Preliminary Results From Cecilia, An Open-Label Global Safety Study Of Bevacizumab (Bev), Carboplatin (C) And Paclitaxel (P) Therapy For Metastatic, Recurrent Or Persistent Cervical Cancer (Cc)

JOURNAL OF CLINICAL ONCOLOGY(2018)

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5528Background: Adding BEV to chemotherapy (cisplatin + P or topotecan + P) for advanced (a)CC significantly improved overall and progression-free survival (PFS) in the overall population in GOG240. The CECILIA study (NCT02467907) is evaluating BEV with more widely used CP. Methods: The primary objective is 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) have 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 weeks or chemoRT ≤3 mo before the first dose are excluded. Pts receive BEV 15 mg/kg, P 175 mg/m2 and C AUC 5 q3w until progression, unacceptable toxicity or consent withdrawal. If BEV, C or P are stopped for adverse events (AEs), the remaining drug(s) can be continued alone. We report pre...
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