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Randomized Controlled Trial
. 2006 Oct 9;95(7):817-21.
doi: 10.1038/sj.bjc.6603336. Epub 2006 Sep 12.

Randomised study of adjuvant chemotherapy for completely resected p-stage I-IIIA non-small cell lung cancer

K Nakagawa  1 , H Tada, A Akashi, T Yasumitsu, K Iuchi, T Taki, K Kodama; Osaka Lung Cancer Study Group, Japan
Affiliations
Randomized Controlled Trial

Randomised study of adjuvant chemotherapy for completely resected p-stage I-IIIA non-small cell lung cancer

K Nakagawa et al. Br J Cancer. .

Abstract

We evaluated the therapeutic usefulness of adjuvant chemotherapy in patients with completely resected non-small cell lung cancer (NSCLC). We also examined the relation between DNA ploidy pattern and the response to chemotherapy. A total of 267 patients with NSCLC (pathologically documented stage I, II, or IIIA) underwent complete resection, and DNA ploidy pattern was analysed. Patients with stage I disease (n=172) were randomly assigned to receive surgery alone (group A) or surgery followed by adjuvant chemotherapy (UFT (oral anti-cancer drug, a combination of Uracil and Tegaful) 400 mg day-1 for 1 year after surgery; group B). Stage II or IIIA disease patients (n=95) were randomly assigned to surgery alone (group C) or surgery followed by chemotherapy (two 28-day courses of cisplatin 80 mg m-2 on day 1 plus vindesine 3 mg m-2 on days 1 and 8, followed by UFT 400 mg day-1 for at least 1 year; group D). Eight-year overall survival rate in patients with stage I disease was 74.2% (95% confidence interval (CI): 64.4-84.0%) in group B and 57.6% (95% CI: 46.4-68.8%) in group A (P=0.045 by log-rank test). In patients with stage II and IIIA disease, no difference was found between groups C and D. Analysis according to DNA ploidy pattern revealed no difference between the groups. Postoperative chemotherapy with UFT was suggested to be useful in patients with completely resected stage I NSCLC. No difference was seen in relation to DNA pattern in any treatment group.

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Figures

Figure 1
Figure 1
Overall survival of stage I control and UFT group patients. Eight-year survival rate was 57.6% for the control group A (n=87) and 74.2% for the UFT group B (n=85). A significant difference in survival curves for these groups is seen (P=0.045 by log-rank test).
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