A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer

Kei Saito; Hiroyuki Isayama; Yoshihiro Sakamoto; Yousuke Nakai; Kazunaga Ishigaki; Mariko Tanaka; Takeyuki Watadani; Junichi Arita; Naminatsu Takahara; Suguru Mizuno; Hirofumi Kogure; Hideaki Ijichi; Keisuke Tateishi; Minoru Tada; Kiyoshi Hasegawa; Masashi Fukayama; Norihiro Kokudo; Kazuhiko Koike

doi:10.1007/s12032-018-1158-8

A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer

Kei Saito, Hiroyuki Isayama, Yoshihiro Sakamoto, Yousuke Nakai, Kazunaga Ishigaki, Mariko Tanaka, Takeyuki Watadani, Junichi Arita, Naminatsu Takahara, Suguru Mizuno, Hirofumi Kogure, Hideaki Ijichi, Keisuke Tateishi, Minoru Tada, Kiyoshi Hasegawa, Masashi Fukayama, Norihiro Kokudo, Kazuhiko Koike

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

14 Citations (Scopus)

Abstract

There has been a pressing need to develop optimal regimen for neoadjuvant chemotherapy (NAC) for pancreatic cancer (PC). The safety and efficacy of gemcitabine, S-1, and LV combination (GSL) therapy as NAC for borderline resectable (BR) and locally advanced (LA) PC was evaluated in this phase II study. Patients with pathologically proven BR or LA PC were enrolled and gemcitabine 1000 mg/m² by 30-min infusion on day 1, S-1 40 mg/m² orally twice daily, and LV 25 mg orally twice daily on days 1–7 every 2 weeks were provided, and evaluation by CT every 2 courses was performed. The primary end point was R0 resection rate, and the secondary endpoints were resection rate, response rate, adverse events, surgical outcomes, and survival. Twenty-four patients with PC (21 BR and 3 LA) were enrolled. Response rate and disease control rate of NAC were 17.4 and 87.0%. Grade 3 and 4 toxicities involved neutropenia (34.8%), anorexia (17.4%), and mucositis (17.4%). Serum CA19-9 level decreased by 52.2%. Resection rate was 60.9% after the median of 4 cycles and R0 resection rate was 76.5% in patients undergoing laparotomy. NAC-GSL is a feasible treatment option for BR and LAPC.

Original language	English
Article number	100
Journal	Medical Oncology
Volume	35
Issue number	7
DOIs	https://doi.org/10.1007/s12032-018-1158-8
Publication status	Published - 1 Jul 2018
Externally published	Yes

Keywords

Gemcitabine
Leucovorin
Neoadjuvant chemotherapy
Pancreatic cancer
S-1

UN SDGs

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

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10.1007/s12032-018-1158-8

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Saito, K., Isayama, H., Sakamoto, Y., Nakai, Y., Ishigaki, K., Tanaka, M., Watadani, T., Arita, J., Takahara, N., Mizuno, S., Kogure, H., Ijichi, H., Tateishi, K., Tada, M., Hasegawa, K., Fukayama, M., Kokudo, N., & Koike, K. (2018). A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer. Medical Oncology, 35(7), Article 100. https://doi.org/10.1007/s12032-018-1158-8

@article{cc4e0540465140cea4d756e28acb999d,

title = "A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer",

abstract = "There has been a pressing need to develop optimal regimen for neoadjuvant chemotherapy (NAC) for pancreatic cancer (PC). The safety and efficacy of gemcitabine, S-1, and LV combination (GSL) therapy as NAC for borderline resectable (BR) and locally advanced (LA) PC was evaluated in this phase II study. Patients with pathologically proven BR or LA PC were enrolled and gemcitabine 1000 mg/m2 by 30-min infusion on day 1, S-1 40 mg/m2 orally twice daily, and LV 25 mg orally twice daily on days 1–7 every 2 weeks were provided, and evaluation by CT every 2 courses was performed. The primary end point was R0 resection rate, and the secondary endpoints were resection rate, response rate, adverse events, surgical outcomes, and survival. Twenty-four patients with PC (21 BR and 3 LA) were enrolled. Response rate and disease control rate of NAC were 17.4 and 87.0%. Grade 3 and 4 toxicities involved neutropenia (34.8%), anorexia (17.4%), and mucositis (17.4%). Serum CA19-9 level decreased by 52.2%. Resection rate was 60.9% after the median of 4 cycles and R0 resection rate was 76.5% in patients undergoing laparotomy. NAC-GSL is a feasible treatment option for BR and LAPC.",

keywords = "Gemcitabine, Leucovorin, Neoadjuvant chemotherapy, Pancreatic cancer, S-1",

author = "Kei Saito and Hiroyuki Isayama and Yoshihiro Sakamoto and Yousuke Nakai and Kazunaga Ishigaki and Mariko Tanaka and Takeyuki Watadani and Junichi Arita and Naminatsu Takahara and Suguru Mizuno and Hirofumi Kogure and Hideaki Ijichi and Keisuke Tateishi and Minoru Tada and Kiyoshi Hasegawa and Masashi Fukayama and Norihiro Kokudo and Kazuhiko Koike",

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

year = "2018",

month = jul,

day = "1",

doi = "10.1007/s12032-018-1158-8",

language = "English",

volume = "35",

journal = "Medical Oncology",

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Saito, K, Isayama, H, Sakamoto, Y, Nakai, Y, Ishigaki, K, Tanaka, M, Watadani, T, Arita, J, Takahara, N, Mizuno, S, Kogure, H, Ijichi, H, Tateishi, K, Tada, M, Hasegawa, K, Fukayama, M, Kokudo, N & Koike, K 2018, 'A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer', Medical Oncology, vol. 35, no. 7, 100. https://doi.org/10.1007/s12032-018-1158-8

TY - JOUR

T1 - A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer

AU - Saito, Kei

AU - Isayama, Hiroyuki

AU - Sakamoto, Yoshihiro

AU - Nakai, Yousuke

AU - Ishigaki, Kazunaga

AU - Tanaka, Mariko

AU - Watadani, Takeyuki

AU - Arita, Junichi

AU - Takahara, Naminatsu

AU - Mizuno, Suguru

AU - Kogure, Hirofumi

AU - Ijichi, Hideaki

AU - Tateishi, Keisuke

AU - Tada, Minoru

AU - Hasegawa, Kiyoshi

AU - Fukayama, Masashi

AU - Kokudo, Norihiro

AU - Koike, Kazuhiko

PY - 2018/7/1

Y1 - 2018/7/1

N2 - There has been a pressing need to develop optimal regimen for neoadjuvant chemotherapy (NAC) for pancreatic cancer (PC). The safety and efficacy of gemcitabine, S-1, and LV combination (GSL) therapy as NAC for borderline resectable (BR) and locally advanced (LA) PC was evaluated in this phase II study. Patients with pathologically proven BR or LA PC were enrolled and gemcitabine 1000 mg/m2 by 30-min infusion on day 1, S-1 40 mg/m2 orally twice daily, and LV 25 mg orally twice daily on days 1–7 every 2 weeks were provided, and evaluation by CT every 2 courses was performed. The primary end point was R0 resection rate, and the secondary endpoints were resection rate, response rate, adverse events, surgical outcomes, and survival. Twenty-four patients with PC (21 BR and 3 LA) were enrolled. Response rate and disease control rate of NAC were 17.4 and 87.0%. Grade 3 and 4 toxicities involved neutropenia (34.8%), anorexia (17.4%), and mucositis (17.4%). Serum CA19-9 level decreased by 52.2%. Resection rate was 60.9% after the median of 4 cycles and R0 resection rate was 76.5% in patients undergoing laparotomy. NAC-GSL is a feasible treatment option for BR and LAPC.

AB - There has been a pressing need to develop optimal regimen for neoadjuvant chemotherapy (NAC) for pancreatic cancer (PC). The safety and efficacy of gemcitabine, S-1, and LV combination (GSL) therapy as NAC for borderline resectable (BR) and locally advanced (LA) PC was evaluated in this phase II study. Patients with pathologically proven BR or LA PC were enrolled and gemcitabine 1000 mg/m2 by 30-min infusion on day 1, S-1 40 mg/m2 orally twice daily, and LV 25 mg orally twice daily on days 1–7 every 2 weeks were provided, and evaluation by CT every 2 courses was performed. The primary end point was R0 resection rate, and the secondary endpoints were resection rate, response rate, adverse events, surgical outcomes, and survival. Twenty-four patients with PC (21 BR and 3 LA) were enrolled. Response rate and disease control rate of NAC were 17.4 and 87.0%. Grade 3 and 4 toxicities involved neutropenia (34.8%), anorexia (17.4%), and mucositis (17.4%). Serum CA19-9 level decreased by 52.2%. Resection rate was 60.9% after the median of 4 cycles and R0 resection rate was 76.5% in patients undergoing laparotomy. NAC-GSL is a feasible treatment option for BR and LAPC.

KW - Gemcitabine

KW - Leucovorin

KW - Neoadjuvant chemotherapy

KW - Pancreatic cancer

KW - S-1

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U2 - 10.1007/s12032-018-1158-8

DO - 10.1007/s12032-018-1158-8

M3 - Article

C2 - 29846849

AN - SCOPUS:85048032081

SN - 1357-0560

VL - 35

JO - Medical Oncology

JF - Medical Oncology

IS - 7

M1 - 100

ER -

A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer

Abstract

Keywords

UN SDGs

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