SOX 化疗联合 PD-1 抗体和分割放疗二线治疗转移性胰腺癌的单臂、Ⅱ期临床试验。
Hypofractionated radiotherapy plus PD-1 antibody and SOX chemotherapy as second-line therapy in metastatic pancreatic cancer: a single-arm, phase II clinical trial.
机构信息
Department of Oncology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, 210008, China.
Department of Oncology, Nanjing Drum Tower Hospital, Clinical College of Nanjing Drum Tower Hospital, Nanjing University of Chinese Medicine, Nanjing, 210008, China.
出版信息
Cancer Immunol Immunother. 2024 Aug 6;73(10):201. doi: 10.1007/s00262-024-03744-z.
PURPOSE
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.
CLINICAL TRIAL REGISTRATION
https://www.chictr.org.cn/showproj.html?proj=130211 , identifier: ChiCTR2100049799, date of registration: 2021-08-09.
目的
评估一线化疗失败后的转移性胰腺癌（mPC）患者同步接受低分割放疗+抗 PD-1 抗体+SOX 化疗的疗效和安全性。
方法
本研究纳入了经病理证实的一线化疗失败的 mPC 患者。患者在我院接受低分割放疗、SOX 化疗和免疫检查点抑制剂治疗。我们收集了患者的临床信息和疗效评估。中位无进展生存期（mPFS）是本研究的主要终点，随后是疾病控制率（DCR）、客观缓解率（ORR）、中位总生存期（mOS）和安全性。探索性分析包括与获益相关的生物标志物。
结果
2021 年 2 月 24 日至 2023 年 8 月 30 日期间，共纳入 25 例患者，其中 23 例患者至少接受了一剂研究药物，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%。7 例 PR 患者的中位缓解持续时间为 7.41 个月。治疗期间血清 CA19-9 水平下降与总生存时间改善相关。此外，治疗前的炎症标志物血小板与淋巴细胞比值（PLR）、淋巴细胞与单核细胞比值（LMR）、乳酸脱氢酶（LDH）与肿瘤反应和生存相关。
结论
在难治性 mPC 患者中，这些联合治疗方案显示出有临床意义的抗肿瘤活性和良好的安全性。治疗期间血清 CA19-9 水平下降和治疗前炎症标志物 PLR、LMR、LDH 可能与临床获益相关。
临床试验注册
https://www.chictr.org.cn/showproj.html?proj=130211 ，标识符：ChiCTR2100049799，注册日期：2021-08-09。
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