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/m(2) 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.
RCT Entities:
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 NSCLCpatients. 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/m(2) 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 carcinomapatients, 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 adenocarcinomapatients, 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 NSCLCpatients. Subset analyses suggested that UFT might be effective in pT1N0M0 adenocarcinomapatients.
Authors: R Arriagada; A Auperin; S Burdett; J P Higgins; D H Johnson; T Le Chevalier; C Le Pechoux; M K B Parmar; J P Pignon; R L Souhami; R J Stephens; L A Stewart; J F Tierney; H Tribodet; J van Meerbeeck Journal: Lancet Date: 2010-03-24 Impact factor: 79.321