1053P - Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab (BEV), carboplatin (C) and paclitaxel (P) for advanced cervical cancer (aCC)

Adding BEV to P + cisplatin/topotecan for aCC significantly improved overall survival (OS) and progression-free survival (PFS) in the phase 3 GOG240 trial. CECILIA (NCT02467907) evaluated BEV with a more widely used CP backbone. The primary objective was to determine the safety of BEV + CP for aCC, defined by the frequency and severity of gastrointestinal (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula. Eligible patients (pts) had metastatic/recurrent/persistent CC not amenable to curative surgery and/or radiotherapy (RT). Pts with ongoing bladder/rectal involvement, prior cobalt RT, history of fistula/GI perforation, or bowel resection ≤6 wk or chemoRT ≤3mo before first dose were excluded. Pts received BEV 15mg/kg, P 175mg/m2 and C AUC 5 q3w until disease progression (PD), unacceptable toxicity or consent withdrawal. If BEV, C or P was stopped for adverse events (AEs), the remaining drug(s) could be continued alone. From Jul 2015 to Dec 2016, 150 pts began treatment. Disease status at study entry was persistent in 20%, recurrent in 53% and metastatic at diagnosis in 27%; 71% had received prior RT (chemoRT in 58%) and 59% prior platinum. At data cutoff (31 Dec 2018), median follow-up was 27.8mo. The most common reasons for stopping treatment were PD (39%) and AEs (34%). Median BEV duration was 6.7 (range