Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer Journal Article
| Authors: | Aghajanian, C.; Goff, B.; Nycum, L. R.; Wang, Y. V.; Husain, A.; Blank, S. V. |
| Article Title: | Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer |
| Abstract: | Objective OCEANS is a randomized, placebo (PL)-controlled, phase 3 trial evaluating the efficacy and safety of bevacizumab combined with gemcitabine + carboplatin (GC) for patients with platinum-sensitive recurrent ovarian cancer (ROC). The study met its primary endpoint, demonstrating improved progression-free survival with GC + bevacizumab compared with GC + PL. Herein, we describe results of final overall survival (OS) and updated safety. Methods Patients with recurrent platinum-sensitive ROC (recurring ≥ 6 months after first-line platinum-based therapy) and measurable disease at baseline were randomized to receive GC + bevacizumab or GC + PL for 6-10 cycles; PL or bevacizumab was then continued until disease progression. In this updated analysis, a Cox proportional hazards model was used to compare OS between the 2 treatment arms. Results At the data cutoff date (July 19, 2013), 353 patients (72.9%) had died. Median follow-up for OS was 58.2 months in the experimental arm and 56.4 months in the control arm. Consistent with interim analyses, median OS was comparable between arms (GC + bevacizumab: 33.6 months; GC + PL: 32.9 months; hazard ratio = 0.95; log-rank p = 0.65), and was consistent across all examined patient subgroups. The frequency and severity of adverse events were consistent with previous analyses; no new safety concerns were identified. Conclusions Results from final OS analysis of the phase 3 OCEANS study showed no significant difference in OS for patients treated with GC + bevacizumab compared with GC + PL. © 2015 Elsevier Inc. All rights reserved.. |
| Keywords: | cancer chemotherapy; cancer survival; aged; survival rate; major clinical study; overall survival; disease course; fatigue; neutropenia; cancer recurrence; fistula; bevacizumab; doxorubicin; placebo; diarrhea; drug safety; hypertension; treatment duration; gemcitabine; paclitaxel; cancer patient; follow up; ovarian cancer; cytoreductive surgery; carboplatin; multiple cycle treatment; ovary cancer; nausea; stomatitis; thrombocytopenia; risk factor; arthralgia; backache; coughing; dyspnea; febrile neutropenia; drug induced headache; insomnia; disease severity; thromboembolism; safety; phase 3 clinical trial; digestive system perforation; wound healing impairment; epistaxis; brain hemorrhage; proteinuria; hemorrhoid; dysphonia; abscess; sinusitis; gingiva bleeding; rhinorrhea; left ventricular systolic dysfunction; human; female; priority journal; article; oropharynx pain; oceans; sinus congestion |
| Journal Title: | Gynecologic Oncology |
| Volume: | 139 |
| Issue: | 1 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2015-10-01 |
| Start Page: | 10 |
| End Page: | 16 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2015.08.004 |
| PROVIDER: | scopus |
| PUBMED: | 26271155 |
| PMCID: | PMC4993045 |
| DOI/URL: | |
| Notes: | Export Date: 2 November 2015 -- Source: Scopus |
