Cowey Charles Lance, Scherrer Emilie, Boyd Marley, Aguilar Kathleen M, Beeks April, Krepler Clemens
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas.
Ontada, The Woodlands, TX.
J Immunother. 2021;44(6):224-233. doi: 10.1097/CJI.0000000000000363.
Favorable outcomes have been observed with pembrolizumab among patients with advanced melanoma in clinical trials; however, limited evidence exists on the long-term efficacy in the real-world setting. This was an updated, retrospective observational study of adult patients with advanced (unresectable or metastatic) melanoma who initiated pembrolizumab (in any line of therapy) between January 1, 2014, and December 31, 2016, in The US Oncology Network and were followed through December 31, 2019 [median follow-up: 18.2 mo (range: 0.1-63.1 mo)]. Study data were sourced from electronic health records. Patient demographic, clinical, and treatment characteristics were assessed descriptively. Kaplan-Meier methods were used to evaluate overall survival (OS), time to treatment discontinuation, time to next treatment, physician-assessed time to tumor progression, and physician-assessed progression-free survival (rwPFS). Independent risk factors for OS and rwPFS were identified with multivariable Cox regression models. Of the 303 study-eligible patients, 119, 131, and 53 received pembrolizumab in the first-line, second-line, and third-line or beyond setting, respectively. Median OS across the study population was 29.3 months [95% confidence interval (CI): 20.3-49.7] and was the longest among those who received first-line pembrolizumab [42.8 mo (95% CI: 24.8-not reached)]. Median rwPFS across the study population was 5.1 months (95% CI: 4.0-7.6) and 8.1 months (95% CI: 4.6-14.4) among those who received first-line pembrolizumab. In the multivariable analyses for OS, increased age, worsening performance status, elevated lactate dehydrogenase, brain metastases, and pembrolizumab use in later lines were significantly associated a worse prognosis.
在临床试验中，帕博利珠单抗治疗晚期黑色素瘤患者已观察到良好疗效；然而，在真实世界环境中的长期疗效证据有限。这是一项更新的回顾性观察性研究，研究对象为2014年1月1日至2016年12月31日期间在美国肿瘤学网络开始使用帕博利珠单抗（任何治疗线）的晚期（不可切除或转移性）黑色素瘤成年患者，并随访至2019年12月31日[中位随访时间：18.2个月（范围：0.1 - 63.1个月）]。研究数据来源于电子健康记录。对患者的人口统计学、临床和治疗特征进行了描述性评估。采用Kaplan-Meier方法评估总生存期（OS）、治疗中断时间、下次治疗时间、医生评估的肿瘤进展时间和医生评估的无进展生存期（rwPFS）。通过多变量Cox回归模型确定OS和rwPFS的独立危险因素。在303例符合研究条件的患者中，分别有119例、131例和53例在一线、二线和三线及以上治疗中接受了帕博利珠单抗治疗。整个研究人群的中位OS为29.3个月[95%置信区间（CI）：20.3 - 49.7]，在接受一线帕博利珠单抗治疗的患者中最长[42.8个月（95%CI：24.8 - 未达到）]。整个研究人群的中位rwPFS为5.1个月（95%CI：4.0 - 7.6），在接受一线帕博利珠单抗治疗的患者中为8.1个月（95%CI：4.6 - 14.4）。在OS的多变量分析中，年龄增加、体能状态恶化、乳酸脱氢酶升高、脑转移以及在后续治疗线中使用帕博利珠单抗与较差的预后显著相关。
