PMID- 24637999
OWN - NLM
STAT- MEDLINE
DCOM- 20140723
LR  - 20231104
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 32
IP  - 12
DP  - 2014 Apr 20
TI  - 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.
PG  - 1210-7
LID - 10.1200/JCO.2013.53.6524 [doi]
AB  - 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.
FAU - Burger, Robert A
AU  - Burger RA
AD  - Robert 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; Matthew Boente, Minnesota Oncology 
      Hematology, Minneapolis, MN; Gini F. Fleming, University of Chicago, Chicago, IL; 
      Peter C. Lim, Center of Hope at Renown Regional Medical Center, Reno, NV; Stephen 
      C. Rubin, University of Pennsylvania Cancer Center, Philadelphia, PA; Noriyuki 
      Katsumata, Saitama Medical University/International Medical Center-GOG Japan, 
      Saitama, Japan; and Sharon X. Liang, North Shore University Hospital, Manhasset, 
      NY.
FAU - Brady, Mark F
AU  - Brady MF
FAU - Bookman, Michael A
AU  - Bookman MA
FAU - Monk, Bradley J
AU  - Monk BJ
FAU - Walker, Joan L
AU  - Walker JL
FAU - Homesley, Howard D
AU  - Homesley HD
FAU - Fowler, Jeffrey
AU  - Fowler J
FAU - Greer, Benjamin E
AU  - Greer BE
FAU - Boente, Matthew
AU  - Boente M
FAU - Fleming, Gini F
AU  - Fleming GF
FAU - Lim, Peter C
AU  - Lim PC
FAU - Rubin, Stephen C
AU  - Rubin SC
FAU - Katsumata, Noriyuki
AU  - Katsumata N
FAU - Liang, Sharon X
AU  - Liang SX
LA  - eng
GR  - UL1 TR000430/TR/NCATS NIH HHS/United States
GR  - U10 CA037517/CA/NCI NIH HHS/United States
GR  - UG1 CA233180/CA/NCI NIH HHS/United States
GR  - CA 37517/CA/NCI NIH HHS/United States
GR  - U10 CA180867/CA/NCI NIH HHS/United States
GR  - CA 27469/CA/NCI NIH HHS/United States
GR  - U10 CA027469/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20140317
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Taxoids)
RN  - 2S9ZZM9Q9V (Bevacizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/therapeutic use
MH  - Bevacizumab
MH  - Disease-Free Survival
MH  - Double-Blind Method
MH  - Female
MH  - Gastrointestinal Diseases/*chemically induced/drug therapy
MH  - Humans
MH  - Logistic Models
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Organoplatinum Compounds/administration & dosage
MH  - Ovarian Neoplasms/*drug therapy/pathology
MH  - Risk Factors
MH  - Taxoids/administration & dosage
MH  - Young Adult
PMC - PMC3986384
COIS- Authors' disclosures of potential conflicts of interest and author contributions 
      are found at the end of this article.
EDAT- 2014/03/19 06:00
MHDA- 2014/07/24 06:00
PMCR- 2015/04/20
CRDT- 2014/03/19 06:00
PHST- 2014/03/19 06:00 [entrez]
PHST- 2014/03/19 06:00 [pubmed]
PHST- 2014/07/24 06:00 [medline]
PHST- 2015/04/20 00:00 [pmc-release]
AID - JCO.2013.53.6524 [pii]
AID - 36524 [pii]
AID - 10.1200/JCO.2013.53.6524 [doi]
PST - ppublish
SO  - J Clin Oncol. 2014 Apr 20;32(12):1210-7. doi: 10.1200/JCO.2013.53.6524. Epub 2014 
      Mar 17.