Ifosfamide and mitoxantrone in the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck

A phase II study was performed to assess the safety and efficacy of ifosfam ide and mitoxantrone in recurrent and/or metastatic squamous cell carcinoma s of the head and neck. Treatment consisted of ifosfamide 1500 mg/m(2) in 1 000 ml saline, infused over 60 min and mesna 20% of the total dose of ifosf amide in three doses for 3 days combined with mitoxantrone 12 mg/m(2) given as a short infusion on day 1. Treatment courses were repeated every 4 week s until a total of six cycles. Twenty-two patients entered this trial, 13 o f whom had received chemo- and radiation therapy, and nine patients who und erwent radiation therapy with or without prior surgery. We observed no obje ctive response, with the exception of two patients who experienced minor re sponse (reduction of tumor size of 25%). The dose-limiting toxicity was mye losuppression with grade 3/4 leukocytopenia in seven patients (32%) and gra de 3/4 neutropenia in 15 (68%). Severe organ toxicity except alopecia (91%) was not observed. Ifosfamide combined with mitoxantrone does not improve t he therapeutic armentarium in recurrent squamous cell carcinoma of the head and neck. [(C) 2001 Lippincott Williams & Wilkins].