Neoadjuvant atezolizumab for resectable non-small cell lung cancer: an open-label, single-arm phase II trial.
Neoadjuvant atezolizumab for resectable non-small cell lung cancer: an open-label, single-arm phase II trial.
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DOI：
10.1038/s41591-022-01962-5
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发表时间：
2022-10
期刊：
影响因子：
82.9
通讯作者：
Carbone, David P.
中科院分区：
文献类型：
--
作者：
Chaft, Jamie E.;Oezkan, Filiz;Kris, Mark G.;Bunn, Paul A.;Wistuba, Ignacio I.;Kwiatkowski, David J.;Owen, Dwight H.;Tang, Yan;Johnson, Bruce E.;Lee, Jay M.;Lozanski, Gerard;Pietrzak, Maciej;Seweryn, Michal;Byun, Woo Yul;Schulze, Katja;Nicholas, Alan;Johnson, Ann;Grindheim, Jessica;Hilz, Stephanie;Shames, David S.;Rivard, Chris;Toloza, Eric;Haura, Eric B.;McNamee, Ciaran J.;Patterson, G. Alexander;Waqar, Saiama N.;Rusch, Valerie W.;Carbone, David P.
在一项正在进行的开放标签、单组 II 期研究 (NCT02927301) 中，181 名未经治疗、可切除、IB-IIIB 期非小细胞肺癌患者接受了两剂新辅助 atezolizumab 单药治疗。主要终点是无 EGFR 或 ALK 改变的切除肿瘤的主要病理反应（MPR；≤10% 活恶性细胞）。在主要终点分析的 143 名患者中，MPR 为 20%（95% 置信区间，14-28%）。最短随访时间为 3 年，3 年生存率为 80%，令人鼓舞。新辅助阶段最常见的不良事件是疲劳（39%，181 例中的 71 例）和操作性疼痛（29%，181 例中的 53 例），以及预期的免疫相关毒性；没有出现意外的安全信号。在探索性分析中，使用基于 14 个免疫细胞亚群的治疗前外周血免疫表型来预测 MPR。外周血中预测 MPR 的免疫细胞亚群也在肿瘤微环境中得到鉴定，并且与 MPR 相关。这项新辅助阿替利珠单抗在大型可切除非小细胞肺癌患者队列中的研究是安全的，并且达到了 MPR ≥ 15% 的主要终点。这项单组非随机试验的数据表明，治疗前外周血中的先天免疫细胞谱可以预测新辅助阿替利珠单抗后的病理反应，但需要进一步的研究来确定这些谱是否可以为患者选择和新的治疗方法提供信息。在一项单组非随机试验中，对一大群可切除的非小细胞肺癌患者进行新辅助阿特珠单抗治疗是安全的，并且该研究达到了主要病理缓解 ≥15%的主要终点。
In an ongoing, open-label, single-arm phase II study (NCT02927301), 181 patients with untreated, resectable, stage IB–IIIB non-small cell lung cancer received two doses of neoadjuvant atezolizumab monotherapy. The primary end point was major pathological response (MPR; ≤10% viable malignant cells) in resected tumors without EGFR or ALK alterations. Of the 143 patients in the primary end point analysis, the MPR was 20% (95% confidence interval, 14–28%). With a minimum duration of follow-up of 3 years, the 3-year survival rate of 80% was encouraging. The most common adverse events during the neoadjuvant phase were fatigue (39%, 71 of 181) and procedural pain (29%, 53 of 181), along with expected immune-related toxicities; there were no unexpected safety signals. In exploratory analyses, MPR was predicted using the pre-treatment peripheral blood immunophenotype based on 14 immune cell subsets. Immune cell subsets predictive of MPR in the peripheral blood were also identified in the tumor microenvironment and were associated with MPR. This study of neoadjuvant atezolizumab in a large cohort of patients with resectable non-small cell lung cancer was safe and met its primary end point of MPR ≥ 15%. Data from this single-arm, non-randomized trial suggest that profiles of innate immune cells in pre-treatment peripheral blood may predict pathological response after neoadjuvant atezolizumab, but additional studies are needed to determine whether these profiles can inform patient selection and new therapeutic approaches. In a single-arm, non-randomized trial, neoadjuvant atezolizumab therapy in a large cohort of patients with resectable non-small cell lung cancer was safe and the study met its primary end point of major pathological response ≥15%.
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影响因子：
3.7
作者：
Nielsen N;Ødum N;Ursø B;Lanier LL;Spee P
通讯作者：
Spee P
DOI：
10.1016/s1470-2045(13)70334-6
发表时间：
2014-01
期刊：
The Lancet. Oncology
影响因子：
--
作者：
Hellmann MD;Chaft JE;William WN Jr;Rusch V;Pisters KM;Kalhor N;Pataer A;Travis WD;Swisher SG;Kris MG;University of Texas MD Anderson Lung Cancer Collaborative Group
通讯作者：
University of Texas MD Anderson Lung Cancer Collaborative Group
影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
影响因子：
14.9
作者：
Ritchie ME;Phipson B;Wu D;Hu Y;Law CW;Shi W;Smyth GK
通讯作者：
Smyth GK
DOI：
10.1016/j.jtho.2015.12.104
发表时间：
2016-04
期刊：
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
影响因子：
--
作者：
Chaft JE;Dunphy M;Naidoo J;Travis WD;Hellmann M;Woo K;Downey R;Rusch V;Ginsberg MS;Azzoli CG;Kris MG
通讯作者：
Kris MG