Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age

被引:46
作者
Saba, Nabil F. [1 ]
Blumenschein, George, Jr. [2 ]
Guigay, Joel [3 ]
Licitra, Lisa [4 ,5 ]
Fayette, Jerome [6 ]
Harrington, Kevin J. [7 ]
Kiyota, Naomi [8 ]
Gillison, Maura L. [2 ]
Ferris, Robert L. [9 ]
Jayaprakash, Vijayvel [10 ]
Li, Li [10 ]
Brossart, Peter [11 ]
机构
[1] Emory Univ, Winship Canc Inst, 1365-C Clifton Rd NE, Atlanta, GA 30322 USA
[2] MD Anderson Canc Ctr, 1515 Holcombe Blvd, Houston, TX 77030 USA
[3] Univ Cote Azur, FHU OncoAge, Ctr Antoine Lacassagne, 33 Ave Valombrose, F-06189 Nice, France
[4] Fdn IRCCS Ist Nazl Tumori, Via Venezian 1, I-20133 Milan, Italy
[5] Univ Milan, Via Venezian 1, I-20133 Milan, Italy
[6] Ctr Leon Berard, 28 Prom Lea & Napoleon Bullukian, F-69008 Lyon, France
[7] Royal Marsden NHS Fdn Trust, Inst Canc Res, Fulham Rd, London SW3 6JJ, England
[8] Kobe Univ Hosp, Canc Ctr, 7 Chome 5-2 Kusunokicho, Kobe, Hyogo 6500017, Japan
[9] Univ Pittsburgh, Hillman Canc Ctr, Med Ctr, 5115 Ctr Ave, Pittsburgh, PA 15232 USA
[10] Bristol Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ 08648 USA
[11] Univ Hosp Bonn, Sigmund Freud Str 25, D-53127 Bonn, Germany
关键词
Biomarkers; Nivolumab; Squamous cell carcinoma of the head and neck; Age; Phase 3 clinical trial; GERIATRIC ONCOLOGY; ELDERLY-PATIENTS; OLDER-ADULTS; CANCER; IMMUNOTHERAPY; CHEMOTHERAPY; IRRADIATION; MANAGEMENT; INHIBITORS;
D O I
10.1016/j.oraloncology.2019.06.017
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objectives: Many patients with squamous cell carcinoma of the head and neck (SCCHN) are >= 65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. Patients and methods: Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and >= 65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months). Results: At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were >= 65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (>= 65 years) and 13.0% (65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. Conclusion: In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients < 65 and >= 65 years, with a manageable safety profile in both age groups.
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收藏
页码:7 / 14
页数:8
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