© 2005 European Society for Medical Oncology
Original article |
A randomized phase III trial of adjuvant chemotherapy with UFT for completely resected pathological stage I non-small-cell lung cancer: the West Japan Study Group for Lung Cancer Surgery (WJSG)—the 4th study
1 Department of Thoracic Surgery, Kyoto University, Kyoto; 2 Department of Thoracic Surgery, Hyogo Medical Center for Adults, Akashi; 3 Department of Thoracic Surgery, National Okinawa Hospital, Okinawa; 4 Department of Thoracic and Cardiovascular Surgery, Mie University, Mie, Japan
* Correspondence to: Dr H. Wada, Department of Thoracic Surgery, Kyoto University Hospital, Shogoin-kawara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan. Tel: +81-75-751-3835; Fax: +81-75-751-4647; Email: wadah{at}kuhp.kyoto-u.ac.jp
Purpose: To examine the efficacy of UFT, an oral 5-fluorouracil derivative agent, as post-operative adjuvant therapy for pathologic (p-) stage I non-small-cell lung cancer (NSCLC), because a previous randomized study had suggested it was efficacious for early-stage NSCLC patients.
Patients and methods: Patients with completely resected p-stage I, adenocarcinoma or squamous cell carcinoma were eligible. A total of 332 patients were randomized to the surgery-alone group (control group) and the treatment group (UFT 400 mg/m2 for 1 year after surgery, UFT group) after stratification by the histologic types.
Results: For all patients, the 5- and 8-year survival rates for the UFT group were 82.2% and 73.0%, and those for the control group were 75.9% and 61.2%, respectively; no statistically significant improvement of survival was achieved by UFT administration (P=0.105). For Ad patients, the 5- and 8-year survival rates of the UFT group (n=120) were 85.2% and 79.5%, respectively, which seemed better than those of the control group (n=121) (79.2% and 64.0%, respectively; P=0.081). For squamous cell carcinoma patients, there was also no difference in survival between the control group (n=48) and the UFT group (n=43) (P=0.762). For all pT1 patients, the 5- and 8-year survival rates of the UFT group were 83.6% and 82.1%, respectively, significantly better than those of the control group (77.9% and 57.6%, respectively, P=0.036); UFT was not significantly effective for pT2 patients. For pT1 adenocarcinoma patients, UFT administration markedly improved the survival (P=0.011).
Conclusion: Post-operative UFT administration did not significantly improve post-operative survival of p-stage I NSCLC patients. Subset analyses suggested that UFT might be effective in pT1N0M0 adenocarcinoma patients.
Key words: adenocarcinoma, adjuvant chemotherapy, lung cancer, squamous cell carcinoma, surgery, UFT
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