Safety, efficacy and pharmacokinetics of S-1 in a hemodialysis patient with advanced gastric cancer.

Purpose: The safety and efficacy of S-1 in hemodialysis patients have not been established. We evaluated the safety and efficacy and pharmacokinetics of S-1 in a hemodialysis patient with advanced gastric cancer.

Patient: A 66-year-old Japanese man with chronic renal failure, who had undergone hemodialysis three times a week for 3 years. Based on the diagnosis of stage IV gastric cancer, S-1 therapy was started. S-1 was administered 11 times at a daily dose of 23.5 mg/m(2) (40 mg/body)after hemodialysis, followed by a rest. One course was a period of 28 days. Blood samples were obtained after the first administration of S-1 and before beginning the fourth course. The concentration of 5-FU was determined by high-performance liquid chromatography.

Results: Area under the concentration-time curve (AUC)of 5-FU was 2647.2 ng h/mL after administration of S-1 of 23.5 mg/m(2) (40 mg/body). During the S-1 treatment,serious adverse events such as neutropenia were not observed; however, decreases in hemoglobin level were observed (grade 3). The treatment was well tolerated. After the second course of chemotherapy, the primary lesion showed a partial response and lymph node metastases and liver metastases showed stable disease.

Conclusions: Our results suggest that S-1 is an important treatment option for patients with hemodialysis with advanced gastric cancer.