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Eur J Cancer. 2013 Dec;49(18):3831-8. doi: 10.1016/j.ejca.2013.08.002. Epub 2013 Sep 2.

Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer.

Author information

  • 1GEICO and MD Anderson Cancer Center Spain, Madrid, Spain. Electronic address: agonzalezm@seom.org.

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 (7.5mg/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.

Copyright © 2013 Elsevier Ltd. All rights reserved.

KEYWORDS:

Angiogenesis; Bevacizumab; Front-line; Ovarian cancer; Weekly paclitaxel

PMID:
24007819
[PubMed - indexed for MEDLINE]
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