Patients with refractory malignant lymphoma (RML) have a poor prognosis whe
n treated with conventional chemotherapy, as less than 20% remain alive and
free of disease after 5 years. The use of myeloablative chemotherapy follo
wed by BMT has improved the complete remission (CR) rate. Nevertheless, rel
apse rates remain unchanged, and only a few patients remain alive and free
of disease for more than 3 years. For this reason, we began a prospective r
andomized clinical trial to determine if IFN-alpha 2B (5.0 MU three times a
week for 1 year) can improve the prognosis in RML. Ninety-six patients wit
h high or high-intermediate clinical risk RML and in CR after intensive che
motherapy were randomly assigned to receive or not to receive IFN as mainte
nance therapy. A median follow-up of 48.1 months, the time to treatment fai
lure and survival were similar in both groups. Toxicity secondary to IFN ad
ministration was mild, and all patients received the planned doses of IFN,
We conclude that IFN is not recommended at this dose and schedule as mainte
nance therapy in patients with RML who achieve CR, Different therapeutic ap
proaches may be developed to improve outcomes for these patients.