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Effect of thalidomide with melphalan and prednisone on health-related quality of life (HRQoL) in elderly patients with newly diagnosed multiple myeloma: a prospective analysis in a randomized trial

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Abstract

Thalidomide with melphalan/prednisone (MPT) was defined as standard treatment in elderly patients with multiple myeloma (MM) based on five randomized trials. In one of these trials, HOVON49, a prospective health-related quality-of-life (HRQoL) study was initiated in order to assess the impact of thalidomide on QoL. Patients aged >65 years with newly diagnosed MM were randomized to receive melphalan plus prednisone (MP) or MPT, followed by thalidomide maintenance in the MPT arm. Two hundred eighty-four patients were included in this side study (MP, n = 149; MPT n = 135). HRQoL was assessed with the EORTC Core QoL Questionnaire (QLQ-C30) and the myeloma-specific module (QLQ-MY24) at baseline and at predetermined intervals during treatment. The QLQ-C30 subscales physical function (P = 0.044) and constipation (P < 0.001) showed an improvement during induction in favour of the MP arm. During thalidomide maintenance, the scores for the QLQ-MY24 paraesthesia became significantly higher in the MPT arm (P<0.001). The QLQ-C30 subscales pain (P = 0.12), insomnia (P = 0.068), appetite loss (P = 0.074) and the QLQ-MY24 item sick (P = 0.086) scored marginally better during thalidomide maintenance. The overall QoL-scale QLQ-C30-HRQoL showed a significant time trend towards more favourable mean values during protocol treatment without differences between MP and MPT. For the QLQ-C30 subscales emotional function and future perspectives, difference in favour of the MPT arm from the start of treatment was observed (P = 0.018 and P = 0.045, respectively) with no significant ‘time × arm’ interaction, indicating a persistent better patient perspective with MPT treatment. This study shows that the higher frequency of toxicity associated with MPT does not translate into a negative effect on HRQoL and that MPT holds a better patient perspective.

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Acknowledgments

This study was supported by a grant from The Dutch Cancer Society (KWF). Furthermore, we thank the coordinators in the different hospitals and the people at the Hovon Data Centre for the data collection and, last but certainly not least, all the patients who participated and took the time to fill out the questionnaires.

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Correspondence to Silvia G. R. Verelst.

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Verelst, S.G.R., Termorshuizen, F., Uyl-de Groot, C.A. et al. Effect of thalidomide with melphalan and prednisone on health-related quality of life (HRQoL) in elderly patients with newly diagnosed multiple myeloma: a prospective analysis in a randomized trial. Ann Hematol 90, 1427–1439 (2011). https://doi.org/10.1007/s00277-011-1224-1

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  • DOI: https://doi.org/10.1007/s00277-011-1224-1

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