 2017. All histologic subtypes were included; patients with borderline ovarian tumor and those undergoing emergency surgery were excluded from analysis. Univariate analyses for survival were generated by Kaplan-Meier survival curves and log-rank (Mantel-Cox) tests for statistical significance. Patients who underwent surgery for recurrence were excluded from survival analysis. Inter-group statistics were performed using Student's t-test for continuous variables, and chi-square test and Fisher's exact test for categorical variables. A total of 156/804 (19.4%) women underwent splenectomy, and of these 22 (14.1%) patients had distal pancreatectomy. Of patients who underwent splenectomy only, 2/134 (1.5%) developed grade B post-operative pancreatic fistula and 6/22 (27.3%) patients who underwent distal pancreatectomy developed grade B and C post-operative pancreatic fistula. Five (83.3%) of six of these patients were symptomatic. Distal pancreatectomy patients had a higher risk of developing post-operative pancreatic fistula when compared with patients who underwent splenectomy only (63.7% vs 9.7%, p=0.0001). Median length of hospital stay was longer in patients with post-operative pancreatic fistula: 16.5 (range 7-38) days compared with 10 (range 7-15) days (p=0.019). There was no progression-free survival (p=0.42) and disease-specific survival (p=0.33) difference between patients undergoing splenectomy with or without distal pancreatectomy. Clinically relevant post-operative pancreatic fistula is a relatively frequent complication (27.3%) following distal pancreatectomy and it is a possible complication after splenectomy only (1.5%).

The prognostic role of systemic inflammatory markers in apparent early-stage ovarian cancer

Abstract Background Few studies analyzed the prognostic role of systemic inflammatory markers in early-stage ovarian cancer. The primary endpoint of the present study was to assess the prognostic impact of baseline inflammatory markers in early-stage ovarian cancer. The secondary endpoints were to compare the disease-free survival (DFS) of inflammatory markers with standard risk factors and to correlate these with BRCA mutational status. Methods Retrospective, single-center, observational study. Patients with FIGO-stage I–II and IIIA1 epithelial ovarian cancer undergoing primary surgery between 10/2012 and 12/2019 were included. Inflammatory markers were evaluated on the results of the complete blood count and coagulation tests, performed before ovarian cancer surgery. The Receiver Operating Characteristic curve was used to determine the optimal cut-off value of different baseline inflammatory biomarkers for the DFS analysis. Results Three hundred fifty-nine patients were included in the study period. Baseline neutrophil–lymphocyte ratio (NLR) ≥ 3 and systemic immune inflammation index (SII, defined as platelet x neutrophil–lymphocyte ratio) ≥ 1000 were associated with worse 3 year DFS and baseline SII ≥ 1000 was associated with worse 3 year OS. BRCA-mutated patients with SII ≥ 1000 and with NLR ≥ 3 had significantly worse DFS compared to SII &lt; 1000 and with NLR &lt; 3. FIGO stage &gt; I was the only independent risk factor for higher risk of recurrence. Conclusion SII ≥ 1000 and NLR ≥ 3 were associated with worse 3 year DFS and SII ≥ 1000 was associated with worse 3 year OS. The subgroups of BRCA-mutated patients with higher inflammation markers (SII ≥ 1000 and NLR ≥ 3) were associated with worse DFS. These findings might be helpful to design personalized treatment and more intensive surveillance.

Patient outcomes following interval and delayed cytoreductive surgery in advanced ovarian cancer: protocol for a multicenter, international, cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative)

The Global Gynecological Oncology Surgical Outcomes Collaborative (GO SOAR) has developed a network of gynecological oncology surgeons, surgical departments, and other interested parties that have the long-term ability to collaborate on outcome studies. Presented is the protocol for the GO SOAR2 study. To compare survival following interval and delayed cytoreductive surgery, between delayed cytoreductive surgery and no surgery (chemotherapy alone); and international variations in access to cytoreductive surgery for women with stage III-IV epithelial ovarian cancer. There is no difference in survival following interval and delayed cytoreductive surgery; there is poorer survival with no surgery compared with delayed cytoreductive surgery; and there are international disparities in prevalent practice and access to cytoreductive surgery in women with stage III-IV epithelial ovarian cancer. International, multicenter, mixed-methods cohort study. Participating centers, will review medical charts/electronic records of patients who had been consecutively diagnosed with stage III-IV ovarian cancer between January 1, 2006 and December 31, 2021. Qualitative interviews will be conducted to identify factors determining international variations in prevalent practice and access to cytoreductive surgery. Inclusion criteria include women with stage III-IV epithelial ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (≥5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (≥5 cycles of chemotherapy alone). Overall survival (defined from date of diagnosis to date of death); progression-free survival (defined from date of diagnosis to date of first recurrence); facilitator/barriers to prevalent practice and access to cytoreductive surgery. In order to determine whether there is a difference in survival following interval and delayed cytoreductive surgery and no surgery, data will be abstracted from 1000 patients. It is estimated that recruitment will be completed by 2023, and results published by 2024. NCT05523804.

Risk of ovarian recurrence after ovarian conservation in early-stage cervical cancer treated with radical surgery: A propensity match analysis

The primary aim of the present study was to assess the incidence of ovarian metastasis/recurrence and the survival of patients undergoing radical hysterectomy with ovarian conservation (CONSERV) versus oophorectomy (OOPHOR). Secondary aim was to assess the incidence and the characteristics of menopausal symptoms in both groups. Retrospective, multi-center, observational cohort study including patients <50 years with clinical FIGO 2009 stage IA1-IB1/IIA1 cervical carcinoma, treated by primary surgical treatment between 02/2007 and 07/2019. One-to-one case-control matching was used to adjust the baseline prognostic characteristics in survival analysis. 419 patients were included. 264 in the OOPHOR (63.0%) and 155 (37.0%) in the CONSERV group. Ovarian transposition was performed in 28/155 (18.1%) patients. 1/264 (0.4%) patient had ovarian metastasis from endocervical adenocarcinoma. After propensity-matching, 310 patients were included in the survival analysis (155 per group). 5-year disease-free survival of patients undergoing CONSERV versus OOPHOR was 90.6% versus 82.2%, respectively (p = 0.028); 5-year overall survival was 94.3% versus 90.8%, respectively (p = 0.157). Two patients (1.3%) developed recurrence on the conserved ovary. CONSERV represented an independent protective factor of recurrence (HR:0.361, 95%CI 0.169-0.769; p = 0.008). 28 (20.6%) in the CONSERV group versus 116 (60.4%) in the OOPHOR group complained of menopausal symptoms during follow up (p < 0.001). HRT was prescribed to 12.0% of patients (median HRT time was 20 months). CONSERV was associated with reduced risk of recurrence and menopausal symptoms in early-stage cervical cancer. As the risk of ovarian metastasis and ovarian recurrence is relatively low, CONSERV in pre-menopausal women has to be considered.

Peritoneal HPV‐DNA test in cervical cancer (PIONEER study): A proof of concept

AbstractThe aim of this study was to investigate the prevalence of peritoneal human papillomavirus (HPV) infection in different clinical cervical cancer (CC) settings, and its association with potential clinical and/or histological factors. This is a single‐center, prospective, observational study. Consecutive patients with newly diagnosed or recurrent/persistent CC, between March 2019 and April 2020, were included. A group of patients undergoing surgery for benign gynecological conditions was included as control group. All patients underwent HPV‐DNA test in the cervix and in the peritoneal cavity simultaneously at time of surgery. Two‐hundred seventy‐two patients had cervical and peritoneal HPV test analyzed. Cervical and peritoneal HPV positivity (PHP) was found in 235 (88.0%) and 78 (28.7%) patients, respectively; the prevalence of PHP was 17.7% in early stage, 28.8% in locally advanced cervical cancer (LACC) and 46.6% in the metastatic/persistent/recurrent setting (P = .001). No control patient was found to have peritoneal HPV infection. Higher frequency of PHP was documented in patients with larger tumor size (P = .003), presence of cervical HPV 16/18 genotypes (P &lt; .001), higher number of cervical high‐risk (HR)‐HPV per patient (P = .018) and peritoneal carcinomatosis (P &lt; .001). Multivariate analysis demonstrated that lack of preoperative cervical conization in early stages (P = .030), while higher International Federation of Gynecology and Obstetrics (FIGO) stage (P = .021) and presence of cervical HPV 16/18 (P = .001) in LACC, was associated with PHP. This is a proof‐of‐concept study. A number of potential clinical implications, including prognosis, could be obtained by further studies.

Standard ultrastaging compared to one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node metastases in early stage cervical cancer

We compared ultrastaging and one-step nucleic acid amplification (OSNA) examination of sentinel lymph nodes in two homogeneous patient populations diagnosed with early stage cervical cancer. The primary aim of our study was to evaluate the rate and type of sentinel lymph node metastases detected by ultrastaging and OSNA assay. Secondary aims were to define the sensitivity and the negative predictive value of sentinel lymph node biopsy assessed with OSNA and ultrastaging and to define the role of sentinel lymph node assessment in predicting non-sentinel lymph node status. Consecutive patients who underwent surgery (radical hysterectomy or trachelectomy or cervical conization) at our institution, between January 2018 and March 2020, were enrolled. All patients had a preoperative diagnosis of early-stage cervical carcinoma (International Federation of Gynecology and Obstetrics (FIGO) 2018 stages IA-IIB) and underwent sentinel lymph node assessment with ultrastaging or OSNA. Patients with advanced FIGO stages and special histology subtypes (other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma) or patients with sentinel lymph nodes analyzed only with hematoxylin and eosin were excluded. Clinical data were compared using the χ A total of 116 patients were included in this retrospective analysis (53 ultrastaging, 63 OSNA). Overall, 531 and 605 lymph nodes were removed in the ultrastaging and OSNA groups, respectively, and 140 and 129 sentinel lymph nodes were analyzed in the ultrastaging and OSNA groups, respectively. 22 patients had metastatic sentinel lymph nodes: 6 (11.3%) of 53 patients in the ultrastaging group and 16 (25.4%) of 63 patients in the OSNA group. The total amount of positive SLNs was 7 (5%) of 140 in the ultrastaging group and 21 (16.3%) of 129 in the OSNA group, respectively (p=0.0047). Pelvic lymphadenectomy was performed in 26 (49.1%) of 53 patients in the ultrastaging group and in 34 (54%) of 63 patients in the OSNA group due to comorbidities. Metastatic non-sentinel lymph nodes were found in 4 patients: 2 (7.7%) of 26 patients in the ultrastaging group and 2 (5.9%) of 34 patients in the OSNA group, respectively. The total amount of positive pelvic lymph nodes was 3 (0.6%) of 531 in the ultrastaging group and 4 (0.7%) of 605 in the OSNA group (p=0.61). In the OSNA group, only 2 patients with negative sentinel lymph nodes had metastatic disease in the pelvic lymph nodes. By contrast, no patients with OSNA-positive sentinel lymph nodes had metastases in the pelvic lymph nodes. In the ultrastaging group, all patients with negative sentinel lymph nodes did not have metastatic disease in other pelvic lymph nodes. OSNA assessment of sentinel lymph nodes was associated with a negative predictive value of 91% but poor reliability in detecting node metastases in non-sentinel pelvic lymph nodes. Of note, the ultrastaging protocol revealed higher sensitivity and more reliability in predicting pelvic non-sentinel lymph node status.

Investigating the possible impact of peritoneal tumor exposure amongst women with early stage cervical cancer treated with minimally invasive approach

Recent findings show a detrimental impact of the minimally invasive approach on patients with early stage cervical cancer (ECC). Reasons beyond these results are unclear. The aim of the present article is to investigate the possible role of peritoneal contamination during intracorporeal colpotomy. patients with early stage cervical cancer were divided into 2 groups: no intraperitoneal exposure (N-IPE) intraperitoneal exposure (IPE) during minimally invasive surgery. Patients of the 2 groups were propensity-matched according to the major risk factors. 226 cases of the IPE group had a significant worst prognosis than the 142 cases of the N-IPE group (4.5-years disease free survival: 86.6% vs 95.9% respectively, p = 0.005), while N-IPE had similar survival to open surgery (4.5-years disease free survival: 95.0% vs 90.5% respectively, p = 0.164). Distant recurrence was more frequent among IPE patients with a borderline significance (3.5% vs 0.4% among IPE and N-IPE respectively, p = 0.083). On multivariate analysis, intraperitoneal tumor exposure was an independent prognostic factors for worse survival; patients belonging to the N-IPE group had a risk of recurrence of about 3-fold lower compared to patients of the IPE group (hazard ratio: 0.37, 95% confidence interval: 0.15-0.88, p = 0.025). it would be advisable that further prospective studies investigating the efficacy of different surgical approach in ECC take into consideration of this issue. Moreover, all other measures that could potentially prevent peritoneal exposure of tumor should be adopted during minimally invasive surgery for early stage cervical cancer to provide higher survival outcomes.

Sentinel lymph node mapping with indocyanine green in cervical cancer patients undergoing open radical hysterectomy: a single-institution series

Abstract Purpose To assess the rate of bilateral sentinel lymph node (SLN) detection with indocyanine green (ICG), to evaluate the sensitivity and the negative predictive value of cervical cancer patients undergoing open radical hysterectomy; to compare open versus minimally invasive SLN biopsy performance and to assess factors related to no/unilateral SLN mapping. Methods We retrospectively reviewed consecutive patients with FIGO 2018 stage IA1 with lymph-vascular space involvement to IIB and IIIC1p cervical carcinoma who underwent SLN mapping with ICG followed by systematic pelvic lymphadenectomy between 05/2017 and 06/2020. Patients were divided according to surgical approach for statistical analysis. Results Eighty-five patients met inclusion criteria. Twenty-seven (31.8%) underwent open and 58 (68.2%) underwent minimally invasive SLN mapping. No difference in any SLN mapping (laparotomy 92.6% and minimally invasive 91.4%) or in SLN bilateral detection (laparotomy 72.0% and minimally invasive 84.9%) (p = 0.850 and p = 0.222, respectively), in median number of SLNs mapped and retrieved (2 in both groups, p = 0.165) and in site of SLN mapping per hemi-pelvis (right side, p = 0273 and left side, p = 0.618) was evident between open and minimally invasive approach. Per-patient sensitivity of SLN biopsy in laparotomy was 83.3% (95% CI 35.9–99.6%) and the negative predictive value was 95.0% (95% CI 76.0–99.1%). No difference in per-patient sensitivity was noted between two approaches (p = 0.300). None of the analyzed variables was associated with no/unilateral SLN mapping. Conclusion The use of ICG to detect SLN in cervical cancer treated with open surgery allows a bilateral detection, sensitivity and negative predictive value comparable to minimally invasive surgery with potential advantages of ICG compared to other tracers.

How to Perform Bilateral Sentinel Lymph Node Biopsy in Vulvar Cancer with Indocyanine Green by Video-Endoscopic Approach

Abstract Background The standard surgical treatment of early stage vulvar carcinoma  &lt; 4 cm consists of resection of the vulvar tumor with sentinel lymph node (SLN) biopsy (Oonk in Int J Gynecol Cancer 33:1023–1043, 2023). Video-endoscopic inguinal SLN biopsy with indocyanine green (ICG) has been described (Capomacchia et al. in Int J Gynecol Cancer, 2024). However, ICG induces fleeting mapping of lymphatic pathways, making bilateral SLN mapping more challenging. The aim of this video is to show how to perform bilateral inguinal SLN biopsy with ICG by video-endoscopic approach. Patients and Methods We present the case of an 81-year-old patient with a 3.8 cm midline vulvar cancer. Bilateral inguinal SLN biopsy was performed by video-endoscopic approach using ICG along with radioactive tracer. The surgery was performed in a tertiary cancer center. Results The day before the surgery, radioactive tracer was injected in the peritumoral area. The procedure began with the placement of a 12 mm trocar at the apex of the femoral triangle and two 5 mm trocars in both thighs. The working space was developed, and a blunt dissection was bilaterally performed up to the inguinal ligament. ICG was then injected into the four cardinal points around the tumor. SLNs were bilaterally visualized and then resected. A gamma camera was used to ensure that the ones removed were the correct SLNs. There were no intra- or post-operative complications. Conclusions To minimize the fleeting uptake of ICG, dye injection should be performed after bilateral positioning of the trocars and development of surgical spaces. A double check with a gamma camera is needed as radioactive tracer is still considered the standard approach for SLN biopsy in vulvar cancer.

Predictive factors of surgical complications after pelvic exenteration for gynecological malignancies: a large single-institution experience

To evaluate pre-operative predictors of early (<30 days) severe complications (grade Dindo 3+) in patients with gynecological malignancy submitted to pelvic exenteration (PE). We retrospectively analyzed 129 patients submitted to surgery at Fondazione Policlinico Gemelli between 2010 and 2019. We included patients affected by primary or recurrent/persistent cervical, endometrial, or vulvar/vaginal cancers. Post-operative complications were graded according to the Dindo classification. Logistic regression was used to analyze potential predictors of complications. We performed 63 anterior PE, 10 posterior PE, and 56 total PE. The incidence of early severe post-operative complications was 27.9% (n=36), and the early mortality rate was 2.3% (n=3). More frequent complications were related to the urinary diversion and intestinal surgery. In univariable analysis, hemoglobin ≤10 g/dL (odds ratio [OR]=4.2; 95% confidence interval [CI]=1.65-10.7; p=0.003), low albumin levels (OR=3.9; 95% CI=1.27-12.11; p=0.025), diabetes (OR=4.15; 95% CI=1.22-14.1; p=0.022), 2+ comorbidities at presentation (OR=5.18; 95% CI=1.49-17.93; p=0.012) were predictors of early severe complications. In multivariable analysis, only low hemoglobin and comorbidities at presentation were independent predictors of complications. Pelvic exenteration is an aggressive surgery characterized by a high rate of post-operative complications. Pre-operative assessment of comorbidities and patient health status are crucial to better select the right candidate for this type of surgery.

Oncologic and obstetric outcomes after simple conization for fertility-sparing surgery in FIGO 2018 stage IB1 cervical cancer

Conization/simple trachelectomy is feasible in patients with early-stage cervical cancer. Retrospective data suggest that conization with negative lymph nodes could be a safe option for these patients. This study aims to provide oncologic and obstetric outcomes of a large series of patients with 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IB1 cervical cancer managed by conization. Patients with early cervical cancer and a desire to preserve fertility who underwent conization and pelvic lymphadenectomy from January 1993 to December 2019 in two Italian centers were included. Inclusion criteria were: age >18 years and ≤45 years, 2018 FIGO stage IB1, no prior irradiation or chemotherapy, absence of pre-operative radiologic evidence of nodal metastases, a strong desire to preserve fertility, and absence of concomitant malignancies. We excluded patients with confirmed infertility, neuroendocrine tumor, clear cell or mucinous carcinoma. A total of 42 patients were included. The median age was 32 years (range 19-44) and median tumor size was 11 mm (range 8-20). Squamous cell carcinoma was found in 27 (64.3%). Grade 3 tumor was present in 7 (16.7%) patients and lymphovascular space involvement was detected in 15 (35.7%). At a median follow-up of 54 months (range 1-185), all patients were alive without evidence of disease. In the entire series three patients experienced recurrence resulting in an overall recurrence rate of 7.1%. All the recurrences occurred in the pelvis (2 in the cervix and 1 in the lymph nodes), resulting in a 3-year disease-free survival of 91.6%. Twenty-two (52%) patients tried to conceive; 18 pregnancies occurred in 17 patients and 12 live births were reported (6 pre-term and 6 term pregnancies). Two miscarriages were recorded, one first trimester and one second trimester fetal loss. Our study showed that conization is feasible for the conservative management of women with stage IB1 cervical cancer desiring fertility. Oncologic outcomes appear favorable in this series of patients. Future prospective studies will hopefully provide further insight into this important question.

SUCCOR quality: validation of ESGO quality indicators for surgical treatment of cervical cancer

To evaluate whether compliance with European Society of Gynaecological Oncology (ESGO) surgery quality indicators impacts disease-free survival in patients undergoing radical hysterectomy for cervical cancer. In this retrospective cohort study, 15 ESGO quality indicators were assessed in the SUCCOR database (patients who underwent radical hysterectomy for International Federation of Gynecology and Obstetrics (FIGO) stage 2009 IB1, FIGO 2018 IB1, and IB2 cervical cancer between January 2013 and December 2014), and the final score ranged between 0 and 16 points. Centers with more than 13 points were classified as high-quality indicator compliance centers. We constructed a weighted cohort using inverse probability weighting to adjust for the variables. We compared disease-free survival and overall survival using Cox proportional hazards regression analysis in the weighted cohort. A total of 838 patients were included in the study. The mean number of quality indicators compliance in this cohort was 13.6 (SD 1.45). A total of 479 (57.2%) patients were operated on at high compliance centers and 359 (42.8%) patients at low compliance centers. High compliance centers performed more open surgeries (58.4% vs 36.7%, p<0.01). Women who were operated on at centers with high compliance with quality indicators had a significantly lower risk of relapse (HR=0.39; 95% CI 0.25 to 0.61; p<0.001). The association was reduced, but remained significant, after further adjustment for conization, surgical approach, and use of manipulator surgery (HR=0.48; 95% CI 0.30 to 0.75; p=0.001) and adjustment for adjuvant therapy (HR=0.47; 95% CI 0.30 to 0.74; p=0.001). Risk of death from disease was significantly lower in women operated on at centers with high adherence to quality indicators (HR=0.43; 95% CI 0.19 to 0.97; p=0.041). However, the association was not significant after adjustment for conization, surgical approach, use of manipulator surgery, and adjuvant therapy. Patients with early cervical cancer who underwent radical hysterectomy in centers with high compliance with ESGO quality indicators had a lower risk of recurrence and death.

Laparoscopic Ovarian Transposition with Extraperitonealization of the Infundibulopelvic Ligament for Cervical Cancer in Ten Steps

AbstractPreservation of ovarian function is important for the physical and psychosexual well-being of young patients with cancer. Patients with pelvic malignancies such as cervical or rectal cancer planned for radiotherapy may benefit from ovarian transposition with the aim of moving the ovaries outside the radiation field.1 Different surgical techniques have been reported previously.2,3 With the present video, we aim to standardize the surgical technique of laparoscopic ovarian transposition in ten steps. We present the case of a 30-year-old nulliparous woman diagnosed with grade 3 squamous cell cervical carcinoma having a largest tumor diameter of 41 mm on magnetic resonance imaging (MRI) scan. The tumor was staged as FIGO 2018 stage IIIC1r with a common iliac lymphadenopathy reported on both MRI and positron emission tomography (PET)/computed tomography (CT) scan. The multidisciplinary team recommended exclusive chemoradiation extended to paraaortic area. The patient underwent laparoscopic bilateral salpingectomy and bilateral ovarian transposition with extraperitonealization of the infundibulopelvic ligament. The procedure was divided into the following ten steps: division of uteroovarian ligament, incision of lateral pelvic peritoneum, identification of ureter, incision of medial pelvic peritoneum, skeletonization of the infundibulopelvic ligament, retroperitoneal tunnel in paracolic gutter, creating the window (as high as possible), mobilization of the ovary without torsion, intraperitonealization of the ovary, and fix ovary with clips (Fig. 1). Surgical time was 30 min, with minimal estimated blood loss. No intra- or postoperative complication was recorded. The patient started radiotherapy 14 days after the procedure. In conclusion, we showed that laparoscopic ovarian transposition in cervical cancer before radiotherapy can be standardized in ten steps with encouraging perioperative results, making it an easily reproducible procedure. Ovarian function is reported to be preserved in 62–65% of cases undergoing ovarian transposition and radiation therapy.4,5

Locally advanced cervical carcinoma patients treated with chemoradiation followed by radical surgery: clinical response and oncological outcomes according to histotype after propensity score analysis

The aims of this study were to analyze the pathological response, and survival outcomes of adenocarcinoma/adenosquamous (AC/ASC) versus squamous cell carcinoma (SCC) in patients with locally advanced cervical cancer (LACC) managed by chemoradiotherapy followed by radical surgery. Retrospective, multicenter, observational study, including patients with SCC and AC/ACS LACC patients treated with preoperative CT/RT followed by tailored radical surgery (RS) between 06/2002 and 05/2017. Clinical-pathological characteristics were compared between patients with SCC versus AC/ASC. A 1:3 ratio propensity score (PS) matching was applied to remove the variables imbalance between the two groups. After PS, 320 patients were included, of which 240 (75.0%) in the SCC group, and 80 (25.0%) in the AC/ASC group. Clinico-pathological and surgical baseline characteristics were balanced between the two study groups. Percentage of pathologic complete response was 47.5% in SCC patients versus 22.4% of AC/ASC ones (p < 0.001). With a median follow-up of 51 months (range:1-199), there were 54/240 (22.5%) recurrences in SCC versus 28/80 (35.0%) in AC/ASC patients (p = 0.027). AC/ASC patients experienced worse disease free (DFS), and overall survival (OS) compared to SCC patients (p = 0.019, and p = 0.048, respectively). In multivariate analysis, AC/ACS histotype, and FIGO stage were associated with worse DFS and OS. In LACC patients treated with CT/RT followed by RS, AC/ASC histology was associated with lower pathological complete response to CT/RT, and higher risk of recurrence and death compared with SCC patients. This highlights the need for specific therapeutic strategies based on molecular characterization to identify targets and develop novel treatments.

The potential role of systemic inflammatory markers in predicting recurrence in early-stage cervical cancer

The influence of systemic inflammatory markers on early-stage cervical cancer (ECC) patients is contradictory. No previous study analyzed whether these markers may be suggestive of recurrence. The aim of this study was to assess whether the inflammatory markers level of patients with recurrence during surveillance was different from those of patients without recurrence representing a risk factor for recurrence. Retrospective, single-center, observational study. Patients with 2009 FIGO EEC surgically treated between 2012 and 2019 were included. Baseline inflammatory markers were evaluated on the results of the complete blood count (CBC) and coagulation tests. Inflammatory markers of relapsed patients were evaluated on the last CBC performed before the relapse diagnosis. Inflammatory markers of patients with no recurrence were evaluated on the available CBC taken at the same median follow-up time as the one from relapsed patients. 174 patients were included. Baseline Systemic immune inflammation index (SII) > 663 and Systemic inflammation response index (SIRI) > 0.98 were associated with significant risk of recurrence. SII>663 and Neutrophil to lymphocyte ratio (NLR) > 2.41 were associated with increased risk of death. Significant changes between relapsed (n = 23) and non-relapsed (n = 151) patients in median values of SII (615 versus 490, p-value = 0.001), SIRI (0.74 versus 1.05, p-value = 0.005), NRL (2.95 versus 2.15, p-value = 0.0035), and MLR (0.26 versus 0.22 p-value = 0.020), showed that different levels of inflammatory markers could help identifying recurrent disease during surveillance. Baseline SII>663 and SIRI>0.98 were associated with increased risk of recurrence. Higher median values of SII, SIRI, NLR and MLR in relapsed patients highlight their potential association with recurrence.

Radiomics systematic review in cervical cancer: gynecological oncologists’ perspective

Radiomics is the process of extracting quantitative features from radiological images, and represents a relatively new field in gynecological cancers. Cervical cancer has been the most studied gynecological tumor for what concerns radiomics analysis. The aim of this study was to report on the clinical applications of radiomics combined and/or compared with clinical-pathological variables in patients with cervical cancer. A systematic review of the literature from inception to February 2023 was performed, including studies on cervical cancer analysing a predictive/prognostic radiomics model, which was combined and/or compared with a radiological or a clinical-pathological model. A total of 57 of 334 (17.1%) screened studies met inclusion criteria. The majority of studies used magnetic resonance imaging (MRI), but positron emission tomography (PET)/computed tomography (CT) scan, CT scan, and ultrasound scan also underwent radiomics analysis. In apparent early-stage disease, the majority of studies (16/27, 59.3%) analysed the role of radiomics signature in predicting lymph node metastasis; six (22.2%) investigated the prediction of radiomics to detect lymphovascular space involvement, one (3.7%) investigated depth of stromal infiltration, and one investigated (3.7%) parametrial infiltration. Survival prediction was evaluated both in early-stage and locally advanced settings. No study focused on the application of radiomics in metastatic or recurrent disease. Radiomics signatures were predictive of pathological and oncological outcomes, particularly if combined with clinical variables. These may be integrated in a model using different clinical-pathological and translational characteristics, with the aim to tailor and personalize the treatment of each patient with cervical cancer.

Survival associated with extent of radical hysterectomy in early-stage cervical cancer: a subanalysis of the Surveillance in Cervical CANcer (SCCAN) collaborative study

International guidelines recommend tailoring the radicality of hysterectomy according to the known preoperative tumor characteristics in patients with early-stage cervical cancer. This study aimed to assess whether increased radicality had an effect on 5-year disease-free survival in patients with early-stage cervical cancer undergoing radical hysterectomy. The secondary aims were 5-year overall survival and pattern of recurrence. This was an international, multicenter, retrospective study from the Surveillance in Cervical CANcer (SCCAN) collaborative cohort. Patients with the International Federation of Gynecology and Obstetrics 2009 stage IB1 and IIA1 who underwent open type B/C1/C2 radical hysterectomy according to Querleu-Morrow classification between January 2007 and December 2016, who did not undergo neoadjuvant chemotherapy and who had negative lymph nodes and free surgical margins at final histology, were included. Descriptive statistics and survival analyses were performed. Patients were stratified according to pathologic tumor diameter. Propensity score match analysis was performed to balance baseline characteristics in patients undergoing nerve-sparing and non-nerve-sparing radical hysterectomy. A total of 1257 patients were included. Of note, 883 patients (70.2%) underwent nerve-sparing radical hysterectomy, and 374 patients (29.8%) underwent non-nerve-sparing radical hysterectomy. Baseline differences between the study groups were found for tumor stage and diameter (higher use of non-nerve-sparing radical hysterectomy for tumors >2 cm or with vaginal involvement; P<.0001). The use of adjuvant therapy in patients undergoing nerve-sparing and non-nerve-sparing radical hysterectomy was 27.3% vs 28.6%, respectively (P=.63). Five-year disease-free survival in patients undergoing nerve-sparing vs non-nerve-sparing radical hysterectomy was 90.1% (95% confidence interval, 87.9-92.2) vs 93.8% (95% confidence interval, 91.1-96.5), respectively (P=.047). Non-nerve-sparing radical hysterectomy was independently associated with better disease-free survival at multivariable analysis performed on the entire cohort (hazard ratio, 0.50; 95% confidence interval, 0.31-0.81; P=.004). Furthermore, 5-year overall survival in patients undergoing nerve-sparing vs non-nerve-sparing radical hysterectomy was 95.7% (95% confidence interval, 94.1-97.2) vs non-nerve-sparing 96.5% (95% confidence interval, 94.3-98.7), respectively (P=.78). In patients with a tumor diameter ≤20 mm, 5-year disease-free survival was 94.7% in nerve-sparing radical hysterectomy vs 96.2% in non-nerve-sparing radical hysterectomy (P=.22). In patients with tumors between 21 and 40 mm, 5-year disease-free survival was 90.3% in non-nerve-sparing radical hysterectomy vs 83.1% in nerve-sparing radical hysterectomy (P=.016) (no significant difference in the rate of adjuvant treatment in this subgroup, P=.47). This was confirmed after propensity match score analysis (balancing the 2 study groups). The pattern of recurrence in the propensity-matched population did not demonstrate any difference (P=.70). For tumors ≤20 mm, no survival difference was found with more radical hysterectomy. For tumors between 21 and 40 mm, a more radical hysterectomy was associated with improved 5-year disease-free survival. No difference in the pattern of recurrence according to the extent of radicality was observed. Non-nerve-sparing radical hysterectomy was associated with better 5-year disease-free survival than nerve-sparing radical hysterectomy after propensity score match analysis.

Electronic nose-based volatile organic compound profiling in gynecologic oncology: current evidence and diagnostic accuracy

Volatile organic compounds profiling has emerged as a promising approach for cancer detection. Electronic noses are portable sensor-based devices capable of recognizing volatile organic compound patterns in various biological matrices, offering a rapid, non-invasive, and cost-effective diagnostic alternative. The aim of this systematic review was to evaluate the diagnostic performance of electronic noses in gynecologic oncology and to delineate their technical characteristics. This review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and was registered in International Prospective Register of Systematic Reviews (CRD420251122293). PubMed, Scopus, and Google Scholar were searched up to August 2025. Eligible studies included prospective investigations evaluating volatile organic compound analysis through electronic noses in ovarian, cervical, endometrial, and vulvar cancers, as well as high-grade squamous intraepithelial lesions, using histopathology as the reference standard. Diagnostic performance parameters were extracted, and the risk of bias was assessed with Quality Assessment of Diagnostic Accuracy Studies 2. No meta-analysis was performed due to study heterogeneity. Fifteen studies with a total of 1224 patients were included. Among them, 562 (45.9%) had gynecologic malignancies, and 662 (54.1%) served as controls. Ten studies (66.7%) investigated ovarian cancer, 4 (26.7%) cervical cancer, and 1 (6.7%) high-grade squamous intraepithelial lesions of the cervix; no studies evaluated endometrial or vulvar cancers. Biological matrices analyzed included breath (33.3%), urine (20%), tissue (20%), plasma (6.7%), genitourinary secretions (6.7%), or combined samples (6.7%). Reported diagnostic performance ranged from 71% to 97.7% for sensitivity, from 63% to 100% for specificity, and from 71% to 95% for accuracy across all cancer types. In ovarian cancer studies, sensitivity ranged from 71% to 97.7%, specificity from 63% to 91.4%, and accuracy from 71% to 87%. In cervical cancer studies, sensitivity ranged from 88% to 93%, and specificity from 85% to 100%. Electronic nose technologies show encouraging diagnostic accuracy in gynecologic oncology, particularly for cervical cancer, whereas performance in ovarian cancer remains more variable depending on the biological matrix and comparator group. Despite promising results, the lack of standardized protocols and the heterogeneity of current evidence limit immediate clinical translation. Larger, multicenter, and standardized studies are needed to validate their integration into diagnostic workflows.

Pelvic exenteration for vulvar cancer: contemporary outcomes from a multinational cohort study

Women with vulvar cancer are considerably older than those with other gynaecological malignancies, raising concerns about the tolerability of radical surgery. Yet, for locally advanced or recurrent disease, pelvic exenteration may be the only curative option. Robust evidence to guide decision-making in this population is lacking. This multicentre observational cohort study used data from the COREPEX registry including women who underwent anterior or total pelvic exenteration between 2005 and 2023 across 20 European tertiary referral centres. The primary outcome was overall survival (OS); secondary outcomes were progression-free survival (PFS) and major postoperative complications. Associations were assessed using multivariable Cox and binomial regression models adjusted for relevant covariates. Among 861 women, 79 (9.2%) had vulvar cancer. Median follow-up was 49 months for OS and 40 months for PFS. Women with vulvar cancer were older and more often overweight. Five-year OS was 32% (95% CI, 19-46) in vulvar cancer versus 29% (95% CI, 25-34) in other cancers, adjusted HR 1.05 (95% CI, 0.75-1.46). Five-year PFS was 34% versus 29%, adjusted HR 0.96 (95% CI, 0.69-1.34). Major complications occurred in 33% vs 29%, adjusted RR 1.12 (95% CI, 0.77-1.58). Lymph node metastases, positive margins, and recurrent or persistent disease independently predicted poorer survival. Despite their older age, women with vulvar cancer had survival and morbidity comparable to those with other gynaecological malignancies. These findings support pelvic exenteration as a curative option for selected women with vulvar cancer when complete resection is feasible.

SUCCOR 10 years: a decade's perspective on radical hysterectomy outcomes in cervical cancer.

Interest in long-term outcomes of radical hysterectomy for cervical cancer has increased, especially after the LACC trial findings, which showed worse outcomes for minimally invasive surgery. However, limited information is available on 10-year oncological outcomes, particularly, recurrence and survival. The primary objective of this study was to analyze the 10-year oncological outcomes of patients with International Federation of Gynecology and Obstetrics 2009 stage IB1 cervical cancer treated with radical hysterectomy performed via minimally invasive or open approaches. This retrospective, multi-center, observational study updates the data from the SUCCOR cohort. Patients diagnosed between January 2013 and December 2014 with tumors ≤4 cm without extra-cervical metastasis and treated with radical hysterectomy as the primary treatment were included, and a 10-year follow-up after surgery was successfully conducted. A total of 556 patients were analyzed. The median age was 46 years (range; 18-82). The most common final International Federation of Gynecology and Obstetrics 2009 stage was IB1, 474 patients (85%), and the most common histology was squamous carcinoma, 376 patients (67.6%). The 5-year disease-free survival was 93%, and the 10-year disease-free survival was 90%. The overall survival was 97% at 5 years and 89% at 10 years. During follow-up, 9% (n = 49) of patients experienced recurrences, 78% (n = 38) within the first 5 years. Comparing surgical approaches, 10-year disease-free survival was 92% for minimally invasive surgery and 88% for open surgery (p = .12). Similarly, 10-year overall survival was 92% for minimally invasive surgery and 88% for open surgery (p = .12). Post-recurrence disease-specific survival was 47% at 60 months and 39% at 96 months. The 2-year survival after recurrence was 80% for late recurrences (>5 years) versus 69% for early recurrences. The overall survival after radical hysterectomy at 5-years was 97% in patients with early-stage cervical cancer. The recurrence rate at 10 years was 9%. No differences in 10-year survival were observed between the surgical approaches.

Global survey on training and practice in sentinel lymph node mapping for endometrial and cervical cancer among early-career gynecologic oncologists

This survey was designed to evaluate exposure to sentinel mapping for cervical and endometrial cancers in addition to the quality and availability of surgical training in sentinel procedures around the world. Furthermore, we aimed to identify obstacles in surgical training in the sentinel procedure to support the adoption of this technique in clinical practice. A 52-item survey was developed and computed using Qualtrics XM and SurveyMonkey software. The target population were members of the European Society of Gynaecological Oncology and the International Gynecological Cancer Society aged ≤40 years. The study invitation was disseminated within both organizations' database. The survey hyperlink was active between September and December 2022. Respondents using the same Internet Protocol address were excluded to avoid duplication of responses. Responses to <50% questions were excluded. Overall, 238 respondents joined the survey, and 182 (76.5%) provided answers that met the inclusion criteria. Sentinel mapping was implemented for a longer period and used more frequently in endometrial than in cervical carcinoma; 55% of the responders were initially trained in systematic lymph node dissection, and 22% were not yet trained in any lymph node staging. The main challenges in applying sentinel procedure for early-career gynecologic oncologists were no access to hands-on training (n = 22, 12.1%) and no clinical routine in performing systematic pelvic (n = 15, 8.2%) and para-aortic (n = 35, 19.2%) lymph node dissection in case of failed mapping. Although sentinel lymph node biopsy is integrated in cervical and endometrial cancer guidelines, a significant number of institutions do not implement this procedure in clinical routine, and 22% of early-career gynecologic oncologists are not trained in any type of surgical lymph node staging. Support for sentinel mapping in national guidelines and guided training opportunities are needed to apply this method globally.

Current practice with operative hysteroscopy for fertility preservation in endometrial cancer and endometrial premalignancies

The primary aim was to analyze the current practices on the use of operative hysteroscopy for preserving fertility in patients diagnosed with endometrial cancer and premalignancies. Our secondary objectives included investigating medical therapy and analyzing reported pregnancy-related outcomes subsequent to fertility preservation procedures. We performed a semi-systematic literature review on PubMed, employing pertinent terms related to hysteroscopy, fertility preservation, and endometrial cancer and premalignancies. Patients undergoing operative hysteroscopy with or without following medical treatment were included. We adhered to the PRISMA 2020 statement and utilized Covidence software to manage our systematic review. We performed a pooled analysis on various outcomes. Our final analysis included 15 studies evaluating 458 patients, where 238 (52.0%) were diagnosed with endometrial cancer, and 220 (48.0%) had endometrial premalignancies. With 146 pregnancies in our study, the overall pregnancy rate was 31.9%. Among these, 97 resulted in live births, accounting for 66.4% of the reported pregnancies. In terms of medical treatment, various forms of progestins were reported. Complications or adverse effects related to operative hysteroscopy were not reported in more than half of the studies. Among those studies that did report them, no complications nor adverse effects were documented. After hysteroscopic resection, complete response to medical treatment has been reported in 65.5% of the overall cases. Our review sheds light on the contemporary landscape of operative hysteroscopy for fertility preservation in endometrial cancer and premalignancies. Future studies should include the integration of molecular classification into fertility-preserving management of endometrial malignancies to offer a more personalized and precise strategy.

Consensus on surgical technique for sentinel lymph node dissection in cervical cancer

The purpose of this study was to establish a consensus on the surgical technique for sentinel lymph node (SLN) dissection in cervical cancer. A 26 question survey was emailed to international expert gynecological oncology surgeons. A two-step modified Delphi method was used to establish consensus. After a first round of online survey, the questions were amended and a second round, along with semistructured interviews was performed. Consensus was defined using a 70% cut-off for agreement. Twenty-five of 38 (65.8%) experts responded to the first and second rounds of the online survey. Agreement ≥70% was reached for 13 (50.0%) questions in the first round and for 15 (57.7%) in the final round. Consensus agreement identified 15 recommended, three optional, and five not recommended steps. Experts agreed on the following recommended procedures: use of indocyanine green as a tracer; superficial (with or without deep) injection at 3 and 9 o'clock; injection at the margins of uninvolved mucosa avoiding vaginal fornices; grasping the cervix with forceps only in part of the cervix is free of tumor; use of a minimally invasive approach for SLN biopsy in the case of simple trachelectomy/conization; identification of the ureter, obliterated umbilical artery, and external iliac vessels before SLN excision; commencing the dissection at the level of the uterine artery and continuing laterally; and completing dissection in one hemi-pelvis before proceeding to the contralateral side. Consensus was also reached in recommending against injection at 6 and 12 o'clock, and injection directly into the tumor in cases of the tumor completely replacing the cervix; against removal of nodes through port without protective maneuvers; absence of an ultrastaging protocol; and against modifying tracer concentration at the time of re-injection after mapping failure. Recommended, optional, and not recommended steps of SLN dissection in cervical cancer have been identified based on consensus among international experts. These represent a surgical guide that may be used by surgeons in clinical trials and for quality assurance in routine practice.

Lymph node staging in grade 1–2 endometrioid ovarian carcinoma apparently confined to the ovary: Is it worth?

The aim of this study was to assess the disease-free survival (DFS) and overall survival (OS) of patients with grade 1-2 endometrioid ovarian carcinoma apparently confined to the ovary, according to surgical staging. Multicenter, retrospective, observational cohort study. Patients with endometrioid ovarian carcinoma, surgical procedure performed between May 1985 and December 2019, stage pT1 N0/N1/Nx, grade 1-2 were included. Patients were stratified according to lymphadenectomy (defined as removal of any lymph node versus no lymph node assessment), and subgroup analyses according to tumor grade were performed. Kaplan-Meier curves and cox regression analyses were used to perform survival analyses. 298 patients were included. 199 (66.8 %) patients underwent lymph node assessment. Of these, 166 (83.4 %) had unilateral/bilateral pelvic and para-aortic/caval lymphadenectomy. Eleven (5.5 %) patients of those who underwent lymph node assessment showed pathologic metastatic lymph nodes (FIGO stage IIIA1). Twenty-seven patients (9.1 %) had synchronous endometrioid endometrial cancer. After a median follow up of 45 months (95 %CI:37.5-52.5), 5-year DFS and OS of the entire cohort were 89.8 % and 96.2 %, respectively. Age ≤ 51 years (HR=0.24, 95 %CI:0.06-0.91; p = 0.036) and performance of lymphadenectomy (HR=0.25, 95 %CI: 0.07-0.82; p = 0.022) represented independent protective factors toward risk of death. Patients undergoing lymphadenectomy had better 5-year DFS and OS compared to those not receiving lymphadenectomy, 92.0 % versus 85.6 % (p = 0.016) and 97.7 % versus 92.8 % (p = 0.013), respectively. This result was confirmed after exclusion of node-positive patients. When stratifying according to tumor grade (node-positive excluded), patients with grade 2 who underwent lymphadenectomy had better 5-year DFS and OS than those without lymphadenectomy (93.0 % versus 83.1 %, p = 0.040 % and 96.5 % versus 90.6 %, p = 0.037, respectively). Staging lymphadenectomy in grade 2 endometrioid ovarian carcinoma patients was associated with improved DFS and OS. Grade 1 and grade 2 might be considered as two different entities, which could benefit from different approach in terms of surgical staging. Prospective studies, including molecular profiles are needed to confirm the survival drivers in this rare setting.

Clinical Trials (6)

NCT07508306Faculty of Medicine of Tunis

Patent Blue SLN in Early Ovarian Cancer Prospective Study (FIGO I-II) Evaluating Patent Blue SLN Mapping. Injection Into IP/UO Ligaments in Situ. Goals: Assess Feasibility and Accuracy vs Standard Lymphadenectomy to Minimize Surgical Morbidity

the standard of care in case of early ovarian cancer (stage I or II) is a complete surgery. This surgery includes : hysterectomy (remove of the uterus), bilateral salpingo-oophorectomy (remove of the adnexa), omentectomy (remove of the epiploon), bilateral pelvic lymphadenectomy (remove of pelvic lymph nodes) and para-aortic lymphadenectomy (remove of para-aortic lymph nodes). This procedure is diagnostic, curative and prognostic surgery. In fact, it allows us provider care giver to stratify the stage of the cancer, hence we give the appropriate adjuvant therapy. However, this surgery, especially the extended lymphadenectomy, is associated with some risks: lymphocele, vessel injury, blood loss, morbidity, long recovery period ... In order to reduce these risks, we propose a sentinel lymph node biopsy. This intervention allows us to detect first lymph node relay whether pelvic or para-aortic. In our study, we chose the patent blue dye as a tracer. This tracer is widely used in oncologic surgery (for example in breast cancer) and approved but not in ovarian cancer yet. During surgery for early stage ovarian cancer, we will inject the patent blue dye on both side of the ovarian tumor. Then, we will check for first colorful lymph node, in both pelvic and para-aortic regions. We will send these dissected lymph node to pathology for analysis. Finally, we will continue the procedure as the standard of care. Our objective is to compare the results between the sentinel lymph node and the complete lymphadenectomy and to study the technique of sentinel lymph node biopsy using the blue patent dye as tracer.

134Works
59Papers
204Collaborators
6Trials
Uterine Cervical NeoplasmsNeoplasm StagingPrognosisOvarian NeoplasmsEndometrial NeoplasmsNeoplasm Recurrence, LocalVulvar Neoplasms
Country

IT