Delayed publication of clinical trials in gynecologic oncology.

OBJECTIVES: Delays in clinical trial publication can hinder timely implementation of evidence-based practices. We sought to determine publication rates and time to publication for clinical trials addressing gynecologic malignancies. METHODS: All clinical trials addressing gynecologic cancers in the ClinicalTrials.gov registry with a primary completion date between 1/1/2018 and 1/1/2020 were identified. The primary outcome was publication rate. All included studies had been completed for at least 3 years. Secondary outcomes were time to publication and associations between publication rate and sponsor, cancer type, and the number and location of primary study sites. RESULTS: Of the 290 trials included, 161 (55.5%) had a peer-reviewed publication for the primary outcome within at least 3 years after completion. Of these, 123 had positive results (76.4%) and 38 were negative (23.6%). The average duration from primary completion to manuscript publication was 23.6 months (SD 13.9; median 21.4, IQR 15.1-32.4). Only 73 had results posted on the ClinicalTrials.gov registry (25.2%). Studies with positive findings had a significantly faster time to publication than those with negative results (22.0 mo vs 29.0 mo, p = 0.009). There was no significant difference between publication rate and funding source, cancer type, or location and number of primary sites. CONCLUSIONS: Timely publication of clinical trials addressing gynecologic cancers remains an issue. Studies with positive findings were published faster than those with negative results, but the average publication time was still almost 2 years from trial completion. Further efforts should be made to identify and address barriers to clinical trial publication.

Adjuvant therapy and recurrence risk in non-myoinvasive high-grade (stage IC) endometrial cancer: A systematic review and meta-analysis.

OBJECTIVE: To summarize practice patterns and outcomes among patients with non-myoinvasive high-grade (formerly stage IA, now stage IC) endometrial cancer. METHODS: We conducted a systematic search using MEDLINE, Embase, Cochrane, Web of Science, and ClinicalTrials.gov databases from inception to May 8, 2024 to identify studies reporting on treatment and outcomes of non-myoinvasive high-grade endometrial cancer. We included full-text English reports of patients undergoing adjuvant therapy or surveillance for polyp- or endometrium-confined high-grade endometrial cancer without myometrial invasion containing data on recurrence or survival outcomes. Two reviewers independently screened studies; a third reviewer resolved disagreements. Data were extracted using a standardized form. The primary outcome was recurrence risk. Random-effects meta-analysis was used to summarize binomial proportions and to compare outcomes by adjuvant treatment strategy. RESULTS: A total of 29 studies were included, representing 2770 unique patients. Overall, 49.0 % of patients were managed with observation and 37.9 % with chemotherapy. Most patients (92.5 %) had serous histology. Of 23 studies with data on recurrence, 13.7 % of patients recurred, with a meta-analysis estimate recurrence risk of 11 % (95 % confidence interval [CI]: 8-15 %). Across 13 studies reporting on recurrence by receipt of chemotherapy versus no chemotherapy, comparative meta-analysis showed similar likelihood of recurrence (8.0 % versus 13.2 %; odds ratio 0.73, 95 % CI: 0.38-1.42). Comparative meta-analyses for (1) adjuvant therapy versus observation and (2) observation or vaginal brachytherapy versus chemotherapy and/or external beam radiation therapy demonstrated no statistically significant difference in recurrence risk. Sensitivity analyses results, including those limiting to studies of patients with serous histology (12 studies) or complete surgical staging (10 studies), were overall consistent with the primary analysis. Survival data was inconsistently reported and not amenable to meta-analysis. CONCLUSION: Among patients with non-myoinvasive high-grade endometrial cancer, recurrence risk was 11 % and use of adjuvant therapy was not associated with reduced recurrence risk. Prospective study of this population is warranted.

Development and testing of patient-centered education about hormone replacement therapy for women at high genetic risk of breast and ovarian cancer.

OBJECTIVE: In this study, we aimed to develop education to assist BRCA mutation carriers in making informed decisions about HRT in the context of risk-reducing surgery, while simultaneously clarifying their treatment-specific values and reducing decisional conflict. METHODS: We enrolled premenopausal BRCA mutation carriers ages 19-49 without prior cancer or risk-reducing salpingo-oophorectomy to structured interviews in which they reviewed education about the risks and benefits of HRT. Materials included literature-derived data demonstrating associations between HRT and commonly considered health outcomes (breast cancer, vasomotor symptoms, sexual functioning, cardiovascular disease, osteoporosis, and blood clots). Participants completed the 16-item Decisional Conflict Scale (DCS) before and after education, communicated their preferences by rating and ranking the six outcomes, and provided feedback to inform iterative revisions of the educational content. RESULTS: 25 participants completed interviews. DCS scores decreased significantly from 54.6 to 22.8 following education (p < 0.001); sub-scores for uncertainty (71.7 to 37.3), informed (71.7 to 15.3), values clarity (53.7 to 17.0), effective decision (44.2 to 25.5), and support (35.0 to 17.7) also decreased significantly. Participants ranked cardiovascular disease as the most important outcome to consider, followed by breast cancer, osteoporosis, blood clots, decline in sexual function, and hot flashes. Participants with prior mastectomy (N = 10) ranked breast cancer as the most important outcome 25% of the time, compared to 80% in participants without mastectomy (N = 15). CONCLUSION: Following education, BRCA mutation carriers had significantly less decisional conflict regarding the choice to use HRT. This pilot study was successful in generating a prototype educational aid for further testing.