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

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

doi:10.1007/s10637-018-0691-9

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

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

Research output: Contribution to journal › Article › peer-review

6 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	338-344
Number of pages	7
Journal	Investigational New Drugs
Volume	37
Issue number	2
DOIs	https://doi.org/10.1007/s10637-018-0691-9
Publication status	Published - 15 Apr 2019
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Chemotherapy
Gemcitabine
Leucovorin
Pancreatic cancer
S-1

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10.1007/s10637-018-0691-9

Cite this

Saito, K., Isayama, H., Nakai, Y., Takahara, N., Ishigaki, K., Takeda, T., Hakuta, R., Saito, T., Uchino, R., Kishikawa, T., Hamada, T., Mizuno, S., Sasaki, T., Kogure, H., Matsubara, S., Yamamoto, N., Ijichi, H., Tateishi, K., Tada, M., & Koike, K. (2019). A phase II trial of gemcitabine, S-1 and LV combination (GSL) therapy in patients with advanced pancreatic cancer. Investigational New Drugs, 37(2), 338-344. https://doi.org/10.1007/s10637-018-0691-9

@article{55a5783f3c984a79b753a53cb3e8b34e,

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

abstract = "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-na{\"i}ve 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.",

keywords = "Chemotherapy, Gemcitabine, Leucovorin, Pancreatic cancer, S-1",

author = "Kei Saito and Hiroyuki Isayama and Yousuke Nakai and Naminatsu Takahara and Kazunaga Ishigaki and Tsuyoshi Takeda and Ryunosuke Hakuta and Tomotaka Saito and Rie Uchino and Takahiro Kishikawa and Tsuyoshi Hamada and Suguru Mizuno and Takashi Sasaki and Hirofumi Kogure and Saburo Matsubara and Natsuyo Yamamoto and Hideaki Ijichi and Keisuke Tateishi and Minoru Tada and Kazuhiko Koike",

note = "Publisher Copyright: {\textcopyright} 2018, Springer Science+Business Media, LLC, part of Springer Nature.",

year = "2019",

month = apr,

day = "15",

doi = "10.1007/s10637-018-0691-9",

language = "English",

volume = "37",

pages = "338--344",

journal = "Investigational New Drugs",

issn = "0167-6997",

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number = "2",

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Saito, K, Isayama, H, Nakai, Y, Takahara, N, Ishigaki, K, Takeda, T, Hakuta, R, Saito, T, Uchino, R, Kishikawa, T, Hamada, T, Mizuno, S, Sasaki, T, Kogure, H, Matsubara, S, Yamamoto, N, Ijichi, H, Tateishi, K, Tada, M & Koike, K 2019, 'A phase II trial of gemcitabine, S-1 and LV combination (GSL) therapy in patients with advanced pancreatic cancer', Investigational New Drugs, vol. 37, no. 2, pp. 338-344. https://doi.org/10.1007/s10637-018-0691-9

TY - JOUR

T1 - A phase II trial of gemcitabine, S-1 and LV combination (GSL) therapy in patients with advanced pancreatic cancer

AU - Saito, Kei

AU - Isayama, Hiroyuki

AU - Nakai, Yousuke

AU - Takahara, Naminatsu

AU - Ishigaki, Kazunaga

AU - Takeda, Tsuyoshi

AU - Hakuta, Ryunosuke

AU - Saito, Tomotaka

AU - Uchino, Rie

AU - Kishikawa, Takahiro

AU - Hamada, Tsuyoshi

AU - Mizuno, Suguru

AU - Sasaki, Takashi

AU - Kogure, Hirofumi

AU - Matsubara, Saburo

AU - Yamamoto, Natsuyo

AU - Ijichi, Hideaki

AU - Tateishi, Keisuke

AU - Tada, Minoru

AU - Koike, Kazuhiko

PY - 2019/4/15

Y1 - 2019/4/15

N2 - 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.

AB - 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.

KW - Chemotherapy

KW - Gemcitabine

KW - Leucovorin

KW - Pancreatic cancer

KW - S-1

UR - https://www.scopus.com/pages/publications/85056296893

U2 - 10.1007/s10637-018-0691-9

DO - 10.1007/s10637-018-0691-9

M3 - Article

C2 - 30411217

AN - SCOPUS:85056296893

SN - 0167-6997

VL - 37

SP - 338

EP - 344

JO - Investigational New Drugs

JF - Investigational New Drugs

IS - 2

ER -

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

Abstract

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Keywords

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