In an Indian single-center phase II/III trial reported in the Journal of Clinical Oncology, Patil et al found that the use of docetaxel as a radiosensitizer was associated with better outcomes than radiotherapy alone in patients with locally advanced head and neck squamous cell carcinoma who were ineligible for cisplatin-based chemoradiation.
Study Details
In the open-label trial, 356 patients at Tata Memorial Hospital were randomly assigned between July 2017 and May 2021 to receive radiotherapy with concurrent docetaxel at 15 mg/m2 once weekly for a maximum of seven cycles (n = 180) or radiotherapy alone (n = 176). Radiotherapy was delivered by conventional two- or three-dimensional conformal or intensity-modulated radiation techniques at doses of 70 Gy in 2 Gy per fraction 5 days a week over 7 weeks in the definitive setting, and at 60 Gy in 2 Gy per fraction 5 days a week over 6 weeks in the adjuvant setting. The primary endpoint was 2-year disease-free survival.
Key Findings
Median follow-up was 32.4 months (interquartile range = 26.3–42.1 months). Disease-free survival at 2 years was 42% (95% confidence interval [CI] = 34.6%–49.2%) in the docetaxel/radiotherapy group vs 30.3% (95% CI = 23.6%–37.4%) in the radiotherapy group (hazard ratio [HR] = 0.67, 95% CI = 0.52–0.87, P = .002).
Median locoregional failure–free survival was 12.4 months (95% CI = 8.6–23.5 months) in the docetaxel/radiotherapy group vs 5.9 months (95% CI = 4.9–7.5 months) in the radiotherapy group (P = .001). The hazard ratio for locoregional failure was 0.66 (95% CI = 0.51–0.85, P = .002).
Overall survival at 2 years was 50.8% (95% CI = 43.1%–58.1%) in the docetaxel/radiotherapy group vs 41.7% (95% CI = 34.1%–49.1%) in the radiotherapy group (HR = 0.75, 95% CI = 0.57–0.98, P = .035). Median overall survival was 25.5 months (95% CI = 17.6–32.5 months) vs 15.3 months (95% CI = 13.1–22.0 months, P = .035).
Acute grade ≥ 3 adverse events were observed in 81.6% of the docetaxel/radiotherapy group vs 50.0% of the radiotherapy group (P = .001), with the docetaxel/radiotherapy group having significantly higher rates of grade ≥ 3 mucositis (49.7% vs 22.2%, P < .001), odynophagia (52.5% vs 33.5%, P < .001), and dysphagia (49.7% vs 33.0%, P = .002).
The investigators concluded, “The addition of docetaxel to radiation improved disease-free survival and overall survival in cisplatin-ineligible patients with locally advanced HNSCC.”
Kumar Prabhash, MBBS, MD, DM, of Tata Memorial Hospital, Mumbai, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was funded by ICON. For full disclosures of the study authors, visit ascopubs.org.
