International Journal of Gynecological Cancer最新文献

Objective: To investigate the safety of neoadjuvant chemotherapy and conization in early-stage cervical cancer with a tumor size >2 cm using a fertility-sparing approach.

Methods: The ETERNITY project is a retrospective, multi-institutional study that collected data from patients with early-stage cervical cancer undergoing fertility-sparing treatment. In the present study, we report the outcomes of stage IB2 to IB3 cervical cancer undergoing nodal assessment, neoadjuvant chemotherapy, and conization. A propensity-matching algorithm was used to compare patients who underwent upfront radical surgery.

Results: A total of 395 patients were included in the ETERNITY project. Among these, 25 underwent a fertility-sparing attempt with nodal assessment, neoadjuvant chemotherapy, and conization. The median (range) patient age was 37 (24-41) years. Four (16%) patients with positive nodes required definitive chemo-radiation. Twenty-one (84%) patients received neoadjuvant chemotherapy. Two (8%) patients with stable disease underwent radical hysterectomy, whereas the remaining 19 (76%) patients who achieved a clinical response underwent cervical conization. Three (12%) patients underwent radical hysterectomy owing to persistent positive margins, leaving 16 (64%) patients who completed the planned fertility-sparing attempt. After a median (range) follow-up of 36.2 (21.9-88) months, 3 recurrences occurred. Two patients with cervical recurrence underwent hysterectomy, while 1 patient who received definitive chemoradiotherapy owing to the presence of positive nodes developed distant recurrence. Regarding obstetric outcomes, 6 patients attempted to conceive, and 4 (66.7%) pregnancies were achieved (1 was achieved with assisted reproductive technology). In a propensity-matched group of patients who underwent upfront radical surgery, no differences in morbidity or survival rates were recorded.

Conclusions: Neoadjuvant chemotherapy followed by conization should be investigated in selected patients with cervical cancer who wish to preserve their childbearing potential. Further prospective studies are needed to assess the long-term safety and identify predictors of response.

Clinical trial identifier: NCT06351228.

Objective: The HALO study (NCT04991051) determined the prevalence of homologous recombination deficiency and its associated factors in patients with high-grade serous/endometrioid ovarian, primary peritoneal, and/or fallopian tube cancers across Asia, the Middle East, and Russia.

Methods: This multinational, cross-sectional, real-world study enrolled adult women with newly diagnosed stage III or IV high-grade serous/endometrioid ovarian, primary peritoneal, and/or fallopian tube cancers. Formalin-fixed paraffin-embedded tumor blocks were collected within 120 days of enrollment. The prevalence of homologous recombination deficiency, high genomic instability score (GIS) without tumor BRCA mutations, and BRCA mutations were evaluated along with patient characteristics. Factors associated with homologous recombination deficiency, high GIS without BRCA mutations, and BRCA mutations were identified using a logistic-regression model.

Results: Of the 734 patients (median [range] age; 59.0 [23.0-89.0] years), most (92.9%) had a primary ovarian tumor, followed by primary peritoneal (4.1%) and fallopian tube cancers (3.0%). Of the tested 662 patients; 56.0% (371) were homologous recombination deficiency-positive (Asia, 52.0%; the Middle East, 52.2%; Russia, 58.5%). Overall, 204 (30.8%) patients had a high GIS without BRCA mutations (Middle East, 23.9%; Russia, 31.9%; Asia, 41.3%), and 167 (25.2%) had BRCA mutations (Asia, 10.7%; Russia, 26.6%; Middle East, 28.3%). Patients with 1 comorbidity versus no comorbidities (96 vs 207, OR 1.54), a family history of genetically-related cancers versus no family history of cancer (82 vs 224, OR 2.64), and contraceptive use versus no history of contraceptive use (47 vs 323, OR 2.04) were more likely to have homologous recombination deficiency.

Conclusions: This real-world study reported a homologous recombination deficiency prevalence of 56.0% (ranging from 52.0% to 58.5%) across Asia, the Middle East, and Russia. Our results highlight the unmet need to implement guideline-recommended testing and real-world data collection for all patients newly diagnosed with advanced high-grade epithelial ovarian cancer to optimize treatment strategies.

Background: The standard treatment for endometrial cancer is hysterectomy with or without bilateral salpingo-oophorectomy; however, this may not be an optimal choice for women who have not completed childbearing or who are at a high risk of surgical complications. Conservative treatment with levonorgestrel intrauterine devices appear to be effective in patients with early-stage endometrial cancer; however, patients with mismatch repair-deficient (dMMR) tumors have a low likelihood of responding to levonorgestrel intrauterine devices.

Primary objective: To assess the efficacy of dostarlimab, an active immune checkpoint inhibitor that targets the programmed cell death protein-1 receptor, in patients with early-stage dMMR endometrioid endometrial adenocarcinoma.

Study hypothesis: Administration of 4 3-weekly cycles of 500 mg dostarlimab followed by a 3-week rest period and 3 6-weekly cycles of 1000 mg dostarlimab will be safe and efficacious in early-stage dMMR endometrial cancer patients.

Trial design: Non-randomized, open-label, pilot, multicenter phase2b study designed to evaluate the efficacy and safety of dostarlimab in 10 women aged ≥18 years with a clinically confirmed diagnosis of early-stage and dMMR endometrioid endometrial adenocarcinoma.

Major inclusion/exclusion criteria: Eligible patients must have histologically proven stage I, International Federation of Gynecology and Obstetrics grade 1 or 2 dMMR endometrioid endometrial adenocarcinoma and desire for fertility preservation. Exclusions include, but are not limited to, patients with other high-risk endometrial cancer cell types, a poor medical risk due to uncontrolled medical conditions, or those who experienced grade 3 or higher immune-related adverse events from prior immunotherapy.

Primary endpoint(s): The primary endpoint is the number of participants achieving investigator-assessed pathological complete response within 6 months of treatment.

Sample size: Ten (10) women ≥18 years of age will be enrolled.

Estimated dates for completing accrual and presenting results: Accruals are expected to be completed by 2027, with the presentation of results by 2029.

Trial registration: NCT06278857.

Objective: This study aimed to identify factors influencing the decision to perform diverting ileostomy during cytoreductive surgery with colon resection for advanced ovarian cancer and investigate the associated complications and survival outcomes.

Methods: This was a retrospective cohort study of patients with advanced ovarian cancer who underwent cytoreductive surgery with colon resection and re-anastomosis between January 2010 and July 2020. Multivariate analysis was performed on the factors contributing to diverting ileostomy identified in the univariate analysis.

Results: Of the 134 patients, 60 (44.8%) underwent diverting ileostomies. The median follow-up was 35.75 months (range; 0.03-145.05) and the median age was 57 (range; 26-86). The anastomotic leakage rate was 3.7% (n = 5). On the univariate analysis, longer operative time (10 vs 6.4 hours), multiple bowel resections (>1 vs 1 hour), total colon resection length, pre-operative paracentesis, intraoperative ascites, and transfusion were associated with diverting ileostomy. In the multivariate analysis, longer operative time (OR 1.61, p < .0001) and total colon resection length (OR 1.06, p = .027) remained significant. Diverting ileostomy was associated with higher rates of intensive care unit admission (14.3% vs 2.8%, p = .001), dehydration (40% vs 9.5%, p < .0001), and acute kidney injury (16.4% vs 1.4%, p = .002). The median progression-free survival was similar (23.87 vs 21.24 months in non-diverted vs diverted ileostomy, p = .82).

Conclusions: Longer operative time and total length of colon resection influenced the selection of diverting ileostomy. The patients selected for diversion underwent multiple bowel resections more frequently, received more transfusions, and developed intraoperative ascites. These findings suggest that surgeons favor diversion for more extensive procedures. Patients who underwent diverted ileostomy experienced more short-term complications, likely reflecting the surgical complexity. Progression-free survival remained similar between the 2 groups, with diverse patients experiencing stoma-related morbidity over time, mainly dehydration and acute kidney injury. A prospective model to predict anastomotic leak risk may reduce diverting ileostomy rates.

Objective: We evaluated the effectiveness of chemoradiation compared with radiotherapy alone in older patients with cervical cancer and determined the age sub-group wherein chemotherapy loses its significance using the Surveillance, Epidemiology, and End Results database.

Methods: Women aged ≥65 years with cervical cancer who received definitive radiotherapy or chemoradiation were identified on the basis of the 2000-2019 Surveillance, Epidemiology, and End Results data. Overall and cancer-specific survival were compared in treatment groups, with survival prognostic factors assessed using multivariate analysis. Exploratory sub-group analyses at 5-year age increments determined the age threshold at which chemotherapy benefits became non-significant, with a multivariate p value ≥ .05 indicating reduced impact on overall and cancer-specific survival.

Results: A total of 1832 patients were included in the study. Of these, 563 patients received radiotherapy, and 1269 patients received chemoradiation. The median age of the cohort was 74 years (Q1-Q3, 69.00-80.00). The 5-year overall and cancer-specific survival rates were 40.52% and 53.47%, respectively. In the multivariate analysis, chemotherapy significantly improved both overall (HR 0.47, p < .001) and cancer-specific (HR 0.57, p < .001) survival. For cancer-specific survival, the chemotherapy benefits progressively decreased with age, remaining significant until the age of >75 years (HR 0.63, p < .001) and decreasing after the age of 80 years (HR 0.79, p = .12). However, for overall survival, the chemotherapy benefit was observed in all age groups, except for patients aged >85 years (HR 0.72, p = 0.14).

Conclusions: Chemotherapy was beneficial for women aged ≥65 years with cervical cancer who underwent radiotherapy. However, in patients aged >80 years, chemotherapy had no significant impact on cancer-specific survival.

Objective: To assess the use of non-curative interventions and palliative pain management for patients with advanced gynecologic malignancy in the United States.

Methods: This retrospective cohort study queried the Commission-on-Cancer's National Cancer Database. The study population was 2,098,291 patients with stage IV malignancies from 2004 to 2020, including 5 gynecologic malignancies (uterine cervix, uterine corpus, tubo-ovary, vulva, and vagina) and 7 non-gynecologic malignancies (lung, pancreas, colorectum, breast, kidney, liver, and bladder), stratified by gender. Utilization rates and temporal trends of non-curative interventions (systemic therapy, surgery, radiotherapy) and palliative pain management in the first course of intervention were evaluated across the malignancy types.

Results: In 19 gender-stratified malignancy groups, the median rate of non-curative interventions and palliative pain management use rate was 18.3%. All the gynecologic malignancies ranked below the median, including the 3 lowest groups (12.6%, 10.5%, and 7.8% for uterine corpus, vulva, and tubo-ovary, respectively). Non-curative interventions and palliative pain management use increased significantly in non-gynecologic malignancies, whereas utilization remained unchanged over several years for most gynecologic malignancies, including uterine cervix (19.8% to 20.1% for 2012-2020, p-trend = .744), uterine corpus (12.0% to 13.4% for 2013-2020, p-trend = .072), and tubo-ovary (8.3% to 9.2% for 2011-2020, p-trend = .311). Compared with non-gynecologic malignancies, patients with gynecologic malignancy were less likely to receive non-curative systemic therapy by 48% to 80% (all 5 types), non-curative surgery by 15% to 61% (all but vagina), non-curative radiotherapy by 37% to 95% (uterus, tubo-ovary, vulva), and palliative pain management by 18% to 45% (all 5 types) (all, adjusted-p < .05).

Conclusions: In this cohort study, the initial utilization of non-curative interventions and palliative pain management has been unchanged for patients with advanced gynecologic malignancy, and fewer patients receive palliative care than those with non-gynecologic malignancy, including palliative pain management. Possible under-utilization of palliative care services for patients with advanced gynecologic malignancy call for attention and further investigation.

Background: This study aimed to identify the survival benefits of hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery for platinum-resistant recurrent ovarian cancer.

Primary objectives: The primary objective is to evaluate the efficacy of cytoreductive surgery and HIPEC on progression-free survival in platinum-resistant recurrent ovarian cancer.

Study hypothesis: The implementation of cytoreductive surgery and HIPEC combined with doxorubicin and mitomycin C may extend progression-free survival with manageable safety in patients with platinum-resistant recurrent ovarian cancer.

Trial design: This trial (KOV-HIPEC-02) is a multicenter, open-label, 1:1 randomized, phase III trial that enrolled 140 patients with platinum-resistant recurrent ovarian cancer. The patients will receive or will not receive cytoreductive surgery and HIPEC with doxorubicin 35 mg/m² and mitomycin 15 mg/m². Enrolled patients will receive non-platinum compound systemic chemotherapy until disease progression.

Major inclusion/exclusion criteria: Patients with recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer, who demonstrate resistance or refractory to platinum-based chemotherapy, are eligible for this trial. Patients exhibiting resectable intraperitoneal disease, as determined by clinical history, recent imaging findings, and laparoscopic assessment, will be enrolled. Furthermore, they must have an Eastern Cooperative Oncology Group Performance Status of 0 to 2, a life expectancy of at least 3 months, adequate organ function, and must provide informed consent to participate in the study.

Primary endpoint: Progression-free survival defined as the time from random assignment in a clinical trial to disease progression or death from any cause.

Sample size: Assuming that the enrollment period is 3 years and the follow-up period is 2 years, 140 patients will be randomized in this study design (70 patients in the HIPEC group and 70 patients in the control group).

Estimated dates for completing accrual and presenting results: The expected date of interim analysis of primary end point is early 2025, and the patient enrollment is expected to be completed in 2025.

Trial registration: The trial is registered at ClinicalTrials.gov (NCT05316181).

Objective: Ovarian cancer is the most prevalent gynecologic malignancy in adolescents, predominantly characterized by non-epithelial cancer. We aim to analyze the epidemiological characteristics of ovarian cancer in various regions and countries within this specific population.

Methods: This is a cross-sectional study using data from the Global Burden of Disease 2021 study, which included adolescents with ovarian cancer aged 15 to 24 years in 204 countries and territories from 1990 to 2021. We retrieved data on incidence, mortality, and disability-adjusted life years, and calculated estimated annual percentage changes to assess the temporal trends. In addition, we explored the relationship between the disease burden and the Socio-demographic Index and performed decomposition analysis.

Results: Globally, in 2021, the incidence, mortality, and disability-adjusted life years for ovarian cancer among adolescents were reported as 11,087 (95% CI 8893-12,899), 1573 (95% CI 1249-1832), and 115,075 (95% CI 91,622-134,050), respectively, with all corresponding age-standardized rates showing increasing trends from 1990 to 2021. Among the 5 Socio-demographic Index regions, the middle Socio-demographic Index region exhibited the highest age-standardized incidence rate (2.27, 95% CI 1.75-2.66), while the region with the highest age-standardized mortality rate and the most significant increase in disease burden was the low-middle region. Furthermore, out of 21 geographical regions, Southeast Asia reported the highest age-standardized incidence rate (4.48, 95% CI 3.00-6.12), while Central Latin America had the highest age-standardized mortality rate (0.42, 95% CI 0.36-0.49). Andean Latin America had the greatest increase in disease burden, while Australasia had the greatest decrease.

Conclusions: The disease burden of ovarian cancer among adolescents continues to rise globally, particularly in regions and countries with moderate to low economic development. Enhancing the equitable allocation of health care resources to facilitate early diagnosis and treatment is essential for future treatment and research strategies.