Journal of Clinical Oncology, Vol 4, 565-570, Copyright © 1986 by American Society of Clinical Oncology
Combination chemotherapy (5-fluorouracil, methyl-CCNU, mitomycin C) versus 5-fluorouracil alone for advanced previously untreated colorectal carcinoma. A phase III study of the Piedmont Oncology Association
F Richards 2d, LD Case, DR White, HB Muss, CL Spurr, DV Jackson, MR Cooper, P Zekan, J Cruz and JJ Stuart
One-hundred thirty eligible patients with advanced colorectal carcinoma who
had received no prior chemotherapy were randomized to either methyl- CCNU,
70 mg/m2 orally every 6 weeks on day 1, mitomycin C, 10 mg/m2 intravenously
every 6 weeks on day 1, and 5-fluorouracil (5-FU), 400 mg/m2 intravenously
weekly--(MMF)--or 5-FU, 600 mg/m2 intravenously weekly (5-FU). One hundred
twenty-six patients are evaluable for response. Of 62 patients treated with
MMF, one (2%) achieved complete remission, and three (5%) attained partial
remission. Of 64 patients treated with 5-FU, two (3%) achieved complete
remission, and eight (13%) attained partial remission. The median survival
for patients receiving MMF was 9.5 months compared with 10.3 months for
patients receiving 5-FU. The survival distributions for the two regimens
were not significantly different, either unadjusted or adjusted for
pretreatment characteristics. Performance status and lactic dehydrogenase
(LDH) were both significantly associated with survival. Patients with liver
metastases only and normal liver function tests had a median survival of
19.8 months and a 40% response rate. This randomized phase III trial did
not show any therapeutic advantage for MMF compared to 5-FU therapy alone
in advanced colorectal cancer. In addition, hematologic toxicity was
significantly greater with the combination (MMF) regimen.
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