International Journal of Gynecological Cancer最新文献

Objective: The phase 3 ENGOT-en9/LEAP-001 trial (NCT03884101) comparing first-line lenvatinib+pembrolizumab with carboplatin+paclitaxel did not meet pre-specified statistical criteria for overall survival or progression-free survival in participants with advanced/recurrent endometrial cancer. We report results after an additional year of follow-up (overall median 54.5 [range; 46.5-69.0] months).

Methods: Eligible participants were adult females with stage III to IV or recurrent, histologically confirmed endometrial cancer. Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and radiographically apparent disease per blinded independent central review was required. Participants were randomly allocated 1:1 to lenvatinib+pembrolizumab or chemotherapy (paclitaxel+carboplatin). The primary end points were overall survival and progression-free survival per RECIST version 1.1 by blinded independent central review. Secondary end points included objective response rate per RECIST version 1.1 by blinded independent central review and safety.

Results: The median overall survival (95% confidence interval [CI]) was 30.9 (range; 25.4-37.6) months with lenvatinib+pembrolizumab versus 29.4 (range; 26.2-34.8) months with chemotherapy in mismatch repair-proficient endometrial cancer (hazard ratio [HR] 0.99, 95% CI 0.82 to 1.21), 37.9 (range; 32.2-43.0) versus 32.3 (range; 27.2-35.7) months in all-comers (HR 0.91, 95% CI 0.77 to 1.09), and not reached in either treatment group in mismatch repair-deficient endometrial cancer (HR 0.60, 95% CI 0.39 to 0.93]). Corresponding results for progression-free survival were 9.6 (range; 8.2-11.9) versus 10.2 (range; 8.4-10.5) months (HR 1.01, 95% CI 0.83 to 1.22), 12.5 (range; 10.3-15.1) versus 10.2 (range; 8.4-10.4) months (HR 0.92, 95% CI 0.77 to 1.10]), and 31.8 (22.5 to not reached) versus 9.0 (range; 8.2-17.1) months (HR 0.62, 95% CI 0.41-0.93). Objective response rates were 50.6% versus 54.7%, 55.7% versus 55.5%, and 72.0% versus 58.0%, respectively. No new safety signals were identified. The results were consistent with those at the final analysis.

Conclusions: The mismatch repair-proficient, all-comer, and mismatch repair-deficient populations continued to demonstrate antitumor activity for lenvatinib+pembrolizumab after an additional year of follow-up. These results should be interpreted with caution due to the exploratory nature of the analysis.

Trial registration: ClinicalTrials.gov No. NCT03884101.

Objective: Hyperthermic intraperitoneal chemotherapy (HIPEC) administered during interval cytoreductive surgery has shown survival benefits in advanced ovarian cancer. However, predictive biomarkers to guide patient selection for HIPEC are lacking. We evaluated the prognostic and predictive value of the modeled CA125 elimination rate constant K (KELIM), a surrogate marker of tumor chemosensitivity, in relation to the benefit of HIPEC.

Methods: This pooled analysis included patients from the KOV-HIPEC-01 phase III trial and the KGOG3042 cohort study. KELIM values were estimated using CA125 kinetics during neoadjuvant chemotherapy. Patients were stratified by KELIM score as favorable (≥1.0) or unfavorable (<1.0). The impact of HIPEC on progression free survival and overall survival was evaluated using univariable and multivariable Cox regression analyses.

Results: KELIM was assessable in 213 patients. In those with an unfavorable KELIM score, HIPEC significantly improved progression free survival (20.04 vs 10.25 months; HR 0.42, 95% CI 0.25 to 0.71) and overall survival (not reached vs 45.5 months; HR 0.29, 95% CI 0.12 to 0.73). No significant benefit from HIPEC was observed in patients with a favorable KELIM score. Subgroup analyses revealed that the benefit of HIPEC in patients with an unfavorable KELIM was more pronounced in those with high-grade serous carcinoma, BRCA1/2 wild-type status, age >60 years, and stage IV disease.

Conclusions: HIPEC may provide survival benefit primarily in patients with an unfavorable KELIM score. KELIM may be a clinically useful biomarker to guide patient selection for HIPEC during interval cytoreductive surgery in advanced ovarian cancer.

Objectives: To ascertain outcome differences between human papillomavirus (HPV)-associated and non-HPV-associated endocervical adenocarcinoma within an integrated healthcare system.

Methods: This retrospective cohort study examined patients aged 18 to 90 years diagnosed with invasive endocervical adenocarcinoma from 2011 to 2017 using our institution's cancer registry. Demographic and clinical variables were abstracted from records. Five-year overall survival and progression-free survival were assessed for HPV-associated and non-HPV-associated cancer types. Chi-square and Fisher exact tests compared categorical, while Wilcoxon rank-sum tests analyzed continuous variables. Kaplan-Meier curves compared 5-year survival between groups.

Results: Among 144 patients, 34 (24%) had non-HPV-associated and 110 (76%) had HPV-associated cancers. Patients with non-HPV-associated endocervical adenocarcinoma had worse 5-year progression-free survival (72% vs 88%, p = .03) and overall survival (75% vs 92%, p < .01). Non-HPV-associated endocervical adenocarcinoma was more likely to be diagnosed at older ages (median 54 years vs 42 years, p < .01). A high percentage of early-stage diagnoses were observed (74% of non-HPV-associated endocervical adenocarcinoma and 86% of HPV-associated endocervical adenocarcinoma were diagnosed at stage I).

Conclusions: While 5-year survival was worse in non-HPV-associated endocervical adenocarcinoma, differences were less pronounced than previously reported, potentially due to the high percentage of early-stage diagnoses, suggesting that stage remains the most important prognostic factor.

Objective: To inform follow-up protocols, we investigated differences in incidence, number, and timing of recurrence by site between human papillomavirus (HPV)-Independent and HPV-associated vulvar squamous cell carcinoma.

Methods: A retrospective clinicopathological single-institution cohort study was conducted of 471 patients with vulvar squamous cell carcinoma between 1990 and 2020. Tumors were classified as HPV-independent or HPV-associated, and the number, site, and time to recurrence were compared. Kaplan-Meier curves were developed for recurrence-free survival by stage, disease-specific survival by recurrence site, and cumulative incidence of recurrence for each tumor type.

Results: A total of 471 consecutive vulvar squamous cell carcinomas were identified during the study period; 251 HPV-independent and 208 HPV-associated, with 12 tumors unable to be classified. The median follow-up time was 41 months (range; 0-326). The median time to first recurrence was 22 months for HPV-independent and 43.5 months for HPV-associated (p = .014). In all-stage cancers, any type of recurrence occurred in 38.2% HPV-independent and 8.7% HPV-associated cases (p < .001). The cumulative recurrence rate (any site) for HPV-independent tumors at 5 years was 44% (95% confidence interval [CI] 37% to 52%) and 7% (95% CI 4% to 13%) for HPV-associated tumors. Local recurrence occurred in 29.5% of HPV-independent and 7.7% HPV-associated cases (p < .001), groin recurrence in 14.3% of HPV-independent and 1.4% of HPV-associated cases (p < .001), and distant recurrence in 8.4% of HPV-independent and 2.4% of HPV-associated cases (p = .006). HPV- independent tumors had a significantly higher number of multiple recurrences (18.7% vs 1.9%, p < .001). Following a first local recurrence, disease-specific survival was 86% (95% CI 33% to 98%) at both 3 and 5 years for HPV-associated tumors, compared with 61% (95% CI 47% to 73%) at 3 years and 48% (95% CI 33% to 62%) at 5 years for HPV-independent tumors.

Conclusions: HPV-independent tumors have a 4.4-fold increased risk of any type of recurrence, with the first recurrence occurring 21 months earlier and with ongoing lifelong risk. Surveillance could be tailored by HPV status, extended for HPV-independent and reduced or patient-initiated for HPV-associated tumors.

Objective: This study aimed to evaluate the feasibility and safety of Tru-Cut biopsy as a complementary diagnostic tool in the pre-operative evaluation of sonographically atypical myometrial lesions in patients scheduled for uterine surgery. Secondary objectives included determining the diagnostic accuracy, sensitivity, and specificity of Tru-Cut biopsy in pre-operative tumor characterization and patient's perceived peri-procedural pain.

Methods: In this pilot study, all consecutive patients aged ≥18 years with atypical myometrial lesions based on ultrasonography referred to our institution's Centre of Minimally Invasive Surgery between June 2022 and June 2023 underwent pre-operative trans-vaginal or trans-cervical ultrasound-guided Tru-Cut biopsy, followed by surgical treatment. Samples were considered adequate if histologic tumor typing was possible. Diagnostic accuracy was determined by comparing Tru-Cut biopsy histology with final post-operative histology.

Results: Of 39 patients who underwent Tru-Cut biopsy, 27 (69.2%) were diagnosed with conventional leiomyoma, 9 (23.1%) with benign atypical myometrial lesion, 1 (2.6%) with smooth muscle tumor of uncertain malignant potential, and 2 (5.1%) had inadequate samples. The median pain score immediately post-Tru-Cut biopsy was 4 (interquartile range; 3-5), with no pain reported 24 hours later. Complications occurred in 2 patients (5.2%): 1 required hospitalization for collapse and another underwent laparoscopic intervention for abdominal bleeding. Among the 37 adequate samples, Tru-Cut biopsy findings were concordant with final histology in 34 cases (diagnostic accuracy 91.9%; 95% confidence interval [CI] 78.7 to 97.2). Tru-Cut biopsy sensitivity and specificity were 88.9% (95% CI 56.5 to 98.0) and 92.9% (95% CI 77.4 to 98.0), respectively.

Conclusions: This pilot study indicates that Tru-Cut biopsy is a feasible, safe, and accurate method for pre-operative assessment of atypical myometrial lesions, providing histologically adequate samples for diagnostic evaluation. Larger studies are warranted to validate these results.

Objective: To assess the knowledge, practices, and referral patterns of health care professionals and fertility preservation specialists regarding fertility preservation in gynecologic oncology in France.

Methods: In this cross sectional study, an electronic questionnaire was distributed between June 2023 and January 2024 to health care professionals in metropolitan and overseas territories. It included sections on demographics, fertility preservation practices, and technical knowledge, with tailored sections for physicians who are specialists and non-specialists in reproductive medicine.

Results: Sixty-four professionals participated (mean experience: 12 years); 65.6% (42/64) were gynecologic surgeons, and 18.8% (12/64) were specialists in reproductive medicine. Among non-specialists (52/64), 82.7% (43/52) routinely discussed fertility with patients of childbearing age, and 94.2% (49/52) had referred patients for fertility preservation. The mean knowledge score was 1.4/6. Only 23.1% (12/52) reported having written materials for patients, and 65.4% (34/52) indicated that no fertility specialist was present at multidisciplinary meetings. All reproductive medicine specialists (n = 12) reported access to oocyte and ovarian tissue cryopreservation, but 83.3% (10/12) believed patients were under-referred. They emphasized the need for systematic discussions of fertility preservation in multidisciplinary settings and highlighted risks associated with ovarian stimulation and tissue reimplantation. The upper age limit for oocyte cryopreservation was generally under 40 years. Pregnancy outcomes following fertility preservation were limited, primarily in cases of borderline ovarian tumors.

Conclusions: Fertility preservation is recognized as a critical component of gynecologic oncology care, but significant gaps remain in knowledge, referrals, and integration into multidisciplinary care. Strengthening collaboration between oncology and fertility teams, standardizing care pathways, and enhancing education for health care providers are essential steps to improving access and outcomes for patients.

Objective: 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.

Methods: Multi-center retrospective study of patients diagnosed with ovarian teratoma and GP between 2000 and 2023. Non-gynecological GP cases were excluded.

Results: 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.

Conclusions: 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.