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Annals of Oncology Advance Access published online on March 1, 2005
Annals of Oncology, doi:10.1093/annonc/mdi125
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© 2005 European Society for Medical Oncology
Received September 14, 2004
Revised November 22, 2004
Accepted December 1, 2004

Original article

Interferon-{alpha} as maintenance therapy in patients with multiple myeloma

C. G. Schaar 1*, H. C. Kluin-Nelemans 2, C. te Marvelde 3, S. le Cessie 4, W. P. Breed 5, W. E. Fibbe 6, W. A. van Deijk 7, M. M. Fickers 8, K. J. Roozendaal 9, P. W. Wijermans 10, and On behalf of the Dutch-Belgian Hemato-Oncology Cooperative Group HOVON

1 Department of Internal Medicine, Gelre Hospitals, Apeldoorn, The Netherlands
2 Department of Hematology, University Medical Center, Groningen, The Netherlands
3 Comprehensive Cancer Center West, Leiden, The Netherlands
4 Departments of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands
5 Department of Internal Medicine, Catharina Hospital, Eindhoven, The Netherlands
6 , Department ofHematology, Leiden University Medical Center, Leiden, The Netherlands
7 Department of Internal Medicine, Rode Kruis Hospital, The Hague, The Netherlands
8 Department of Internal Medicine, Atrium Medical Center, Heerlen, The Netherlands
9 Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
10 Department of Hematology, Leyenburg Hospital, The Hague, The Netherlands

* To whom correspondence should be addressed.
C. G. Schaar, E-mail: c.schaar{at}gelre.nl


  Abstract

Background: The effect of interferon-{alpha} 2b (IFN-{alpha}-2b) on progression-free and overall survival as well as quality of life (QoL) was studied in mainly elderly patients with multiple myeloma (MM), who reached a plateau phase after melphalan/prednisone induction.

Patients and methods: In an open phase III trial, 262 patients, median age 69 years (range 34-91), received at least 10 monthly courses of melphalan/prednisone followed by response evaluation. Plateau phase was reached by 128 patients. Next, 90 patients were randomized between IFN-{alpha}-2b and no maintenance therapy. Reasons for non-randomization were: refusal (18), concomitant disease (nine), protocol violation (six), WHO performance status >2 (four) and allogeneic transplantation (one)

Results: At a median follow-up from diagnosis of 97 months (0-140) for those patients alive, IFN-{alpha}-2b therapy was associated with improved progression-free survival (median 13.5 versus 8.4 months from randomization), although this did not translate in a better overall survival (41 versus 38.4 months). One-third of patients discontinued IFN-{alpha} due to toxicity. No differences were observed between patient groups in QoL.

Conclusions: IFN maintenance therapy in MM prolongs progression-free survival and, provided that the burden of toxicity is not too high, does not adversely affect QoL.

Keywords: interferon-{alpha}; maintenance therapy; multiple myeloma.
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