Department of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University, N-15 W-7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.
Center for Gastroenterology, Teine Keijinkai Hospital, 12-1-40 Maeda 1 Jo, Teine-ku, Sapporo, Hokkaido, 006-0811, Japan.
Sci Rep. 2022 Jun 15;12(1):9966. doi: 10.1038/s41598-022-14094-0.
Although neoadjuvant therapy (Nac) is recommended for high-risk resectable pancreatic cancer (R-PDAC), evidence regarding specific regimes is scarce. This report aimed to investigate the efficacy of S-1 Nac for R-PDAC. In a multicenter phase II trial, we investigated the efficacy of Nac S-1 (an oral fluoropyrimidine agent containing tegafur, gimeracil, and oteracil potassium) in R-PDAC patients. The protocol involved two cycles of preoperative S-1 chemotherapy, followed by surgery, and four cycles of postoperative S-1 chemotherapy. Two-year progression-free survival (PFS) rates were the primary endpoint. Overall survival (OS) rates and median survival time (MST) were secondary endpoints. Forty-nine patients were eligible, and 31 patients underwent resection following Nac, as per protocol (31/49; 63.3%). Per-protocol analysis included data from 31 patients, yielding the 2-year PFS rate of 58.1%, and 2-, 3-, and 5-year OS rates of 96.8%, 54.8%, and 44.0%, respectively. MST was 49.2 months. Intention-to-treat analysis involved 49 patients, yielding the 2-year PFS rate of 40.8%, and the 2-, 3-, and 5-year OS rates of 87.8%, 46.9%, and 33.9%, respectively. MST was 35.5 months. S-1 single regimen might be an option for Nac in R-PDAC; however, the high drop-out rate (36.7%) was a limitation of this study.
虽然新辅助治疗（Nac）被推荐用于高危可切除的胰腺导管腺癌（R-PDAC），但关于具体方案的证据很少。本报告旨在研究 S-1 Nac 对 R-PDAC 的疗效。在一项多中心 II 期试验中，我们研究了 S-1 Nac（一种含有替加氟、吉美嘧啶和奥替拉西钾的口服氟嘧啶类药物）在 R-PDAC 患者中的疗效。方案包括两个周期的术前 S-1 化疗，随后进行手术，以及四个周期的术后 S-1 化疗。两年无进展生存率（PFS）是主要终点。总生存率（OS）和中位生存时间（MST）是次要终点。49 名患者符合条件，根据方案，31 名患者在 Nac 后接受了切除术（31/49；63.3%）。方案分析包括 31 名患者的数据，得出的 2 年 PFS 率为 58.1%，2 年、3 年和 5 年的 OS 率分别为 96.8%、54.8%和 44.0%。MST 为 49.2 个月。意向治疗分析包括 49 名患者，得出的 2 年 PFS 率为 40.8%，2 年、3 年和 5 年的 OS 率分别为 87.8%、46.9%和 33.9%。MST 为 35.5 个月。S-1 单一方案可能是 R-PDAC 中 Nac 的一种选择；然而，高退出率（36.7%）是本研究的一个限制。
