The DAHANCA 6 randomized trial: Effect of 6 vs 5 weekly fractions of radiotherapy in patients with glottic squamous cell carcinoma

• Published in: Radiotherapy and oncology 2015-10, Vol.117 (1), p.91-98
• Main Authors: Lyhne, Nina M, Primdahl, Hanne, Kristensen, Claus A, Andersen, Elo, Johansen, Jørgen, Andersen, Lisbeth J, Evensen, Jan, Mortensen, Hanna R, Overgaard, Jens
• Format: Article
• Language: English
• Subjects: Accelerated radiotherapy; Acute Disease; Adult; Aged; Aged, 80 and over; Carcinoma, Squamous Cell - radiotherapy; Dose Fractionation, Radiation; Female; Glottic cancer; Glottis; Head and Neck Neoplasms - radiotherapy; Head and neck squamous cell carcinoma; Hematology, Oncology and Palliative Medicine; Humans; Incidence; Kaplan-Meier Estimate; Laryngeal Neoplasms - radiotherapy; Male; Middle Aged; Mucositis - etiology; Radiation Injuries - etiology; Radiotherapy - adverse effects; Squamous Cell Carcinoma of Head and Neck
• ISSN: 0167-8140; 1879-0887
• DOI: 10.1016/j.radonc.2015.07.004

Abstract Purpose The DAHANCA 6 trial evaluated tumor response and morbidity after moderate accelerated radiotherapy compared to conventional fractionated radiotherapy in patients treated for glottic squamous cell carcinoma (SCC). Further, the failure pattern and incidence of new primary tumors were explored. Patients and methods Six hundred and ninety-four patients with non-metastatic glottic SCC were randomized between six or five weekly fractions (fx/w) of radiotherapy to the same total dose. The median treatment time was 38 and 46 days, respectively. The primary endpoint was loco-regional failure. Results Median follow-up time was 14.5 years. Of the 177 failures, 167 involved T-site. The cumulative incidence of loco-regional failure (LRF) was 21.6% in the 6 fx/w group and 29.3% in the 5 fx/w group and the corresponding hazard rate (HR) of LRF was 0.72 (CI: 0.53–0.97, p = 0.04). The effect of acceleration on LRF was especially evident in well differentiated tumors (HR = 0.42 (CI: 0.23–0.75) and in T1–2 tumors (HR = 0.60 (CI: 0.41–0.89)). The HR of laryngectomy was 0.72 (CI: 0.50–1.04) in the 6 fx/w group compared to the 5 fx/w group. The hazards of disease-specific death, event-free survival, and overall survival were comparable between the two groups. Significantly more patients experienced severe acute mucositis in the 6 fx/w group but the incidence of late morbidity was comparable between the groups. New primary tumors occurred in 22.5% of the patients. Conclusion Moderate accelerated radiotherapy significantly improved loco-regional control in patients with glottic SCC.