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

Abstract

PURPOSE There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation. METHODS This was a randomized phase II/III study. Adult patients (age ≥ 18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m2 once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS). RESULTS The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (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) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank P value = .035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value = .035). There was a higher incidence of grade 3 or above mucositis (22.2% v 49.7%; P < .001), odynophagia (33.5% v 52.5%; P < .001), and dysphagia (33% v 49.7%; P = .002) with the addition of docetaxel. CONCLUSION The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.

Clinical Outcomes of Curative Intent Radiotherapy by Helical Tomotherapy for Laryngeal Squamous Cell Carcinoma: A Retrospective Analysis in a Tertiary Referral Center

“…Recently, Patil et al evaluated the use of docetaxel as a radiosensitizer in patients with advanced head and neck cancer who could not receive cisplatin. They found that concurrent docetaxel showed promising results as a treatment option for cisplatin-ineligible patients with advanced head and neck cancer treated with radiotherapy [ 25 ]. A rigorous review by a multidisciplinary specialist treatment team is required when deciding on a treatment plan for LSCC.…”

A Systematic Evaluation of Cost-Saving Dosing Regimens for Therapeutic Antibodies and Antibody-Drug Conjugates for the Treatment of Lung Cancer

“…There are some studies that indicate that nivolumab may be dosed lower than proposed by use here [39,40], yet results are conflicting and higher doses of nivolumab appear to be required for the treatment of lung cancer [41][42][43]. Although we specifically focused on monoclonal antibodies and antibody-drug conjugates used for the treatment of lung cancer, most drugs in our analysis have broader indications.…”

Predicting the prognosis, immune response, and immunotherapy in head and neck squamous cell carcinoma using a novel risk model based on anoikis-related lncRNAs

“…Hence, several cytotoxic anti-cancer agents, such as taxane-based anticancer drugs, such as docetaxel and paclitaxel, were more conventionally used for HNSCC [ 1 ]. Combined treatment of docetaxel and cisplatin for advanced HNSCC showed a good response of 33–53% [ 48 ]. Based on the above data, we employed the pRRophetic algorithm to study the impact of the risk model on the response of four common anti-cancer agents, such as cisplatin, paclitaxel, gemcitabine, and docetaxel.…”