Risk Factors for GI Adverse Events in a Phase III Randomized Trial of Bevacizumab in First-Line Therapy of Advanced Ovarian Cancer: A Gynecologic Oncology Group Study

American Society of Clinical Oncology (ASCO) - Tập 32 Số 12 - Trang 1210-1217 - 2014
Robert A. Burger1, Mark F. Brady1, Michael A. Bookman1, Bradley J. Monk1, Joan L. Walker1, Howard D. Homesley1, Jeffrey M. Fowler1, Benjamin E. Greer1, Matthew Boente2,1, Gini F. Fleming1, Peter Lim1, Stephen C. Rubin1, Noriyuki Katsumata1, Sharon X. Liang1
1Robert A. Burger, Fox Chase Cancer Center, Philadelphia, PA; Mark F. Brady, GOG Statistical and Data Center, Buffalo, NY; Michael A. Bookman, Arizona Cancer Center, Tucson, AZ; Bradley J. Monk, University of California at Irvine, Orange, CA; Joan L. Walker, University of Oklahoma, Oklahoma City, OK; Howard D. Homesley, Wake Forest University Medical Center, Winston-Salem, NC; Jeffrey Fowler, Ohio State University, Columbus, OH; Benjamin E. Greer, University of Washington Medical Center, Seattle, WA;...
2 Matthew Boente, Minnesota Oncology Hematology, Minneapolis, MN

Tóm tắt

Purpose

To evaluate risk factors for GI adverse events (AEs) within a phase III trial of bevacizumab in first-line ovarian cancer therapy.

Patients and Methods

Women with previously untreated advanced disease after surgery were randomly allocated to six cycles of platinum-taxane chemotherapy plus placebo cycles (C)2 to C22 (R1); chemotherapy plus bevacizumab C2 to C6 plus placebo C7 to C22 (R2); or chemotherapy plus bevacizumab C2 to C22 (R3). Patients were evaluated for history or on-study development of potential risk factors for GI AEs defined as grade ≥ 2 perforation, fistula, necrosis, or hemorrhage.

Results

Of 1,873 patients enrolled, 1,759 (94%) were evaluable, and 2.8% (50 of 1,759) experienced a GI AE: 10 of 587 (1.7%, R1), 20 of 587 (3.4%, R2), and 20 of 585 (3.4%, R3). Univariable analyses indicated that previous treatment of inflammatory bowel disease (IBD; P = .005) and small bowel resection (SBR; P = .032) or large bowel resection (LBR; P = .012) at primary surgery were significantly associated with a GI AE. The multivariable estimated relative odds of a GI AE were 13.4 (95% CI, 3.44 to 52.3; P < .001) for IBD; 2.05 (95% CI, 1.09 to 3.88; P = .026) for LBR; 1.95 (95% CI, 0.894 to 4.25; P = .093) for SBR; and 2.15 for bevacizumab exposure (aggregated 95% CI, 1.05 to 4.40; P = .036).

Conclusion

History of treatment for IBD, and bowel resection at primary surgery, increase the odds of GI AEs in patients receiving first-line platinum-taxane chemotherapy for advanced ovarian cancer. After accounting for these risk factors, concurrent bevacizumab doubles the odds of a GI AE, but is not appreciably increased by continuation beyond chemotherapy.

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American Society of Clinical Oncology (ASCO)

Tập 32 Số 12

1210-1217

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