Adhikari Arjab, Cha Elaine, Antala Drashti, Sapkota Supriya, Bhattarai Utsuk
Ascension Saint Francis Hospital, 355 Ridge Ave, Evanston, IL 60202, USA.
MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA.
Cancer Epidemiol. 2022 Dec;81:102254. doi: 10.1016/j.canep.2022.102254. Epub 2022 Sep 26.
Immune-checkpoint inhibitors (ICI) have revolutionized the treatment of metastatic melanoma. Ipilimumab and Ipilimumab-Nivolumab combination therapies were approved by the United States Food and Drug Administration in 2011 and 2015, respectively. We aimed to evaluate potential changes in the survival of patients with metastatic melanoma following the approval of these agents.
We extracted data from the Surveillance, Epidemiology, and End Results (SEER) database (Nov 2021 submission). All patients aged 20 and above who were diagnosed with 'distant' melanoma (per 'combined summary stage') from 2007 through 2018 were included in the study. This time period was further sub-categorized into 2007-2010 (pre-ICI era), 2011-2014 (single-agent ICI era), and 2015-2018 (combination ICI era) based on the approval timeline of ICI.
The median overall survival (OS) was 8, 10, and 14 months in the pre-ICI, single-agent ICI, and combination ICI eras respectively (log-rank test, χ² = 189.03, p < 0.001). On Cox-proportional hazard analysis, patients diagnosed in the single-agent and combination ICI eras had a significantly lower risk of dying [HR 0.82 (95% CI 0.78-0.87) and 0.67 (0.64-0.71), respectively] compared to patients diagnosed in the pre-ICI era. Patients who were of the male gender, aged ≥ 65 years, and those receiving chemotherapy and/or radiotherapy were at a significantly higher risk of dying. Married individuals had a significantly lower risk of dying compared to patients who were divorced, separated, or widowed at the time of diagnosis. There was no significant difference in survival demonstrated among non-Hispanic blacks versus non-Hispanic whites.
Survival of patients with metastatic melanoma has improved in the era of immune checkpoint inhibitors. It implies that the survival of patients reported in trials can be correlated at a population level as well. Future analysis from the SEER database is needed when new data becomes available to see if there is a further increase in OS.
免疫检查点抑制剂（ICI）彻底改变了转移性黑色素瘤的治疗方式。伊匹单抗以及伊匹单抗 - 纳武单抗联合疗法分别于2011年和2015年获得美国食品药品监督管理局批准。我们旨在评估这些药物获批后转移性黑色素瘤患者生存率的潜在变化。
我们从监测、流行病学和最终结果（SEER）数据库（2021年11月提交的数据）中提取数据。纳入研究的所有患者年龄在20岁及以上，于2007年至2018年期间被诊断为“远处”黑色素瘤（根据“综合总结分期”）。根据ICI的批准时间线，该时间段进一步细分为2007 - 2010年（ICI前时代）、2011 - 2014年（单药ICI时代）和2015 - 2018年（联合ICI时代）。
在ICI前、单药ICI和联合ICI时代，中位总生存期（OS）分别为8个月、10个月和14个月（对数秩检验，χ² = 189.03，p < 0.001）。在Cox比例风险分析中，与在ICI前时代诊断的患者相比，在单药和联合ICI时代诊断的患者死亡风险显著更低[风险比（HR）分别为0.82（95%置信区间0.78 - 0.87）和0.67（0.64 - 0.71）]。男性、年龄≥65岁以及接受化疗和/或放疗的患者死亡风险显著更高。与诊断时离婚、分居或丧偶的患者相比，已婚个体死亡风险显著更低。非西班牙裔黑人与非西班牙裔白人之间的生存率无显著差异。
在免疫检查点抑制剂时代，转移性黑色素瘤患者的生存率有所提高。这意味着试验中报告的患者生存率在人群水平上也具有相关性。当有新数据可用时，需要对SEER数据库进行进一步分析，以查看总生存期是否会进一步提高。
