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Rusthoven KE , Feigenberg SJ , Raben D , Kane M , Song JI , Nicolaou N , Mehra R , Burtness B , Ridge J , Swing R , Lango M , Cohen R , Jimeno A , Chen CH
INITIAL RESULTS OF A PHASE I DOSE-ESCALATION TRIAL OF CONCURRENT AND MAINTENANCE ERLOTINIB AND REIRRADIATION FOR RECURRENT AND NEW PRIMARY HEAD-AND-NECK CANCER
International Journal of Radiation Oncology Biology Physics. 2010 Nov;78(4) :1020-1025
AbstractPurpose: To present the first report of a Phase I trial evaluating concurrent and maintenance erlotinib and reirradiation in patients with recurrent or secondary primary head-and-neck cancer (HNC). Methods and Materials: Patients with recurrent or new primary HNC with an interval of at least 6 months since prior radiation were eligible. Patients were treated in 3 sequential cohorts: Cohort I, 100 mg of erlotinib daily with reirradiation at 61.6 Gy in 28 fractions; Cohort II, 150 mg of erlotinib with 61.6 Gy in 28 fractions; and Cohort III, 150 mg of erlotinib with 66 Gy in 30 fractions. Maintenance erlotinib started immediately after reirradiation at 150 mg daily and was continued for 2 years or until disease progression or dose-limiting toxicity. Dose-limiting toxicities were defined as any Grade 4 or 5 toxicity or a toxicity-related delay in radiation therapy of greater than 7 days. Results: Fourteen patients were accrued, 3 to Cohort I, 4 to Cohort II, and 7 to Cohort III. Thirteen patients were evaluable for toxicity. Median follow-up was 8.4 months overall and 15.1 months for surviving patients. One patient had a dose-limiting toxicity in Cohort III. This patient declined initial percutaneous endoscopic gastrostomy tube placement, was hospitalized with Grade 3 dysphagia and aspiration, and required a delay in radiation therapy of greater than 7 days. No Grade 4 acute toxicity was observed. Acute Grade 3 toxicity occurred in 9 of 13 patients. No erlotinib-related toxicity of Grade 3 or greater was observed during maintenance therapy. One patient had Grade 5 carotid hemorrhage 6 months after reirradiation, and another patient had Grade 3 osteoradionecrosis. Conclusions: Reirradiation (66 Gy in 2.2 Gy fractions) with concurrent and maintenance erlotinib (150 mg daily) for recurrent or new primary HNC is feasible. (C) 2010 Elsevier Inc.
NotesRusthoven, Kyle E. Feigenberg, Steven J. Raben, David Kane, Madeleine Song, John I. Nicolaou, Nicos Mehra, Ranee Burtness, Barbara Ridge, John Swing, Robyn Lango, Miriam Cohen, Roger Jimeno, Antonio Chen, Changhu 23 Elsevier science inc; 360 park ave south, new york, ny 10010-1710 usa 677bc