A phase II study of gemcitabine/nab-paclitaxel/S-1 combination neoadjuvant chemotherapy for patients with borderline resectable pancreatic cancer with arterial contact
A phase II study of gemcitabine/nab-paclitaxel/S-1 combination neoadjuvant chemotherapy for patients with borderline resectable pancreatic cancer with arterial contact
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DOI：
10.1016/j.ejca.2021.10.012
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发表时间：
2021-12-01
影响因子：
8.4
通讯作者：
Takahashi, Shinya
中科院分区：
文献类型：
--
作者：
Kondo, Naru;Uemura, Kenichiro;Takahashi, Shinya
背景：伴有动脉接触的交界性可切除胰腺癌(BRPC-A)患者预后极差，有效的术前治疗必不可少。我们评价了吉西他滨、NAB-紫杉醇和S-1(GAS)等新辅助化疗方案治疗乳腺癌的临床疗效和安全性。材料和方法：采用多中心、单臂、II期研究。吉西他滨1000 mg/m(2)，第1天；NaB-紫杉醇125 mg/m(2)，第1天；S-1，60~100 mg/d，第1~7天，共14天。然后在六个周期后评估患者的可切除性和治疗反应。主要终点是2年总生存率(OS)和中位OS时间(试验登记：jRCTs061180045，UMIN000016630)。结果：47例BRPC-A患者符合本研究条件。所有符合条件的患者均完成了6个疗程的新辅助化疗。14例(30%)患者在新辅助GAS方案治疗期间发生III/IV级毒性反应。有效率和疾病控制率分别为43%和96%。45名患者(96%)接受了潜在的根治性胰腺切除术，而两名患者由于疾病进展而没有接受手术。在符合条件的47例患者中，40例(86%)行了R0切除术。11例(24%)患者术后出现严重并发症(III级)，包括1例死亡。47例符合条件的患者2年OS率为70.1%，中位OS时间为41.0个月。结论：新辅助气体化疗方案治疗BRPC-A疗效好，毒副反应轻，可提高BRPC-A患者的R0切除率，延长生存期。(C)2021年爱思唯尔有限公司。保留所有权利。
Background: The prognosis of patients with borderline resectable pancreatic cancer with arterial contact (BRPC-A) is extremely poor, and effective preoperative treatment is indispensable. We evaluated the clinical efficacy and safety of neoadjuvant chemotherapy, including gemcitabine, nab-paclitaxel and S-1 (GAS), for patients with BRPC-A.Material and methods: A multicentre, single-arm, phase II study was performed. Patients were administered 1000 mg/m(2) gemcitabine on day 1, 125 mg/m(2) nab-paclitaxel on day 1 and 60-100 mg/day S-1 on days 1-7 during a 14-day cycle. Patients were then assessed for resectability and response to treatment after six cycles. The primary end-points were 2-year overall survival (OS) rate and median OS time (trial registration: jRCTs061180045, UMIN000016630).Results: Forty-seven patients with BRPC-A were eligible for the present study. Six courses of neoadjuvant GAS regimen were completed in all eligible patients. The rate of grade III/IV toxicities occurred in 14 (30%) patients during the neoadjuvant GAS regimen. The response and disease control rates were 43% and 96%, respectively. Forty-five (96%) patients received potentially curative pancreatectomy, whereas two did not owing to disease progression. R0 resection was performed in 40 (86%) of 47 eligible patients. Eleven (24%) patients experienced postoperative major complications (>grade III), including one mortality. The 2-year OS rate and median OS time among 47 eligible patients were 70.1% and 41.0 months, respectively.Conclusions: The neoadjuvant GAS chemotherapy regimen for BRPC-A showed good efficacy with mild toxicity, resulting in a high R0 resection rate and prolonged survival in patients with BRPC-A. (C) 2021 Elsevier Ltd. All rights reserved.