Adding docetaxel to radiation improves outcomes for patients with locally advanced head and neck squamous cell carcinoma who are not able to receive cisplatin, according to research published in the Journal of Clinical Oncology.
Researchers found that docetaxel improved both disease-free survival (DFS) and overall survival (OS) in this patient group.
The researchers conducted a phase 2/3 trial of 356 patients with locally advanced head and neck squamous cell carcinoma. Patients were randomly assigned to receive radiation alone (n=176) or radiation in combination with docetaxel (n=180).
Baseline characteristics were similar between the treatment arms. The median age was 63 years in the radiation-alone arm and 61 years in the docetaxel arm (overall range, 23-83 years). Most patients were men (85% in the radiation-alone arm and 81.8% in the docetaxel arm).
There were 109 patients in the radiation-alone arm and 108 in the docetaxel arm who received definitive radiation (70 Gy; 2 Gy per fraction, 5 days a week over 7 weeks). There were 67 patients in the radiation-alone arm and 72 in the docetaxel arm who received adjuvant radiation (60 Gy; 2 Gy per fraction, 5 days a week over 6 weeks).
Patients in the docetaxel arm received the drug at 15 mg/m2 once weekly in 500 mL of normal saline intravenously over 1 hour. The first dose was given within 5 days of patients starting radiation.
At a median follow-up of 32.4 months, there was a significant improvement in DFS among patients who received docetaxel. The 2-year DFS rate was 30.3% in the radiation-alone arm and 42% in the docetaxel arm. The unadjusted hazard ratio (HR) for DFS was 0.673 (95% CI, 0.521-0.868; P =.002), and the adjusted HR was 0.631 (95% CI, 0.486-0.818; P <.001).
There was a significant improvement in OS with docetaxel as well. The median OS was 15.3 months in the radiation-alone arm and 25.5 months in the docetaxel arm. The 2-year OS rate was 41.7% and 50.8%, respectively. The unadjusted HR for OS was 0.747 (95% CI, 0.569-0.980; P =.035), and the adjusted HR was 0.694 (95% CI, 0.527-0.915; P <.001).
Grade 3 or higher adverse events were more common in the docetaxel arm than in the radiation-alone arm (81.6% and 58%, respectively; P =.001). The most common grade 3-5 adverse events (in the docetaxel and radiation-alone arms, respectively) were mucositis (49.7% vs 22.2%), odynophagia (52.5% vs 33.5%), and dysphagia (49.7% vs 33%).
“Docetaxel can be used as a radiosensitizer alongside radiation therapy in cisplatin-ineligible patients,” JCO Associate Editor Maura L. Gillison, MD, PhD, wrote in a comment on this research. “This study provides, to our knowledge, the first evidence-based data for the use of concurrent chemotherapy in cisplatin-ineligible patients.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Patil VM, Noronha V, Menon N, et al. Results of phase III randomized trial for use of docetaxel as a radiosensitizer in patients with head and neck cancer, unsuitable for cisplatin-based chemoradiation. J Clin Oncol. Published online January 27, 2023. doi:10.1200/JCO.22.00980