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作者：SCI天天读
SCI
11 April 2024
CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non–Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy
(Journal of Clinical Oncology, IF: 45.30)
Joel Neal, MD, PhD; Nick Pavlakis, MMed, PhD, MBBS, FRACP ; Sang-We Kim, MD, PhD; Yasushi Goto, MD; Sun Min Lim, MD, PhD; Giannis Mountzios, MD, PhD, MSc; Elena Fountzilas, MD; Anastasia Mochalova, MD; Daniel C. Christoph, MD, PhD; Alessandra Bearz, MD; Xavier Quantin, MD, PhD; Ramon Palmero, MD; Vladan Antic, MD, PhD; Elaine Chun, PharmD; Tirupathi Rao Edubilli, MSc; Ya-Chen Lin, PhD; Mahrukh Huseni, MS; Marcus Ballinger, PhD; Vilma Graupner, PhD; Dominic Curran, MBChB; Piet Vervaet, MD; and Thomas Newsom-Davis, PhD, MBBS, FRCP
CORRESPONDENCE TO: jwneal@stanford.edu
PURPOSE 目的
Although checkpoint inhibitors have improved first-line treatment for non–small cell lung cancer (NSCLC), a therapeutic need remains for patients whose disease does not respond or who experience disease progression after anti–PD-L1/PD-1 immunotherapy. CONTACT-01 (ClinicalTrials.gov identifier: NCT04471428) evaluated atezolizumab plus cabozantinib versus docetaxel in patients with metastatic NSCLC who developed disease progression after concurrent or sequential treatment with anti–PD-L1/PD-1 and platinum-containing chemotherapy.
虽然检查点抑制剂改善了非小细胞肺癌（NSCLC）的一线治疗，但对于那些在接受抗PD-L1/PD-1免疫疗法后疾病未响应或疾病进展的患者，仍存在治疗需求。CONTACT-01（ClinicalTrials.gov注册号：NCT04471428）评估在接受抗PD-L1/PD-1和含铂化疗的同步治疗或序贯治疗后疾病进展的转移性NSCLC患者使用阿替利珠单抗联合卡博替尼与多西他赛的效果。
METHODS 方法
This multicenter, open-label, phase III trial randomly assigned patients 1:1 to atezolizumab 1,200 mg intravenously once every 3 weeks (q3w) plus cabozantinib 40 mg orally once daily or docetaxel 75 mg/m2 intravenously once every 3 weeks. The primary end point was overall survival (OS).
这项多中心、开放标签、三期临床试验将患者1:1随机分配，接受阿替利珠单抗每3周一次1200毫克静脉注射、联合卡博替尼每天一次40毫克口服，或多西他赛每3周一次75毫克/平方米静脉注射。主要终点是总生存期（OS）。
RESULTS 结果
One hundred eighty-six patients were assigned atezolizumab plus cabozantinib, and 180 docetaxel. Minimum OS follow-up was 10.9 months. Median OS was 10.7 months (95% CI, 8.8 to 12.3) with atezolizumab plus cabozantinib and 10.5 months (95% CI, 8.6 to 13.0) with docetaxel (stratified hazard ratio [HR], 0.88 [95% CI, 0.68 to 1.16]; P 5 .3668). Median progression-free survival was 4.6 months (95% CI, 4.1 to 5.6) and 4.0 months (95% CI, 3.1 to 4.4), respectively (stratified HR, 0.74 [95% CI, 0.59 to 0.92]). Serious adverse events (AEs) occurred in 71 (38.4%) patients receiving atezolizumab plus cabozantinib and 58 (34.7%) receiving docetaxel. Grade 3/4 treatment related AEs occurred in 73 (39.5%) patients receiving atezolizumab plus cabozantinib and 58 (34.7%) receiving docetaxel. Grade 5 AEs occurred in 14 (7.6%) and 10 (6.0%) patients in the atezolizumab plus cabozantinib and docetaxel arms, respectively (treatment-related in four [2.2%] and one [0.6%], respectively).
186名患者接受阿替利珠单抗加卡博替尼治疗，180名接受多西他赛治疗。最短OS随访时间为10.9个月。阿替利珠单抗加卡博替尼治疗组患者的中位OS为10.7个月（95% CI，8.8至12.3），多西他赛治疗组患者的中位OS为10.5个月（95% CI，8.6至13.0）（分层风险比[HR]，0.88 [95% CI，0.68至1.16]；P = .3668）。中位无进展生存期分别为4.6个月（95% CI，4.1至5.6）和4.0个月（95% CI，3.1至4.4）（分层HR，0.74 [95% CI，0.59至0.92]）。接受阿替利珠单抗加卡博替尼的患者中有71名（38.4%）出现严重不良事件（AEs），接受多西他赛的患者中有58名（34.7%）出现严重不良事件。3/4级治疗相关AEs分别在73名（39.5%）接受阿替利珠单抗加卡博替尼的患者和接受多西他赛的58名（34.7%）患者中发生。5级AEs分别在阿替利珠单抗加卡博替尼组的14名（7.6%）患者和多西他赛组的10名（6.0%）患者中发生（分别有4名（2.2%）和1名（0.6%）与治疗相关）。
CONCLUSION 结论
Atezolizumab plus cabozantinib after disease progression following anti–PDL1/ PD-1 immunotherapy and platinum-containing chemotherapy for metastatic NSCLC did not improve OS compared with docetaxel. Safety was consistent with known profiles of these agents.
对于在接受抗PD-L1/PD-1免疫治疗和含铂化疗后疾病进展的转移性NSCLC患者，阿替利珠单抗加卡博替尼与多西他赛相比，并未改善OS。安全性与这些药物的已知特性一致。
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