New standard-of-care for cisplatin-ineligible locally advanced head and neck squamous cell carcinoma

Docetaxel added to radiation improved the disease-free survival (DFS) and overall survival (OS) of patients with locally advanced head-and-neck squamous cell carcinoma (LAHNSCC). The current randomised trial is the first study to assess docetaxel as a radiosensitiser in cisplatin-ineligible patients with LAHNSCC and resulted in the presentation of a new reference standard-of-care for this population. 

Although chemoradiation with cisplatin is a main standard therapy for patients with LAHNSCC, patients who are unsuitable to receive cisplatin are not uncommon. Prof. Vanita Noronha (Tata Memorial Hospital, India) discussed a phase 3 trial that randomised patients with LAHNSCC, who were ineligible for cisplatin, to radiotherapy alone (n=176) or docetaxel and radiotherapy (n=180) [1]. The main outcomes of the trial were DFS and OS after 2 years, quality-of-life, and adverse events (AEs).

The 2-year DFS was significantly higher in participants who received docetaxel and radiotherapy than in participants who received radiotherapy alone (42% vs 30.3%; HR 0.67; P=0.0021). Likewise, the 2-year OS data favoured participants who received docetaxel over those who did not (50.8% vs 41.7%; HR 0.75; P=0.035; see Figure). The results of these efficacy endpoints were consistent across prespecified subgroups. Furthermore, the functional assessment of cancer therapy – general (FACT-G) score displayed lower reductions in quality-of-life for patients receiving docetaxel at 6 months (-25.4 vs -40.5; P=0.035).

Figure: Overall survival results of docetaxel plus radiotherapy versus radiotherapy alone [1]



AEs that were more common in the docetaxel-radiotherapy arm than in the radiotherapy alone arm included grade 3–5 mucositis (49.7% vs 22.2%; P<0.001), grade 3–5 odynophagia (52.5% vs 33.5%; P<0.001), grade 3–5 dysphagia (49.7% vs 33.0%; P=0.002), and any grade weight loss (51.4% vs 36.4%; P=0.005). Grade 3–5 hyponatraemia was also more frequently observed in the docetaxel-radiotherapy arm (30.2% vs 19.3%; P=0.02).

“The improved DFS and OS in cisplatin-ineligible patients with LAHNSCC who received the addition of docetaxel to radiation represents a new reference standard-of-care for this group of patients,” concluded Prof. Noronha.

1. Noronha V, 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. LBA 6003, ASCO 2022 Annual meeting, 3–7 June, Chicago, IL, USA.

Copyright ©2022 Medicom Medical Publishers



Posted on 5 August 202225 March 2024