Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: A GELA study

Background: Fludarabine was associated with a good response and was well to lerated in patients with follicular lymphoma in phase II trials and this tr eatment may be associated with less adverse events than treatment with CHVP plus interferon in elderly patients. Patients and methods: One hundred thirty-one patients older than 59 years w ith a follicular lymphoma and poor prognosis were randomized between the as sociation of CHVP (12 cycles in 18 months) plus interferon (5 MU TIW for 18 months) or fludarabine alone (25 mg/m(2)/d x5 days for 6 cycles, then 20 m g/m(2)/day for 6 further cycles for 18 months). Poor prognosis was defined by the presence of a large tumor mass, poor performance status, the presenc e of B symptoms, above normal LDH level, or greater than or equal to 3 mg/l beta-microglobulin level. Results: Patients treated with CHVP plus interferon had a higher response t o treatment, a longer time to progression and a longer survival than those treated with fludarabine alone (P < 0.05 for all analyses). With a median f ollow-up of 29 months, the 2-year failure-free survival was 63% for the CHV P-plus-interferon arm compared to 49% for the fludarabine arm and the two-y ear survival was 77% and 62%, respectively. This benefit was confirmed in a multivariate analysis including initial prognostic parameters. Fludarabine alone was associated with less neutropenia than CHVP plus interferon. Inte rferon was decreased or stopped in 39% of the patients because of severe fa tigue. Conclusions: CHVP plus interferon over 18 months was associated with a bett er outcome, even though the combination of interferon plus chemotherapy was less well tolerated than fludarabine.