Journal article
Bevacizumab in Stage II-III Colon Cancer: 5-Year Update of the National Surgical Adjuvant Breast and Bowel Project C-08 Trial
Journal of clinical oncology, Vol.31(3), pp.359-364
01/20/2013
DOI: 10.1200/JCO.2012.44.4711
PMCID: PMC3732014
PMID: 23233715
Abstract
PurposeThe National Surgical Adjuvant Breast and Bowel Project trial C-08 was designed to investigate the safety and efficacy of adding bevacizumab to fluorouracil, leucovorin, and oxaliplatin (FOLFOX6) for the adjuvant treatment of patients with stage 2-3 colon cancer. Our report summarizes the primary and secondary end points of disease-free and overall survival, respectively, with 5 years median follow-up time.Patients and MethodsPatients received modified FOLFOX6 once every 2 weeks for a 6-month period (control group) or modified FOLFOX6 for 6 months plus bevacizumab (5 mg/kg) once every 2 weeks for a 12-month period (experimental group). The primary end point of the study was disease-free survival (DFS) and overall survival (OS) was a secondary end point.ResultsOf 2,673 analyzed patients, demographic factors were well-balanced by treatment. With a median follow-up of 5 years, the addition of bevacizumab to mFOLFOX6 did not result in an overall significant increase in DFS (hazard ratio [HR], 0.93; 95% CI, 0.81 to 1.08; P = .35). Exploratory analyses found that the effect of bevacizumab on DFS was different before and after a 1.25-year landmark (time-by-treatment interaction P value <.0001). The secondary end point of OS was no different between the two study arms for all patients (HR, 0.95; 95% CI, 0.79 to 1.13; P = .56) and for those with stage 3 disease (HR, 1.0; 95% CI, 0.83 to 1.21; P = .99).ConclusionBevacizumab for 1 year with modified FOLFOX6 does not significantly prolong DFS or OS in stage 2-3 colon cancer. We observed no evidence of a detrimental effect of exposure to bevacizumab. A transient effect on disease-free survival was observed during bevacizumab exposure in the study's experimental arm.
Details
- Title: Subtitle
- Bevacizumab in Stage II-III Colon Cancer: 5-Year Update of the National Surgical Adjuvant Breast and Bowel Project C-08 Trial
- Creators
- Carmen J Allegra - Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DEGreg Yothers - Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DEMichael J O'Connell - Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DESaima Sharif - Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DENicholas J Petrelli - Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DESamia H Lopa - Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DENorman Wolmark - Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DE
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.31(3), pp.359-364
- DOI
- 10.1200/JCO.2012.44.4711
- PMID
- 23233715
- PMCID
- PMC3732014
- NLM abbreviation
- J Clin Oncol
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 01/20/2013
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984094521302771
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