Docetaxel as a Radiosensitizer for Cisplatin-Ineligible Patients With Head and Neck Squamous Cell Carcinoma

According to results from a phase 3 trial, adding docetaxel to radiation improved the disease-free survival and overall survival in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma.

According to Vijay Maruti Patil, MBBS, MD, DM, Tata Memorial Hospital, Mumbai, India, and coauthors, “There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma undergoing chemoradiation.” The aim of this study was to assess docetaxel as a radiosensitizer for this population.

There were 356 patients with locally advanced head and neck squamous cell carcinoma who were cisplatin-ineligible recruited to this trial, between July 2017 and May 2021. Patients were randomized on a 1-to-1 basis to receive either radiation alone (n = 176) or radiation with concurrent 15 mg/m² docetaxel (n = 180) weekly for a maximum of 7 cycles. The primary end point was disease-free survival (DFS) at 2 years.

The 2-year DFS was 30% for patients in the radiation alone arm, compared to 42% in the docetaxel arm (hazard ratio [HR], 0.673; 95% confidence interval [CI], 0.521 to 0.868; P = .002). The median overall survival was 15.3 months vs 25.5 months (log-rank P = .035) and the 2-year overall survival was 41.7% vs 50.8% (HR, 0.747; 95% CI, 0.569 to 0.980; P = .035) respectively.

In the docetaxel arm, there was a higher incidence of grade ≥3 mucositis, odynophagia, and dysphagia compared to the radiation alone arm. The study authors noted that these complications were manageable and did not affect patient compliance with radiation.

There were 2 main limitations to the study: the use of 2-dimensional radiation and the fact that it took place at a single-center.

Dr Patil et al concluded, “Considering these results, the addition of docetaxel to radiation will be considered grade A as per the ESMO-Magnitude of Clinical Benefit Scale version 1.1 for new approaches to adjuvant therapy or new potentially curative therapies.”

Source:

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