- 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.
- 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.
- 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.
- Single-arm study.