INTRODUCTION: The feasibility of using S-1, a novel oral dihydropyrimidine dehydrogenase (DPD)-inhibitory 5-fluorouracil, as postoperative adjuvant chemotherapy for completely resected non-small cell lung cancer (NSCLC) was analyzed. METHODS: Adjuvant chemotherapy consisted of eight courses (2-week administration and 1-week withdrawal) of S-1, at 80-120 mg/body per day in an outpatient setting. From July 2006 through March 2007, 30 patients were enrolled in this multi-institutional trial. RESULTS: The planned eight courses of S-1 administration were accomplished to 17 patients (56.7%; 95% confidence interval 37.4-74.5%). Two patients discontinued the treatment due to the disease recurrence, and therefore the completion rate was calculated to be 60.7%. The completion rate in patients younger than 70 years old was 78.6% while it was 42.9% in those of 70 years old or older. In seven patients including five elderly patients (> or =70 years old), S-1 administration was discontinued due to subjective symptoms, such as anorexia, during the early courses. The rate of patients with mild renal impairment (60< or =creatinine clearance<80 ml/min) tended to be higher in the elderly patients than that in the younger patients. Although grade 3 neutropenia (6.7%), anemia (6.7%), thrombocytopenia (3.3%) and digestive hemorrhage (3.3%) were observed, no grade 4 adverse events occurred. CONCLUSION: Postoperative long-term administration of S-1 seems feasible as adjuvant chemotherapy for NSCLC, with few adverse events except for the early development of anorexia, especially in the elderly patients. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.
INTRODUCTION: The feasibility of using S-1, a novel oral dihydropyrimidine dehydrogenase (DPD)-inhibitory 5-fluorouracil, as postoperative adjuvant chemotherapy for completely resected non-small cell lung cancer (NSCLC) was analyzed. METHODS: Adjuvant chemotherapy consisted of eight courses (2-week administration and 1-week withdrawal) of S-1, at 80-120 mg/body per day in an outpatient setting. From July 2006 through March 2007, 30 patients were enrolled in this multi-institutional trial. RESULTS: The planned eight courses of S-1 administration were accomplished to 17 patients (56.7%; 95% confidence interval 37.4-74.5%). Two patients discontinued the treatment due to the disease recurrence, and therefore the completion rate was calculated to be 60.7%. The completion rate in patients younger than 70 years old was 78.6% while it was 42.9% in those of 70 years old or older. In seven patients including five elderly patients (> or =70 years old), S-1 administration was discontinued due to subjective symptoms, such as anorexia, during the early courses. The rate of patients with mild renal impairment (60< or =creatinine clearance<80 ml/min) tended to be higher in the elderly patients than that in the younger patients. Although grade 3 neutropenia (6.7%), anemia (6.7%), thrombocytopenia (3.3%) and digestive hemorrhage (3.3%) were observed, no grade 4 adverse events occurred. CONCLUSION: Postoperative long-term administration of S-1 seems feasible as adjuvant chemotherapy for NSCLC, with few adverse events except for the early development of anorexia, especially in the elderly patients. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.