A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000006592
- Lead Sponsor
- Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
- Brief Summary
Results: Fifty patients were eligible. The completion rate for the planned 8 courses of S-1 administration was 72.0% (36 patients). Total percentage administration amount was 71.1%. Grade 3 adverse reactions such as neutropenia (4.0%), anorexia (4.0%), thrombopenia (2.0%), anemia (2.0%), elevated total bilirubin (2.0%), hypokalemia (2.0%), nausea (2.0%), and diarrhea (2.0%) were observed, but no grade 4 adverse effects were encountered. Overall and relapse-free survival rates at 3 years were 87.7% and 69.4%, respectively. Conclusions: Postoperative 1-year administration of S-1 seems feasible as oral adjuvant chemotherapy for lung cancer. The oral formulation and low incidence of adverse reactions permit treatment on an outpatient basis. The present study would be reasonable to follow up with a properly powered phase III trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 55
Not provided
1.History of drug hypersensitivity. 2.Contraindication of oral S-1 administration (refer appended papaer). 3.Serious surgical or non-surgical complications 4.Active secondary cancer. 5.Watery diarrea. 6.Pregnant or lactating women. 7.Male who has intension to make pregnant 8.Patient to whom primary doctor judjed inadequate to register.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method