완전 절제된 비소세포폐암 병기 IB (pT2N0) 환자에서 수술 후 UFT의 효과

Abstract

Background: Recent studies have suggested that UFT may be an effective adjuvant therapy for completely resected IB (pT2N0) non-small cell lung cancer (NSCLC). We designed this study to clarify the feasibility of performing adjuvant chemotherapy with UFT for completely resected IB nor-small cell lung cancer, Material and Method: We randomly assigned patients suffering with completely resected IB non-small cell lung cancer to receive either UFT 3g for 2 year or they received no treatment. All patients had to be followed until death or the cut-off date (December 31 2006). Result: From June 2002 through December 2004, 64 patients were enrolled. Thirty five patients were assigned to receive UFT (the UFT group) and 29 patients were assigned to observation (the control group). A follow-up surrey on the 3 year survival rate was successfully completed for all the patients. The median follow-up time for all the patients was 32.8 months. In the UFT group, the median time of administration was 98 weeks (range: $2{\sim}129$ weeks). The rate of compliance was 88.2% at 6 months, 87.5% at 12 months, 80.6% at 18 month and 66.7% at 24 months. Seven recurrences (24.1%) occurred in the control group and six (17.1%) occurred in the UFT group (p=0,489). The three-year disease free survival rate was 71.3% for the control group and 82.0% for the UFT group (p=0.331). On the subgroup analysis, the three-year disease free survival rate for the patients with adenocacinoma was 45.0% for the control group and 75.2% for the UFT group (p=0.121). The three-year disease free survival rate for the patients with non-adenocarcinoma was 88.1% for the control group and 88.9% for the UFT group (p=0.964), Conclusion: Postoperative oral administration of UFT was well-tolerated. Adjuvant chemotherapy with UFT for completely resected pT2N0 adenocarcinoma of the lung could be expected to improve the disease free survival, but this failed to achieve statistical significance. A prospective randomized study for a large number of patients will be necessary.