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二线帕博利珠单抗单药治疗非小细胞肺癌的疗效:一项针对52例越南患者的单机构回顾性研究。

Effectiveness of Second-Line Pembrolizumab Monotherapy for the Treatment of Nonsmall Cell Lung Cancer: A Retrospective-Single Institution Study of 52 Vietnamese Patients.

作者信息

Tai Nguyen Van, Kien Do Hung, Van Le Quang, Tu Do Anh, Chu Nguyen Van, Phuong Nguyen Thi Bich, Hoa Nguyen Thi Nhu

机构信息

Vietnam National Cancer Hospital-K Hospital, Hanoi, Vietnam.

Department of Medical Oncology I, Vietnam National Cancer Hospital-K Hospital, Hanoi, Vietnam.

出版信息

Clin Med Insights Oncol. 2025 Aug 7;19:11795549251359142. doi: 10.1177/11795549251359142. eCollection 2025.

Abstract

BACKGROUND

Our aim was to demonstrate the efficacy and safety of pembrolizumab monotherapy as second-line treatment in Vietnamese nonsmall cell lung cancer (NSCLC) patients.

METHODS

We performed a single-center retrospective study of patients with advanced NSCLC who received pembrolizumab as second-line therapy at the Vietnam National Cancer Hospital between January 2017 and October 2023. The primary endpoints were overall survival (OS) and tumor response.

RESULTS

A total of 52 patients were included. Adenocarcinoma was observed in 43 of 52 cases (82.7%), and 40.4% of patients had PD-L1 expression in at least 50% of tumor cells. Median body weight was 57 kg (range, 45-80), and 73.1% of patients received pembrolizumab at a dose of 100 mg/3 weeks, with a median dose of 1.9 mg/kg/3-weeks (range, 1.3-4.3). The overall response rate and disease control rate were 26.9% and 51.9%, respectively. Median PFS was 6.5 months (95% CI, 3.3-9.7), and 1-year and 2-year PFS rates were 28.5% and 15.9%, respectively. Median OS was 12.0 months (95% CI, 9.8-14.2); 1-year, 2-year, and 3-year OS rates were 53.1%, 22.3%, and 8.5%, respectively. ECOG status and number of organs metastases were significantly associated with PFS and OS in the multivariate analysis. No adverse events of grades 3 to 4 were reported during the treatment.

CONCLUSIONS

Second-line pembrolizumab has a good disease control rate and prolonged survival and is a viable option for the treatment of Vietnamese NSCLC patients. Further clinical studies are necessary to determine the effectiveness of administering a low dose of pembrolizumab in this setting, particularly in Asian population.

摘要

背景

我们的目的是证明帕博利珠单抗单药作为二线治疗方案在越南非小细胞肺癌(NSCLC)患者中的疗效和安全性。

方法

我们对2017年1月至2023年10月期间在越南国家癌症医院接受帕博利珠单抗作为二线治疗的晚期NSCLC患者进行了一项单中心回顾性研究。主要终点为总生存期(OS)和肿瘤反应。

结果

共纳入52例患者。52例中有43例(82.7%)观察到腺癌,40.4%的患者肿瘤细胞中至少50%表达PD-L1。中位体重为57千克(范围45 - 80千克),73.1%的患者接受100毫克/3周剂量的帕博利珠单抗治疗,中位剂量为1.9毫克/千克/3周(范围1.3 - 4.3毫克/千克/3周)。总缓解率和疾病控制率分别为26.9%和51.9%。中位无进展生存期(PFS)为6.5个月(95%置信区间,3.3 - 9.7个月),1年和2年PFS率分别为28.5%和15.9%。中位OS为12.0个月(95%置信区间,9.8 - 14.2个月);1年、2年和3年OS率分别为53.1%、22.3%和8.5%。多因素分析中,东部肿瘤协作组(ECOG)状态和器官转移数量与PFS和OS显著相关。治疗期间未报告3至4级不良事件。

结论

二线使用帕博利珠单抗具有良好的疾病控制率和延长生存期的效果,是治疗越南NSCLC患者的一个可行选择。有必要进行进一步的临床研究以确定在这种情况下给予低剂量帕博利珠单抗的有效性,特别是在亚洲人群中。

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