S-1 Monotherapy as Second-line Treatment for Advanced Pancreatic Cancer after Gemcitabine Failure

OBJECTIVE: No standard salvage chemotherapy regimen has been established for patients with advanced pancreatic cancer after failure of gemcitabine-based treatment. Although a Phase II study of S-1 monotherapy was conducted in patients with gemcitabine-refractory advanced pancreatic cancer, the number of patients enrolled was small. METHODS: We retrospectively reviewed 84 consecutive patients who received S-1 monotherapy as a second-line treatment after gemcitabine failure at the Shizuoka Cancer Center between May 2004 and April 2008. The selection criteria in this study were age 20-75 years, ECOG performance status <or=2 and preserved organ functions. S-1 was administered orally twice a day at a dose of 40 mg/m(2) for 28 days, followed by 14-day rest. RESULTS: Fifty-two patients were selected for the analysis. Out of the 47/52 patients with measurable lesions, only 2 patients (4%) showed a partial response and 15 patients (32%) showed stable disease. The median progression-free survival was 2.1 months and the median overall survival was 5.8 months, with a 1-year survival rate of 12%. The common grade 3/4 toxicities were diarrhea (8%), anorexia (6%), fatigue (6%), anemia (6%) and leucopenia (4%). CONCLUSIONS: S-1 monotherapy is marginally effective and well tolerated in the second-line setting in patients with gemcitabine-refractory advanced pancreatic cancer.