Clinical Study

British Journal of Cancer (2006) 95, 817–821. doi:10.1038/sj.bjc.6603336 www.bjcancer.com
Published online 12 September 2006

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

We dedicate this paper to the late Dr Takashi Mori, who died before completion of the study.

See Appendix.

K Nakagawa1, H Tada2, A Akashi3, T Yasumitsu1, K Iuchi4, T Taki5 and K Kodama6 , The Osaka Lung Cancer Study Group, Japan

  1. 1Department of Thoracic Surgery, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, 3-7-1 Habikino, Habikino 583-8588, Japan
  2. 2Department of Pulmonary Surgery, Osaka City General Hospital, Osaka 534-0021, Japan
  3. 3Department of Thoracic Surgery, Takarazuka Municipal Hospital, Takarazuka 665-0827, Japan
  4. 4Department of Surgery, National Kinki Central Hospital for Chest Diseases, Sakai 591-8555, Japan
  5. 5Department of Thoracic Surgery, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka 530-8480, Japan
  6. 6Department of Thoracic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka 537-8511, Japan

Correspondence: Dr K Nakagawa, E-mail: katuhiro@hbk.pref.osaka.jp

Received 5 May 2006; Revised 27 July 2006; Accepted 27 July 2006; Published online 12 September 2006.

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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.

Keywords:

adjuvant chemotherapy, complete resection, non-small cell lung cancer, DNA ploidy pattern, randomised controlled trial, UFT

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