Published in:
01-09-2009 | Original Article
Phase II trial of S-1 in combination with gemcitabine for chemo-naïve patients with locally advanced or metastatic pancreatic cancer
Authors:
Gyeong-Won Lee, Hye Jung Kim, Ji-Hyun Ju, Seok-Hyun Kim, Hoon Gu Kim, Tae Hyo Kim, Hyun Jin Kim, Chi-Young Jeong, Jung Hun Kang
Published in:
Cancer Chemotherapy and Pharmacology
|
Issue 4/2009
Login to get access
Abstract
Background
We performed a phase II study of combination chemotherapy with S-1 plus gemcitabine for treating chemo-naïve patients with unresectable pancreatic cancer to evaluate the efficacy and toxicity.
Patients and methods
Patients with histologically confirmed unresectable pancreatic cancer were eligible. The treatment consisted of S-1 (40 mg/m2 p.o. b.i.d. from D1 to 14) and gemcitabine (1,250 mg/m2 on D1 and 8), repeated every 3 weeks.
Results
Thirty-two patients were enrolled between March 2005 and December 2007. No complete response was observed and a partial response was observed in 14 patients (44.0%), stable disease in eight patients (25.0%), and progressive disease in eight patients (25.0%). The median time to progression was 4.92 months (95% CI: 4.16–5.67 months), and the median overall survival was 7.89 months (95% CI: 5.96–9.82 months). The survival duration was significantly longer for the patients with a good performance status compared with that of the patients with a poor performance status. The major toxicities were grade 3–4 neutropenia (9, 28.1%), grade 3/4 thrombocytopenia (5, 15.6%), and grade 3 diarrhea (5, 15.6%).
Conclusion
The combination chemotherapy of S-1 and gemcitabine showed promising antitumor activity and manageable toxicities, and especially for the good performance status patients with unresectable pancreatic cancer.