• Pirus Ghadjar, Mathew Simcock, Gabriela Studer, Abdelkarim S Allal, Mahmut Ozsahin, Jacques Bernier, Michael Töpfer, Frank Zimmermann, Michael Betz, Christoph Glanzmann, Daniel M Aebersold, and Swiss Group for Clinical Cancer Research (SAKK).
• Department of Radiation Oncology, Inselspital, Bern University Hospital, and University of Bern, Switzerland, 3010 Bern, Switzerland. pirus.ghadjar@insel.ch
• Int. J. Radiat. Oncol. Biol. Phys. 2012 Feb 1; 82 (2): 524-31.

PurposeTo compare the long-term outcome of treatment with concomitant cisplatin and hyperfractionated radiotherapy versus treatment with hyperfractionated radiotherapy alone in patients with locally advanced head and neck cancer.Methods And MaterialsFrom July 1994 to July 2000, a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to receive either hyperfractionated radiotherapy alone (median total dose, 74.4 Gy; 1.2 Gy twice daily; 5 days per week) or the same radiotherapy combined with two cycles of cisplatin (20 mg/m(2) for 5 consecutive days during weeks 1 and 5). The primary endpoint was the time to any treatment failure; secondary endpoints were locoregional failure, metastatic failure, overall survival, and late toxicity assessed according to Radiation Therapy Oncology Group criteria.ResultsMedian follow-up was 9.5 years (range, 0.1-15.4 years). Median time to any treatment failure was not significantly different between treatment arms (hazard ratio [HR], 1.2 [95% confidence interval {CI}, 0.9-1.7; p = 0.17]). Rates of locoregional failure-free survival (HR, 1.5 [95% CI, 1.1-2.1; p = 0.02]), distant metastasis-free survival (HR, 1.6 [95% CI, 1.1-2.5; p = 0.02]), and cancer-specific survival (HR, 1.6 [95% CI, 1.0-2.5; p = 0.03]) were significantly improved in the combined-treatment arm, with no difference in major late toxicity between treatment arms. However, overall survival was not significantly different (HR, 1.3 [95% CI, 0.9-1.8; p = 0.11]).ConclusionsAfter long-term follow-up, combined-treatment with cisplatin and hyperfractionated radiotherapy maintained improved rates of locoregional control, distant metastasis-free survival, and cancer-specific survival compared to that of hyperfractionated radiotherapy alone, with no difference in major late toxicity.Copyright © 2012 Elsevier Inc. All rights reserved.

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