Phase III Prospectively Randomized Trial of Perioperative 5-FU After Curative Resection for Colon Cancer: An Intergroup Trial of the ECOG-ACRIN Cancer Research Group (E1292)
Year: 2022
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Studies suggest that adjuvant chemotherapy should be initiated at the earliest possible time. The Eastern Cooperative Oncology Group (ECOG) and Intergroup evaluated the effect of perioperative fluorouracil (5-FU) on overall survival (OS) for colon cancer. PATIENTS AND METHODS: This phase III trial randomized patients to receive continuous infusional 5-FU for 7 days starting within 24 h after curative resection (arm A) or no perioperative 5-FU (arm B). Patients with Dukes' B3 and C disease received adjuvant chemotherapy per standard of care. The primary endpoint of the trial was overall survival in patients with Dukes' B3 and C disease. The secondary objective was to determine whether a week of perioperative infusion would affect survival in patients with Dukes' B2 colon cancer with no additional chemotherapy. RESULTS: From August 1993 to May 2000, 859 patients were enrolled and 855 randomized (arm A: 427; arm B: 428). The trial was terminated early due to slow accrual. The median follow-up is 15.4 years (0.03-20.3 years). Among patients with Dukes' B3 and C disease, there was no statistically significant difference in OS [median 10.3 years (95% CI 8.4, 13.2) for perioperative chemotherapy and 9.3 years (95% CI 5.7, 12.3) for no perioperative therapy, one-sided log-rank p = 0.178, HR = 0.88 (95% CI 0.66, 1.16)] or disease-free survival (DFS). For patients with Dukes' B2 disease, there was also no significant difference in OS (median 16.1 versus 12.9 years) or DFS. There was no difference between treatment arms in operative complications. One week of continuous infusion of 5-FU was tolerable; 18% of arm A patients experienced grade 3 or greater toxicity.
Source: Annals of Surgical Oncology
Authors: M. Margaret Kemeny, Fengmin Zhao, Arlene A. Forastiere, Paul Catalano, Stanley R. Hamilton, Brent W. Miedema, Nancy A. Dawson, Louis M. Weiner, Brian D. Smith, Bernard A. Mason, Stephen L. Graziano, Paul B. Gilman, Alan P. Venook, Harlan A. Pinto, Robert P. Whitehead, Peter J. O’Dwyer, Al B. Benson
Institutions: Queens Hospital Center, Mount Sinai Queens, Icahn School of Medicine at Mount Sinai, Dana-Farber Cancer Institute, Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, The University of Texas MD Anderson Cancer Center, University of Missouri, Georgetown Lombardi Comprehensive Cancer Center, University of Rochester, Pennsylvania Hospital, SUNY Upstate Medical University, Lankenau Medical Center, UCSF Helen Diller Family Comprehensive Cancer Center, Stanford Cancer Institute, Abramson Cancer Center, University of Pennsylvania, Northwestern University
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,190
Awards: G1291646684, ECOG-ACRIN Network Group Operations Center, G1946161885, G3475623468, SWOG Network Group Operations Center of the NCTN, NRG Oncology Network Group Operations Center, Rochester Network Lead Academic Participating Site, ECOG-ACRIN Network Group Statistics and Data Management Center, Johns Hopkins University NCTN Lead Academic Site Program, Alliance for Clinical Trials in Oncology Operations Center, NRG Oncology - Statistical and Data Management Center
OpenAlex ID: W4307503744