A TOTAL OF 128 PATIENTS were randomly assigned to two induction treatment programs: Adriamycin and L-PAM versus Cytoxan, 5-Fluorouracil, and Prednisone in an effort to assess their primary capacity for objective response. The two regimens appeared quite comparable in this respect.
The 100 patients who had achieved clinical benefit following initial treatment were subsequently randomly allocated to receive either a fixed alternate treatment program involving the two drug regimens or were continued on the treatment program responsible for their initial improvement.
Although those patients who received the fixed alternate treatment schedule had a somewhat longer progression-free interval compared to the two single-treatment programs (median duration of 16 months versus 12 months, respectively), the three treatment programs including the fixed alternate treatment schedules had comparable median survivals of 21–24 months with little difference noted in survival curves at any point thus far in the analysis. There were no differences noted in survival for the fixed alternating treatment group of patients, with respect to which induction regimen had been utilized to achieve initial response.
The toxicity for these treatment programs was tolerable and compatible with outpatient administration. Myelosuppression occurred in the vast majority of patients on either regimen but in both regimens was relatively platelet sparing.