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Efficacy of adjuvant fluorouracil and leucovorin in stage B2 and C colon cancer. International Multicenter Pooled Analysis of Colon Cancer Trials Investigators



Efficacy of adjuvant fluorouracil and leucovorin in stage B2 and C colon cancer. International Multicenter Pooled Analysis of Colon Cancer Trials Investigators



Seminars in Oncology 28(1 Suppl 1): 14-19



The International Multicenter Pooled Analysis of Colon Cancer Trials (IMPACT) investigators have now completed two large systematic reviews of adjuvant therapy trials in colon cancer. The IMPACT 1 study pooled data from three separate trials each comparing the efficacy of 5-fluorouracil (5-FU)/leucovorin with observation alone as adjuvant treatment for 1,526 patients with Dukes' B or C colon cancer. The results showed that treatment with 5-FU/leucovorin significantly reduced mortality by 22% (P = .029) and events such as relapse, second tumor, or death by 35% (P < .0001) after 3 years of follow-up. The side effects associated with 5-FU/leucovorin were clinically acceptable. The IMPACT 1 study also showed a clear benefit of adjuvant treatment for patients with Dukes' C colon cancer, but not for stage-B patients. After up to 10 years of follow-up, 5-FU/leucovorin significantly reduced mortality by 30% for patients with Dukes' C disease (P = .003), but only reduced mortality by 8% in patients with Dukes' B colon cancer (P = .658). The aim of the IMPACT 2 study was to determine whether 5-FU/leucovorin is an effective adjuvant treatment for patients with Dukes' B2 colon cancer. Results were pooled from five separate trials that randomized 1,016 patients. After a median of 5.75 years of follow-up, B2 patients receiving 5-FU/leucovorin did not have a significant increase in overall survival or event-free survival. At 5 years, the hazard ratio for overall survival was 0.86 (90% confidence interval, 0.68 to 1.07) and for event-free survival was 0.83 (90% confidence interval, 0.72 to 1.07). 5-Fluorouracil/leucovorin was not recommended as a standard adjuvant treatment for all patients with Dukes' B2 colon cancer.

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Accession: 045927474

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PMID: 11273584



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