Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck may benefit more from treatment with nivolumab than standard, single agent therapy, according to results from a trial published in The New England Journal of Medicine.
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The recurrence and growth of squamous cell carcinoma of the head and neck are driven largely by immune evasion, which is mediated in part by expression of the programmed death ligands (PD-L1 and PD-L2) of the T-cell–suppressive immune-checkpoint receptor programmed death 1 (PD-1). Nivolumab, which belongs to a class of drugs known as immunotherapies, has demonstrated an antitumor efficacy when used to treat a number of cancer types with this same mechanism.
In a clinical trial led by Kevin Harrington, PhD, Institute of Cancer Research (London, United Kingdom), investigators randomly assigned 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab or standard, single-agent systemic therapy. The primary endpoint was overall survival, though progression-free survival, rate of objective response, safety, and patient-reported quality of life were also examined.
Investigators found that median overall survival was significantly longer in patients who received nivolumab compared with those who received standard therapy (7.5 months vs 5.1 months). Additionally, a larger proportion of patients in the nivolumab group were alive at 1 year compared with the standard therapy group (36% vs 16.6%), though median progression-free survival was slightly longer among those receiving therapy versus nivolumab (2.3 months vs 2 months). Response rate in the nivolumab group was also more than double what was observed in the standard therapy group (13.3% vs 5.8%).
Further, 13.3% of patients in the nivolumab group experienced grade 3 or 4 adverse events while more than a third (35.1%) of patients did in the standard therapy group. Patients also reported a greater quality of life when treated with immunotherapy while these same measures were meaningfully worse in the standard-therapy group.
“In conclusion, nivolumab prolonged survival, as compared with standard therapy, among patients with platinum-refractory squamous-cell carcinoma of the head and neck,” authors wrote. “Nivolumab was associated with fewer toxic effects of grade 3 or 4 than standard therapy (13.1% vs. 35.1%) and with maintenance of quality of life among patients with a treatment-refractory cancer that otherwise has serious adverse effects on quality of life as it leads to death.”
