尽管全身治疗有所改善，但胰腺导管腺癌（PDAC）患者经常出现局部复发。我们旨在确定在辅助化疗期间低剂量质子束放射治疗（PBT）的安全性。2019年至2022年，我们在一家医疗机构开展了一项单机构I期试验（NCTXXXXXXXX），共纳入了9位患者。患者患有胰头PDAC，并进行了R0或R1切除和辅助修饰的FOLFIRINOX（mFFX）化疗。主要终点是确定辅助PBT（5 Gy x 5次）的给药方案，该方案使用有限治疗容积，在mFFX的第6和第7个周期之间给予。患者在开始第7个周期之前于28天周期的第15-19天接受PBT（剂量级别1，DL1），或在开始第7个周期之前于21天周期的第8-12天接受PBT（剂量级别2，DL2）。患者的中位年龄为66岁（范围52-78岁），从mFFX开始到随访时间为12.5个月（范围6.2-37.4个月）。没有患者接受术前治疗。共有4例R1切除，5例淋巴结阳性疾病。3例患者被纳入DL1组，6例患者被纳入DL2组。在DL2组中发生1例剂量限制性毒性（持续3级中性粒细胞减少，导致在第7个周期后停止mFFX）。未观察到其他剂量限制性毒性。4例患者完成12个周期的mFFX（范围7-12个周期，中位数为11个周期）。未发生局部复发。9例患者中有5例复发：3例出现在肝脏，1例出现在腹膜，1例出现在骨骼。目前仍有6例患者存活，其中4例无复发。复发的中位时间为12个月（95%置信区间[CI] 4-NR），中位总生存期为NR（95% CI 6-NR，2年生存率为57%）。将PBT纳入辅助mFFX中耐受良好，且未观察到局部复发。这些发现需要在II期试验中进一步研究。版权所有 © 2023年。由Elsevier Inc.发表。

Despite improvement in systemic therapy, patients with pancreatic ductal adenocarcinoma (PDAC) frequently experience local recurrence. We sought to determine the safety of hypofractionated proton beam radiotherapy (PBT) during adjuvant chemotherapy.Nine patients were enrolled in a single-institution phase I trial (NCTXXXXXXXX) between 2019 and 2022. Patients had PDAC of the pancreatic head and underwent R0 or R1 resection and adjuvant modified FOLFIRINOX (mFFX) chemotherapy. The primary endpoint was to determine the dosing schedule of adjuvant PBT (5 Gy x 5 fractions) using limited treatment volumes given between cycles 6 and 7 of mFFX. Patients received PBT on days 15-19 in a 28-day cycle before starting cycle 7 (dose level 1, DL1) or on days 8-12 in a 21-day cycle before starting cycle 7 (DL2).The median patient age was 66 (range 52-78), and the follow-up time from mFFX initiation was 12.5 months (range 6.2-37.4 months). No patients received preoperative therapy. Four had R1 resections and 5 had node-positive disease. Three patients were enrolled on DL1 and 6 patients on DL2. One dose-limiting toxicity (DLT) occurred at DL2 (prolonged grade 3 neutropenia resulting in discontinuation of mFFX after cycle 7). No other DLTs were observed. Four patients completed 12 cycles of mFFX (range 7-12, median 11). No patients have had local recurrence. Five of 9 patients had recurrence: 3 in the liver, 1 in the peritoneum, and 1 in the bone. Six patients are still alive, 4 of whom are recurrence-free. The median time to recurrence was 12 months (95% confidence interval [CI] 4-not reached [NR]), and median overall survival was NR (95% CI 6-NR, 2-year survival rate 57%).PBT integrated within adjuvant mFFX was well tolerated, and no local recurrence was observed. These findings warrant in a phase II trial.Copyright © 2023. Published by Elsevier Inc.