Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo Bunkyo-ku, Tokyo, 113-8655, Japan.
Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Med Oncol. 2018 May 30;35(7):100. doi: 10.1007/s12032-018-1158-8.
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/m by 30-min infusion on day 1, S-1 40 mg/m 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.
对于胰腺癌（PC），人们迫切需要开发新辅助化疗（NAC）的最佳方案。本 II 期研究评估了吉西他滨、替吉奥（S-1）和亚叶酸钙（LV）联合（GSL）治疗作为边界可切除（BR）和局部晚期（LA）PC 的 NAC 的安全性和有效性。入组患者为经病理证实的 BR 或 LA PC，并接受吉西他滨 1000mg/m 静脉输注 30 分钟，第 1 天；S-1 40mg/m 口服，每日 2 次；LV 25mg 口服，每日 2 次，每 2 周为一个疗程，每 2 个疗程评估 CT 结果。主要终点为 R0 切除率，次要终点为切除率、缓解率、不良反应、手术结果和生存情况。共入组 24 例 PC 患者（21 例 BR 和 3 例 LA）。NAC 的缓解率和疾病控制率分别为 17.4%和 87.0%。34.8%的患者出现 3 级和 4 级中性粒细胞减少症，17.4%的患者出现厌食症，17.4%的患者出现黏膜炎。血清 CA19-9 水平下降 52.2%。中位 4 个疗程后，切除率为 60.9%，行剖腹术的患者 R0 切除率为 76.5%。NAC-GSL 是 BR 和 LAPC 的一种可行的治疗选择。
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