OCEANS: A randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer Journal Article


Authors: Aghajanian, C.; Blank, S. V.; Goff, B. A.; Judson, P. L.; Teneriello, M. G.; Husain, A.; Sovak, M. A.; Yi, J.; Nycum, L. R.
Article Title: OCEANS: A randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
Abstract: Purpose: This randomized, multicenter, blinded, placebo-controlled phase III trial tested the efficacy and safety of bevacizumab (BV) with gemcitabine and carboplatin (GC) compared with GC in platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC). Patients and Methods: Patients with platinum-sensitive ROC (recurrence ≥ 6 months after front-line platinum-based therapy) and measurable disease were randomly assigned to GC plus either BV or placebo (PL) for six to 10 cycles. BV or PL, respectively, was then continued until disease progression. The primary end point was progression-free survival (PFS) by RECIST; secondary end points were objective response rate, duration of response (DOR), overall survival, and safety. Results: Overall, 484 patients were randomly assigned. PFS for the BV arm was superior to that for the PL arm (hazard ratio [HR], 0.484; 95% CI, 0.388 to 0.605; log-rank P < .0001); median PFS was 12.4 v 8.4 months, respectively. The objective response rate (78.5% v 57.4%; P < .0001) and DOR (10.4 v 7.4 months; HR, 0.534; 95% CI, 0.408 to 0.698) were significantly improved with the addition of BV. No new safety concerns were noted. Grade 3 or higher hypertension (17.4% v <1%) and proteinuria (8.5% v < 1%) occurred more frequently in the BV arm. The rates of neutropenia and febrile neutropenia were similar in both arms. Two patients in the BV arm experienced GI perforation after study treatment discontinuation. Conclusion: GC plus BV followed by BV until progression resulted in a statistically significant improvement in PFS compared with GC plus PL in platinum-sensitive ROC. © 2012 by American Society of Clinical Oncology.
Keywords: adult; controlled study; treatment response; aged; disease-free survival; middle aged; major clinical study; overall survival; neutropenia; fistula; bevacizumab; placebo; area under the curve; cancer combination chemotherapy; cancer growth; drug efficacy; drug safety; drug withdrawal; heart left ventricle failure; hypertension; treatment duration; antineoplastic agents; gemcitabine; recurrent cancer; ovarian neoplasms; carboplatin; progression free survival; multiple cycle treatment; peritoneum cancer; peritoneal neoplasms; bleeding; randomized controlled trial; antineoplastic combined chemotherapy protocols; recurrence; drug resistance, neoplasm; febrile neutropenia; disease progression; multicenter study; ovary carcinoma; phase 3 clinical trial; uterine tube carcinoma; fallopian tube neoplasms; double blind procedure; double-blind method; digestive system perforation; wound healing impairment; congestive heart failure; proteinuria; placebos; venous thromboembolism; neoplasms, glandular and epithelial; abscess; posterior reversible encephalopathy syndrome; antibodies, monoclonal, humanized; arterial thromboembolism
Journal Title: Journal of Clinical Oncology
Volume: 30
Issue: 17
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2012-06-10
Start Page: 2039
End Page: 2045
Language: English
DOI: 10.1200/jco.2012.42.0505
PROVIDER: scopus
PUBMED: 22529265
PMCID: PMC3646321
DOI/URL:
Notes: --- - "Cited By (since 1996): 1" - "Export Date: 30 August 2012" - "CODEN: JCOND" - "Source: Scopus"
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