Wang Qi, Cui Zhi, Deng Muhong, Zhang Guoqing, Jing Fangfang, Ma Yue, Pang Fang, Han Quanli
Department of Oncology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Senior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.
Front Pharmacol. 2025 Jul 2;16:1585048. doi: 10.3389/fphar.2025.1585048. eCollection 2025.
Nimotuzumab has shown promising efficacy in esophageal squamous cell carcinoma (ESCC). However, the efficacy and safety of nimotuzumab plus chemotherapy and immunotherapy as first-line/neoadjuvant therapy for patients with advanced ESCC remain unclear.
We performed a real world study of patients with advanced ESCC from December 2019 to April 2024. Patients were classified into resectable and unresectable group. Dosing regimen: nimotuzumab (400 mg, Q3W) plus chemotherapy (nab-paclitaxel: 240 mg/m, paclitaxel liposome: 135-175 mg/m, platinum: 200-400 mg/m, Q3W) and immunotherapy (PD-1/PD-L1: 200-240 mg, Q3W). Overall survival (OS) and progression-free survival (PFS) were primary endpoints, objective response rate (ORR), disease control rate (DCR), and safety were secondary endpoints.
Totally 55 patients were included, 15 in resectable group and 40 in unresectable group. The median follow-up was 36.70 months and 34.00 months, respectively. In resectable group, ORR was 100.0%, DCR was 100.0%, R0 resection rate was 100.00%, 1-year OS was 84.00%, 2-year OS was 74.67% with 34.46 months median OS, 1-year PFS was 84.00%, and 2-year PFS was 37.33% with 21.68 months median PFS. In unresectable group, ORR was 70.0%, DCR was 90.0%, 1-year OS was 76.70%, 2-year OS was 51.29% with 28.06 months median OS, 1-year PFS was 56.64%, and 2-year PFS was 31.15% with 14.95 months median PFS. 14 (25.5%) patients developed Grade 3-5 adverse events (AEs) not related to nimotuzumab, no serious AEs or deaths occurred.
Our treatment combination for advanced ESCC showed a favorable survival profile, and safety was tolerable.
尼妥珠单抗在食管鳞状细胞癌（ESCC）中显示出有前景的疗效。然而，尼妥珠单抗联合化疗和免疫疗法作为晚期ESCC患者的一线/新辅助治疗的疗效和安全性仍不清楚。
我们对2019年12月至2024年4月的晚期ESCC患者进行了一项真实世界研究。患者被分为可切除组和不可切除组。给药方案：尼妥珠单抗（400mg，每3周一次）联合化疗（白蛋白结合型紫杉醇：240mg/m²，紫杉醇脂质体：135 - 175mg/m²，铂类：200 - 400mg/m²，每3周一次）和免疫疗法（PD - 1/PD - L1：200 - 240mg，每3周一次）。总生存期（OS）和无进展生存期（PFS）是主要终点，客观缓解率（ORR）、疾病控制率（DCR）和安全性是次要终点。
共纳入55例患者，可切除组15例，不可切除组40例。中位随访时间分别为36.70个月和34.00个月。在可切除组中，ORR为100.0%，DCR为100.0%，R0切除率为100.00%，1年OS为84.00%，2年OS为74.67%，中位OS为34.46个月，1年PFS为84.00%，2年PFS为37.33%，中位PFS为21.68个月。在不可切除组中，ORR为70.0%，DCR为90.0%，1年OS为76.70%，2年OS为51.29%，中位OS为28.06个月，1年PFS为56.64%，2年PFS为31.15%，中位PFS为14.95个月。14例（25.5%）患者发生了与尼妥珠单抗无关的3 - 5级不良事件（AE），未发生严重AE或死亡。
我们对晚期ESCC的治疗组合显示出良好的生存情况，且安全性可耐受。
