Journal of Clinical Oncology, Vol 9, 606-613, Copyright © 1991 by American Society of Clinical Oncology
A randomized trial in inoperable non-small-cell lung cancer: vindesine and cisplatin versus mitomycin, vindesine, and cisplatin versus etoposide and cisplatin alternating with vindesine and mitomycin
M Fukuoka, N Masuda, K Furuse, S Negoro, M Takada, K Matsui, N Takifuji, S Kudoh, M Kawahara and M Ogawara
Department of Internal Medicine, Osaka Prefectural Habikino Hospital, Habikino, Japan.
Patients with inoperable non-small-cell lung cancer (NSCLC) were randomly
assigned to receive one of three dosage regimens: (1) vindesine and
cisplatin (VP); (2) mitomycin, vindesine, and cisplatin (MVP); or (3)
etoposide and cisplatin alternating with vindesine and mitomycin (EP/VM).
In 199 assessable patients, the response rates were VP, 33%; MVP, 43%; and
EP/VM, 19%. The addition of mitomycin to the VP regimen did not
significantly improve the response rate. The response rate was
significantly lower with the EP/VM regimen than with the MVP regimen (P
less than .01). The median survival times were VP, 50 weeks; MVP, 42 weeks;
and EP/VM, 40 weeks. These differences were not significant. Grade III or
IV thrombocytopenia was significantly greater (P less than .01) in MVP
patients (22%) than in the VP (5%). Other toxicities were similar in the
three groups. Analyses of prognostic factors showed that treatment with
MVP, sex, and histologic classification (squamous cell carcinoma) were
predictive of improved response. Important factors for improved survival,
according to the Cox regression analysis, were the stage of disease,
performance status, sex, weight loss before diagnosis, and hemoglobin
concentration.
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