Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study

被引:609
作者
Gettinger, Scott [1 ]
Horn, Leora [2 ]
Jackman, David [4 ]
Spigel, David [3 ]
Antonia, Scott [6 ]
Hellmann, Matthew [7 ]
Powderly, John [8 ]
Heist, Rebecca [5 ]
Sequist, Lecia V. [5 ]
Smith, David C. [9 ]
Leming, Philip [10 ]
Geese, William J. [11 ]
Yoon, Dennis [11 ]
Li, Ang [11 ]
Brahmer, Julie [12 ]
机构
[1] Yale Canc Ctr, New Haven, CT USA
[2] Vanderbilt Univ, Med Ctr, Nashville, TN USA
[3] Tennessee Oncol, Sarah Cannon Res Inst, Nashville, TN USA
[4] Dana Farber Canc Inst, Boston, MA 02115 USA
[5] Massachusetts Gen Hosp, Boston, MA 02114 USA
[6] H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA
[7] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
[8] Carolina BioOncol Inst, Huntersville, NC USA
[9] Univ Michigan, Ann Arbor, MI 48109 USA
[10] Christ Hosp, Ctr Canc, Cincinnati, OH 45219 USA
[11] Bristol Myers Squibb, Princeton, NJ USA
[12] Johns Hopkins Univ, Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA
关键词
LONG-TERM SAFETY; OPEN-LABEL; DOCETAXEL; GUIDELINES; SURVIVAL; ANTIBODY;
D O I
10.1200/JCO.2017.77.0412
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose In two phase III studies, nivolumab, a programmed death-1 (PD-1) inhibitor antibody, improved overall survival (OS) versus docetaxel in pretreated advanced non-small-cell lung cancer (NSCLC). We report 5-year follow-up results from an early phase I study of nivolumab in this patient population and describe characteristics of 5-year survivors. Patients and Methods Patients with pretreated, advanced NSCLC received nivolumab 1, 3, or 10 mg/kg every 2 weeks in 8-week cycles for up to 96 weeks. OS from the time of first dose was estimated by the Kaplan-Meier method. Results The estimated 5-year OS rate was 16% for all treated patients (N = 129); 5-year OS rates were similar for squamous (16%) and nonsquamous (15%) NSCLC. Of 16 5-year survivors, most (88%) were known current or former smokers. Of 10 5-year survivors with quantifiable PD-1 ligand 1 expression, 70% had >= 1% PD-1 ligand 1 expression at baseline. Twelve 5-year survivors (75%) achieved a partial response to nivolumab per Response Evaluation Criteria in Solid Tumors, version 1.0, and two each (12%) had stable disease and progressive disease as best response. Nine 5-year survivors (56%) completed the maximum 96 weeks of nivolumab; four (25%) discontinued owing to adverse events and three (19%) owing to disease progression. As of a November 2016 database lock, 12 5-year survivors (75%) received no subsequent therapy and were without evidence of progressive disease at last follow-up. Conclusions Nivolumab treatment resulted in long-term OS and durable responses in a proportion of patients with pretreated advanced NSCLC. Long-term survivors had diverse baseline and on-treatment characteristics.
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收藏
页码:1675 / +
页数:13
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