目的:评价同步大分割放疗联合抗PD-1抗体和SOX化疗治疗一线化疗失败后转移性胰腺癌(mPC)的疗效和安全性。
方法:纳入经病理证实的标准一线化疗失败的mPC患者。患者接受大分割放疗方案治疗,SOX化疗,和我们机构的免疫检查点抑制剂。我们收集了患者的临床信息和结果测量。中位无进展生存期(mPFS)是研究的主要终点,其次是疾病控制率(DCR),客观反应率(ORR),中位总生存期(mOS)和安全性。探索性分析包括与益处相关的生物标志物。
结果:在2021年2月24日至2023年8月30日之间,有25名患者被纳入研究,23例接受至少1剂研究药物的患者进行了客观疗效评估.mPFS为5.48个月,MOS为6.57个月,DCR和ORR分别为69.5%和30.4%,分别。在获得PR的七名患者中,中位缓解持续时间为7.41个月.治疗中降低的血清CA19-9水平与更好的总生存率相关。此外,治疗前炎症标志物与肿瘤反应和生存率相关。
结论:在难治性mPC患者中使用这些联合疗法治疗后,证明了临床上有意义的抗肿瘤活性和良好的安全性。治疗中降低血清CA19-9水平和治疗前炎症标志物血小板淋巴细胞比(PLR),淋巴细胞与单核细胞比率(LMR),乳酸脱氢酶(LDH)可能是与临床获益相关的生物标志物。
背景:https://www.chictr.org.cn/showproj.html?proj=130211,标识符:ChiCTR2100049799,注册日期:2021-08-09。
OBJECTIVE: To assess the efficacy and safety of concurrent hypofractionated radiotherapy plus anti-PD-1 antibody and SOX chemotherapy in the treatment of metastatic pancreatic cancer (mPC) after failure of first-line chemotherapy.
METHODS: Patients with pathologically confirmed mPC who failed standard first-line chemotherapy were enrolled. The patients were treated with a regimen of hypofractionated radiotherapy, SOX chemotherapy, and immune checkpoint inhibitors at our institution. We collected the patients\' clinical information and outcome measurements. The median progression-free survival (mPFS) was the primary endpoint of the
study, followed by disease control rate (DCR), objective response rate (ORR), median overall survival (mOS) and safety. Exploratory analyses included biomarkers related to the benefits.
RESULTS: Between February 24, 2021, and August 30, 2023, twenty-five patients were enrolled in the
study, and twenty-three patients who received at least one dose of the
study agent had objective efficacy evaluation. The mPFS was 5.48 months, the mOS was 6.57 months, and the DCR and ORR were 69.5% and 30.4%, respectively. Among the seven patients who achieved a PR, the median duration of the response was 7.41 months. On-treatment decreased serum CA19-9 levels were associated with better overall survival. Besides, pretreatment inflammatory markers were associated with tumor response and survival.
CONCLUSIONS: Clinically meaningful antitumor activity and favorable safety profiles were demonstrated after treatment with these combination therapies in patients with refractory mPC. On-treatment decreased serum CA19-9 levels and pretreatment inflammatory markers platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), lactate dehydrogenase (LDH) might be biomarkers related to clinical benefits.
BACKGROUND: https://www.chictr.org.cn/showproj.html?proj=130211 , identifier: ChiCTR2100049799, date of registration: 2021-08-09.