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Annals of Oncology Advance Access originally published online on February 2, 2005
Annals of Oncology 2005 16(3):466-472; doi:10.1093/annonc/mdi091
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© 2005 European Society for Medical Oncology

Long-term follow-up of a randomized trial of fludarabine–mitoxantrone, compared with cyclophosphamide, doxorubicin, vindesine, prednisone (CHVP), as first-line treatment of elderly patients with advanced, low-grade non-Hodgkin's lymphoma before the era of monoclonal antibodies

C. Foussard1, P. Colombat2, H. Maisonneuve3, C. Berthou4, R. Gressin5, M.-C. Rousselet6, P. Rachieru1, B. Pignon7, B. Mahé8, C. Ghandour9, B. Desablens10, P. Casassus11, T. Lamy12, V. Delwail13 and E. Deconinck14,* On behalf of the Groupe Ouest-Est des Leucémies et Autres Maladies du Sang (GOELAMS)

1 Hematology Department, CHU Angers; 2 Hematology Department, CHU Tours; 3 Hematology Department, CH La Roche-sur-Yon; 4 Hematology Department, CHU Brest; 5 Hematology Department, CHU Grenoble; 6 Pathological Department, CHU Angers; 7 Hematology Department, CHU Reims; 8 Hematology Department, CHU Nantes; 9 Hematological Center, Rennes; 10 Hematology Department, CHU Amiens; 11 Hematology Department, CHU Bobigny; 12 Hematology Department, CHU Rennes; 13 Hematology Department, CHU Poitiers; 14 Hematology Department, CHU Besançon, France

* Correspondence to: Dr E. Deconinck, Service d'Hématologie, CHU Besançon, 25 030 Besançon Cedex, France. Tel: +33-3-81-66-82-32; Fax: +33-3-81-66-82-15; Email: edeconinck{at}chu-besancon.fr

Background: This randomized study compared the efficacy and safety of fludarabine–mitoxantrone (FM) with mini-CHVP (cyclophosphamide, doxorubicin, vindesine, prednisone) in elderly patients with advanced, low-grade non-Hodgkin's lymphoma.

Patients and methods: End points were remission rates [overall response (OR) and complete response (CR)], failure-free survival (FFS), survival and toxicity. One hundred and fifty-five patients were randomized, 144 were evaluable for safety and 142 for response. Each treatment arm was given as six monthly cycles, followed by three bimonthly cycles. FM comprised fludarabine (20 mg/m2 i.v.), days 1–5, plus mitoxantrone (10 mg/m2 i.v.), day 1. CHVP cycles comprised cyclophosphamide (750 mg/m2 i.v. infusion), doxorubicin (25 mg/m2 i.v.) and vindesine (3 mg/m2 i.v.) on day 1, and prednisone (50 mg/m2) on days 1–5.

Results: FM therapy resulted in superior remission rates (OR 81% versus 64%, CR 49% versus 17%; P=0.0004). Median FFS for FM patients was 36 months, compared with 19 months for CHVP patients, and has not yet been reached for early CR patients at 53 months. Treatment arm was the major risk factor influencing survival. Both treatments were well tolerated, with only few infectious complications.

Conclusion: FM was more effective than CHVP in achieving OR and CR, and favorably affected the outcome.

Key words: anthrayclines, fludarabine, follicular lymphoma, mitoxantrone, purine analogs


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