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).

Autor: Kemeny MM; Icahn School of Medicine at Mount Sinai, Queens Cancer Center of NYC Health + Hospitals/Queens, Jamaica, NY, USA. kemenym@nychhc.org., Zhao F; Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA, USA., Forastiere AA; John Hopkins University and Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA., Catalano P; Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA, USA., Hamilton SR; MD Anderson Cancer Center, Houston, TX, USA., Miedema BW; University of Missouri-Ellis Fischel, Columbia, MO, USA., Dawson NA; Lombardi Comprehensive Cancer Center, Washington, DC, USA., Weiner LM; Lombardi Comprehensive Cancer Center, Washington, DC, USA., Smith BD; Wilmont Cancer Center, Rochester, NY, USA., Mason BA; Pennsylvania Hospital, Philadelphia, PA, USA., Graziano SL; State University of New York Upstate Medical University, Syracuse, NY, USA., Gilman PB; Lankenau Medical Center, Wynnewood, PA, USA., Venook AP; Helen Diller Family Comprehensive Cancer Center, USCF, San Francisco, CA, USA., Pinto HA; Stanford Cancer Institute, Palo Alto, CA, USA., Whitehead RP; Nevada Cancer Institute, Las Vegas, NV, USA., O'Dwyer PJ; University of Pennsylvania and Abramson Cancer Center, Philadelphia, PA, USA., Benson AB; Northwestern University, Chicago, IL, USA.
Jazyk: angličtina
Zdroj: Annals of surgical oncology [Ann Surg Oncol] 2023 Feb; Vol. 30 (2), pp. 1099-1109. Date of Electronic Publication: 2022 Oct 28.
DOI: 10.1245/s10434-022-12705-8
Abstrakt: 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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