From the Department of Hepatobiliary Pancreatic and Transplant Surgery, Graduate School of Medicine, Mie University.
Mie University Hospital, Tsu, Japan.
Pancreas. 2021 Sep 1;50(8):1230-1235. doi: 10.1097/MPA.0000000000001902.
This study aimed to assess the feasibility of preoperative chemoradiotherapy using gemcitabine plus nab-paclitaxel (GnP) and to determine the recommended dose (RD) of nab-paclitaxel for patients with localized pancreatic ductal adenocarcinoma (PDAC).
The participants had localized PDAC with contact or invasion to major arteries. They received GnP on days 1, 15, 29, and 43. The dose of gemcitabine was fixed at 600 mg/m2, whereas that of nab-paclitaxel was at 3 dose levels in accordance with a standard 3 + 3 dose escalation scheme. Three-dimensional radiotherapy was administered concurrently to a total dose of 50.4 Gy per 28 fractions.
The study cohort comprised 15 patients. Grade 3 or 4 neutropenia was observed in 4 (26.7%), leukopenia in 1 (6.7%), biliary infection in 2 (13.3%), appetite loss and nausea in 1 (6.7%), and anaphylaxis in 1 (6.7%). The RD was determined as level 2 (gemcitabine, 600 mg/m2; nab-paclitaxel, 100 mg/m2). Three patients underwent pancreatectomy after additional chemotherapy and achieved R0 resection.
The RD of nab-paclitaxel in our chemoradiotherapy protocol using GnP was 100 mg/m2 with gemcitabine 600 mg/m2 and 3-dimensional conformal radiotherapy to a total dose of 50.4 Gy per 28 fractions for patients with localized PDAC.
本研究旨在评估吉西他滨联合 nab-紫杉醇（GnP）术前放化疗的可行性，并确定局部胰腺导管腺癌（PDAC）患者 nab-紫杉醇的推荐剂量（RD）。
参与者患有局部 PDAC，主要动脉接触或侵犯。他们在第 1、15、29 和 43 天接受 GnP 治疗。吉西他滨的剂量固定为 600mg/m2，而 nab-紫杉醇的剂量则根据标准的 3+3 剂量递增方案分为 3 个剂量水平。三维放疗同时进行，总剂量为 50.4Gy/28 个分次。
研究队列包括 15 名患者。4 名（26.7%）患者出现 3 级或 4 级中性粒细胞减少症，1 名（6.7%）患者出现白细胞减少症，2 名（13.3%）患者出现胆道感染，1 名（6.7%）患者出现食欲下降和恶心，1 名（6.7%）患者出现过敏反应。RD 确定为 2 级（吉西他滨，600mg/m2；nab-紫杉醇，100mg/m2）。3 名患者在额外化疗后接受了胰切除术，并实现了 RO 切除。
在使用 GnP 的局部 PDAC 三维适形放疗 50.4Gy/28 个分次的方案中，nab-紫杉醇的 RD 为吉西他滨 600mg/m2 联合 nab-紫杉醇 100mg/m2。
