医学
贝伐单抗
西妥昔单抗
伊立替康
福尔菲里
养生
克拉斯
内科学
结直肠癌
肿瘤科
奥沙利铂
化疗方案
氟尿嘧啶
化疗
无进展生存期
外科
癌症
作者
Alan P. Venook,Donna Niedzwiecki,Heinz Josef Lenz,Federico Innocenti,Briant Fruth,Jeffrey A. Meyerhardt,Deborah Schrag,Claire Greene,Bert H. O'Neil,James N. Atkins,Scott R. 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,Daniel Mulkerin,Robert J. Mayer,Charles D. Blanke
出处
期刊:JAMA
[American Medical Association]
日期:2017-06-20
卷期号:317 (23): 2392-2392
被引量:601
标识
DOI:10.1001/jama.2017.7105
摘要
Combining biologic monoclonal antibodies with chemotherapeutic cytotoxic drugs provides clinical benefit to patients with advanced or metastatic colorectal cancer, but the optimal choice of the initial biologic therapy in previously untreated patients is unknown.To determine if the addition of cetuximab vs bevacizumab to the combination of leucovorin, fluorouracil, and oxaliplatin (mFOLFOX6) regimen or the combination of leucovorin, fluorouracil, and irinotecan (FOLFIRI) regimen is superior as first-line therapy in advanced or metastatic KRAS wild-type (wt) colorectal cancer.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.Cetuximab vs bevacizumab combined with either mFOLFOX6 or FOLFIRI chemotherapy regimen chosen by the treating physician and patient.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.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).Among patients with KRAS wt untreated advanced or metastatic colorectal cancer, there was no significant difference in overall survival between the addition of cetuximab vs bevacizumab to chemotherapy as initial biologic treatment.clinicaltrials.gov identifier: NCT00265850.