SCI
6August
Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non–Small Cell Lung Cancer Treated With Nivolumab
Topalian Suzanne L,Hodi F Stephen,Brahmer Julie R et al. Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab.[J] .JAMA Oncol, , undefined: undefined.
IMPORTANCE 重要性
Nivolumab, a monoclonal antibody that inhibits programmed cell death 1, is approved by the US Food and Drug Administration for treating advanced melanoma, renal cell carcinoma (RCC), non–small cell lung cancer (NSCLC), and other malignancies. Data on long-term survival among patients receiving nivolumab are limited.
Nivolumab是一种抑制程序性细胞死亡的单克隆抗体1，经美国食品和药物管理局批准用于治疗晚期黑色素瘤，肾细胞癌（RCC），非小细胞肺癌（NSCLC）和其他恶性肿瘤。接受nivolumab的患者的长期存活数据有限。
OBJECTIVES 目标
To analyze long-term overall survival (OS) among patients receiving nivolumab and identify clinical and laboratory measures associated with tumor regression and OS.
分析接受nivolumab的患者的长期总生存期（OS），并确定与肿瘤消退和OS相关的临床和实验室措施。
DESIGN, SETTING, AND PARTICIPANTS 设计，设置和参与者
This was a secondary analysis of the phase 1 CA209-003 trial (with expansion cohorts), which was conducted at 13 US medical centers and included 270 patients with advanced melanoma, RCC, or NSCLC who received nivolumab and were enrolled between October 30, , and December 28, . The analyses were either specified in the original protocol or included in subsequent protocol amendments that were implemented between and . Statistical analysis was performed from October 30, , to November 11, .
这是对第1阶段CA209-003试验（扩展队列）的二次分析，该试验在美国13个医疗中心进行，包括270名于10月30日之间接受nivolumab治疗的晚期黑色素瘤，RCC或NSCLC患。分析要么在原始协议中指定，要么包含在和之间实施的后续协议修订中。统计分析于10月30日至11月11日进行。
INTERVENTION 介入
In the CA209-003 trial, patients received nivolumab (0.1-10.0 mg/kg) every 2 weeks in 8-week cycles for up to 96 weeks, unless they developed progressive disease, achieved a complete response, experienced unacceptable toxic effects, or withdrew consent.
在CA209-003试验中，患者每2周接受nivolumab（0.1-10.0 mg / kg），持续8周，持续96周，除非他们疾病进展，达到完全病情缓解，经历不可接受的毒性作用，或主动要求退出试验。
MAIN OUTCOMES AND MEASURES 主要成果和措施
Safety and activity of nivolumab; OS was a post hoc end point with a minimum follow-up of 58.3 months.
nivolumab的安全性和活性; OS是一个事后终点，最低随访时间为58.3个月。
RESULTS 结果
Of 270 patients included in this analysis, 107 (39.6%) had melanoma, 34 (12.6%) had RCC , and 129 (47.8%) had NSCLC. Overall survival curves showed estimated 5-year rates of 34.2% among patients with melanoma, 27.7% among patients with RCC, and 15.6% among patients with NSCLC. In a multivariable analysis, the presence of liver or bone metastases was independently associated with reduced likelihood of survival at 5 years, whereas an Eastern Cooperative Oncology Group performance status of 0 was independently associated with an increased likelihood of 5-year survival. Overall survival was significantly longer among patients with treatment-related AEs of any grade or grade 3 or more compared with those without treatment-related AEs.
在该分析中包括的270名患者中，107名（39.6％）患有黑素瘤，34名（12.6％）患有RCC，129名（47.8％）患有NSCLC。总生存曲线显示，黑色素瘤患者的估计5年率为34.2％，RCC患者为27.7％，NSCLC患者为15.6％。在多变量分析中，肝脏或骨转移的存在与5年生存可能性降低独立相关，而东部肿瘤协作组的0表现状态与5年生存的可能性增加独立相关。与没有治疗相关的AE的患者相比，任何级别或3级或更高级别的治疗相关AE患者的总生存期显着更长。
CONCLUSIONS AND RELEVANCE 结论和相关性
Nivolumab treatment was associated with long-term survival in a subset of heavily pretreated patients with advanced melanoma, RCC, or NSCLC.
Characterizing factors associated with long-term survival may inform treatment approaches and strategies for future clinical trial development.
Nivolumab治疗与晚期黑素瘤，RCC或NSCLC的重度预治疗患者的长期生存期相关。
表征与长期存活相关的因素可以为未来临床试验开发的治疗方法和策略提供信息。
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