Adding docetaxel to radiation therapy improved disease-free survival (DFS) and overall survival (OS) in patients with cisplatin-ineligible locally advanced head and neck squamous cell carcinoma (LAHNSCC) and represents a new standard of care, according to research presented at the 2022 ASCO Annual Meeting.
“There are various systemic therapy choices for patients who are cisplatin-ineligible. Although for most of these choices, the data has come from cohorts of patients who are actually cisplatin-eligible,” explained presenter Vanita Noroha, MD, professor of oncology at Tata Memorial Centre in India.
Dr Noroha and colleagues conducted a randomized open-label trial to evaluate docetaxel as a radiosensitizer in patients with LAHNSCC who are cisplatin-ineligible (Clinical Trial Information: CTRI/2017/05/008700).
The phase 3 study included adults with LAHNSCC planned for radical or adjuvant chemoradiation, with ECOG PS 0-2, and who were cisplatin-ineligible. Patients were randomly assigned (1:1) to receive radiation (RT) alone or radiation with docetaxel (15 mg/m2 weekly, for up to 7 cycles). The primary endpoint was DFS and key secondary endpoints were OS, adverse events, and quality of life (QoL).
A total of 356 patients, 176 in the RT arm and 180 in the docetaxel-RT arm, participated in the study. Patients had a median age of 63 years (range, 26-83) and 61 years (range, 23-83) and 15.3% and 17.2% were 70 years of age or older in the RT and docetaxel-RT arms, respectively. Approximately 80% of patients in both groups had stage IV disease.
The 2-year DFS rate was higher in the docetaxel-RT arm (42%; 95% CI, 34.6-49.2) compared with the RT arm (30.3%; 95% CI, 23.6-37.4). The median OS was prolonged in the docetaxel-RT arm compared with the RT arm (25.5 vs 15.3 months). The 2-year OS rate was 50.8% (95% CI, 43.1-58.1) in the docetaxel-RT arm compared with 41.7% (95% CI, 34.1-49.1) in the RT arm (HR, 0.747; 95% CI, 0.57-0.98; P =.035). DFS and OS benefit were observed across all patient subgroups assessed.
Grade 3 or higher adverse events (AEs) were reported in 102 patients (58%) in the RT arm and 146 patients (81.6%) in the docetaxel-RT arm. Compared with the RT arm, the docetaxel arm had a higher incidence of grade 3 or higher mucositis (22.2% vs 49.7%), odynophagia (33.5% vs 52.5%), and dysphagia (33% vs 49.7%). The addition of docetaxel did not lead to a worsening of QoL scores at 6 months.
“To the best of our knowledge, this is the first randomized study in cisplatin-ineligible patients,” concluded Dr Noronha. “[The addition of docetaxel to radiotherapy] now represents a new reference standard of care for [cisplatin-ineligible patients with LAHNSCC] planned for chemoradiotherapy.”
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 NS, et al. Results of phase 3 randomized trial for use of docetaxel as a radiosensitizer in patients with head and neck cancer unsuitable for cisplatin-based chemoradiation. Presented at ASCO 2022; June 3-7, 2022. Abstract LBA6003.