Evaluation of cyclocytidine in reinduction and maintenance therapy of children with acute nonlymphocytic leukemia previously treated with cytosine arabinoside: A report from children's cancer study group

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Abstract
A study of children in relapse with acute nonlymphocytic leukemia (ANLL) previously maintained in remission with combination chemotherapy including cytosine arabinoside (Ara‐C) was undertaken by Children's Cancer Study Group (CCSG) to assess the efficacy of cyclocytidine (Cyclo‐C), a depot Ara‐C, compared to parenteral Ara‐C given every 12 hr. The reinduction protocol consisted of daunomycin combined with either Ara‐C (Regimen 1) or Cyclo‐C (Regimen 2). One‐hundred thirty eligible patients were entered on the randomized study. Hematologic toxicity was significant in both regimens and resulted in four drug‐related deaths. Cardiac toxicity was observed in five patients, manifested only by abnormal echocardiogram or electrocardiogram patterns in three and congestive heart failure in two patients. Seventy‐seven of 112 evaluable patients achieved M‐1 or M‐2A marrow remissions (69%): 46 of 60 on Regimen 1 (75%), 30 of 52 on Regimen 2 (60%). The remission rate between the two regimens was not significantly different. There was no significant difference in the duration of remission comparing maintenance cyclophosphamide combined with Ara‐C or with Cyclo‐C. Addition of VP‐16 and CCNU to the maintenance therapy did not prolong the duration of remission. This study indicates that patients with childhood ANLL previously treated with Ara‐C and daunomycin can obtain a successful second remission. A single daily subcutaneous dose of Cyclo‐C was found to be as efficacious as Ara‐C given intravenously every 12 hr. The single dose schedule provides a convenient way to treat patients with relapsed ANLL in the outpatient setting.