Efficacy of Adjuvant Fluorouracil and Folinic Acid in B2 Colon Cancer

PURPOSE: The goal of this analysis was to determine whether fluorouracil (FU) and folinic acid (leucovorin, LV) is an effective adjuvant therapy for patients after potentially curative resection of colon cancer in patients with B2 tumors. PATIENTS AND METHODS: One thousand sixteen patients with B2 c...

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Bibliographic Details
Published inJournal of clinical oncology Vol. 17; no. 5; pp. 1356 - 1363
Main Author International Multicentre Pooled Analysis of B2 Colon Cancer Trials (IMPACT B2) Investigators
Format Journal Article
LanguageEnglish
Published Baltimore, MD American Society of Clinical Oncology 01.05.1999
Lippincott Williams & Wilkins
Subjects
Antineoplastic agents
Biological and medical sciences
Chemotherapy
Medical sciences
Pharmacology. Drug treatments
Adenocarcinoma
Antineoplastic agent
Human
Drug combination
Prognosis
Fluoropyrimidine derivatives
Adjuvant treatment
Early stage
Calcium folinate
Malignant tumor
Colonic disease
Chemotherapy
Digestive diseases
Intestinal disease
Pyrimidine derivatives
Colon
Fluorine Organic compounds
Fluorouracil
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Summary:PURPOSE: The goal of this analysis was to determine whether fluorouracil (FU) and folinic acid (leucovorin, LV) is an effective adjuvant therapy for patients after potentially curative resection of colon cancer in patients with B2 tumors. PATIENTS AND METHODS: One thousand sixteen patients with B2 colon cancer entered onto five separate trials were randomized to FU + LV or observation. A pooled analysis for event-free (EFS) and overall survival (OS) using a stratified log-rank and Cox model was performed. RESULTS: The median follow-up duration was 5.75 years. Patients receiving FU + LV did not experience a significant increase in EFS or OS. The hazards ratio at 5 years was 0.83 (90% confidence interval, 0.72 to 1.07) for EFS and 0.86 (90% confidence interval, 0.68 to 1.07) for OS. The 5-year EFS was 73% for controls and 76% for FU + LV. The 5-year OS was 80% for controls and 82% for FU + LV. Increasing age and poorly differentiated tumors were significant indicators of poor prognosis (P < .02). CONCLUSION: This data set does not support the routine use of FU + LV in all patients with B2 colon cancer. Longer follow-up may identify a small benefit. At present, studies in B2 colon cancer designed with a no-treatment control arm should be considered appropriate.
ISSN:0732-183X
1527-7755
DOI:10.1200/jco.1999.17.5.1356