Journal article
Nivolumab (Nivo) vs investigator’s choice (IC) for platinum-refractory (PR) recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN; Checkmate 141): Outcomes in first-line (1L) R/m patients and updated safety and efficacy.
- Gillison, Maura L. The Ohio State University, Columbus, OH;
- Blumenschein, George R. MD Anderson Cancer Center, Houston, TX;
- Fayette, Jérôme Centre Léon-Bérard, Lyon, France;
- Guigay, Joel Centre Antoine Lacassagne, Nice, France;
- Colevas, A. Dimitrios Stanford University, Stanford, CA;
- Licitra, Lisa Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy;
- Harrington, Kevin Royal Marsden NHS Foundation Trust, The Institute of Cancer Research, London, United Kingdom;
- Kasper, Stefan West German Cancer Center, University Hospital, Essen, Germany;
- Vokes, Everett E. University of Chicago Medical Center, Chicago, IL;
- Even, Caroline Gustave Roussy, Villejuif, France;
- Worden, Francis P. University of Michigan, Ann Arbor, MI;
- Saba, Nabil F. Winship Cancer Institute, Atlanta, GA;
- Iglesias Docampo, Lara Carmen Hospital Universitario 12 de Octubre, Madrid, Spain;
- Haddad, Robert I. Dana-Farber Cancer Institute/Harvard Cancer Center, Boston, MA;
- Rordorf, Tamara Universitätsspital Zurich, Zurich, Switzerland;
- Kiyota, Naomi Kobe University Hospital, Kobe, Japan;
- Tahara, Makoto National Cancer Center Hospital East, Kashiwa, Japan;
- Lynch, Mark John Bristol-Myers Squibb, Princeton, NJ;
- Kopit, Justin Bristol-Myers Squibb, Princeton, NJ;
- Ferris, Robert L. University of Pittsburgh Medical Center Cancer Center Pavilion, Pittsburgh, PA;
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2017, vol. 35, no. 15_suppl, p. 6019-6019
English
6019 Background: In CheckMate 141, a randomized, phase 3 trial, nivo demonstrated superior overall survival (OS) and better tolerability in patients (pts) with PR R/M SCCHN compared with IC. Pts with SCCHN progressing within 6 mos of platinum in the primary treatment setting have dismal prognosis. We report outcomes in pts who were PR in the primary or adjuvant setting, and updated results in the overall population. Methods: Pts (N = 361) with PR R/M SCCHN were randomized 2:1 to nivo 3 mg/kg every 2 weeks or weekly IC (methotrexate, docetaxel, or cetuximab). Primary endpoint was OS estimated by Kaplan-Meier method. Cox proportional hazards models were used to estimate hazard ratios (HRs) and confidence intervals (CIs). Additional endpoints include objective response rate (ORR) and safety. Outcomes were analyzed overall and post hoc in pts who were PR in the primary/adjuvant setting and received nivo/IC as 1L R/M therapy. Results: Characteristics of the 78 (21.6%) pts who received nivo (n = 52) or IC (n = 26) in the 1L R/M setting were similar to the overall population.Nivo significantly improved OS vs IC among 1L R/M pts (median [95% CI]: 7.7 mo [3.1, 13.8] vs 3.3 mo [2.1, 6.4]; HR [95% CI] = 0.56 [0.33, 0.95]); 12-mo OS rate: 39.2% vs 15.4%. ORR was 19.2% for nivo vs 11.5% for IC in this subgroup. At 11.4-mo minimum follow-up, updated efficacy and safety in the overall population were similar to the primary analysis. Median OS (95% CI) was 7.7 mo (5.7, 8.8) for nivo vs 5.1 mo (4.0, 6.2) for IC; HR (95% CI) = 0.71 (0.55, 0.90); P = 0.0048. For nivo vs IC, the 18-mo OS rate was 21.5% vs 8.3% and ORR was 13.3% vs 5.8%. Nivo doubled the median duration of response vs IC (9.7 vs 4.0 mo). Grade 3–4 treatment-related adverse event rates for nivo vs IC were 15.3% vs 36.0% overall and 27.5% vs 32.0% for 1L R/M pts; there were no new deaths due to study drug toxicity. Conclusions: Nivo significantly improved OS and increased ORR vs IC in a 1L R/M subgroup, supporting its use as 1L therapy for pts with PR R/M SCCHN. Nivo continued to show a significant survival benefit and better tolerability vs IC in pts with PR R/M SCCHN. Clinical trial information: NCT02105636.
- Language
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- English
- Open access status
- closed
- Identifiers
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- DOI 10.1200/jco.2017.35.15_suppl.6019
- ISSN 0732-183X
- Persistent URL
- https://sonar.ch/global/documents/291613
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