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Annals of Oncology 2007 18(8):1388-1394; doi:10.1093/annonc/mdm180
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© 2007 European Society for Medical Oncology

hematologic malignancies

An open, randomized, controlled, phase II, single centre, two-period cross-over study to compare the quality of life and toxicity experienced on PEG interferon with interferon-{alpha}2b in patients with multiple myeloma maintained on a steady dose of interferon-{alpha}2b

B Sirohi, R Powles*, D Lawrence, J Treleaven, S Kulkarni, A Leary, C Rudin, C Horton and G Morgan

Leukaemia and Myeloma Units, Royal Marsden NHS Trust, Surrey SM2 5PT and Clinical Trials and Statistics Unit, Institute of Cancer Research, UK

* Correspondence to: Prof. R. Powles, Parkside Cancer Centre, 49 Parkside, Wimbledon SW19 5NB, UK. Tel: +44-20-8944-7979; Fax: +44-20-8605-9103; E-mail: myeloma{at}clara.co.uk

Purpose: To compare the effects of pegylated interferon-{alpha}2b (P-IFN) and interferon-{alpha}2b (IFN) on quality of life (QoL) and toxicity in patients with multiple myeloma maintained on a steady dose of IFN.

Patients and methods: Consenting, eligible myeloma patients on IFN maintenance therapy for at least 6 weeks were randomly (1:1) allocated to receive P-IFN for 3 months followed by IFN for 3 months, or to continue with IFN for 3 months followed by P-IFN for 3 months (cross-over design). Patients were assessed for toxicity and QoL. Dose of P-IFN was equivalent to IFN.

Results: The study enrolled 60 patients. At enrolment, 35 patients were in complete remission, 20 in partial remission and 5 were minimal responders. P-IFN was associated with significantly better global QoL score (mean difference 8.4; P = 0.0002). There was a significant improvement in functional scales—physical (P = 0.03), emotional (P = 0.04), social (P = 0.0008) with P-IFN. Fatigue (P = 0.0003), pain (P = 0.02) and appetite loss (P = 0.003) symptom scales were less in patients while on P-IFN. There were no statistically significant differences between treatment arms in QoL as measured by QLQ-MY24.

Conclusion: These data suggest that patients on P-IFN have a better QoL. Dose escalation studies are warranted to investigate potential impact on survival.

Key words: maintenance therapy, myeloma, pegylated interferon, quality of life

Received for publication December 22, 2006. Revision received March 30, 2007. Accepted for publication April 4, 2007.


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