Gonzalez-Martin, A., Gladieff, L., Tholander, B., Stroyakovsky, D., Gore, M., Scambia, G., Kovalenko, N., Oaknin, A., Ronco, J. P., Freudensprung, U., Pignata, S., Investigators, Octavia (2013) Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer. EUROPEAN JOURNAL OF CANCER, 49 (18). pp. 3831-3838. ISSN 0959-8049

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Abstract

Purpose: The single-arm OCTAVIA study evaluated front-line bevacizumab plus weekly paclitaxel and q3w carboplatin. Patients and methods: Patients with newly diagnosed ovarian cancer (International Federation of Gynecology and Obstetrics [FIGO] stage IIb-IV or grade 3/clear-cell stage I/IIA) received bevacizumab (7.5 mg/kg, day 1), weekly paclitaxel (80 mg/m(2) days 1, 8, 15) and carboplatin (area under the curve 6 [AUC6], day 1) intravenously q3w for 6-8 cycles, followed by single-agent bevacizumab (total 1 year). The primary objective was to demonstrate median progression-free survival (PFS) > 18 months according to the lower 90% confidence limit. Secondary end-points included objective response rate, overall survival, safety and tolerability. Results: Most (74%) of the 189 treated patients had stage IIIC/IV disease, similar to the ICON7 population. Patients received a median of six chemotherapy and 17 bevacizumab cycles. At the predefined cutoff 24 months after last patient enrolment, 99 patients (52%) had progressed and 19 (10%) had died, all from ovarian cancer. Median PFS was 23.7 months (95% confidence interval [CI], 19.8-26.4 months), 1-year PFS rate was 85.6%, Response Evaluation Criteria in Solid Tumors (RECIST) response rate was 84.6% and median response duration was 14.7 months. Most patients (>= 90%) completed at least six chemotherapy cycles. Grade >= 3 peripheral sensory neuropathy occurred in 5% and febrile neutropenia in 0.5%. Grade >= 3 adverse events typical of bevacizumab were no more common than in phase III bevacizumab ovarian cancer trials. There was one case of gastrointestinal perforation (0.5%) and no treatment-related deaths. \Conclusion: OCTAVIA met its primary objective, demonstrating median PFS of approximately 2 years. This bevacizumab-containing regimen is active and tolerable. (C) 2013 Elsevier Ltd. All rights reserved.

Item Type:	Article
Authors (ICR Faculty only):	Gore, Martin
All Authors:	Gonzalez-Martin, A., Gladieff, L., Tholander, B., Stroyakovsky, D., Gore, M., Scambia, G., Kovalenko, N., Oaknin, A., Ronco, J. P., Freudensprung, U., Pignata, S., Investigators, Octavia
Additional Information:	Gonzalez-Martin, Antonio Gladieff, Laurence Tholander, Bengt Stroyakovsky, Daniel Gore, Martin Scambia, Giovanni Kovalenko, Nadezhda Oaknin, Ana Ronco, Julian Perez Freudensprung, Ulrich Pignata, Sandro
Research teams:	Clinical Units > Gynaecology Unit Clinical Units > Skin Unit
Depositing User:	Barry Jenkins
Date Deposited:	23 Dec 2013 15:54
Last Modified:	01 May 2014 14:19
URI:	http://publications.icr.ac.uk/id/eprint/12925

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