Concomitant Cisplatin Significantly Improves Locoregional Control in Advanced Head and Neck Cancers Treated With Hyperfractionated Radiotherapy

• DOI: 10.1200/jco.2004.12.193
• Publication Date: 2004-11-09T01:25:35Z
• Authors: Pia Huguenin; Karl T. Beer; Abdelkarim Allal; Kaspar Rufibach; Corinne Friedli; Jacques Bernard D...; Bernhard Pestalozzi; Stephan Schmid; Armin Thöni; Mahmut Ozsahin; Jacques Bernier; Michael Töpfer; Roger Kann; Urs Richard Meier; Peter Thum; Sabine Bieri; Markus Notter; Norbert Lombriser; Christoph Glanzmann
• Keywords: Concomitant; Clinical endpoint; Log-rank test

Purpose To determine whether the application of two courses cisplatin simultaneously with hyperfractionated radiotherapy improves outcome in locally advanced and/or node-positive nonmetastatic carcinomas head and neck, compared alone. Patients Methods From July 1994 to 2000, 224 patients squamous cell neck (excluding nasopharynx paranasal sinus) were randomly assigned (median dose, 74.4 Gy; 1.2 Gy twice daily) or same combined cycles concomitant (20 mg/m 2 on 5 days weeks 1 5). The primary end point was time any treatment failure; secondary points locoregional failure, metastatic relapse, overall survival, late toxicity. Results There no difference between both arms (74.4 44 days). full dose applied 93% 71% during first second cycles, respectively. Acute toxicity similar arms. Median failure not significantly different (19 months for 16 only, respectively) failure-free rate at 2.5 years 45% 33%, Locoregional control distant disease–free survival improved (log-rank test, P = .039 .011, respectively). did reach significance .147). Late comparable groups. Conclusion therapeutic index is by cisplatin.