Purpose: The goal of this analysis was to determine whether fluorouracil (F
U) and folinic acid (leucovorin, LV) is an effective adjuvant therapy for p
atients after potentially curative resection of colon cancer in patients wi
th B2 tumors.
Patients and Methods: One thousand sixteen patients with B2 colon cancer en
tered onto five separate trials were randomized to FU + LV or observation,
A pooled analysis for event-free (EFS) and overall survival (OS) using a st
ratified lag-rank and Cox model was performed.
Results: The median follow-vp duration was 5.75 years. Patients receiving F
U + 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 a
nd 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 war 80% for controls and
82% for FU + LV. Increasing age and pearly differentiated tumors were sign
ificant indicators of poor prognosis (P <.02).
Conclusion: This data set does not support the routine use of + LV in all p
atients with B2 colon cancer. ranger follow-up may identify a small benefit
. At present, studies in B2 colon cancer designed with a no-treatment contr
ol arm should be considered appropriate. J Clin Oncol 17:1356-1363. (C) 199
9 by American Society of Clinical Oncology.