Adjuvant nivolumab improves DFS in high-risk head and neck cancer
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Key takeaways:
- Patients who received nivolumab had longer DFS than those who received standard care.
- OS will be evaluated after a prespecified number of deaths occur.
The addition of adjuvant nivolumab to standard-of-care radiotherapy and cisplatin improved survival for patients with locally advanced squamous cell carcinoma of the head and neck.
"This is the first time in decades where a therapy demonstrated superiority over standard of care cisplatin-radiotherapy in high-risk patients with [locally advanced squamous cell carcinoma of the head and neck],” Jean Bourhis, MD, PhD, medical director of Head and Neck Oncology group (GORTEC) and radiation oncologist at Lausanne University Hospital in Switzerland, said in a press release issued by GORTEC, known as Head and Neck Radiation Oncology Group.
Nivolumab (Opdivo, Bristol Myers Squibb) is an anti-PD-1 antibody.
Researchers conducted the randomized phase 3 NIVOPOSTOP GORTEC 2018-01 trial to evaluate nivolumab as a part of adjuvant treatment for patients with resected, locally advanced squamous cell carcinoma of the head and neck.
The trial included 680 patients deemed at high risk for relapse by based on several factors, such as multiple nodal involvement, nodal extra capsular extension, positive tumor margins after surgery and multiple peri-neural invasion.
Researchers randomly assigned patients after surgery to standard care — which consisted of 66 Gy radiotherapy and 100 mg/m2 cisplatin once every three weeks for three cycles — or to an experimental regimen that consisted of 240 mg nivolumab, followed by standard cisplatin and radiotherapy plus concurrent 360 mg nivolumab every 3 weeks, followed by 480 mg nivolumab every 4 weeks for six cycles.
DFS served as the primary endpoint. OS, quality of life and safety served as secondary endpoints.
Results showed a statistically significant improvement in DFS with nivolumab.
Researchers observed a trend toward improved OS among patients assigned nivolumab; however, a full OS analysis will not be conducted until the prespecified number of deaths in the study have occurred.
Nivolumab exhibited a safety profile consistent with prior reports, according to the release.
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