Low-Dose Anti-PD(L)1 for the Treatment of Solid Malignancies.

IF 3.2 Q2 ONCOLOGY JCO Global Oncology Pub Date : 2024-11-01 Epub Date: 2024-11-21 DOI:10.1200/GO.24.00122
Iza Andrade de A Souza, Beatriz de M Dobbert, Barbara G Sao Jose, Joao Pedro Homse-Netto, Larissa L Furlan, Maira S Abreu, Camila Ferrari, Bruno Uchoa, Kathia Abdallah, Stephano N Lucio, Joao A Soler, Fabio L C Fernandez, Luiza Ferreira, Joao D Guedes, Aline F Fares, Daniel V Araujo
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Abstract

Purpose: Mounting data suggest that lower doses of anti-PD(L)1 agents can be as efficacious as label-approved doses at a fraction of its cost. We compare the outcomes of patients treated with low-dose (LD) and with conventional-dose (CD) anti-PD(L)1 agents.

Methods: This observational study evaluates the outcomes of patients with solid malignancies treated with anti-PD(L)1 agents (LD or CD) at Hospital de Base, Brazil. Patients were classified as receiving LD if the dose administered in the first cycle was below the label-approved dose. Efficacy outcomes, including best clinical overall response rate (cORR), clinical progression-free survival (cPFS), and overall survival (OS), were evaluated.

Results: From January 2020 to May 2023, 71 patients were included: 49 (69%) with LD and 22 (31%) with CD agents. The most frequent tumor sites were the lung (41% LD, 22.9% CD) and skin (melanoma; 24.6% LD, 50% CD). Most of the patients were treated with pembrolizumab (65% LD and 72% CD). The mean dose of pembrolizumab was 95.3 mg (1.5 mg/kg) in LD and 168.7 mg (2.12 mg/kg) in CD groups, once a day, q21d (every 21 days). After a median follow-up of 10.9 months, there were no significant differences between LD versus CD in cORR (38.1% v 35.2%, P = .31), cPFS (5.3 m v 7 m, P = .36), and OS (12.8 m v not reached, P = .17). A subgroup analysis with patients receiving pembrolizumab was performed, and similar results were obtained.

Conclusion: Our study found no differences in cORR, cPFS, and OS between patients treated with LD and CD anti-PD(L)1. LD anti-PD(L)1 could be an alternative to promote accessibility, which warrants further investigation in randomized trials.

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治疗实体恶性肿瘤的低剂量抗-PD(L)1。
目的:越来越多的数据表明,低剂量抗PD(L)1药物的疗效可与标签批准的剂量相媲美,而成本仅为标签批准剂量的一小部分。我们比较了接受低剂量(LD)和常规剂量(CD)抗 PD(L)1 药物治疗的患者的疗效:这项观察性研究评估了巴西基地医院使用抗PD(L)1药物(低剂量或常规剂量)治疗实体恶性肿瘤患者的疗效。如果患者第一周期的用药剂量低于标签批准的剂量,则将其归类为接受LD治疗的患者。疗效结果包括最佳临床总反应率(cORR)、临床无进展生存期(cPFS)和总生存期(OS):结果:2020 年 1 月至 2023 年 5 月,共纳入 71 例患者:49人(69%)使用LD药物,22人(31%)使用CD药物。最常见的肿瘤部位是肺部(41%为LD,22.9%为CD)和皮肤(黑色素瘤;24.6%为LD,50%为CD)。大多数患者接受了pembrolizumab治疗(65%为LD,72%为CD)。LD 组和 CD 组的 pembrolizumab 平均剂量分别为 95.3 毫克(1.5 毫克/千克)和 168.7 毫克(2.12 毫克/千克),每天一次,q21d(每 21 天一次)。中位随访 10.9 个月后,LD 组与 CD 组在 cORR(38.1% 对 35.2%,P = .31)、cPFS(5.3 m 对 7 m,P = .36)和 OS(12.8 m 对未达到,P = .17)方面无显著差异。对接受pembrolizumab治疗的患者进行了亚组分析,结果相似:我们的研究发现,接受LD抗PD(L)1和CD抗PD(L)1治疗的患者在cORR、cPFS和OS方面没有差异。LD anti-PD(L)1 可能是促进可及性的一种替代方法,值得在随机试验中进一步研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
JCO Global Oncology
JCO Global Oncology Medicine-Oncology
CiteScore
6.70
自引率
6.70%
发文量
310
审稿时长
7 weeks
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