Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Thorac Cancer. 2021 May;12(9):1373-1381. doi: 10.1111/1759-7714.13913. Epub 2021 Mar 24.
This multicentre, open-label study evaluated the efficacy and safety of antiprogrammed death ligand 1 antibody SHR-1316 plus liposomal irinotecan and 5-fluorouracil as the first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC).
Eligible patients received SHR-1316 (10 mg/kg), liposomal irinotecan (60 mg/m for the first cycle, 80 mg/m thereafter), and 5-fluorouracil (2400 mg/m ) every 14 days until disease progression, intolerable toxicity or withdrawal of consent. The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
We enrolled 23 patients between 11 March 2019 and 31 May 2019. The median follow-up duration was 15.2 months (95% CI 14.2-16.2). The median PFS was 8.5 months (95% CI 1.2-15.8), and ORR and DCR were 52.2% (95% CI 30.1-74.3) and 73.9% (95% CI 54.5-93.3), respectively. The median OS was 11.6 months (95% CI 6.7-16.6). The most common treatment-related grade 3-4 adverse events (AEs) were neutropenia (17.4%), nausea (13.0%), and anorexia (13.0%). Treatment-related serious AEs occurred in two patients. No treatment-related deaths occurred.
SHR-1316 plus liposomal irinotecan and 5-fluorouracil has a promising efficacy and manageable safety profile, and could be a new first-line treatment approach for patients with unresectable locally advanced or distant metastatic ESCC.
本多中心、开放标签研究评估了抗程序性死亡配体 1 抗体 SHR-1316 联合脂质体伊立替康和 5-氟尿嘧啶作为晚期食管鳞状细胞癌（ESCC）患者一线治疗的疗效和安全性。
符合条件的患者每 14 天接受一次 SHR-1316（10mg/kg）、脂质体伊立替康（第 1 个周期为 60mg/m，此后为 80mg/m）和 5-氟尿嘧啶（2400mg/m），直至疾病进展、无法耐受毒性或患者撤回同意。主要终点是无进展生存期（PFS）。次要终点是客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和安全性。
我们于 2019 年 3 月 11 日至 2019 年 5 月 31 日期间纳入了 23 名患者。中位随访时间为 15.2 个月（95%CI 14.2-16.2）。中位 PFS 为 8.5 个月（95%CI 1.2-15.8），ORR 和 DCR 分别为 52.2%（95%CI 30.1-74.3）和 73.9%（95%CI 54.5-93.3）。中位 OS 为 11.6 个月（95%CI 6.7-16.6）。最常见的治疗相关 3-4 级不良事件（AE）为中性粒细胞减少症（17.4%）、恶心（13.0%）和厌食（13.0%）。两名患者发生与治疗相关的严重 AE。无治疗相关死亡。
SHR-1316 联合脂质体伊立替康和 5-氟尿嘧啶具有良好的疗效和可管理的安全性，可能成为不可切除的局部晚期或远处转移性 ESCC 患者的新一线治疗方法。
