Marie Plante

Comparison of Weekly Paclitaxel Regimens in Recurrent Platinum-Resistant Ovarian Cancer: A Single Institution Retrospective Study

Weekly paclitaxel (WP) is a chemotherapeutic cornerstone in the management of patients with platinum-resistant ovarian carcinoma. Multiple WP dosing regimens have been used clinically and studied individually. However, no formal comparison of these regimens is available to provide objective guidance in clinical decision making. The primary objective of this study was to compare the cumulative dose of paclitaxel delivered using 80 mg/m2/week, administered using either a 3 weeks out of 4 (WP3) or a 4 weeks out of 4 (WP4) regimen. The secondary objective was to evaluate the clinical outcomes associated with both regimens, including efficacy and toxicity parameters. Our retrospective cohort comprised 149 patients harboring platinum-resistant ovarian cancer treated at the CHU de Québec from January 2012 to January 2023. WP3 and WP4 reached a similar cumulative dose (1353.7 vs. 1404.2 mg/m2; p = 0.29). No significant differences in the clinical outcomes were observed. The frequency of dose reduction was significantly higher for WP4 than WP3 (44.7% vs. 4.9%; p < 0.01), mainly due to treatment intolerance from toxicity (34.0% vs. 3.9%; p < 0.01). Our data suggest that a WP3 regimen delivers a similar cumulative dose to WP4, hence offering a better tolerability profile without compromising efficacy.

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).

Sexual Health and Quality of Life in Patients With Low-Risk Early-Stage Cervical Cancer: Results From GCIG/CCTG CX.5/SHAPE Trial Comparing Simple Versus Radical Hysterectomy

PURPOSE Simple hysterectomy and pelvic node assessment (SHAPE) is a phase III randomized trial (ClinicalTrials.gov identifier: NCT01658930 ) reporting noninferiority of simple compared with radical hysterectomy for oncologic outcomes in low-risk cervical cancer. This study presents secondary outcomes of sexual health and quality of life (QOL) of the SHAPE trial. METHODS Participants were randomly assigned to receive either radical or simple hysterectomy. Sexual health was assessed up to 36 months postoperatively using the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised and QOL using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Cervical Cancer-Specific Module (QLQ-CX24) questionnaires. RESULTS Among participants with at least one QOL measure, clinical and pathologic characteristics were balanced and with no differences in preoperative baseline scores for sexual health or QOL between groups. FSFI total score met the cutoff for dysfunction up to 6 months ( P = .02) in the radical hysterectomy group. Group differences favored simple hysterectomy for FSFI subscales: desire and arousal at 3 months ( P ≤ .001) and pain and lubrication up to 12 months ( P ≤ .018). Both groups met the cutoff for sexual distress but was higher in radical hysterectomy at 3 months ( P = .018). For QLQ-CX24, symptom experience was significantly better up to 24 months ( P = .031) and body image better at 3, 24, and 36 months ( P ≤ .01) for simple hysterectomy. Sexual-vaginal functioning was significantly better up to 24 months ( P ≤ .022) and more sexual activity up to 36 months ( P = .024) in the simple hysterectomy arm. Global health status was significantly higher at 36 months for simple hysterectomy ( P = .025). CONCLUSION Simple hysterectomy was associated with lower rates of sexual dysfunction than radical hysterectomy, with a lower proportion of women having sustained sexual-vaginal dysfunction. These results further support the benefit of surgical de-escalation for low-risk cervical cancer.

Closing the gap for cervical cancer research in Vietnam: current perspectives and future opportunities: a report from the 5th Gynecologic Cancer InterGroup (GCIG) Cervical Cancer Research Network (CCRN) Education Symposium

Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.The SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach. The favorable oncological outcome observed in SHAPE despite 75% of patients were treated with minimally invasive approach suggests that this approach may be safe. However, the trial was not designed to analyze oncological outcomes from surgical approach.

Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer

The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.