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

Gynecologic Oncology

Volumn 139, Issue 1, 2015, Pages 10-16

  Aghajanian, Carol ^a   Goff, Barbara ^b   Nycum, Lawrence R ^c   Wang, Yan V ^d   Husain, Amreen ^d   Blank, Stephanie V ^e  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c Forsyth Regional Cancer Center   (United States)

^d GENENTECH INC   (United States)

^e NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Bevacizumab; OCEANS; Ovarian cancer; Overall survival; Safety

Indexed keywords

BEVACIZUMAB; CARBOPLATIN; DOXORUBICIN; GEMCITABINE; PACLITAXEL; PLACEBO; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE;

ABSCESS; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BRAIN HEMORRHAGE; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER RECURRENCE; CANCER SURVIVAL; COUGHING; CYTOREDUCTIVE SURGERY; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DISEASE COURSE; DISEASE SEVERITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSPHONIA; DYSPNEA; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FISTULA; FOLLOW UP; GINGIVA BLEEDING; HEMORRHOID; HUMAN; HYPERTENSION; INSOMNIA; LEFT VENTRICULAR SYSTOLIC DYSFUNCTION; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OROPHARYNX PAIN; OVARY CANCER; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; RHINORRHEA; RISK FACTOR; SINUS CONGESTION; SINUSITIS; STOMATITIS; SURVIVAL RATE; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT DURATION; WOUND HEALING IMPAIRMENT; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; MIDDLE AGED; MULTICENTER STUDY; NEOPLASMS, GLANDULAR AND EPITHELIAL; OVARIAN NEOPLASMS; RANDOMIZED CONTROLLED TRIAL; TUMOR RECURRENCE;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BEVACIZUMAB; CARBOPLATIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASMS, GLANDULAR AND EPITHELIAL; OVARIAN NEOPLASMS; SURVIVAL RATE;

EID: 84943365399     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2015.08.004     Document Type: Article

References (20)

1. American Cancer Society Ovarian cancer Available at http://www.cancer.org/acs/groups/cid/documents/webcontent/003130-pdf.pdf 2014 (Last Medical Review: 08/05/2014; Last Revised: 12/23/2014)
2. L.A. Baldwin, B. Huang, R.W. Miller, T. Tucker, S.T. Goodrich, I. Podzielinski, and et al. Ten-year relative survival for epithelial ovarian cancer Obstet. Gynecol. 120 2012 612 618
3. W.P. McGuire, W.J. Hoskins, M.F. Brady, P.R. Kucera, E.E. Partridge, K.Y. Look, and et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer N. Engl. J. Med. 334 1996 1 6
4. M.J. Piccart, K. Bertelsen, K. James, J. Cassidy, C. Mangioni, E. Simonsen, and et al. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results J. Natl. Cancer Inst. 92 2000 699 708
5. R.L. Coleman, B.J. Monk, A.K. Sood, and T.J. Herzog Latest research and treatment of advanced-stage epithelial ovarian cancer Nat. Rev. Clin. Oncol. 10 2013 211 224
6. G.M. Keating Bevacizumab: a review of its use in advanced cancer Drugs 74 2014 1891 1925
7. R.A. Burger, M.F. Brady, M.A. Bookman, G.F. Fleming, B.J. Monk, H. Huang, and et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer N. Engl. J. Med. 365 2011 2473 2483
8. T.J. Perren, A.M. Swart, J. Pfisterer, J.A. Ledermann, E. Pujade-Lauraine, G. Kristensen, and et al. A phase 3 trial of bevacizumab in ovarian cancer N. Engl. J. Med. 365 2011 2484 2496
9. C. Aghajanian, S.V. Blank, B.A. Goff, P.L. Judson, M.G. Teneriello, A. Husain, and et al. 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 J. Clin. Oncol. 30 2012 2039 2045
10. E. Pujade-Lauraine, F. Hilpert, B. Weber, A. Reuss, A. Poveda, G. Kristensen, and et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial J. Clin. Oncol. 32 2014 1302 1308
11. C. Aghajanian, B. Goff, L.R. Nycum, Y. Wang, A. Husain, and S. Blank Independent radiologic review: bevacizumab in combination with gemcitabine and carboplatin in recurrent ovarian cancer Gynecol. Oncol. 133 2014 105 110
12. R. Brookmeyer, and J. Crowley A confidence interval for median survival time Biometrics 38 1982 29 41
13. C. Aghajanian, L.R. Nycum, B. Goff, H. Nguyen, A. Husain, and S.V. Blank Updated overall survival analysis in OCEANS, a randomized phase 3 trial of gemcitabine (G) + carboplatin (C) and bevacizumab (BV) or placebo (PL) followed by BV or PL in platinum-sensitive recurrent epithelial ovarian (ROC), primary peritoneal (PPC), or fallopian tube cancer (FTC) Ann. Oncol. 23 Suppl. 9 2012 ix319 33
14. J. Pfisterer, M. Plante, I. Vergote, A. du Bois, H. Hirte, A.J. Lacave, and et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG J. Clin. Oncol. 24 2006 4699 4707
15. U. Wagner, C. Marth, R. Largillier, J. Kaern, C. Brown, M. Heywood, and et al. Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients Br. J. Cancer 107 2012 588 591
16. R.L. Coleman, M.F. Brady, T.J. Herzog, P. Sabbatini, D.K. Armstrong, J.L. Walker, and et al. A phase III randomized controlled clinical trial of carboplatin and paclitaxel alone or in combination with bevacizumab followed by bevacizumab and secondary cytoreductive surgery in platinum-sensitive, recurrent ovarian, peritoneal primary and fallopian Gynecol. Oncol. 137 Suppl. 1 2015 1 210
17. R.L. Siegel, K.D. Miller, and A. Jemal Cancer statistics, 2015 CA Cancer J. Clin. 65 2015 5 29
18. Thigpen J. Tate Contemporary phase III clinical trial endpoints in advanced ovarian cancer: assessing the pros and cons of objective response rate, progression-free survival, and overall survival Gynecol. Oncol. 136 2015 121 129
19. U.A. Matulonis, A.M. Oza, T.W. Ho, and J.A. Ledermann Intermediate clinical endpoints: a bridge between progression-free survival and overall survival in ovarian cancer trials Cancer 121 2015 1737 1746
20. L.M. Randall, and B.J. Monk Bevacizumab toxicities and their management in ovarian cancer Gynecol. Oncol. 117 2010 497 504