Lin Yu, Shen Wenbin, Ye Jinjun, Luo Honglei, Zhang Xizhi, Xu Yuanji, Lin Qin, Liu Wenyang, Zhang Yingying, Xu Yujin, Jiang Wei, Zhao Lina, Liu Anwen, Wu Lei, Ge Hong, Xie Conghua, Zhao Kuaile, Chen Junqiang, Wang Luhua, Liu Qi
Department of Radiation Oncology, Fudan University Shanghai Cancer Center Fujian Hospital, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China.
Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Ther Adv Med Oncol. 2024 Nov 19;16:17588359241297092. doi: 10.1177/17588359241297092. eCollection 2024.
There are currently limited real-world data on the effectiveness and safety of first-line pembrolizumab combined with chemotherapy in patients with advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in China. This study was conducted to address this knowledge gap.
This multicenter retrospective cohort study was conducted at 17 hospitals in China and included adults (⩾18 years) with stage IV primary ESCC, or recurring 6 months after radical radiotherapy/surgery-based combination therapy, who had received first-line pembrolizumab plus chemotherapy. Data were collected from electronic medical records. Endpoints included objective response rate (ORR), disease control rate (DCR) progression-free survival (PFS), overall survival (OS), and safety. Subgroup analyses were conducted to identify patient characteristics and treatment patterns associated with treatment response.
In total, 202 patients who had received treatment from 2018 to 2023 were included: 125 (61.9%) newly diagnosed and 77 (38.1%) with recurrence, 181 (89.1%) were male. Pembrolizumab was most commonly combined with paclitaxel + platinum (69.8%) or fluorouracil + platinum (19.3%). After a median follow-up of 22.6 months (95% confidence interval (CI) 20.1-25.4), the ORR and DCR were 60.9% and 87.6% and the median PFS and OS were 10.8 months (95% CI 9.1-13.5) and 17.3 months (95% CI 14.9-19.9), respectively. OS was similar in patients with treatment-naïve and recurrent disease. Among the combination chemotherapy regimens, paclitaxel + platinum was associated with the longest median OS (18.2 months, 95% CI 16.1-22.5). Favorable survival outcomes were observed in patients with oligometastases. No new safety signals were observed.
These real-world data indicate that the first-line treatment with pembrolizumab plus chemotherapy is effective and safe in Chinese patients with advanced ESCC and show that paclitaxel + platinum is the most commonly used and most effective partner chemotherapy in China.
目前在中国，关于一线帕博利珠单抗联合化疗治疗晚期/复发或转移性食管鳞状细胞癌（ESCC）患者的有效性和安全性的真实世界数据有限。本研究旨在填补这一知识空白。
本多中心回顾性队列研究在中国的17家医院开展，纳入年龄≥18岁的IV期原发性ESCC患者，或在基于放疗/手术的联合根治性治疗6个月后复发且接受一线帕博利珠单抗联合化疗的患者。数据从电子病历中收集。终点指标包括客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和安全性。进行亚组分析以确定与治疗反应相关的患者特征和治疗模式。
总共纳入了202例在2018年至2023年期间接受治疗的患者：125例（61.9%）为新诊断患者，77例（38.1%）为复发患者，181例（89.1%）为男性。帕博利珠单抗最常与紫杉醇+铂类（69.8%）或氟尿嘧啶+铂类（19.3%）联合使用。中位随访22.6个月（95%置信区间（CI）20.1 - 25.4）后，ORR和DCR分别为60.9%和87.6%，中位PFS和OS分别为10.8个月（95% CI 9.1 - 13.5）和17.3个月（95% CI 14.9 - 19.9）。初治患者和复发患者的OS相似。在联合化疗方案中，紫杉醇+铂类与最长的中位OS相关（18.2个月，95% CI 16.1 - 22.5）。寡转移患者观察到良好的生存结果。未观察到新的安全信号。
这些真实世界数据表明，一线帕博利珠单抗联合化疗在中国晚期ESCC患者中是有效且安全的，并且表明紫杉醇+铂类是中国最常用且最有效的联合化疗药物。
