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[摘要]
目的:观察帕博利珠单抗联合白蛋白结合型紫杉醇及奈达铂一线治疗晚期食管鳞状细胞癌(ESCC)的临床疗效及安全性。方法:收集2020年3月至2021年9月长海医院收治的晚期 ESCC 且有可评价病灶的患者35例,一线给予帕博利珠单抗联合白蛋白结合型紫杉醇及奈达铂治疗,用药方案为:第 1 天,帕博利珠单抗 200 mg、白蛋白结合型紫杉醇130 mg/m2、奈达铂70 mg/m2;第8天,白蛋白结合型紫杉醇 130 mg/m2;每 3 周重复1次。采用实体瘤客观疗效评价RECIST1.1标准评估疗效,按NCI-CTC5.0标准评估治疗过程中产生的不良反应。结果:全部35例患者均可评价疗效,其中完全缓解(CR)4例(11.4%)、部分缓解(PR)21 例(60.0%)、疾病稳定(SD)10 例(28.6%)、疾病进展(PD)0 例,客观有效率(ORR)为 71.4%,疾病控制率(DCR)为100%,中位无进展生存期(PFS)为13.4个月。最常见不良反应包括骨髓抑制、甲状腺功能异常、皮疹、发热、关节、肌肉酸痛及脱发,仅有3例(8.6%)患者发生Ⅲ级以上不良反应。结论:帕博利珠单抗联合白蛋白结合型紫杉醇及奈达铂一线治疗本组晚期ESCC的疗效较好,不良反应患者可耐受,有待进一步扩大样本进行随机对照临床研究验证。
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[Abstract]
Objective: To observe the clinical efficacy and safety of pembrolizumab plus albumin-bound paclitaxel and nedaplatin as a first-line therapy in patients with advanced esophageal squamous cell carcinoma (ESCC). Methods: 35 patients with advanced ESCC and evaluable foci admitted in Changhai Hospital from March 2020 to September 2021 were included in this study. All patients were given pembrolizumab 200 mg and albumin-bound paclitaxel 130 mg/m2 on day 1 and 8, and nedaplatin 70 mg/m2 on day 1. The treatment was repeated every 21 days. Evaluation of tumor response was performed according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1). Adverse effects were graded using version 5.0 of the National Cancer Institute Common Toxicity Criteria (NCI-CTC). Results: All 35 patients were available for evaluation, with 4 patients (11.4%) achieving complete response (CR), 21 patients (60.0%) partial response (PR), 10 patients (28.6%) stable disease (SD) and 0 patients progression disease (PD). The objective response rate (ORR) was 71.4%. The disease control rate (DCR) was 100%. The median progression free survival (PFS) was 13.4 months. The main adverse effects include bone marrow suppression, thyroid dysfunction, rash, fever, arthralgia, myalgia and alopecia. Treatment-related adverse events of grade 3 or higher occurred only in 3 patients (8.6%). onclusion: Pembrolizumab plus albuminbound paclitaxel and nedaplatin as a first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety in patients with advanced ESCC. Randomized trials with expanded samples to evaluate this new combination strategy are warranted.
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