Premium
A comparative clinical trial of 5‐azacytidine and guanazole in previously treated adults with acute nonlymphocytic leukemia
Author(s) -
Levi John A.,
Wiernik Peter H.
Publication year - 1976
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(197607)38:1<36::aid-cncr2820380107>3.0.co;2-m
Subject(s) - medicine , leukopenia , gastroenterology , leukemia , toxicity , surgery , lethargy , absolute neutrophil count , neutropenia
Adults with previously treated acute nonlymphocytic leukemia received either 5‐azacytidine or guanazole in a randomized study. Eighteen patients were treated with 5‐azacytidine at a dosage of 200–250 mg/m 2 /day × 5 intravenously (i.v.) and six achieved a remission (five complete). The median duration of complete remission was 100 days. Among the 12 patients who received guanazole, at a dosage of 25–30 g/m 2 /day × 5 by continuous i.v. infusion, only one partial remission ensued. Patients who responded to 5‐azacytidine had a more profound degree of leukopenia (median 600 WBC/mm 3 ) than nonresponders (median 1700 WBC/mm 3 ). Both the time taken to reach the nadir white blood count (median, 14 days) and the duration of the nadir (median, 17 days) were long after each course of 5‐azacytidine, particularly for those patients who achieved a remission. Principal toxicities seen after 5‐azacytidine administration were gastrointestinal intolerance, fever, and neuromuscular toxicity. Fever was the principal toxicity observed after guanazole therapy; one patient developed erythema nodosum with arthralgias and another, recurrent pulmonary infiltrates. Survival from the start of therapy was clearly longer for the patients receiving 5‐azacytidine (median 140 days) because of the prolongation of survival seen in the responding patients (median 266+ days). 5‐Azacytidine has significant activity as an induction agent in adults with acute nonlymphocytic leukemia, but guanazole does not appear to be of particular value for patients with this disease.