Marcin Jedryka

Sentinel SENECA risk factors for unsuccessful bi-lateral sentinel lymph node mapping in endometrial cancer

Our study aims to assess the risk factors associated with bi-lateral sentinel lymph node (SLN) mapping failure in endometrial cancer. The SENECA study was a retrospective multi-center international observational study that reviewed data from 2139 women with clinical stage I-to-II endometrial cancer across 64 centers in 17 countries. Between January 2021 and December 2022, patients underwent surgical treatment with SLN assessment, following the guidelines of the European Society of Gynaecological Oncology. Risk factors associated with the absence of bi-lateral mapping were analyzed using χ Among the 2139 patients, the bi-lateral lymph node detection rate was 82.7%, whereas the unilateral detection rate was 97.3%. In multi-variate analysis, 5 risk factors remained statistically associated with unsuccessful bi-lateral lymph node mapping: high-grade histology (OR 1.35, 95% CI 1.02 to 1.79, p=.03), myometrial invasion >50% (OR 1.37, 95% CI 1.07 to 1.75, p=.012), low-volume surgeon <20 cases/year (OR 2.11, 95% CI 1.55 to 2.89, p<.01), open surgical approach (OR 1.72, 95% CI 1.06 to 2.78 , p=.03), and non-indocyanine green tracer (OR 4.59, 95% CI 2.64 to 7.99, p<.01). The addition of bi-lateral pelvic lymphadenectomy and/or paraaortic lymphadenectomy to SLN biopsy caused an increased rate of intra-operative complications (2% vs 8.4%, p<.01) and all-grade post-operative complications (4.1% vs 11.2%, p<.01). Our study identifies 5 risk factors associated with unsuccessful lymph node mapping in endometrial cancer. Efforts should be made to perform this technique with indocyanine green, through minimally invasive surgery, and performed or supervised by an experienced surgeon with ≥20 endometrial cancer cases per year.

Superparamagnetic Iron Oxide Nanoparticles as a Tracer for Sentinel Lymph Node Mapping in Endometrial Cancer

Sentinel lymph node (SLN) detection has been widely investigated in recent years as a part of the surgical staging of women with endometrial cancer (EC), gradually overtaking lymphadenectomy (LND) in this respect. In this study, thirty EC patients, assumed as stage I, were investigated using superparamagnetic iron oxide (SPIO) as a tracer for SLN detection followed by LND. The endpoints of this research were the proportion of successful SLN detection, the average number of SLNs per patient, the percentage of bilaterally detected SLNs, and the proportion of metastatic SLNs. Safety endpoints were the summary of all reported adverse events. SLNs were detected in all cases and bilaterally in 21 patients (70%). The diagnostic accuracy parameters of the SPIO detection of metastatic SLNs evaluated by Receiver Operating Characteristic (ROC) curve analysis with the area under the ROC curve (AUC) demonstrated a sensitivity of 80% and AUC of 0.9 (p &lt; 0.001), confirming the SPIO technique’s efficacy in women with EC. No adverse events were reported. SPIO nanoparticles as a tracer for SLN mapping in apparent early-stage EC patients demonstrated satisfactory accuracy parameters and safety; however, these data need to be evaluated by further research.

Translational molecular research has established a novel clinical approach in endometrial cancer patients

Endometrial cancer (EC) is the most common gynecological tumor in developed countries. Nowadays, molecular biomarkers have become increasingly important in the management of EC patients, helping in early detection, risk stratification, prognosis and response to the treatment, and qualification for novel immunotherapies, especially in EC patients with metastatic disease or recurrence. When EC tumor molecular profiling is combined with the standard histopathological features such as clinical stage, histologic grading and evaluation of lymphovascular space invasion, the final therapeutic outcome may bring benefits in terms of personalized and efficient management.

Advanced ovarian cancer imitating deep infiltrating endometriosis. Radical resection and reconstructive surgery of the anterior abdominal wall

Endometriosis is a disease affecting approximately 10-15% of the female population of reproductive age [1]. A rare location is endometriosis in the scar after caesarean section - CSE (caesarean scar endometriosis) accounting for 0.5-1.0 % of all cases. Although endometriosis is usually a benign condition, its malignant transformation affects 0.7-1% of cases. In women diagnosed with ovarian cancer, foci of endometriosis are present in up to 30% of patients. This paper presents the case of a 36-year-old patient initially diagnosed with extensive endometriosis involving the anterior abdominal wall and the pelvis minor. After biopsy, a diagnosis of advanced low-grade serous ovarian cancer was established. The diagnostic methods used and the extent of surgery with reconstruction of the anterior abdominal wall were described.

Radical hysterectomy in early cervical cancer in Europe: characteristics, outcomes and evaluation of ESGO quality indicators

Comprehensive updated information on cervical cancer surgical treatment in Europe is scarce. To evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database. The SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified. The mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m In this European cohort, the rate of adjuvant therapy after radical hysterectomy is higher than for most similar patients reported in the literature. The majority of centers were already following the European recommendations even 5 years prior to the ESGO quality indicator implementations.

SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer

Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study was to evaluate disease-free survival in patients with stage IB1 (FIGO 2009) cervical cancer undergoing open vs minimally invasive radical hysterectomy. As a secondary objective, we aimed to investigate the association between protective surgical maneuvers and the risk of relapse. We obtained data from 1272 patients that underwent a radical hysterectomy by open or minimally invasive surgery for stage IB1 cervical cancer (FIGO 2009) from January 2013 to December 2014. After applying all the inclusion-exclusion criteria, we used an inverse probability weighting to construct a weighted cohort of 693 patients to compare outcomes (minimally invasive surgery vs open). The first endpoint compared disease-free survival at 4.5 years in both groups. Secondary endpoints compared overall survival among groups and the impact of the use of a uterine manipulator and protective closure of the colpotomy over the tumor in the minimally invasive surgery group. Mean age was 48.3 years (range; 23-83) while the mean BMI was 25.7 kg/m Minimally invasive surgery in cervical cancer increased the risk of relapse and death compared with open surgery. In this study, avoiding the uterine manipulator and using maneuvers to avoid tumor spread at the time of colpotomy in minimally invasive surgery was associated with similar outcomes to open surgery. Further prospective studies are warranted.

Superparamagnetic iron oxide: a novel tracer for sentinel lymph node detection in vulvar cancer

Superparamagnetic techniques for sentinel lymph node (SLNs) biopsy in breast cancer is well recognized but remains novel in the literature in relation to early stage vulvar cancer. The aim of this study was to compare and validate SLN detection using a superparamagnetic iron oxide tracer and a magnetometer probe compared with the standard procedure with a radioisotope ( Patients were included in the study with squamous vulvar tumors less than 4 cm in diameter and without suspicious groin lymph nodes on preoperative magnetic resonance imaging. Patients must have previously qualified for SLN biopsy with a radiotracer as the standard of care. The primary endpoint was the proportion of successful SLN detection with superparamagnetic iron oxide tracer versus A total of 20 patients were included in the study. SLNs were found in all patients with both methods, resulting in similar average distributions (3.1/3.2 SLN per patient). The SLN detection rate per patient was 100% with both techniques. Nodal detection sensitivity was 98.5% for the superparamagnetic technique and 93.8% for the radiotracer. Percentage of metastatic lymph nodes detected was 100% with both tracers. The rate of lymph node positivity was 21.5% (14 lymph nodes with metastases) and for patients 45% (9 patients with nodal metastases). Additionally, SLN tainted brown due to superparamagnetic iron oxide nanoparticles in 19 of 20 patients. The use of superparamagnetic iron oxide tracer in patients with vulvar cancer seems reliable and not inferior to the standard approach with radiotracer.

SUCCOR cone study: conization before radical hysterectomy

To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009). A multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width ≤0.2 standard deviations of the logit odds of the estimated propensity score. We obtained a weighted cohort of 374 patients (187 patients with prior conization and 187 non-conization patients). We found a 65% reduction in the risk of relapse for patients who had cervical conization prior to radical hysterectomy (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.16 to 0.75, p=0.007) and a 75% reduction in the risk of death for the same sample (HR 0.25, 95% CI 0.07 to 0.90, p=0.033). In addition, patients who underwent minimally invasive surgery without prior conization had a 5.63 times higher chance of relapse compared with those who had an open approach and previous conization (HR 5.63, 95% CI 1.64 to 19.3, p=0.006). Patients who underwent minimally invasive surgery with prior conization and those who underwent open surgery without prior conization showed no differences in relapse rates compared with those who underwent open surgery with prior cone biopsy (reference) (HR 1.94, 95% CI 0.49 to 7.76, p=0.349 and HR 2.94, 95% CI 0.80 to 10.86, p=0.106 respectively). In this retrospective study, patients undergoing cervical conization before radical hysterectomy had a significantly lower risk of relapse and death.

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.

SENECA study: staging endometrial cancer based on molecular classification

Management of endometrial cancer is advancing, with accurate staging crucial for guiding treatment decisions. Understanding sentinel lymph node (SLN) involvement rates across molecular subgroups is essential. To evaluate SLN involvement in early-stage (International Federation of Gynecology and Obstetrics 2009 I-II) endometrial cancer, considering molecular subtypes and new European Society of Gynaecological Oncology (ESGO) risk classification. The SENECA study retrospectively reviewed data from 2139 women with stage I-II endometrial cancer across 66 centers in 16 countries. Patients underwent surgery with SLN assessment following ESGO guidelines between January 2021 and December 2022. Molecular analysis was performed on pre-operative biopsies or hysterectomy specimens. Among the 2139 patients, the molecular subgroups were as follows: 272 (12.7%) p53 abnormal (p53abn, 1191 (55.7%) non-specific molecular profile (NSMP), 581 (27.2%) mismatch repair deficient (MMRd), 95 (4.4%) POLE mutated (POLE-mut). Tracer diffusion was detected in, at least one side, in 97.2% of the cases; with a bilateral diffusion observed in 82.7% of the cases. By ultrastaging (90.7% of the cases) or one-step nucleic acid amplification (198 (9.3%) of the cases), 205 patients were identified with affected sentinel lymph nodes, representing 9.6% of the sample. Of these, 139 (67.8%) had low-volume metastases (including micrometastases, 42.9%; and isolated tumor cells, 24.9%) while 66 (32.2%) had macrometastases. Significant differences in SLN involvement were observed between molecular subtypes, with p53abn and MMRd groups having the highest rates (12.50% and 12.40%, respectively) compared with NSMP (7.80%) and POLE-mut (6.30%), (p=0.004); (p53abn, OR=1.69 (95% CI 1.11 to 2.56), p=0.014; MMRd, OR=1.67 (95% CI 1.21 to 2.31), p=0.002). Differences were also noted among ESGO risk groups (2.84% for low-risk patients, 6.62% for intermediate-risk patients, 21.63% for high-intermediate risk patients, and 22.51% for high-risk patients; p<0.001). Our study reveals significant differences in SLN involvement among patients with early-stage endometrial cancer based on molecular subtypes. This underscores the importance of considering molecular characteristics for accurate staging and optimal management decisions.

Modified Tumor-free Techniques Operation to Cervical Cancer

The goal of this clinical trial is to learn if laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) works to treat FIGO stage IB2 cervical cancer as good as abdominal radical hysterectomy (ARH). It will also learn about the safety of LRH-MTF. The main questions it aims to answer are: Does LRH-MTF achieve a non-inferior disease-free survival rate at 4.5 years post - operation compared to ARH? What complications do patients have during and after the operation when receiving LRH-MTF? Researchers will compare LRH-MTF to ARH to see if LRH-MTF works no worse than ARH in treating FIGO stage IB2 cervical cancer. Participants will: 1. Undergo either LRH-MTF or ARH as assigned by randomization. 2. Visit the hospital for follow-up according to the study schedule for various examinations including blood tests, imaging studies, and assessment of complications. 3. Complete quality-of-life questionnaires such as EORTC QLQ-C30, QLQ-CX24, FSFI, and FSDS-R at baseline (pre-operation) and specific time points during the follow - up period (post-operation 6 months, 1 year, 2 years, 3 years, 4.5 years).

Prognostic Value of Conization and Negative HPV After Conization in AIS and Early Stage Cervical Cancer

In women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma, Adeno-squamous carcinoma or AIS we want to examine prospectively: 1. Examine if negative HR-HPV after conization to the HR-HPV the women had before conization has a high prognostic value for no residual tumor in the final pathology. 2. To examine if conization in women with cervical tumor up to Stage I B 2 (FIGO 2018) is corelated with better prognosis.