6533b86dfe1ef96bd12ca0a5

RESEARCH PRODUCT

Treatment of 11 patients with chronic myelogenous leukemia with interferon-alpha-2C and low-dose cytosine arabinoside

subject

description

Abstract Patients with Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML) and on interferon (IFN)-α-2c treatment for at least two months were entered in the present pilot study. IFN-α treatment was maintained identically and cytosine arabinoside (Ara-C) was added at monthly cycles of 10 mg/m 2 /day for ten days subcutaneously. In the case of a leukocyte nadir above 10 G/1, the Ara-C dose was increased to 20 mg/m 2 /day for 10 days per month. Ten of the eleven patients entered in this study were evaluable for toxicity and response. They received a total of 87 IFN-α/Ara-C cycles (3–14/patient). Five patients received 1–5 cycles with Ara-C dose intensification to 20 mg/m 2 /day. The following gastrointestinal and hematological toxicities were attributable to Ara-C, as they had not been observed in these patients during the preceding IFN-α monotherapy period. Gastrointestinal side effects consisted of nausea grade 1 ( n = 5) and diarrhea grade 2 ( n = 1). Hematotoxicity was observed in eight patients, grade 1 in five patients and grades 2, 3 and 4 in one of the patients each. Both episodes of grades 3 and 4 toxicity were seen during dose escalation to 20 mg/m 2 . Small cytogenetic responses (4–14%) were observed in 3 patients and a larger one (50%) in one patient, hematological improvement or stable disease in an additional three patients. These preliminary data suggest that the combination of IFN-α and low-dose Ara-C is active in inducing cytogenetic responses in CML patients at an acceptable rate of toxicity and therefore warrant further investigation.