Ikenaga Naoki, Miyasaka Yoshihiro, Ohtsuka Takao, Nakata Kohei, Adachi Tomohiko, Eguchi Susumu, Nishihara Kazuyoshi, Inomata Masafumi, Kurahara Hiroshi, Hisaka Toru, Baba Hideo, Nagano Hiroaki, Ueki Toshiharu, Noshiro Hirokazu, Tokunaga Shoji, Ishigami Kousei, Nakamura Masafumi
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Ann Surg Oncol. 2023 Jan;30(1):193-202. doi: 10.1245/s10434-022-12566-1. Epub 2022 Oct 7.
Only two clinical trials have shown the effects of neoadjuvant treatment for borderline resectable pancreatic cancer with arterial involvement (BRPC-A). Here, we aimed to analyze the efficacy and safety of neoadjuvant gemcitabine plus nab-paclitaxel (GnP) for BRPC-A.
A prospective, single-arm, multicenter phase II trial was conducted. Patients who were radiologically and histologically diagnosed with BRPC-A were enrolled. A central review was conducted to confirm the presence of BRPC-A. Patients received two to four cycles of GnP before surgery. The primary endpoint of the study was the R0 resection rate. Overall survival (OS) was evaluated in an ancillary study.
Thirty-five patients were enrolled, of whom 33 were subjected to central review and 28 were confirmed to have BRPC-A. All eligible patients with BRPC-A received neoadjuvant GnP. Nineteen patients underwent pancreatic resections. Postoperative complications of Clavien-Dindo IIIa or lower were observed in 11 patients. No treatment-related mortalities were observed. R0 resection was achieved in 17 patients (89%); the R0 resection rate was 61% in eligible patients. One patient underwent curative resection after termination of the treatment protocol, resulting in an overall R0 resection rate of 64%. The median overall survival (OS) and 2-year OS rate were 24.9 months [95% confidence interval (CI) 19.0 months to not estimatable] and 53.6%, respectively. OS in patients with BRPC-A who achieved overall R0 resection was significantly longer than that in the other patients (p = 0.0255).
Neoadjuvant GnP is a safe and effective strategy for BRPC-A, providing a chance for curative resection and improved survival.
仅有两项临床试验显示了新辅助治疗对伴有动脉侵犯的可切除边缘性胰腺癌（BRPC-A）的疗效。在此，我们旨在分析新辅助吉西他滨联合纳米白蛋白结合型紫杉醇（GnP）治疗BRPC-A的疗效和安全性。
开展了一项前瞻性、单臂、多中心II期试验。纳入经放射学和组织学诊断为BRPC-A的患者。进行了中心评估以确认BRPC-A的存在。患者在手术前接受两至四个周期的GnP治疗。该研究的主要终点是R0切除率。在一项辅助研究中评估了总生存期（OS）。
共纳入35例患者，其中33例接受了中心评估，28例被确诊为BRPC-A。所有符合条件的BRPC-A患者均接受了新辅助GnP治疗。19例患者接受了胰腺切除术。11例患者出现了Clavien-Dindo IIIa级或更低级别的术后并发症。未观察到与治疗相关的死亡病例。17例患者（89%）实现了R0切除；符合条件的患者中R0切除率为61%。1例患者在治疗方案结束后接受了根治性切除，使得总体R0切除率达到64%。中位总生存期（OS）和2年OS率分别为24.9个月[95%置信区间（CI）19.0个月至无法估计]和53.6%。实现总体R0切除的BRPC-A患者的OS显著长于其他患者（p = 0.0255）。
新辅助GnP是治疗BRPC-A的一种安全有效的策略，为根治性切除和改善生存提供了机会。
