Head and neck cancer: pembrolizumab+radiotherapy active, well-tolerated

  • Ferris RL & et al.
  • ASTRO
  • 27 Mar 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In cisplatin-ineligible patients with locally advanced head and neck squamous cell cancer (HNSCC), radiotherapy+pembrolizumab is well-tolerated and shows good disease control.

Why this matters

  • Cisplatin with definitive radiotherapy is the standard for locally advanced head and neck cancer, but about one-third of patients are ineligible for cisplatin in everyday practice.
  • Findings need validation in large trials.

Study design

  • Phase 2 study of 29 cisplatin-ineligible patients with locally advanced HNSCC.
  • Patients received 3 cycles of pembrolizumab and concurrent radiation therapy over 6 weeks, followed by 3 additional cycles of the immunotherapy drug.
  • Funding: Merck & Co.

Key results

  • Primary sites were base of tongue and tonsils.
  • Median follow-up was 21 months.
  • 1-year PFS was 76% (95% CI, 56%-88%), and OS was 86% (95% CI, 67%-95%).
  • Estimated 2-year PFS was 71% (95% CI, 49%-84%), and OS was 75% (95% CI, 51%-88%).
  • Subgroup analysis: 1-year PFS and OS in:
    • Patients with p16+ oropharynx cancer: 88% and 94%, respectively;
    • For the other patients: 58% and 75%, respectively.
  • Most toxicities were mild (grade 1-2). 59% of patients experienced grade 3-4 lymphopenia.

Limitations

  • Single-arm study.