Uprety Dipesh, Bista Amir, Chennamadhavuni Adithya, Niroula Abesh, Jafri Syed Imran Mustafa, Smith Angela, Arjyal Lubina
Departments of Hematology and Medical Oncology.
Internal Medicine, Robert Packer Hospital/Guthrie Clinic, Sayre.
Melanoma Res. 2018 Feb;28(1):56-60. doi: 10.1097/CMR.0000000000000394.
In 2011, ipilimumab was approved by the US Food and Drug Administration (FDA) for metastatic melanoma. Since its approval, numerous targeted therapies have been approved by the FDA. Population-based studies assessing the survival benefit from these agents are lacking. We therefore carried out this study to compare the 1-year, 2-year, and median overall survival (OS) among metastatic melanoma patients in pretargeted and post-targeted eras. This is a retrospective study that utilized the Surveillance, Epidemiology, and End Results (SEER-18) database, version 8.3.4 (22 March 2017). The patient groups were defined as the pretargeted era (2004-2010) and the post-targeted era (2011-2014) as ipilimumab was approved by the FDA in 2011. The database comprised of 5471 patients (3314 in the pretargeted era and 2157 in the post-targeted era). OS in the post-targeted era was found to be significantly better compared with the pretargeted era by Kaplan-Meier curve (1-year OS: 38.9 vs. 36.8%, 2-year OS: 28.3 vs. 23.5%, and median survival: 8 vs. 7 months, P=0.001 by the log-rank test). The survival was significantly better in the post-targeted era compared with the pretargeted era on multivariate analysis using a Cox proportional hazard model after adjusting for age, sex, race, and metasectomy status (adjusted hazard ratio of 0.889, 95% CI: of 0.832-0.951, P=0.001). There is significant survival benefit in metastatic melanoma patients since the introduction of immune checkpoint-blocking agents.
2011年，伊匹单抗获美国食品药品监督管理局（FDA）批准用于治疗转移性黑色素瘤。自其获批以来，FDA又批准了众多靶向疗法。目前尚缺乏基于人群的研究来评估这些药物的生存获益情况。因此，我们开展了本研究，以比较靶向治疗时代之前和之后转移性黑色素瘤患者的1年、2年总生存期（OS）及中位总生存期。这是一项回顾性研究，使用了监测、流行病学和最终结果（SEER-18）数据库，版本8.3.4（2017年3月22日）。患者组定义为靶向治疗时代之前（2004 - 2010年）和靶向治疗时代之后（2011 - 2014年），因为伊匹单抗于2011年获FDA批准。该数据库包含5471例患者（靶向治疗时代之前3314例，靶向治疗时代之后2157例）。通过Kaplan-Meier曲线发现，靶向治疗时代之后的总生存期显著优于靶向治疗时代之前（1年总生存期：38.9%对36.8%，2年总生存期：28.3%对23.5%，中位生存期：8个月对7个月，对数秩检验P = 0.001）。在对年龄、性别、种族和转移灶切除状态进行校正后，使用Cox比例风险模型进行多因素分析，结果显示靶向治疗时代之后的生存期显著优于靶向治疗时代之前（校正风险比为0.889，95%置信区间：0.832 - 0.951，P = 0.001）。自引入免疫检查点阻断剂以来，转移性黑色素瘤患者有显著的生存获益。
