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

Abstract

Abstract Background 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. Methods 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 ≤3\xa0mo before first dose were excluded. Pts received BEV 15\xa0mg/kg, P 175\xa0mg/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. Results 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 27.8\xa0mo. The most common reasons for stopping treatment were PD (39%) and AEs (34%). Median BEV duration was 6.7 (range Conclusions These results show that BEV can be combined with CP in the CECILIA study population. The fistula/GI perforation incidence is in line with GOG240 and efficacy results are encouraging. Clinical trial identification NCT02467907. Editorial acknowledgement Jennifer Kelly (Medi-Kelsey Ltd), funded by F. Hoffmann-La Roche. Legal entity responsible for the study F. Hoffmann-La Roche. Funding F. Hoffmann-La Roche. Disclosure A. Redondo: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche Farma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Honoraria (self), Advisory / Consultancy: Clovis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: PharmaMar; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Research grant / Funding (institution): Eisai. N. Colombo: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: PharmaMar; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: BIOCAD; Advisory / Consultancy: Takeda; Advisory / Consultancy: Lilly; Non-remunerated activity/ies, ESMO Clinical Guidelines: ESMO; Non-remunerated activity/ies, Scientific Committee Chair: ACTO Onlus. L.M. Dreosti: Honoraria (self), Advisory / Consultancy: Eli Lilly; Honoraria (self), Advisory / Consultancy: MSD; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Merck. M. McCormack: Honoraria (self): AstraZeneca; Honoraria (self): Roche. A. Nogueira Rodrigues: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD. M. Donica: Shareholder / Stockholder / Stock options: Novartis; Full / Part-time employment: Roche. B. Ulker: Full / Part-time employment: F. Hoffmann-La Roche AG. A. Gonzalez Martin: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Non-remunerated activity/ies, PI of PRIMA: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: ImmunoGen; Advisory / Consultancy, Speaker Bureau / Expert testimony: PharmaMar; Advisory / Consultancy: MSD; Advisory / Consultancy: Genmad. All other authors have declared no conflicts of interest. Scientific clarification