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

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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.

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Acknowledgements

The authors would like to thank Drs. Saburo Matsubara, Natsuyo Yamamoto, Kenji Hirano for their patient management.

Funding

This research was supported by Japanese foundation for multidisciplinary treatment of cancer.

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Authors and Affiliations

  1. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo Bunkyo-ku, Tokyo, 113-8655, Japan

    Kei Saito, Hiroyuki Isayama, Yousuke Nakai, Kazunaga Ishigaki, Naminatsu Takahara, Suguru Mizuno, Hirofumi Kogure, Hideaki Ijichi, Keisuke Tateishi, Minoru Tada & Kazuhiko Koike

  2. Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan

    Hiroyuki Isayama

  3. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Yoshihiro Sakamoto, Junichi Arita, Kiyoshi Hasegawa & Norihiro Kokudo

  4. Department of Pathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Mariko Tanaka & Masashi Fukayama

  5. Department of Radiology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Takeyuki Watadani

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  1. Kei Saito
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Correspondence to Hiroyuki Isayama.

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Conflict of interest

Hiroyuki Isayama and Yousuke Nakai received research funding from Taiho Pharmaceutical Co. All remaining authors declare that they have no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Hilsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Saito, K., Isayama, H., Sakamoto, Y. et al. A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer. Med Oncol 35, 100 (2018). https://doi.org/10.1007/s12032-018-1158-8

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