在至少60个月的随访中，依普利单抗组的中位总生存期为19.9个月，Nivolumab+依普利单抗组为60个月，死亡风险比为0.52；Nivolumab组为36.9个月，死亡风险比为0.63。Nivolumab+依普利单抗组的5年总生存率为52%，Nivolumab组为44%，而依普利单抗组为26%。在使用Nivolumab+依普利单抗或单独Nivolumab治疗期间或之后，均未观察到与健康相关的生活质量持续恶化，亦未发现新的晚期毒性作用。
总之，接受Nivolumab+依普利单抗或Nivolumab单药治疗的晚期黑色素瘤患者，5年持续长期总生存率显著高于单独依普利单抗治疗的患者，且生活质量未明显下降。
RESULTS
At a minimum follow-up of 60 months, the median overall survival was more than 60.0 months (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death with nivolumab vs. ipilimumab, 0.63). Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group. No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone. No new late toxic effects were noted.
CONCLUSIONS
Among patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab.
联合疗法可提高晚期黑色素瘤5年生存率
作者：小柯机器人 发布时间：2019/9/29 16:04:31
英国伦敦皇家马斯登NHS基金会James Larkin等研究人员，探究了Nivolumab和依普利单抗联合治疗晚期黑色素瘤的5年生存率。2019年9月28日，《新英格兰医学杂志》在线发表了这项成果。
在一项涉及晚期黑色素瘤患者的试验中，与单独使用依普利单抗相比，Nivolumab联合依普利单抗或Nivolumab单药治疗均显著延长了患者的无进展和总生存期。该研究扩展了5年的试验结果。
研究人员随机分配先前未经治疗的晚期黑色素瘤患者接受以下治疗方案之一：Nivolumab（每公斤体重1毫克）+依普利单抗（每公斤3毫克）每3周一次，共4次，之后Nivolumab（每公斤3毫克）每2周一次；Nivolumab（每公斤3毫克）+安慰剂，每2周一次；或依普利单抗（每公斤3毫克）+安慰剂，每3周一次，共4次。
在至少60个月的随访中，依普利单抗组的中位总生存期为19.9个月，Nivolumab+依普利单抗组为60个月，死亡风险比为0.52；Nivolumab组为36.9个月，死亡风险比为0.63。Nivolumab+依普利单抗组的5年总生存率为52%，Nivolumab组为44%，而依普利单抗组为26%。在使用Nivolumab+依普利单抗或单独Nivolumab治疗期间或之后，均未观察到与健康相关的生活质量持续恶化，亦未发现新的晚期毒性作用。
总之，接受Nivolumab+依普利单抗或Nivolumab单药治疗的晚期黑色素瘤患者，5年持续长期总生存率显著高于单独依普利单抗治疗的患者，且生活质量未明显下降。
附：英文原文
Title:Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma
Author:James Larkin, F.R.C.P., Ph.D., Vanna Chiarion-Sileni, M.D., Rene Gonzalez, M.D., Jean-Jacques Grob, M.D., Piotr Rutkowski, M.D., Ph.D., Christopher D. Lao, M.D., C. Lance Cowey, M.D., M.P.H., Dirk Schadendorf, M.D., John Wagstaff, M.D., Reinhard Dummer, M.D., Pier F. Ferrucci, M.D., Michael Smylie, M.D., David Hogg, M.D., Andrew Hill, M.D., Ivan Márquez-Rodas, M.D., Ph.D., John Haanen, M.D., Massimo Guidoboni, M.D., Michele Maio, M.D., Patrick Schöffski, M.D., Ph.D., Matteo S. Carlino, M.D., Céleste Lebbé, M.D., Ph.D., Grant McArthur, F.R.A.C.P., Ph.D., Paolo A. Ascierto, M.D., Gregory A. Daniels, M.D., Georgina V. Long, M.D., Lars Bastholt, M.D., Jasmine I. Rizzo, M.D., M.P.H., Agnes Balogh, M.Sc., Andriy Moshyk, M.D., F. Stephen Hodi, M.D., and Jedd D. Wolchok, M.D., Ph.D.
Issue&Volume:2019-09-28
Abstract:
BACKGROUND
Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial.
Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial.
METHODS
We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group.
We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group.
RESULTS
At a minimum follow-up of 60 months, the median overall survival was more than 60.0 months (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death with nivolumab vs. ipilimumab, 0.63). Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group. No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone. No new late toxic effects were noted.
CONCLUSIONS
Among patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab.
DOI:10.1056/NEJMoa1910836
期刊信息
The New England Journal of Medicine：《新英格兰医学杂志》，创刊于1812年。隶属于麻省医学协会，最新IF：70.67
官方网址：http://www.nejm.org/
投稿链接：http://www.nejm.org/page/author-center/home