Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan.
Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan.
Eur J Cancer. 2021 Dec;159:215-223. doi: 10.1016/j.ejca.2021.10.012. Epub 2021 Nov 12.
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.
A multicentre, single-arm, phase II study was performed. Patients were administered 1000 mg/m gemcitabine on day 1, 125 mg/m 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).
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.
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.
有动脉侵犯的可切除边界胰腺肿瘤(BRPC-A)患者的预后极差,术前的有效治疗必不可少。我们评估了吉西他滨、nab-紫杉醇和替吉奥(GAS)新辅助化疗在 BRPC-A 患者中的临床疗效和安全性。
进行了一项多中心、单臂、二期研究。患者接受 14 天周期内第 1 天 1000mg/m2 吉西他滨、第 1 天 125mg/m2 nab-紫杉醇和第 1-7 天 60-100mg/d 替吉奥。六周期后评估患者的可切除性和治疗反应。主要终点为 2 年总生存率(OS)率和中位 OS 时间(试验注册:jRCTs061180045,UMIN000016630)。
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六周期新辅助 GAS 方案。新辅助 GAS 方案期间,14 例(30%)患者发生 3/4 级毒性。应答和疾病控制率分别为 43%和 96%。45 例(96%)患者接受了潜在根治性胰腺切除术,而 2 例因疾病进展未行手术。47 例符合条件的患者中,40 例(86%)行 R0 切除。11 例(24%)患者发生术后主要并发症(>3 级),包括 1 例死亡。47 例符合条件的患者的 2 年 OS 率和中位 OS 时间分别为 70.1%和 41.0 个月。
新辅助 GAS 化疗方案治疗 BRPC-A 疗效良好,毒性轻微,可提高 R0 切除率,延长 BRPC-A 患者的生存时间。