Gemcitabine (GEM) was widely used, and cisplatin plus GEM is considered as a standard first-line chemotherapy for patients with advanced biliary tract cancer (BTC). However, no standard therapy was established following the progression to GEM-contained first-line therapy. And S-1 monotherapy as second-line chemotherapy is still not well known in practice medicine.Object
We retrospectively reviewed 55 consecutive patients who received S-1 monotherapy as second-line chemotherapy after the failure to GEM-contained regimen at our institution between September 2007 and March 2011. The key inclusion criteria were with preserved organ function and ECOG PS 0-2 and without massive ascites or pleural effusion. S-1 was administered orally twice a day at a dose of 40 mg/m2 for 28 days, followed by 14 days of rest.Results
Fifty-one patients were selected for this analysis. The overall response rate was 4.0% and the disease control rate was 38.0%. The median survival time was 6.0 months and the median progression-free survival was 2.3 months. Grade 3/4 toxic effects were diarrhea (6%), leucopenia (2%), neutropenia (2%), anemia (2%), thrombocytopenia (2%), nausea (2%), mucositis (2%), and skin rash (2%). No treatment death was occured.Conclusion
S-1 monotherapy is well tolerated and moderately efficacious in the second-line chemotherapy for patients with GEM-refractory advanced BTC in practice. However, advanced BTC consist of plural disease and its background is different from each other; randomized control study is needed.