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.

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  • Author(s): Saba, Nabil F.1 (AUTHOR)
    Blumenschein, George1 (AUTHOR)
    Guigay, Joel1 (AUTHOR)
    Licitra, Lisa1 (AUTHOR)
    Fayette, Jerome1 (AUTHOR)
    Harrington, Kevin J.1 (AUTHOR)
    Kiyota, Naomi1 (AUTHOR)
    Gillison, Maura L.1 (AUTHOR)
    Ferris, Robert L.1 (AUTHOR)
    Jayaprakash, Vijayvel1 (AUTHOR)
    Li, Li1 (AUTHOR)
    Brossart, Peter1 (AUTHOR)
    Blumenschein, George Jr2 (AUTHOR)
  • Source:
    Oral Oncology. Sep2019, Vol. 96, p7-14. 8p.
  • Document Type:
    journal article
  • معلومة اضافية
    • Subject Terms:
    • Author-Supplied Keywords:
      Age
      Biomarkers
      Nivolumab
      Phase 3 clinical trial
      Squamous cell carcinoma of the head and neck
    • Abstract:
      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. ClinicalTrials.gov: NCT02105636. [ABSTRACT FROM AUTHOR]
    • :
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    • Author Affiliations:
      1Winship Cancer Institute of Emory University, 1365-C Clifton Road NE, Atlanta, GA 30322, USA
      2MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA
    • ISSN:
      1368-8375
    • Accession Number:
      10.1016/j.oraloncology.2019.06.017
    • Accession Number:
      138101768
  • Citations
    • ABNT:
      SABA, N. F. et al. 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. Oral Oncology, [s. l.], v. 96, p. 7–14, 2019. DOI 10.1016/j.oraloncology.2019.06.017. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=ddh&AN=138101768&custid=s8280428. Acesso em: 7 dez. 2019.
    • AMA:
      Saba NF, Blumenschein G, Guigay J, et al. 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. Oral Oncology. 2019;96:7-14. doi:10.1016/j.oraloncology.2019.06.017.
    • APA:
      Saba, N. F., Blumenschein, G., Guigay, J., Licitra, L., Fayette, J., Harrington, K. J., … Blumenschein, G., Jr. (2019). 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. Oral Oncology, 96, 7–14. https://doi.org/10.1016/j.oraloncology.2019.06.017
    • Chicago/Turabian: Author-Date:
      Saba, Nabil F., George Blumenschein, Joel Guigay, Lisa Licitra, Jerome Fayette, Kevin J. Harrington, Naomi Kiyota, et al. 2019. “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.” Oral Oncology 96 (September): 7–14. doi:10.1016/j.oraloncology.2019.06.017.
    • Harvard:
      Saba, N. F. et al. (2019) ‘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’, Oral Oncology, 96, pp. 7–14. doi: 10.1016/j.oraloncology.2019.06.017.
    • Harvard: Australian:
      Saba, NF, Blumenschein, G, Guigay, J, Licitra, L, Fayette, J, Harrington, KJ, Kiyota, N, Gillison, ML, Ferris, RL, Jayaprakash, V, Li, L, Brossart, P & Blumenschein, G, Jr 2019, ‘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’, Oral Oncology, vol. 96, pp. 7–14, viewed 7 December 2019, .
    • MLA:
      Saba, Nabil F., et al. “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.” Oral Oncology, vol. 96, Sept. 2019, pp. 7–14. EBSCOhost, doi:10.1016/j.oraloncology.2019.06.017.
    • Chicago/Turabian: Humanities:
      Saba, Nabil F., George Blumenschein, Joel Guigay, Lisa Licitra, Jerome Fayette, Kevin J. Harrington, Naomi Kiyota, et al. “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.” Oral Oncology 96 (September 2019): 7–14. doi:10.1016/j.oraloncology.2019.06.017.
    • Vancouver/ICMJE:
      Saba NF, Blumenschein G, Guigay J, Licitra L, Fayette J, Harrington KJ, et al. 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. Oral Oncology [Internet]. 2019 Sep [cited 2019 Dec 7];96:7–14. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=ddh&AN=138101768&custid=s8280428