The following is a summary of “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,” published in the May 2023 issue of Oncology by Patil, et al.
For a study, researchers sought to evaluate docetaxel as a radiosensitizer in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) who were ineligible for cisplatin-based therapy. In addition, they aimed to determine if adding docetaxel to radiation would improve disease-free survival (DFS) in these patients.
It was a randomized phase II/III study that included adult patients (age ≥ 18 years) with LAHNSCC who were planned for chemoradiation and were ineligible for cisplatin-based therapy. The patients were randomly assigned in a 1:1 ratio to receive radiation alone or with concurrent docetaxel (15 mg/m2 once weekly for a maximum of seven cycles). The primary endpoint was 2-year DFS.
Between July 2017 and May 2021, 356 patients were enrolled in the study. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) in the radiation alone arm and 42% (95% CI, 34.6 to 49.2) in the docetaxel-radiation arm (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; P value = .002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) in the radiation alone arm and 25.5 months (95% CI, 17.6 to 32.5) in the docetaxel-radiation arm (log-rank P value = .035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) in the radiation alone arm and 50.8% (95% CI, 43.1 to 58.1) in the docetaxel-radiation arm (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value = .035). The addition of docetaxel to radiation was associated with a higher incidence of grade 3 or above mucositis (22.2% vs. 49.7%; P < .001), odynophagia (33.5% vs. 52.5%; P < .001), and dysphagia (33% vs 49.7%; P = .002).
In conclusion, adding docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC. However, the approach was associated with increased mucositis, odynophagia, and dysphagia.
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