A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal) of S-1 (FT, gineracil, oteracil potassium; Taiho Pharmaceutical, Tokyo, Japan) at 80-120 mg/body/day according to body surface area (BSA): BSA <1.25 m2, 80 mg/day; BSA >1.25 m2 but <1.5 m2, 100 mg/day; and BSA >1.5 m2, 120 mg/day. S-1 was administered orally, twice daily after meals, starting within 4 weeks after surgery.

Inclusion criteria

• NSCLC with histological proof.
• Pathological stage IB, II, or IIIA NSCLC (fifth edition of UICC/AJCC 1997) after complete resection.
• No prior treatment except for surgery.
• Sufficient oral intake.
• Performance status (PS) 0 or 1.
• Patients also had to have adequate organ function (3500 <leukocytes < 12,000/mm3; thrombocytes, >100,000/mm3; total bilirubin,<1.5 mg/dl; AST and ALT, less than twice the normal limits at each institution; BUN, <25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (Ccr))

Exclusion criteria

• History of drug hypersensitivity.
• Contraindication of oral S-1 administration (refer appended paper).
• Serious surgical or non-surgical complications
• Active secondary cancer.
• Watery diarrhea.
• Pregnant or lactating women.
• Male who has intention to make pregnant
• Patient to whom primary doctor judged inadequate to register.