The current standard treatment for locally advanced head and neck squamous cell carcinoma is a high-dose radiation therapy including about 50Gy of prophylactic nodal irradiation combined with high-dose Cisplatin. While effective, the regimen causes severe late adverse events in over 40% of patients, impacting swallowing, speech, and hearing, and reducing quality of life...
The current standard treatment for locally advanced head and neck squamous cell carcinoma is a high-dose radiation therapy including about 50Gy of prophylactic nodal irradiation combined with high-dose Cisplatin. While effective, the regimen causes severe late adverse events in over 40% of patients, impacting swallowing, speech, and hearing, and reducing quality of life. To reduce toxicity, we tested a less intensive approach by reducing the prophylactic dose in chemo IMRT. Eligible patients had P16 negative oropharyngeal cancer, hypopharyngeal cancer, or laryngeal cancer. The experimental arm used a two-step 40Gy method, while the standard arm used SIB-56Gy. The primary endpoint was time-to-treatment failure, defined as death, progression, treatment discontinuation, or residual disease. We planned for 400 patients, assuming 3-year TTF of 50% in both arms, with a non-inferiority margin. Seven patients showed the hazard ratio for TTF exceeded the non-inferiority margin, leading to early termination. Final analysis including 281 patients, 140 standard, 141 reduced dose at updated analysis on March in this year. Most had hypopharyngeal cancer and were lymph node positive. No P16 positive oropharyngeal cancer were included in this study. Results: 2-year TTF 71% standard versus 58% reduced dose with hazard ratio 1.43 also exceeding non-inferiority margin. Slight improvement in hearing loss and hypothyroidism in the reduced dose arm compared to other RCTs. On reduced prophylactic dose, our study had a homogeneous cohort, all stage three to four, P16 negative, and P16 positive patients didn’t include it. Locally advanced head and neck cancer with P16 negative disease in definitive CRT, SIB56 standard dose CCRT remains standard and reduced prophylactic dose isn’t recommended outside the clinical trial due to the risk of reduced efficacy.
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