In a phase II study reported in JAMA Oncology, Saba et al found that the addition of nivolumab to intensity-modulated radiation therapy (IMRT) reirradiation improved progression-free survival in patients with recurrent or second primary head and neck squamous cell carcinoma.
Study Details
The U.S. multicenter trial included 51 eligible patients enrolled between July 2018 and August 2021. Patients received IMRT reirradiation at 60 to 66 Gy in 30 to 33 daily fractions over 6 to 6.5 weeks plus nivolumab at 240 mg 2 weeks prior and every 2 weeks for five cycles during IMRT; nivolumab was then given at 480 mg every 4 weeks for a total of 52 weeks.
The primary endpoint was 1-year progression-free survival. The null hypothesis based on data from historical controls was 1-year progression-free survival less than 43.8%.
Key Findings
Median follow-up was 24.5 months (95% confidence interval [CI] = 19.0–25.0 months). Among the 51 patients, the 1-year progression-free survival rate was 61.7% (95% CI = 49.2%–77.4%), rejecting the null hypothesis (P = .002).
The estimated 2-year progression-free survival rate was 43.2% (95% CI = 29.8%–62.6%). Median overall survival was 21 months (95% CI = 19.3–30.8 months), with rates at 1 and 2 years of 84.4% (95% CI = 74.4%–95.7%) and 48.4% (95% CI = 34.2%–68.6%).
Grade ≥ 3 treatment-related adverse events occurred in 12% of patients, most commonly lymphopenia (4%), with one patient each (2%) having colitis, diarrhea, myositis, nausea, mucositis, and myasthenia gravis. No treatment-related deaths were reported. Quality-of-life scores from both the Functional Assessment of Cancer Therapy–General and Functional Assessment of Cancer Therapy–Head and Neck questionnaires remained stable throughout the study.
The investigators concluded: “This multicenter nonrandomized phase II trial of IMRT reirradiation therapy and nivolumab suggested a promising improvement in [progression-free survival] over historical controls. The treatment was well tolerated and deserves further evaluation.”
Nabil F. Saba, MD, of the Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, is the corresponding author of the JAMA Oncology article.
Disclosure: The study was supported by the National Cancer Institute and Bristol Myers Squibb. For full disclosures of the study authors, visit jamanetwork.com.
