Service de Pneumologie et Oncologie Thoracique, AP-HP, Hôpital Tenon and GRC #04 Theranoscan, Sorbonne Université, Paris, France.
Thoracic Oncology Department, Toulouse University Hospital, Université Paul Sabatier, Toulouse, France.
Lung Cancer. 2021 Aug;158:146-150. doi: 10.1016/j.lungcan.2021.05.031. Epub 2021 May 28.
Therapies targeting immune checkpoints, such as the programmed cell death 1 (PD-1) receptor, have become the standard-of-care for patients with non-small cell lung cancer (NSCLC), but people living with HIV (PLWH) were excluded from these studies.
To evaluate the efficacy and tolerability of nivolumab in PLWH with advanced NSCLC.
The CHIVA2 study was a nonrandomized, open-label, phase 2 clinical trial in PLWH with previously treated advanced NSCLC.
National multicenter prospective study.
patients had viral load of <200 copies/mL, regardless of their CD4+ T-cell count.
Nivolumab was administered in second or third line, as monotherapy intravenously at 3 mg/kg every 2 weeks, until disease progression or limiting toxicity.
The primary endpoint was disease control rate, evaluated using the Response Evaluation Criteria in Solid Tumors, version 1.1. Adverse events were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Sixteen patients with advanced NSCLC were enrolled: 14 (88 %) were men, median age was 58 years (range: 44-71), and all were smokers. The median duration of nivolumab treatment was 3.5 months (range: 0.5-26.5). The median follow-up was 23.6 months. Disease control rate was 62.5 % for 15 evaluable patients at 8 weeks (2 with partial response, 8 with stable disease, and 5 with disease progression). Twelve (75 %) patients had treatment-related adverse events, which were mild or moderate, except for one patient experiencing severe pruritus, onycholysis, and pemphigoid. There were no opportunistic infections or unexpected immune-related events. HIV viral load was stable during treatment. An increase in proliferating CD8+ and CD4+ T-cells was observed after 3 nivolumab cycles in a subgroup of 9 patients.
Second/third-line nivolumab treatment was well-tolerated and beneficial in PLWH with NSCLC. Future trials should investigate immune checkpoint inhibitors in first-line settings.
EudraCT.ema.europa.eu registration number: 2016-003796-22.
针对免疫检查点的疗法，如程序性细胞死亡 1（PD-1）受体，已成为非小细胞肺癌（NSCLC）患者的标准治疗方法，但艾滋病毒感染者（PLWH）被排除在这些研究之外。
评估纳武单抗在 PLWH 中晚期 NSCLC 中的疗效和耐受性。
CHIVA2 研究是一项针对 PLWH 中晚期 NSCLC 的非随机、开放标签、二期临床试验。
国家多中心前瞻性研究。
患者的病毒载量<200 拷贝/mL，无论其 CD4+T 细胞计数如何。
纳武单抗作为二线或三线治疗药物，静脉内每 2 周以 3mg/kg 的剂量单独使用，直至疾病进展或出现限制毒性。
主要终点是根据实体瘤反应评估标准 1.1 评估的疾病控制率。不良事件采用国家癌症研究所不良事件常用术语标准 4.0 分级。
16 名患有晚期 NSCLC 的患者入组：14 名（88%）为男性，中位年龄为 58 岁（范围：44-71），均为吸烟者。纳武单抗治疗的中位持续时间为 3.5 个月（范围：0.5-26.5）。中位随访时间为 23.6 个月。15 名可评估患者在 8 周时疾病控制率为 62.5%（2 名部分缓解，8 名疾病稳定，5 名疾病进展）。12 名（75%）患者出现与治疗相关的不良事件，均为轻度或中度，除 1 名患者出现严重瘙痒、甲分离和天疱疮外。无机会性感染或意外的免疫相关事件。治疗期间 HIV 病毒载量稳定。9 名患者的亚组在接受 3 个纳武单抗周期后观察到增殖的 CD8+和 CD4+T 细胞增加。
二线/三线纳武单抗治疗在 PLWH 中晚期 NSCLC 中是耐受良好且有益的。未来的试验应研究一线治疗中免疫检查点抑制剂的应用。
EudraCT.ema.europa.eu 注册号：2016-003796-22。
