Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial.
Abstract | Importance: Objective: Design, Setting, and Participants: Patients (≥18 years) enrolled at community and academic centers throughout the National Clinical Trials Network in the United States and Canada (November 2005-March 2012) with previously untreated advanced or metastatic colorectal cancer whose tumors were KRAS wt chose to take either the mFOLFOX6 regimen or the FOLFIRI regimen as chemotherapy and were randomized to receive either cetuximab (n = 578) or bevacizumab (n = 559). The last date of follow-up was December 15, 2015. Interventions: Main Outcomes and Measures: The primary end point was overall survival. Secondary objectives included progression-free survival and overall response rate, site-reported confirmed or unconfirmed complete or partial response. Results: Among 1137 patients (median age, 59 years; 440 [39%] women), 1074 (94%) of patients met eligibility criteria. As of December 15, 2015, median follow-up for 263 surviving patients was 47.4 months (range, 0-110.7 months), and 82% of patients (938 of 1137) experienced disease progression. The median overall survival was 30.0 months in the cetuximab- chemotherapy group and 29.0 months in the bevacizumab- chemotherapy group with a stratified hazard ratio (HR) of 0.88 (95% CI, 0.77-1.01; P = .08). The median progression-free survival was 10.5 months in the cetuximab- chemotherapy group and 10.6 months in the bevacizumab- chemotherapy group with a stratified HR of 0.95 (95% CI, 0.84-1.08; P = .45). Response rates were not significantly different, 59.6% vs 55.2% for cetuximab and bevacizumab, respectively (difference, 4.4%, 95% CI, 1.0%-9.0%, P = .13). Conclusions and Relevance: Trial Registration: clinicaltrials.gov identifier: NCT00265850.
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Authors | Alan P Venook, Donna Niedzwiecki, Heinz-Josef Lenz, Federico Innocenti, Briant Fruth, Jeffrey A Meyerhardt, Deborah Schrag, Claire Greene, Bert H O'Neil, James Norman Atkins, Scott Berry, Blase N Polite, Eileen M O'Reilly, Richard M Goldberg, Howard S Hochster, Richard L Schilsky, Monica M Bertagnolli, Anthony B El-Khoueiry, Peter Watson, Al B Benson 3rd, Daniel L Mulkerin, Robert J Mayer, Charles Blanke |
Journal | JAMA
(JAMA)
Vol. 317
Issue 23
Pg. 2392-2401
(06 20 2017)
ISSN: 1538-3598 [Electronic] United States |
PMID | 28632865
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Angiogenesis Inhibitors
- Antineoplastic Agents
- Organoplatinum Compounds
- Bevacizumab
- Cetuximab
- Leucovorin
- Fluorouracil
- Camptothecin
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(adverse effects, therapeutic use)
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects, therapeutic use)
- Bevacizumab
(adverse effects, therapeutic use)
- Camptothecin
(administration & dosage, adverse effects, analogs & derivatives)
- Canada
- Cetuximab
(adverse effects, therapeutic use)
- Colorectal Neoplasms
(drug therapy, genetics, mortality, secondary)
- Disease-Free Survival
- Female
- Fluorouracil
(administration & dosage, adverse effects)
- Genes, ras
- Humans
- Kaplan-Meier Estimate
- Leucovorin
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Organoplatinum Compounds
(administration & dosage, adverse effects)
- Treatment Outcome
- United States
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