Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025
Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025
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DOI：
10.1016/j.eururo.2017.03.037
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发表时间：
2017-09-01
期刊：
影响因子：
23.4
通讯作者：
George, Saby
中科院分区：
文献类型：
--
作者：
Escudier, Bernard;Motzer, Robert J.;George, Saby
背景：对Nivolumab的反应模式与其他认可的靶向疗法的反应模式不同。目标：研究Nivolumab在先前治疗的先前治疗的晚期肾细胞癌患者中的功效，这些患者接受了超出治疗的治疗（固体瘤的反应评估标准）。设置和参与者：这是对在3阶段检查员025研究中接受Nivolumab治疗的患者的亚组分析。继续耐受治疗并展示了对研究者评估的临床益处的患者有资格接受恢复进展（TBP）的治疗，并在第一次进展后接受了> = 4周的治疗。未接受治疗的患者（NTBP）接受0周至= 30％的肿瘤负担减轻，包括术前和肿瘤后肿瘤测量（n = 142）和完全/部分反应的患者（28％，8/29），稳定疾病（6个）， ％，3/47）和进行性疾病（14％，9/66）是TBP之前的最佳反应。患者与治疗相关的不良事件的发生率在（59％）后与（71％）进展后较低。局限性包括分析的非随机性质的潜在偏见。结论：一部分患有晚期肾细胞癌和恢复进展的患者的子集与Nivolumab的肿瘤减少后发生了减少，并且具有可接受的安全性。切换治疗时临床判断仍然至关重要。临床特征识别剂：NCT01668784。病人摘要：一部分患有晚期肾细胞癌和疾病进展的患者可能会继续受益于Nivolumab治疗，超出了肿瘤减少后的肿瘤治疗和可接受的安全性。 （c）2017年欧洲泌尿外科协会。由Elsevier B.V.保留所有权利。
Background: Response patterns to nivolumab differ from those seen with other approved targeted therapies.Objective: To investigate the efficacy of nivolumab in previously treated patients with advanced renal cell carcinoma who were treated beyond (Response Evaluation Criteria In Solid Tumors) RECIST progression.Design, setting, and participants: This was a subgroup analysis of patients treated with nivolumab in the phase 3 CheckMate 025 study. Patients continuing to tolerate therapy and exhibiting investigator-assessed clinical benefit were eligible to be treated beyond RECIST progression (TBP) and received therapy for >= 4 wk after first progression; patients not treated beyond RECIST progression (NTBP) received 0 wk to = 30% tumor burden reduction including patients with preprogression and postprogression tumor measurements (n = 142) and complete/partial response (28%, 8/29), stable disease (6%, 3/47), and progressive disease (14%, 9/66) as their best response before being TBP. Incidence of treatment-related adverse events in patients TBP was lower after (59%) versus before (71%) progression. Limitations included potential bias from the nonrandomized nature of the analysis.Conclusions: A subset of patients with advanced renal cell carcinoma and RECIST progression experienced tumor reduction postprogression with nivolumab, and had an acceptable safety profile. Clinical judgment remains essential when switching therapy. ClinicalTrials.gov Identifier: NCT01668784.Patient summary: A subset of patients with advanced renal cell carcinoma and disease progression may continue to benefit from nivolumab treatment beyond progression as evidenced by tumor reduction postprogression and an acceptable safety profile. (C) 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.