Japanese Journal of Clinical Oncology, Vol 29, Issue 2 78-86, Copyright © 1999 by Foundation for Promotion of Cancer Research
J Sakamoto, C Hamada, S Kodaira, H Nakazato and Y Ohashi
BACKGROUND: Oral 5-fluorouracil and its prodrugs (tegafur, carmofur) is now
being studied for adjuvant chemotherapy of curatively resected colorectal
cancers. To evaluate the effect of these oral fluoropyrimidines (o-FPs), an
individual patient data (IPD) meta-analysis of randomized clinical trials
was performed in Japan as an inter-trialist group study. METHODS: Data from
the three clinical trials in which postoperative adjuvant therapy with
o-FPs was compared with surgery alone in patients with colorectal cancer
were sought. IPD from a total of 4960 patients with follow-up periods of at
least 5 years were analyzed. RESULTS: The results of the meta-analysis on
an 'intention to treat' basis demonstrated a significant benefit of o-FPs
in terms of the disease-free survival (DFS) of the total patients [risk
ratio (RR) 0.830, 95% confidence interval (CI) 0.742-0.929, P = 0.001].
o-FPs were also demonstrated to be effective for survival in rectal cancer
(RR 0.857, 95% CI 0.734-0.999, P = 0.049) and in Dukes'C colorectal cancer
(RR 0.828, 95% CI 0.711-0.965, P = 0.016). CONCLUSION: The results suggest
the advantage of long term o-FPs, possibly with the injection of mitomycin
C, for prognosis for curatively resected colorectal cancer patients.
ORIGINAL ARTICLE
Adjuvant therapy with oral fluoropyrimidines as main chemotherapeutic agents after curative resection for colorectal cancer: individual patient data meta-analysis of randomized trials
Department of Surgery, Aichi Prefectural Hospital, Japan. suchan@sun-inet.or.jp
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