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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

verfasst von: 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

Erschienen in: Investigational New Drugs | Ausgabe 2/2019

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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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Titel: A phase II trial of gemcitabine, S-1 and LV combination (GSL) therapy in patients with advanced pancreatic cancer
verfasst von: 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
Publikationsdatum: 09.11.2018
Verlag: Springer US
Erschienen in: Investigational New Drugs / Ausgabe 2/2019
Print ISSN: 0167-6997
Elektronische ISSN: 1573-0646
DOI: https://doi.org/10.1007/s10637-018-0691-9

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

Summary

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