Clinical outcomes and prognostic factors in advanced high-grade platinum-resistant ovarian carcinoma: evidence from the ESME real-world cancer database.

OBJECTIVE: We aimed to describe real-world outcomes of chemotherapy with or without bevacizumab in patients with platinum-resistant high-grade serous ovarian, peritoneal, or fallopian tube carcinoma and to identify prognostic factors. METHODS: We retrospectively analyzed the French ESME Ovarian Cancer national database. Eligible patients had high-grade ovarian carcinoma after one to three prior treatment lines and received, in the first platinum-resistant setting, paclitaxel, pegylated liposomal doxorubicin, or gemcitabine, with or without bevacizumab. Because of baseline differences, chemotherapy-alone and chemotherapy-plus-bevacizumab groups were analyzed separately. Progression-free survival and overall survival were estimated using Kaplan-Meier methods and multi-variable Cox models. RESULTS: A total of 688 patients were included: 580 (84.3%) received chemotherapy alone and 108 (15.7%) chemotherapy plus bevacizumab. Median progression-free survival and overall survival were 3.2 and 8.8 months. In the chemotherapy-alone group, gemcitabine was associated with inferior progression-free survival compared with paclitaxel (2.5 vs 3.4 months; hazard ratio [HR] 1.31; 95% confidence interval [CI] 1.03 to 1.67), with no significant overall survival difference between regimens. In the bevacizumab group, median progression-free survival was 6.5 months with paclitaxel plus bevacizumab, compared with 4.1 months with pegylated liposomal doxorubicin plus bevacizumab (HR 3.50, 95% CI 1.93 to 6.34) and 3.6 months with gemcitabine plus bevacizumab (HR 2.54, 95% CI 1.10 to 5.88). Pegylated liposomal doxorubicin plus bevacizumab was also associated with worse overall survival than paclitaxel plus bevacizumab (median 9.8 vs 13.4 months; HR 1.99, 95% CI 1.04 to 3.81). In the overall multi-variable model, bevacizumab was independently associated with improved overall survival (HR 0.73, 95% CI 0.56 to 0.94). Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and longer time to platinum resistance were consistent favorable prognostic factors. CONCLUSIONS: ECOG and time to platinum resistance were the strongest prognostic factors. Paclitaxel-based regimen appeared more favorable when combined with bevacizumab, although exploratory. The independent association between bevacizumab and improved overall survival should be interpreted cautiously, likely reflecting confounding by indication.