Weekly cisplatin fails to show fewer serious side effects in p16-negative head and neck cancer
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Physicians typically use either a higher dose of cisplatin given every three weeks or a lower dose given weekly in combination with radiation to treat locally advanced head and neck cancer. However, before NRG-HN009, there was limited randomized evidence to determine which regimen provided the best balance of cancer control and treatment-related side effects.
This question is particularly important for patients with p16-negative disease, who often have multiple other health conditions and may have a lower tolerance for intensive chemoradiation.
The Phase II portion of NRG-HN009 compared the regimens in patients with p16-negative disease and found that weekly cisplatin failed to show significantly lower acute toxicity than cisplatin given every three weeks. Because the study did not meet its predefined criteria for reduced acute toxicity with weekly cisplatin, the p16-negative cohort did not advance to the Phase III portion of the trial.
The results were presented during the Late-Breaking Abstract Session of the 2026 American Society for Radiation Oncology Annual Meeting in Boston, and appear in the International Journal of Radiation Oncology*Biology*Physics.
"These findings provide important evidence that weekly cisplatin induces a similar overall burden of serious acute treatment-related toxicity compared with the standard every-three-week schedule in patients with p16-negative locally advanced head and neck cancer," said Paul Harari, MD, of the University of Wisconsin and lead author of the NRG-HN009 manuscript.
"However, the two treatment approaches resulted in different profiles of side effects. These results underscore the need for future research to identify more individualized treatment strategies that can reduce toxicity while maintaining effective cancer control for advanced head and neck cancer patients.
The Phase II trial enrolled 234 eligible patients with p16-negative squamous cell carcinoma of the head and neck. They were stratified by Zubrod Performance Score, smoking history, tumor stage and age, then randomly assigned to receive either 70 Gy RT with 100 mg/m2 of cisplatin every three weeks (Q3) or 70 Gy RT with 40 mg/m2 of cisplatin weekly (Q1). Of the patients treated in the trial, 91% completed six-month follow-up.
The primary endpoint of NRG-HN009 was acute toxicity as measured by T-score, defined as the number of all treatment-related grade 3-4 adverse events during treatment or within six months of treatment. The mean T-score ratio was 1.11 (90% upper confidence bound 1.33; p=0.77), with mean T-scores of 2.23 (95% confidence interval 1.81, 2.65) for the Q3 treatment arm and 2.48 (95% CI 1.97, 2.99) for the Q1 treatment arm.
The arms differed by ≥5% in rates of several acute grade 3-4 adverse events. The Q3 treatment arm had higher rates of nausea, dehydration and acute kidney injury. The Q1 treatment arm had higher rates of decreased white blood cell counts and magnesium levels. The six-month locoregional failure rates were 4.6% in the Q3 treatment arm and 9.6% in the Q1 treatment arm [absolute difference 5.0% (95% CI 1.0, 8.9)].
Publication details
P.M. Harari et al, First Report from NRG-HN009 Randomized Phase II/III Trial of RT + Cisplatin Q3 Weeks vs RT + Cisplatin Weekly for Patients with Locoregionally Advanced SCCHN: p16+ Phase II Toxicity Results, International Journal of Radiation Oncology*Biology*Physics (2026). DOI: 10.1016/j.ijrobp.2026.02.048
Journal information: International Journal of Radiation Oncology*Biology*Physics
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