Wu Shusheng, Luo Huiqin, Chen Wenju, Liu Xudong, Li Huimin, Li Mengge, Ke Lihong, Niu Jiayu, Hu Bing, Xu Huijun, Wang Gang, Yan Ying, Cao Lulu, Hu Xiaoxiu, Li Chenghui, He Yifu
Department of Medical Oncology, Division of Life Sciences and Medicine, The First Affiliated Hospital of USTC, University of Science and Technology of China, No. 107 Huanhu Road East, Shushan District, Hefei, Anhui, 230031, China.
Department of Medical Oncology, Anhui Provincial Cancer Hospital, Hefei, Anhui, 230031, China.
BMC Cancer. 2025 May 9;25(1):845. doi: 10.1186/s12885-025-14207-8.
Camrelizumab (CAM) combined with apatinib plus chemotherapy as a first-line treatment shows good efficacy in advanced or metastatic esophageal squamous cell carcinoma (ESCC) patients. This study aimed to explore the potential of CAM combined with apatinib plus irinotecan (IRT) as a second-line treatment in advanced or metastatic ESCC patients.
A total of 59 advanced or metastatic ESCC patients receiving CAM combined with apatinib plus IRT as second-line treatment were enrolled in this study between January 2020 and March 2024. The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), the objective response rate (ORR), the disease control rate (DCR), and the assessment of toxicity. Concurrently, a model was constructed utilizing patients' clinical characteristics and radiomic features to predict the patients' prognoses.
At the time of analysis, 58 patients were withdrawn due to disease progression (n = 9), death (n = 43), or lost to follow-up (n = 6), and 1 patient was ongoing. The ORR and DCR were 37.7% and 84.9%, respectively. The median PFS and OS were 6.3 (95% CI: 4.8-7.8) and 16.7 (95% CI: 13.5-19.9) months, respectively. The most common adverse events of any grade were leukopenia (52.5%), fatigue (25.4%), anemia (23.7%), thrombocytopenia (23.7%), neutropenia (22.0%), and hypoalbuminemia (22.0%). Most of the adverse events were grade I-II. The incidence of grade III-IV adverse events was 20.3%. Predictive models were established based on the outcomes of multivariate Cox analyses. The combined model had an excellent ability to predict the 1-year OS [AUC (95% CI): 0.979 (0.930-1.000)].
CAM combined with apatinib plus IRT as a second-line treatment exhibits acceptable efficacy and safety in advanced or metastatic ESCC patients. The model that combines clinical and radiomic features has the greatest ability to predict the survival of advanced or metastatic ESCC patients.
卡瑞利珠单抗(CAM)联合阿帕替尼及化疗作为一线治疗方案,在晚期或转移性食管鳞状细胞癌(ESCC)患者中显示出良好疗效。本研究旨在探索CAM联合阿帕替尼及伊立替康(IRT)作为晚期或转移性ESCC患者二线治疗方案的潜力。
2020年1月至2024年3月期间,共有59例接受CAM联合阿帕替尼及IRT作为二线治疗的晚期或转移性ESCC患者纳入本研究。主要终点为无进展生存期(PFS),次要终点包括总生存期(OS)、客观缓解率(ORR)、疾病控制率(DCR)及毒性评估。同时,利用患者的临床特征和影像组学特征构建模型,以预测患者的预后。
分析时,58例患者因疾病进展(n = 9)、死亡(n = 43)或失访(n = 6)退出研究,1例患者仍在治疗中。ORR和DCR分别为37.7%和84.9%。中位PFS和OS分别为6.3(95%CI:4.8 - 7.8)个月和16.7(95%CI:13.5 - 19.9)个月。任何级别的最常见不良事件为白细胞减少(52.5%)、疲劳(25.4%)、贫血(23.7%)、血小板减少(23.7%)、中性粒细胞减少(22.0%)和低白蛋白血症(22.0%)。大多数不良事件为I-II级。III-IV级不良事件的发生率为20.3%。基于多因素Cox分析结果建立了预测模型。联合模型具有出色的预测1年OS的能力[AUC(95%CI):0.979(0.930 - 1.000)]。
CAM联合阿帕替尼及IRT作为二线治疗方案在晚期或转移性ESCC患者中显示出可接受的疗效和安全性。结合临床和影像组学特征的模型具有最强的预测晚期或转移性ESCC患者生存的能力。