Phase II Open-Label Randomised Controlled Trial Comparing Oxaliplatin and Cisplatin Based Concurrent...

Concurrent cisplatin-based chemoradiotherapy (CCRT) is the standard treatment for locally advanced head and neck cancer (LAHNC); however, it also results in substantial treatment-related toxicities. Oxaliplatin has similar radiosensitisation mechanisms to cisplatin and, if found to have equivalent efficacy in LAHNCs, has the potential to replace cisplatin in CCRT protocols.

This prospective trial compared weekly oxaliplatin 50 mg/m2 to weekly cisplatin 40mg/m² in CCRT protocols for the treatment of non-nasopharyngeal LAHNCs. The primary endpoint was to compare the toxicity profile; secondary endpoints were compliance, locoregional control (LRC), disease-free survival (DFS), and overall survival (OS).

Between January 2019 and June 2020, we randomly assigned 70 LAHNC patients, 35 in each arm, to receive radical CCRT. At a median follow-up of 18 months (range: 3-72), acute toxicities of grade 3 or higher occurred in 31% of patients in the oxaliplatin arm and 77% of patients in the cisplatin arm (P = 0.007). The estimated 3-year LRC, DFS, and OS in the oxaliplatin and cisplatin arms were 32.3% vs 35.9%, 28.7% vs 35.9% and 35.1% vs 37.3%, respectively, while the 5-year LRC, DFS, and OS were 32.3% vs 32.4%, 28.7% vs 28.8%, and 31.2% vs 30.5%, respectively. The absolute differences observed were not statistically significant.

The CCRT with oxaliplatin in non-nasopharyngeal LAHNC exhibits a better toxicity profile and appears comparable to cisplatin in terms of disease control. It may be worthwhile exploring this approach in a larger trial to gather LRC and survival data.

CTRI/2019/01/017198.