International Journal of Gynecological Cancer最新文献

Objective: Adequately managing post-operative pain is essential for improving patient outcomes and reducing post-operative complications. The quadratus lumborum (QL) block is a truncal nerve block technique that was recently developed to provide analgesia during abdominal and hip surgical procedures. While many studies have shown the outstanding analgesic effect of QL blocks, this technique is not well-known or commonly used in gynecologic procedures.

Findings: This narrative review describes evidence in current literature on the safety and effectiveness of QL blocks when used for gynecologic procedures. The studies show that including QL blocks as part of the approach to managing post-operative pain in gynecologic patients can reduce post-operative pain, reduce analgesic consumption, and lengthen time to first analgesic. They also suggest that QL blocks are more effective at managing post-operative pain and have a lower risk for systemic toxicity compared with transversus abdominis plane blocks.

Summary: According to current randomized controlled trials, QL blocks have been shown to be effective in managing post-operative pain after gynecologic surgical procedures. Further studies on effectiveness in different procedures, adjuvants, and optimum dosing of local anesthetic are needed to determine the best application of QL blocks in gynecologic procedures.

Objective: In the ENGOT-EN6-NSGO/GOG3031/RUBY trial, dostarlimab+carboplatin-paclitaxel demonstrated significant improvement in progression free survival and a positive trend in overall survival compared with placebo+carboplatin-paclitaxel, with manageable toxicity, in patients with primary advanced or recurrent endometrial cancer. Here we report on patient-reported outcomes in the mismatch repair-deficient/microsatellite instability-high population, a secondary endpoint in the trial.

Methods: Patients were randomized 1:1 to dostarlimab+carboplatin-paclitaxel or placebo+carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab or placebo monotherapy every 6 weeks for ≤3 years or until disease progression. Patient-reported outcomes, assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Endometrial Cancer Module, were prespecified secondary endpoints. A mixed model for repeated measures analysis, a prespecified exploratory analysis, was conducted to generate least-squares means to compare between-treatment differences while adjusting for correlations across multiple time points within a patient and controlling for the baseline value. Results are provided with 2-sided, nominal p values.

Results: Of 494 patients enrolled, 118 were mismatch repair-deficient/microsatellite instability-high. In this population, mean change from baseline to end of treatment showed visual improvements in global quality of life (QoL), emotional and social function, pain, and back/pelvis pain for dostarlimab+carboplatin-paclitaxel. Meaningful differences (least-squares mean [standard error]) favoring the dostarlimab arm were reported for change from baseline to end of treatment for QoL (14.7 [5.45]; p=0.01), role function (12.7 [5.92]); p=0.03), emotional function (14.3 [4.92]; p<0.01), social function (13.5 [5.43]; p=0.01), and fatigue (-13.3 [5.84]; p=0.03).

Conclusions: Patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer receiving dostarlimab+carboplatin-paclitaxel demonstrated improvements in several QoL domains over patients receiving placebo+carboplatin-paclitaxel. The observed improvements in progression free survival and overall survival while improving or maintaining QoL further supports dostarlimab+carboplatin-paclitaxel as a standard of care in this setting.

Trial registration: ClinicalTrials.gov NCT03981796.

Background: Open surgical procedures for gynecological malignancies have a potential risk of post-operative complications and hence prolonged hospitalization, despite adherence to an Enhanced Recovery After Surgery (ERAS) protocol.

Primary objective: To investigate the relationship between non-compliance to an ERAS protocol in the post-operative setting and the rate of post-operative complications, in women who underwent open surgery for gynecological malignancies.

Study hypothesis: Early non-compliance with the ERAS protocol increases the risk of post-operative complications.

Trial design: Multicenter, prospective, observational, cohort study.

Major inclusion criteria: Patients with histologically proven gynecological cancer (endometrial, uterine, tubo-ovarian, and cervical) undergoing elective open surgery and managed according to ERAS guidelines.

Exclusion criteria: Patients with post-operative recovery in an intensive care unit, undergoing anterior or total pelvic exenteration or intraperitoneal chemotherapy. Previous radiotherapy or previous non-gynecological major abdominal surgery.

Primary endpoint: Association of non-compliance with the ERAS protocol using five selected indicators on post-operative day 2 with the rate of 30-day post-operative complications.

Sample size: 600 patients will be enrolled in the study.

Estimated dates for completing accrual and presenting results: At present, 106 patients have been recruited. Based on this, the accrual should be completed in 2025. Results should be presented at the end of 2025.

Trial registration: NCT05738902.

Objective: This multicenter retrospective cohort study aimed to compare survival outcomes and adverse events between early and late initiation of niraparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer.

Methods: We included patients with stage III-IV ovarian cancer who showed a complete or partial response to frontline platinum-based chemotherapy and received niraparib maintenance therapy between October 2019 and December 2022. The primary endpoint was the HR for progression-free survival based on the median initiation interval, which was defined as the duration between the completion of chemotherapy and commencement of maintenance therapy. The secondary endpoint was the comparison of progression-free survival at another time point that determined the interval that maximized the difference between the survival curves of the two groups using the Contal and O'Quigley method.

Results: This analysis included 146 patients who received niraparib maintenance therapy. The median age was 58 years (IQR 50-63.3). The median initiation interval was 8.4 (IQR 5.7-8.9) weeks. After adjusting for prognostic factors for progression-free survival identified through multivariable analysis, early initiation (≤8 weeks) of niraparib was associated with significantly better progression-free survival (HR=0.57; 95% CI 0.33 to 0.99; p=0.047). Furthermore, the initiation interval that maximized the difference in progression-free survival was 6 weeks. Multivariable analysis revealed that early initiation (≤6 weeks) of niraparib significantly increased progression-free survival (HR=0.37; 95% CI 0.18 to 0.76; p=0.007). The rate of treatment discontinuation due to treatment-emergent adverse events was higher (12.5% versus. 2.8%; p=0.036) in patients receiving niraparib within 6 weeks than those treated later, with no significant effect in those initiating treatment within 8 weeks.

Conclusion: Early initiation of niraparib maintenance therapy within 8 weeks of chemotherapy completion improved progression-free survival, with further benefits observed with treatment within 6 weeks in patients with newly diagnosed advanced ovarian cancer.

Objective: Imaging for staging ovarian cancer is important to determine the extent of disease. The primary objective of this study was to compare gated 18F-fluorodeoxyglucose positron emission tomography coupled with computed tomography (FDG PET/CT) and standard CT scan with intravenous contrast to diagnose thoracic involvement in patients with advanced ovarian cancer prior to treatment. The secondary objective was to estimate changes in the International Federation of Gynecology and Obstetrics (FIGO) stage and clinical management resulting from gated PET/CT.

Methods: The IMAGE trial is a non-randomized phase II clinical trial comparing standard CT scanning with gated PET/CT in diagnosing thoracic involvement in a non-selected group of patients with suspected ovarian cancer on a contrast CT scan. Three sets of PET images were obtained comprising an ungated 2 min whole body image, a static 7.5 min image of the upper abdomen and thorax, and a gated end-expiratory image over the upper abdomen and thorax. Images were evaluated for specificity, sensitivity, diagnostic accuracy, and the proportion of patients with changes in FIGO stage and subsequent clinical management was compared between imaging techniques.

Results: A total of 84 patients were enrolled based on a standard CT scan, 67 of whom were eligible for gated PET/CT scans. Diagnostic accuracy with gated PET/CT was more than 80% for lesions in lung, liver, extra-abdominal sites, and pleura, but less than 50% for extra-abdominal lymph nodes. Compared with CT scan at baseline, 46% of patients who had 7.5 min gated PET/CT had disease upstaged from stage III to IV, and 8% had disease downstaged from stage IV to III. However, this led to a change of management in only 5% of patients.

Conclusions: Gated PET/CT enables upstaging; however, in our institution it altered clinical management only in a minority of patients.

Trial registration number: NCT02258165.

Objective: To evaluate the lymphatic-specific morbidity (specifically, lower extremity lymphedema) associated with laparoscopic management of early-stage endometrial cancer using the sentinel lymph node (SLN) algorithm by type of actual nodal assessment.

Methods: An ambispective study was conducted on consecutive patients surgically treated for apparent early-stage endometrial cancer who underwent laparoscopic staging according to the National Comprehensive Cancer Network SLN algorithm at a single institution from January 2020 to August 2023. Data on patient characteristics, surgical details, and post-operative complications were collected. Lymphedema screening was performed using a validated questionnaire.

Results: A total of 239 patients were analyzed, with a questionnaire response rate of 85.4%. The study population was grouped based on actual surgical staging: hysterectomy+SLN (54.8%), hysterectomy+systematic pelvic lymphadenectomy (27.2%), and hysterectomy only (18%). The prevalence of lymphedema was significantly lower in the hysterectomy+SLN group compared with the hysterectomy+systematic pelvic lymphadenectomy group (21.4% vs 44.6%, p=0.003). Multivariable analysis showed a threefold increase in the risk of lymphedema for the hysterectomy+systematic pelvic lymphadenectomy group compared with the hysterectomy+SLN group: OR 3.11 (95% CI 1.47 to 6.58). No significant associations were found between lymphedema and other patient or tumor characteristics.

Conclusion: In the setting of a laparoscopic approach for early-stage endometrial cancer surgery, SLN mapping is associated with a significant reduction in lymphatic complications compared with a systematic lymph node dissection. Our findings provide additional evidence endorsing the adoption of SLN mapping during minimally invasive surgery for endometrial cancer. This technique ensures comparable diagnostic accuracy and also minimizes complications.