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Gastrointestinal Cancer

NCCTG Study N9741: Leveraging Learning from an NCI Cooperative Group Phase III Trial

^aUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA; ^bMayo School of Medicine, Rochester, Minnesota, USA; ^cIowa Oncology Research Association CCOP, Des Moines, Iowa, USA

Key Words. Colorectal cancer meta-analysis • Clinical trial phase III • Pharmacogenetics

Correspondence: Richard M. Goldberg, M.D., Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, CB 7305, 170 Manning Drive, Chapel Hill, North Carolina 27599, USA. Telephone: 919-843-7711; Fax: 919-966-6735; e-mail: goldberg{at}med.unc.edu

Received August 4, 2009; accepted for publication September 14, 2009; first published online in THE ONCOLOGIST Express on October 14, 2009.

Disclosures: Richard M. Goldberg: Consultant/advisory role: American Society of Clinical Oncology (ASCO), Cancer and Leukemia Group B (CALGB), National Surgical Adjuvant Breast and Bowel Project (NSABP); Honoraria: Myriad, Amgen, Genentech, ImClone, Sanofi-Aventis, Poniard, Bristol-Myers Squibb, Genomic Health; Research funding/contracted research: Pfizer, Sanofi-Aventis, Amgen, Abbott, Enzon; Daniel J. Sargent: None; Roscoe F. Morton: None; Erin Green: None; Hanna K. Sanoff: None; Howard McLeod: None; Jan Buckner: None.

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the independent peer reviewers.

N9741 is a clinical trial in patients with metastatic colorectal cancer that was originally written in 1997 and completed patient accrual in 2004. One thousand seven hundred thirty-one patients were enrolled in the study. During the conduct of the trial, N9741 was repeatedly modified to adapt to toxicity findings, to add evaluation of oxaliplatin to what was originally a trial examining various schedules of irinotecan-based therapy, and to ask evolving questions. The trial led to a new U.S. Food and Drug Administration indication for 5-fluorouracil, leucovorin, and oxaliplatin as indicated for the treatment of previously untreated patients with metastatic colorectal cancer and helped to change the standard of care for the disease in the U.S. and worldwide. The data from the trial have been used to study multiple regimens, pharmacogenetics, and quality of life issues, to correlate plasma protein levels with outcomes, to inform trial methodology, and to perform economic analyses. To date nearly 30 papers and an even larger number of abstracts have been based upon data arising from the study. The history of the trial and the major findings are summarized in this review.