Annals of Oncology 10:1191-1197, 1999
© 1999 European Society for Medical Oncology
research-article |
Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: A GELA study
1Groupe d Etudes des Lymphomes de VAdulte (GELA), Hospices Civils de Lyon and Universite Claude-Bernard Lyon
2Groupe d Etudes des Lymphomes de VAdulte (GELA), Centre Henri Becquerel Rouen
3Groupe d Etudes des Lymphomes de VAdulte (GELA), Hôpital Necker Paris
4Groupe d Etudes des Lymphomes de VAdulte (GELA), Institut Paoli-Calmette Marseille
5Groupe d Etudes des Lymphomes de VAdulte (GELA), Hôpital Henri Mondor Creteil
6Groupe d Etudes des Lymphomes de VAdulte (GELA), Hôpital Saint-Louis Paris
7Groupe d Etudes des Lymphomes de VAdulte (GELA), Centre Hospitalier Valence
8Groupe d Etudes des Lymphomes de VAdulte (GELA), Institut Gustave Roussy Villejuif
9Groupe d Etudes des Lymphomes de VAdulte (GELA), Centre René, Huguenin Saint-Cloud
10Groupe d Etudes des Lymphomes de VAdulte (GELA), Clinique Victor Hugo Le Mans, France
Correspondence to: Prof. B. Coiffier, Hématologie, Centre Hospitalier Lyon-Sud, 69495 Pierre-Benite Cedex, France, E-mail: bertrand.coirner{at}chu-lyon.fr
Background: Fludarabine was associated with a good response and was well tolerated in patients with follicular lymphoma in phase II trials and this treatment 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 with a follicular lymphoma and poor prognosis were randomized between the association of CHVP (12 cycles in 18 months) plus interferon (5 MU TIW for 18 months) or fludarabine alone (25 mg/m2/d x 5 days for 6 cycles, then 20 mg/m2/day for 6 further cycles for 18 months). Poor prognosis was defined by the presence of a large tumor mass, poor performance status, the presence of B symptoms, above normal LDH level, or
3 mg/1 ß-microglobulin level.
Results: Patients treated with CHVP plus interferon had a higher response to 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 follow-up of 29 months, the 2-year failure-free survival was 63% for the CHVP-plus-interferon arm compared to 49% for the fludarabine arm and the two-year 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. Interferon was decreased or stopped in 39% of the patients because of severe fatigue.
Conclusions: CHVP plus interferon over 18 months was associated with a better outcome, even though the combination of interferon plus chemotherapy was less well tolerated than fludarabine.
fludarabine, follicular lymphoma, interferon
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