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09.11.2018 | PHASE II STUDIES

A phase II trial of gemcitabine, S-1 and LV combination (GSL) therapy in patients with advanced pancreatic cancer

Zeitschrift:
Investigational New Drugs
Autoren:
Kei Saito, Hiroyuki Isayama, Yousuke Nakai, Naminatsu Takahara, Kazunaga Ishigaki, Tsuyoshi Takeda, Ryunosuke Hakuta, Tomotaka Saito, Rie Uchino, Takahiro Kishikawa, Tsuyoshi Hamada, Suguru Mizuno, Takashi Sasaki, Hirofumi Kogure, Saburo Matsubara, Natsuyo Yamamoto, Hideaki Ijichi, Keisuke Tateishi, Minoru Tada, Kazuhiko Koike

Summary

Purpose Our previous phase I trial suggested feasibility of addition of leucovorin (LV) to S-1 and gemcitabine therapy in advanced pancreatic cancer. The aim of this phase II trial was to assess the efficacy and toxicity of gemcitabine, S-1 and LV (GSL) combination therapy for advanced pancreatic cancer. Methods Chemotherapy-naïve patients with histologically or cytologically proven advanced pancreatic cancer were enrolled. Gemcitabine was administered at a dose of 1000 mg/m2 by 30 min infusion on days 1, S-1 40 mg/m2 orally twice daily and LV 25 mg orally twice daily on days 1 to 7 every 2 weeks. Primary end point was progression free survival (PFS). Results A total of 49 patients with advanced pancreatic cancer (19 locally advanced and 30 metastatic) were enrolled. Overall response rate and disease control rate were 32.7% and 87.8%. The median PFS and overall survival (OS) were 10.8 (95% confidence interval [CI], 7.4–13.5) and 20.7 (95% CI 13.0-NA) months with 1-year survival rate of 73.4%. Major Grade 3–4 toxicities were neutropenia (22.4%) and stomatitis (14.3%). No toxicity related death was observed. Conclusions In this single center, phase II trial, gemcitabine, S-1 and LV combination therapy was tolerable and can potentially be a treatment option for advanced pancreatic cancer.

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