Neoadjuvant Chemotherapy with Gemcitabine and S-1 for Resectable and Borderline Pancreatic Ductal Adenocarcinoma: Results from a Prospective Multi-institutional Phase 2 Trial |
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Authors: | Fuyuhiko Motoi MD Kazuyuki Ishida MD Fumiyoshi Fujishima MD Shigeru Ottomo MD Masaya Oikawa MD Takaho Okada MD Hiromune Shimamura MD Shinichi Takemura MD Fuminori Ono MD Masanori Akada MD Kei Nakagawa MD Yu Katayose MD Shinichi Egawa MD Michiaki Unno MD |
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Affiliation: | 1. Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan 10. Miyagi-Hepato-Biliary-Pancreatic Clinical Oncology Group (Miyagi-HBPCOG), Sendai, Japan 2. Department of Diagnostic Pathology, Iwate Medical University, Morioka, Japan 3. Department of Pathology, Tohoku University Hospital, Sendai, Japan 4. Department of Gastroenterological Surgery, Sendai Open Hospital, Sendai, Japan 5. Department of Surgery, National Hospital Organization, Sendai Medical Center, Sendai, Japan 6. Department of Surgery, Shirakawa Kosei General Hospital, Shirakawa, Japan 7. Department of Surgery, Senboku Kumiai General Hospital, Daisen, Japan 8. Department of Surgery, South Miyagi Medical Center, ōgawara, Japan 9. Division of Surgery and Oncology, Department of Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan
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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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