Background State-of-the art therapy for recurrent ovarian cancer (ROC) suitable for platinum-based re-treatment includes bevacizumab-containing combinations (eg, carboplatin/paclitaxel, carboplatin/gemcitabine) or the most active non-bevacizumab regimen: carboplatin/pegylated liposomal doxorubicin (PLD). This head-to-head trial compared a standard bevacizumab-containing regimen versus carboplatin/PLD combined with bevacizumab. Methods In this multicentre, open-label, randomised, phase 3 trial, eligible patients had histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with first disease recurrence >6 months after first-line platinum-based chemotherapy, and were aged ≥18 years with Eastern Cooperative Oncology Group performance status 0-2. Patients were stratified by platinum-free interval, residual tumour, prior anti-angiogenic therapy, and study group language, and centrally randomised 1:1 using randomly permuted blocks of size two, four, or six to six intravenous cycles of carboplatin (AUC 4, day 1) plus gemcitabine (1000 mg/m 2 , days 1 and 8) every 3 weeks or six cycles of carboplatin (AUC 5, day 1) plus PLD (30 mg/m 2 , day 1) every 4 weeks, both given with bevacizumab (15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks) until disease progression or toxicity. The primary endpoint was investigator-assessed progression-free survival (PFS). Efficacy data were analysed in the intention-to-treat population (all randomised patients). Safety was analysed in all patients who received at least one dose of study drug. This completed study is registered with ClinicalTrials.gov number NCT01837251.
Our data compare favorably to a theoretical cohort suggesting a clinically reasonable cut-off of > 11 mm endometrial thickness to discriminate between "normal" and "pathological". The data regarding "risk for endometrial cancer" can be used for counseling affected women.
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