Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study
Patients with locally advanced esophageal squamous cell carcinoma (ESCC) show poor survival after concurrent chemoradiotherapy. This study investigated the safety and feasibility of combining concurrent chemoradiotherapy with the anti-PD-1 antibody camrelizumab as first-line treatment for these patients. In this phase 1b study (ClinicalTrials.gov NCT03671265), patients received concurrent chemotherapy (cisplatin [25 mg/m(2)] plus docetaxel [25 mg/m(2)] for 4 weeks) and radiotherapy (2.0 Gy/fraction, total 60 Gy) with camrelizumab (200 mg every 2 weeks for 32 weeks). Primary endpoints were safety and tolerability, and health-related quality of life. Secondary endpoints were radiological and pathological response rates, overall survival (OS), and progression-free survival (PFS). Candidate biomarkers in tumor and peripheral blood were monitored at baseline and after 40 Gy radiation. Twenty patients were enrolled. The most common treatment-related grade 3 adverse events included radiation esophagitis (20%) and esophageal fistula (10%). Serious treatment-related adverse events occurred in eight (40%) patients. No treatment-related deaths were reported. Health-related quality of life did not deteriorate. Thirteen (65%) patients had an objective response after 40 Gy radiation. At a median follow-up of 23.7 months (95% CI 21.9-24.5), OS and PFS time ranged from 8.2-28.5 and 4.0-28.5 months, respectively. The 12-month and 24-month OS rate was 85.0% and 69.6%; PFS rate was 80.0% and 65.0%. Tumor PD-L1 expression and CD11c(+) dendritic cells and peripheral-blood IL-27, IL-15, Eotaxin-3, and IL-22 were associated with OS. First-line concurrent chemoradiotherapy plus camrelizumab had a manageable safety profile and promising antitumour efficacy for ESCC, and deserves further study.
基金:
Chinese National Key Research and Development Project (No. 2018YFC1315601), the National Nature Science Foundation of China under Grant [number 81872462, 81972772, 82073348] and the Clinical Trial Supporting Foundation of Tianjin Medical University Cancer Institute & Hospital under Grant [number C1707].
基金编号:number 818724628197277282073348] and the Clinical Trial Supporting Foundation of Tianjin Medical University Cancer Institute & Hospital under Grant [number C1707
第一作者机构:[1]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy,Dept Radiat Oncol, Tianjin, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[1]Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy,Dept Radiat Oncol, Tianjin, Peoples R China[*1]Tianjin Med Univ Canc Inst & Hosp, Dept Radiat Oncol, Huanhuxi Rd, Huanhuxi 300060, Peoples R China
推荐引用方式(GB/T 7714):
Zhang Wencheng,Yan Cihui,Zhang Tian,et al.Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study[J].ONCOIMMUNOLOGY.2021,10(1):doi:10.1080/2162402X.2021.1971418.
APA:
Zhang, Wencheng,Yan, Cihui,Zhang, Tian,Chen, Xi,Dong, Jie...&Pang, Qingsong.(2021).Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study.ONCOIMMUNOLOGY,10,(1)
MLA:
Zhang, Wencheng,et al."Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study".ONCOIMMUNOLOGY 10..1(2021)