Surgical Oncology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
Department of Surgery and Science, Faculty of Medicine, Academic Assembly University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan.
Ann Surg. 2022 Jun 1;275(6):1043-1049. doi: 10.1097/SLA.0000000000005430. Epub 2022 Mar 3.
Given the frequent adverse events with multidrug chemotherapy, not only the survival benefit but also the feasibility of using neoadjuvant chemotherapy to treat pancreatic cancer need to be clarified.
Although the development of multidrug chemotherapy regimens has improved the survival outcomes of patients with unresectable pancreatic cancer, the benefits of these treatments in the neo-adjuvant setting remain controversial.
Patients with borderline-resectable pancreatic cancer were enrolled and randomly assigned to receive neoadjuvant chemotherapy with either FOLFIRINOX or gemcitabine with nab-paclitaxel (GEM/nab-PTX). After the completion of chemotherapy, patients underwent surgical resection when feasible. This study (NUPAT-01) was a randomized phase II trial, and the primary endpoint was the R0 resection rate.
Fifty-one patients were enrolled in this study [FOLFIRINOX (n = 26) and GEM/nab-PTX (n = 25)]. A total of 84.3% (n = 43/51) of the patients eventually underwent surgery, and R0 resection was achieved in 67.4% (n = 33/ 51) of the patients. Adverse events (grade >3) due to neoadjuvant treatment were observed in 45.1% of the patients (n = 23/51), and major surgical complications occurred in 30.0% (n = 13/43), with no mortality noted. The intention-to-treat analysis showed that the 3-year overall survival rate was 54.7%, with a median survival time of 39.4 months, and a significant difference in overall survival was not observed between the FOLFIRINOX and GEM/nab-PTX groups.
These results indicate that neoadjuvant chemotherapy with FOLFIRINOX or GEM/nab-PTX is feasible and well tolerated, achieving an R0 resection rate of 67.4%. The survival of patients was even found to be favorable in the intention-to-treat analysis.
鉴于多药化疗常出现不良反应,不仅需要明确新辅助化疗治疗胰腺癌的生存获益,还要明确其可行性。
虽然多药化疗方案的发展改善了不可切除胰腺癌患者的生存结局,但这些治疗方法在新辅助治疗中的获益仍存在争议。
入组边界可切除的胰腺癌患者,随机分为接受 FOLFIRINOX 或吉西他滨联合 nab-紫杉醇(GEM/nab-PTX)新辅助化疗的两组。化疗完成后可行手术时,患者行手术切除。本研究(NUPAT-01)是一项随机Ⅱ期临床试验,主要终点为 R0 切除率。
本研究共入组 51 例患者[FOLFIRINOX(n = 26)和 GEM/nab-PTX(n = 25)]。最终共有 84.3%(n = 43/51)的患者行手术,R0 切除率为 67.4%(n = 33/51)。45.1%(n = 23/51)的患者出现新辅助治疗相关不良事件(≥3 级),30.0%(n = 13/43)的患者发生主要手术并发症,无死亡病例。意向治疗分析显示,3 年总生存率为 54.7%,中位生存时间为 39.4 个月,FOLFIRINOX 组和 GEM/nab-PTX 组之间的总生存差异无统计学意义。
FOLFIRINOX 或 GEM/nab-PTX 新辅助化疗是可行且耐受良好的,R0 切除率为 67.4%。意向治疗分析甚至发现患者的生存情况良好。