AN EVALUATION OF COMBINATIONS OF DIAZIQUONE, ETOPOSIDE AND MITOXANTRONE IN THE TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID-LEUKEMIA - RESULTS OF 8722, A RANDOMIZED PHASE-II STUDY CONDUCTED BYCANCER AND LEUKEMIA GROUP-B

A phase II trial was conducted to determine which of the three possibl e two-drug combinations of diaziquone, etoposide and mitoxantrone was associated with the highest response rate in patients with relapsed or refractory acute myeloid leukemia (AML). Of the 167 patients (median age 55) with AML who entered the trial, 123 were in first relapse, 22 were in second relapse and 22 had failed to achieve complete remission (CR). CR rates were 30% for diaziquone and mitoxantrone, and 23% for the other two combinations (mitoxantrone/etoposide and diaziquone/etop oside), NS. Patients in first relapse had higher CR rates (40%) than o ther patients. Of the 166 patients who actually received treatment, 43 died before having either a CR or persistent leukemia. Non-hematologi c toxicity was primarily mucosal with 24% of patients experiencing gra de 3 or greater stomatitis on the two diaziquone arms, and 43% on the mitoxantrone/etoposide arm. The combination of diaziquone and mitoxant rone was selected for further testing in patients with AML.