Yu Lin, Wenbin Shen, Jinjun Ye, Honglei Luo, Xizhi Zhang, Yuanji Xu, Qin Lin, Wenyang Liu, Yingying Zhang, Yujin Xu, Wei Jiang, Lina Zhao, Anwen Liu, Lei Wu, Hong Ge, Conghua Xie, Kuaile Zhao, Junqiang Chen, Luhua Wang, Qi Liu
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This study was conducted to address this knowledge gap.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23053,"journal":{"name":"Therapeutic Advances in Medical Oncology","volume":"16 ","pages":"17588359241297092"},"PeriodicalIF":4.3000,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11574897/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and safety of first-line pembrolizumab plus chemotherapy in patients with advanced/recurrent or metastatic esophageal squamous cell carcinoma in China: a real-world multicenter study.\",\"authors\":\"Yu Lin, Wenbin Shen, Jinjun Ye, Honglei Luo, Xizhi Zhang, Yuanji Xu, Qin Lin, Wenyang Liu, Yingying Zhang, Yujin Xu, Wei Jiang, Lina Zhao, Anwen Liu, Lei Wu, Hong Ge, Conghua Xie, Kuaile Zhao, Junqiang Chen, Luhua Wang, Qi Liu\",\"doi\":\"10.1177/17588359241297092\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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. 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引用次数: 0
摘要
背景：目前在中国，关于一线pembrolizumab联合化疗治疗晚期/复发性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：这项多中心回顾性队列研究在中国的17家医院进行，研究对象包括接受一线pembrolizumab联合化疗的IV期原发性ESCC或根治性放疗/手术联合治疗后6个月复发的成人（⩾18岁）。数据来自电子病历。终点包括客观反应率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和安全性。研究人员还进行了分组分析，以确定与治疗反应相关的患者特征和治疗模式：共纳入2018年至2023年接受过治疗的202名患者：其中125人（61.9%）为新诊断患者，77人（38.1%）为复发患者，181人（89.1%）为男性。Pembrolizumab最常与紫杉醇+铂（69.8%）或氟尿嘧啶+铂（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）。治疗无效和复发患者的OS相似。在联合化疗方案中，紫杉醇+铂类的中位生存期最长（18.2个月，95% CI 16.1-22.5）。在少转移灶患者中观察到了有利的生存结果。没有观察到新的安全信号：这些真实世界的数据表明，在中国晚期ESCC患者中，pembrolizumab联合化疗的一线治疗是有效和安全的，并表明紫杉醇+铂是中国最常用和最有效的伙伴化疗。
Effectiveness and safety of first-line pembrolizumab plus chemotherapy in patients with advanced/recurrent or metastatic esophageal squamous cell carcinoma in China: a real-world multicenter study.
Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
期刊介绍：
Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).
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