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Neoadjuvant Chemotherapy with Gemcitabine and S-1 for Resectable and Borderline Pancreatic Ductal Adenocarcinoma: Results from a Prospective Multi-institutional Phase 2 Trial

  • Pancreatic Tumors
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Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Surgical resection is the only curative strategy for pancreatic ductal adenocarcinoma (PDAC), but recurrence rates are high even after purported curative resection. First-line treatment with gemcitabine and S-1 (GS) is associated with promising antitumor activity with a high response rate. The aim of this study was to assess the feasibility and efficacy of GS in the neoadjuvant setting.

Methods

In a multi-institutional single-arm phase 2 study, neoadjuvant chemotherapy (NAC) with gemcitabine and S-1, repeated every 21 days, was administered for two cycles (NAC-GS) to patients with resectable and borderline PDAC. The primary end point was the 2-year survival rate. Secondary end points were feasibility, resection rate, pathological effect, recurrence-free survival, and tumor marker status.

Results

Of 36 patients enrolled, 35 were eligible for this clinical trial conducted between 2008 and 2010. The most common toxicity was neutropenia in response to 90 % of the relative dose intensity. Responses to NAC included radiological tumor shrinkage (69 %) and decreases in CA19-9 levels (89 %). R0 resection was performed for 87 % in resection, and the morbidity rate (40 %) was acceptable. The 2-year survival rate of the total cohort was 45.7 %. Patients who underwent resection without metastases after NAC-GS (n = 27) had an increased median overall survival (34.7 months) compared with those who did not undergo resection (P = 0.0017).

Conclusions

NAC-GS was well tolerated and safe when used in a multi-institutional setting. The R0 resection rate and the 2-year survival rate analysis are encouraging for patients with resectable and borderline PDAC.

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Acknowledgment

Supported in part by Grants-in-Aid for Scientific Research 21591766 from the Japan Society for the Promotion of Science. We thank Dr. Tetsuyuki Uchiyama for his contribution to this study.

Disclosure

The authors declare no conflict of interest.

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Authors and Affiliations

  1. Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan

    Fuyuhiko Motoi MD, Shigeru Ottomo MD, Takaho Okada MD, Kei Nakagawa MD, Yu Katayose MD, Shinichi Egawa MD & Michiaki Unno MD

  2. Department of Diagnostic Pathology, Iwate Medical University, Morioka, Japan

    Kazuyuki Ishida MD

  3. Department of Pathology, Tohoku University Hospital, Sendai, Japan

    Fumiyoshi Fujishima MD

  4. Department of Gastroenterological Surgery, Sendai Open Hospital, Sendai, Japan

    Masaya Oikawa MD

  5. Department of Surgery, National Hospital Organization, Sendai Medical Center, Sendai, Japan

    Hiromune Shimamura MD

  6. Department of Surgery, Shirakawa Kosei General Hospital, Shirakawa, Japan

    Shinichi Takemura MD

  7. Department of Surgery, Senboku Kumiai General Hospital, Daisen, Japan

    Fuminori Ono MD

  8. Department of Surgery, South Miyagi Medical Center, Ōgawara , Japan

    Masanori Akada MD

  9. Division of Surgery and Oncology, Department of Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan

    Kei Nakagawa MD, Yu Katayose MD & Michiaki Unno MD

  10. Miyagi-Hepato-Biliary-Pancreatic Clinical Oncology Group (Miyagi-HBPCOG), Sendai, Japan

    Fuyuhiko Motoi MD, Masaya Oikawa MD, Hiromune Shimamura MD, Shinichi Takemura MD, Fuminori Ono MD, Masanori Akada MD, Yu Katayose MD, Shinichi Egawa MD & Michiaki Unno MD

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  1. Fuyuhiko Motoi MD
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Correspondence to Fuyuhiko Motoi MD.

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Motoi, F., Ishida, K., Fujishima, F. et al. Neoadjuvant Chemotherapy with Gemcitabine and S-1 for Resectable and Borderline Pancreatic Ductal Adenocarcinoma: Results from a Prospective Multi-institutional Phase 2 Trial. Ann Surg Oncol 20, 3794–3801 (2013). https://doi.org/10.1245/s10434-013-3129-9

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  • DOI: https://doi.org/10.1245/s10434-013-3129-9

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