Comparative analysis of two consecutive phase II studies with IFN-alpha and IFN-alpha + ara-C in untreated...

Two consecutive phase II studies with IFN-alpha (n = 55) and with IFN-alpha/ara-C (n = 84) are compared in a retrospective analysis of untreated chronic-phase CML patients. Hematological responses (CHR and PHR) were seen in 76% of patients after IFN-alpha and in 77% after IFN-alpha/ara-C treatment with a higher CHR rate in the latter group (45% versus 54%). Moreover, cytogenetic responses were observed more frequently in the IFN-alpha/ara-C study (44% versus 34%), including a higher rate of complete cytogenetic responses (13% versus 9%). The combined treatment modality induced higher rates of hematotoxicity (e.g. thrombocytopenia: 44% versus 25%) and gastrointestinal side effects (38% versus 15%) as compared to the monotherapy study.