关于缓解胰腺癌相关疼痛的姑息放射治疗的临床证据有限。我们在疼痛反应方面进行了前瞻性研究，该研究涉及中度至重度胰腺癌相关疼痛患者的短程姑息放射治疗。在此前瞻性二期单中心非随机试验中，我们用短程姑息放射治疗（2015-2018年，每周三次，24 Gy）对30名疼痛程度中度至重度（0-10分，0为无痛，10为最剧痛）的胰腺癌疼痛药物无效的患者进行了治疗。主要终点设定为与基线相比，治疗开始后七周内平均疼痛严重程度下降≥ 2分的临床相关性。次要终点是总体生活质量（QoL），临床相关性增加5-10分（0-100分）。疼痛严重程度降低和QoL分别使用简明疼痛评估表和欧洲癌症研究与治疗组织生活质量问卷-C15-PAL进行九次评估。两个结果均使用联合建模进行分析。此外，基于临床医师报告评估急性毒性和总生存期（OS）。 总体而言，29/30名患者（96.7%）接受姑息放射治疗。在基线时，口服吗啡当量每日剂量的中位数为129.5毫克（范围20.0-540.0毫克），此剂量在放射后降至75.0毫克（范围15.0-360.0毫克），P=0.021。平均疼痛严重程度从基线到七周减少了3.15分（单侧P=0.045）。患者在前三周内的平均疼痛严重程度从5.9分减少到3.8分（P=0.011），然后进一步减少到11周末的3.2分，最终于第21周（第一次放射治疗分次后）为3.4分（P=0.006）。随访期间，总体QoL从50.5分显著提高至60.8分，P=0.001。三名患者出现3级急性毒性，未观察到4-5级毒性。中位OS为11.8周，一年生存率为13.3%。 胰腺癌相关疼痛的短程姑息放射治疗与临床相关的疼痛严重程度迅速减少以及总体QoL显著改善相关，同时毒性较轻。版权所有 © 2023. Elsevier Inc. 发布。

Clinical evidence is limited regarding palliative radiotherapy for relieving pancreatic cancer-related pain. We prospectively investigated pain response following short-course palliative radiotherapy in patients with moderate-to-severe pancreatic cancer-related pain.In this prospective phase II single center non-randomized trial, 30 patients with moderate-to-severe pain (5-10, on a 0-10 scale) of pancreatic cancer refractory to pain medication, were treated with a short-course palliative radiotherapy; 24 Gy in three weekly fractions (2015-2018). Primary endpoint was defined as a clinically relevant average decrease of ≥ 2 points in pain severity, compared to baseline, within seven weeks after the start of treatment. Secondary endpoint was global quality of life (QoL), with a clinically relevant increase of 5-10 points (0-100 scale). Pain severity reduction and QoL were assessed nine times using the Brief Pain Inventory and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C15-PAL, respectively. Both outcomes were analyzed using joint modeling. In addition, acute toxicity based on clinician reporting and overall survival (OS) were assessed.Overall, 29/30 patients (96.7%) received palliative radiotherapy. At baseline, the median oral morphine equivalent daily dose was 129.5 mg (range 20.0-540.0 mg), which decreased to 75.0 mg (range 15.0-360.0 mg) after radiation, P=0.021. Pain decreased on average 3.15 points from baseline to seven weeks (one-sided P=0.045). Patients reported a clinically relevant mean pain severity reduction from 5.9 to 3.8 points (P=0.011) during the first three weeks, which further decreased to 3.2 until week 11, ending at 3.4 (P=0.006) in week 21 after the first radiotherapy fraction. Global QoL significantly improved from 50.5 to 60.8 over the follow-up period, P=0.001. Grade 3 acute toxicity occurred in three patients and no grade 4-5 toxicity was observed. Median OS was 11.8 weeks, with a 13.3% one-year actuarial OS rate.Short-course palliative radiotherapy for pancreatic cancer-related pain was associated with rapid, clinically relevant reduction in pain severity, and clinically relevant improvement in global QoL, with mostly mild toxicity.Copyright © 2023. Published by Elsevier Inc.