Cisplatin Weekly Versus Every 3 Weeks Concurrently with Radiotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinomas: What Is the Best Dosing and Schedule?

PURPOSE: The aim of this prospective randomized study is to compare cisplatin at 2 dose levels given concurrently with intensity modulated radiation therapy (IMRT) in the treatment of locally advanced HNSCC. The main objectives were to evaluate treatment toxicities, loco-regional control, tumor response and patients compliance. METHODS: Patients were randomized into two groups that either received 30 mg/m(2) cisplatin weekly (arm A) or 100 mg/m(2) once every 3 weeks (arm B). Radiotherapy prescribed dose was 70Gy in 33 fractions. Treatment adverse events were documented. RESULTS: Sixty patients with locally advanced HNSCC were included in this study. Recruitment started at the beginning of July 2016 and ended in July 2019. The Median follow-up was 24 months. Acute non-hematological toxicities of grade 3 or higher during the treatment course were significantly more observed in Arm B patients (76.6%) compared to Arm A patients (56.6%) with a P-value of 0.007. Hematological toxicities in the form of anemia, leucopenia and neutropenia were also significantly higher in Arm B patients with a p-value of 0.435, 0.002 and 0,002, respectively. The median 2 year loco-regional control rate in Arm B was 72.8% versus 57.6% in Arm A with a p-value of 0.015. Complete responses were similar between both groups (77%). Compliance to treatment was better in Arm A with 70% of the patients received at least 6 weekly doses where as 60% of the patients in Arm B completed the three cycles of treatment and 40 % received only 2 cycles. CONCLUSION: Once weekly low dose cisplatin treatment showed lower acute toxicity and a better compliance compared to once every 3 weeks high dose cisplatin treatment at the expense of a lower loco-regional control.