High-dose doxorubicin, dexrazoxane, and GM-CSF in malignant mesothelioma: a phase II study - Cancer and Leukemia Group B 9631

Doxorubicin is the most widely studied agent for the treatment of malignant mesothelioma. In conventional doses, the response rate is approximate to 1 7%. Higher dose doxorubicin has been successfully employed in other tumor t ypes. Dexrazoxane has been demonstrated to reduce the cardiac toxicity asso ciated with long term, chronic use of doxorubicin. Based upon phase I data generated by the Cancer and Leukemia Group B (CALGB) indicating that doxoru bicin at a dose of 120 mg/m(2) when combined with dexrazoxane and GM-CSF co uld be safely administered, the CALGB undertook a phase II study of high-do se doxorubicin in patients with malignant mesothelioma. Toxicity was excess ive, necessitating protocol modification and ultimately protocol terminatio n. There were no objective responses observed. We conclude that high-dose d oxorubicin administered with dexrazoxane is unacceptably toxic in this pati ent population, (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.