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

Area of Science:

• Oncology
• Radiotherapy
• Head and Neck Cancer Treatment

Background:

• Concurrent chemoradiotherapy (CCRT) with cisplatin is standard for locally advanced head and neck cancer (LAHNC).
• CCRT with cisplatin is associated with significant treatment-related toxicities.
• Oxaliplatin shares radiosensitization mechanisms with cisplatin.

Purpose of the Study:

• To compare the toxicity profile of oxaliplatin versus cisplatin in CCRT for non-nasopharyngeal LAHNC.
• To evaluate compliance, locoregional control (LRC), disease-free survival (DFS), and overall survival (OS) as secondary endpoints.

Main Methods:

• Prospective trial comparing weekly oxaliplatin (50 mg/m2) to weekly cisplatin (40 mg/m2) in CCRT.
• Random assignment of 70 LAHNC patients (35 per arm).
• Primary endpoint: toxicity profile; Secondary endpoints: compliance, LRC, DFS, OS.

Main Results:

• Grade 3 or higher acute toxicities occurred in 31% of the oxaliplatin arm versus 77% in the cisplatin arm (P = 0.007).
• Estimated 3-year and 5-year LRC, DFS, and OS showed no statistically significant differences between the arms.
• Median follow-up was 18 months.

Conclusions:

• CCRT with oxaliplatin demonstrates a superior toxicity profile in non-nasopharyngeal LAHNC compared to cisplatin.
• Oxaliplatin-based CCRT appears comparable to cisplatin in terms of disease control.
• Larger trials are recommended to further assess LRC and survival data for oxaliplatin-based CCRT.