Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression

被引:595
作者
Ferris, Robert L. [1 ]
Blumenschein, George, Jr. [2 ]
Fayette, Jerome [3 ]
Guigay, Joel [4 ]
Colevas, A. Dimitrios [5 ]
Licitra, Lisa [6 ,7 ]
Harrington, Kevin J. [8 ]
Kasper, Stefan [9 ]
Vokes, Everett E. [10 ]
Even, Caroline [11 ]
Worden, Francis [12 ]
Saba, Nabil F. [13 ]
Iglesias Docampo, Lara Carmen [14 ]
Haddad, Robert [15 ]
Rordorf, Tamara [16 ]
Kiyota, Naomi [17 ]
Tahara, Makoto [18 ]
Lynch, Mark [19 ]
Jayaprakash, Vijayvel [19 ]
Li, Li [19 ]
Gillison, Maura L. [2 ]
机构
[1] Univ Pittsburgh, Med Ctr, Hillman Canc Ctr, Pittsburgh, PA USA
[2] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[3] Ctr Leon Berard, Lyon, France
[4] Univ Cote Azur, FHU OncoAge, Ctr Antoine Lacassagne, Nice, France
[5] Stanford Univ, Stanford, CA 94305 USA
[6] Fdn IRCCS, Ist Nazl Tumori, Milan, Italy
[7] Univ Milan, Milan, Italy
[8] Royal Marsden NHS Fdn Trust, Inst Canc Res, Natl Inst Hlth Res, Biomed Res Ctr, London, England
[9] Univ Hosp, West German Canc Ctr, Essen, Germany
[10] Univ Chicago, Med Ctr, Chicago, IL 60637 USA
[11] Gustave Roussy, Villejuif, France
[12] Univ Michigan, Ann Arbor, MI 48109 USA
[13] Emory Univ, Winship Canc Inst, Atlanta, GA 30322 USA
[14] Hosp Univ 12 Octubre, Madrid, Spain
[15] Dana Farber Harvard Canc Ctr, Boston, MA USA
[16] Univ Spital Zurich, Zurich, Switzerland
[17] Kobe Univ Hosp, Kobe, Hyogo, Japan
[18] Natl Canc Ctr Hosp East, Kashiwa, Chiba, Japan
[19] Bristol Myers Squibb Co, Princeton, NJ USA
关键词
Nivolumab; Head and Neck Neoplasms; Carcinoma; squamous cell of head and neck; Immunotherapy; Papillomaviridae; (HPV; Human Papillomavirus Viruses); Programmed Cell Death 1 Receptor; CD274; protein; human; (PD-L1; Protein; Human); Clinical Trial; Phase III; Survival Analysis; Survivors (Long-term Survivors); CANCER;
D O I
10.1016/j.oraloncology.2018.04.008
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objectives: We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M), platinumrefractory squamous cell carcinoma of the head and neck (SCCHN). Methods: Patients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017. Results: With 24.2 months' minimum follow-up, nivolumab (n = 240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression = 1% (HR [95% CI] = 0.55 [0.39-0.78]) and < 1% (HR [95% CI] = 0.73 [0.49-1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (< 1%/ = 1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3-4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively. Conclusion: Nivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status.
引用
收藏
页码:45 / 51
页数:7
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