Background: Immune checkpoint inhibitors (ICIs) such as pembrolizumab (Pem) have demonstrated clinical benefits in esophageal cancer. Cisplatin, 5-fluorouracil, and Pem combination (CF plus Pem) has emerged as a promising first-line regimen. However, dose reduction of cytotoxic agents is necessary in real-world practice in patients with advanced age and/or renal dysfunction. This study aimed to evaluate the real-world effectiveness and safety of CF plus Pem therapy and assess survival outcomes based on the initial dose intensity. Methods: We retrospectively analyzed patients with unresectable or recurrent esophageal cancer who received CF plus Pem between February 2022 and February 2025. Clinical data, including patient characteristics, treatment details, tumor response, adverse events, and survival outcomes, were collected and analyzed. Results: We included 54 patients (median age, 72.5 years; 74.1% male). The initial CF dose was reduced in 55.6% of the patients. The overall response and disease control rates were 55.6% and 81.5%, respectively. The median overall survival (OS) and progression-free survival (PFS) were 18.6 and 6.5 months, respectively, with no significant differences observed among groups based on dose reduction, age, or change in treatment interval. Grade ≥ 3 adverse events occurred in 16.7% of patients, with fewer events and higher treatment continuity in the dose-reduction group. Conclusions: Thus, CF plus Pem therapy is effective and tolerable in real-world settings. Initial dose reduction does not compromise survival and supports individualized dosing strategies for esophageal cancer treatment.
背景：以帕博利珠单抗（Pem）为代表的免疫检查点抑制剂（ICIs）已在食管癌治疗中显示出临床获益。顺铂、5-氟尿嘧啶联合帕博利珠单抗（CF联合Pem）方案已成为前景广阔的一线治疗方案。然而，在老年和/或肾功能不全患者的临床实践中，常需降低细胞毒性药物的剂量。本研究旨在评估CF联合Pem方案在真实世界中的疗效与安全性，并基于初始剂量强度分析生存结局。 方法：回顾性分析2022年2月至2025年2月期间接受CF联合Pem治疗的不可切除或复发性食管癌患者。收集并分析包括患者特征、治疗方案、肿瘤反应、不良事件及生存结局在内的临床数据。 结果：共纳入54例患者（中位年龄72.5岁；男性占74.1%）。55.6%的患者初始CF剂量进行了下调。总体缓解率和疾病控制率分别为55.6%和81.5%。中位总生存期（OS）和无进展生存期（PFS）分别为18.6个月和6.5个月，在不同剂量调整组、年龄组及治疗间隔调整组间均未观察到显著差异。≥3级不良事件发生率为16.7%，其中剂量下调组不良事件更少且治疗连续性更高。 结论：CF联合Pem方案在真实世界临床实践中具有良好疗效与耐受性。初始剂量下调不影响生存结局，支持在食管癌治疗中实施个体化给药策略。
肿瘤(癌症)患者之家