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Erschienen in: Annals of Hematology 12/2011

01.12.2011 | Original Article

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

verfasst von: Silvia G. R. Verelst, F. Termorshuizen, C. A. Uyl-de Groot, M. R. Schaafsma, A. H. M. Ammerlaan, S. Wittebol, H. A. M. Sinnige, S. Zweegman, M. van Marwijk Kooy, R. van der Griend, H. M. Lokhorst, P. Sonneveld, P. W. Wijermans, Dutch-Belgium Hemato-Oncology Cooperative Group (HOVON)

Erschienen in: Annals of Hematology | Ausgabe 12/2011

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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.
Literatur
1.
Zurück zum Zitat Parkin DM, Bray F, Ferlay J, Pisani P (2005) Global cancer statistics, 2002. CA Cancer J Clin 55(2):74–108PubMedCrossRef Parkin DM, Bray F, Ferlay J, Pisani P (2005) Global cancer statistics, 2002. CA Cancer J Clin 55(2):74–108PubMedCrossRef
2.
Zurück zum Zitat Kumar SK, Rajkumar SV, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Zeldenrust SR, Dingli D, Russell SJ, Lust JA, Greipp PR, Kyle RA, Gertz MA (2008) Improved survival in multiple myeloma and the impact of novel therapies. Blood 111(5):2516–2520. doi:10.1182/blood-2007-10-116129 PubMedCrossRef Kumar SK, Rajkumar SV, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Zeldenrust SR, Dingli D, Russell SJ, Lust JA, Greipp PR, Kyle RA, Gertz MA (2008) Improved survival in multiple myeloma and the impact of novel therapies. Blood 111(5):2516–2520. doi:10.​1182/​blood-2007-10-116129 PubMedCrossRef
3.
Zurück zum Zitat Kyle RA, Gertz MA, Witzig TE, Lust JA, Lacy MQ, Dispenzieri A, Fonseca R, Rajkumar SV, Offord JR, Larson DR, Plevak ME, Therneau TM, Greipp PR (2003) Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc 78(1):21–33PubMedCrossRef Kyle RA, Gertz MA, Witzig TE, Lust JA, Lacy MQ, Dispenzieri A, Fonseca R, Rajkumar SV, Offord JR, Larson DR, Plevak ME, Therneau TM, Greipp PR (2003) Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc 78(1):21–33PubMedCrossRef
4.
Zurück zum Zitat Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H, Intergroupe Francophone du M (2007) Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99–06): a randomised trial. Lancet 370(9594):1209–1218. doi:10.1016/S0140-6736(07)61537-2 PubMedCrossRef Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H, Intergroupe Francophone du M (2007) Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99–06): a randomised trial. Lancet 370(9594):1209–1218. doi:10.​1016/​S0140-6736(07)61537-2 PubMedCrossRef
5.
Zurück zum Zitat Hulin C, Facon T, Rodon P, Pegourie B, Benboubker L, Doyen C, Dib M, Guillerm G, Salles B, Eschard JP, Lenain P, Casassus P, Azais I, Decaux O, Garderet L, Mathiot C, Fontan J, Lafon I, Virion JM, Moreau P (2009) Efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed multiple myeloma: IFM 01/01 trial. J Clin Oncol 27(22):3664–3670. doi:10.1200/JCO.2008.21.0948 PubMedCrossRef Hulin C, Facon T, Rodon P, Pegourie B, Benboubker L, Doyen C, Dib M, Guillerm G, Salles B, Eschard JP, Lenain P, Casassus P, Azais I, Decaux O, Garderet L, Mathiot C, Fontan J, Lafon I, Virion JM, Moreau P (2009) Efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed multiple myeloma: IFM 01/01 trial. J Clin Oncol 27(22):3664–3670. doi:10.​1200/​JCO.​2008.​21.​0948 PubMedCrossRef
6.
Zurück zum Zitat Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M, Italian Multiple Myeloma Network, GIMEMA (2006) Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet 367(9513):825–831. doi:10.1016/S0140-6736(06)68338-4 PubMedCrossRef Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M, Italian Multiple Myeloma Network, GIMEMA (2006) Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet 367(9513):825–831. doi:10.​1016/​S0140-6736(06)68338-4 PubMedCrossRef
7.
Zurück zum Zitat Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M (2008) Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood 112(8):3107–3114. doi:10.1182/blood-2008-04-149427 PubMedCrossRef Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M (2008) Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood 112(8):3107–3114. doi:10.​1182/​blood-2008-04-149427 PubMedCrossRef
8.
Zurück zum Zitat Waage A, Gimsing P, Fayers P, Abildgaard N, Ahlberg L, Bjorkstrand B, Carlson K, Dahl IM, Forsberg K, Gulbrandsen N, Haukas E, Hjertner O, Hjorth M, Karlsson T, Knudsen L, Nielsen JL, Linder O, Mellqvist UH, Nesthus I, Rolke J, Strandberg M, Sorbo JH, Wisloff F, Juliusson G, Turesson I (2010) Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma. Blood. doi:10.1182/blood-2009-08-237974 PubMed Waage A, Gimsing P, Fayers P, Abildgaard N, Ahlberg L, Bjorkstrand B, Carlson K, Dahl IM, Forsberg K, Gulbrandsen N, Haukas E, Hjertner O, Hjorth M, Karlsson T, Knudsen L, Nielsen JL, Linder O, Mellqvist UH, Nesthus I, Rolke J, Strandberg M, Sorbo JH, Wisloff F, Juliusson G, Turesson I (2010) Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma. Blood. doi:10.​1182/​blood-2009-08-237974 PubMed
9.
Zurück zum Zitat Wijermans P, Schaafsma M, Termorshuizen F, Ammerlaan R, Wittebol S, Sinnige H, Zweegman S, van Marwijk Kooy M, van der Griend R, Lokhorst H, Sonneveld P, Dutch-Belgium Cooperative Group HOVON (2010) Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study. J Clin Oncol 28(19):3160–3166. doi:10.1200/JCO.2009.26.1610 PubMedCrossRef Wijermans P, Schaafsma M, Termorshuizen F, Ammerlaan R, Wittebol S, Sinnige H, Zweegman S, van Marwijk Kooy M, van der Griend R, Lokhorst H, Sonneveld P, Dutch-Belgium Cooperative Group HOVON (2010) Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study. J Clin Oncol 28(19):3160–3166. doi:10.​1200/​JCO.​2009.​26.​1610 PubMedCrossRef
10.
Zurück zum Zitat Durie BG, Salmon SE (1975) A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer 36(3):842–854PubMedCrossRef Durie BG, Salmon SE (1975) A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer 36(3):842–854PubMedCrossRef
11.
Zurück zum Zitat Minnema MC, Breitkreutz I, Auwerda JJ, van der Holt B, Cremer FW, van Marion AM, Westveer PH, Sonneveld P, Goldschmidt H, Lokhorst HM (2004) Prevention of venous thromboembolism with low molecular-weight heparin in patients with multiple myeloma treated with thalidomide and chemotherapy. Leukemia 18(12):2044–2046. doi:10.1038/sj.leu.2403533 PubMedCrossRef Minnema MC, Breitkreutz I, Auwerda JJ, van der Holt B, Cremer FW, van Marion AM, Westveer PH, Sonneveld P, Goldschmidt H, Lokhorst HM (2004) Prevention of venous thromboembolism with low molecular-weight heparin in patients with multiple myeloma treated with thalidomide and chemotherapy. Leukemia 18(12):2044–2046. doi:10.​1038/​sj.​leu.​2403533 PubMedCrossRef
12.
Zurück zum Zitat Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):365–376PubMedCrossRef Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):365–376PubMedCrossRef
13.
Zurück zum Zitat Cocks K, Cohen D, Wisloff F, Sezer O, Lee S, Hippe E, Gimsing P, Turesson I, Hajek R, Smith A, Graham L, Phillips A, Stead M, Velikova G, Brown J, Group EQoL (2007) An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer 43(11):1670–1678. doi:10.1016/j.ejca.2007.04.022 PubMedCrossRef Cocks K, Cohen D, Wisloff F, Sezer O, Lee S, Hippe E, Gimsing P, Turesson I, Hajek R, Smith A, Graham L, Phillips A, Stead M, Velikova G, Brown J, Group EQoL (2007) An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer 43(11):1670–1678. doi:10.​1016/​j.​ejca.​2007.​04.​022 PubMedCrossRef
14.
Zurück zum Zitat Lee SJ, Richardson PG, Sonneveld P, Schuster MW, Irwin D, San Miguel JF, Crawford B, Massaro J, Dhawan R, Gupta S, Anderson KC (2008) Bortezomib is associated with better health-related quality of life than high-dose dexamethasone in patients with relapsed multiple myeloma: results from the APEX study. Br J Haematol 143(4):511–519. doi:10.1111/j.1365-2141.2008.07378.x PubMed Lee SJ, Richardson PG, Sonneveld P, Schuster MW, Irwin D, San Miguel JF, Crawford B, Massaro J, Dhawan R, Gupta S, Anderson KC (2008) Bortezomib is associated with better health-related quality of life than high-dose dexamethasone in patients with relapsed multiple myeloma: results from the APEX study. Br J Haematol 143(4):511–519. doi:10.​1111/​j.​1365-2141.​2008.​07378.​x PubMed
15.
Zurück zum Zitat Kvam AK, Fayers P, Hjermstad M, Gulbrandsen N, Wisloff F (2009) Health-related quality of life assessment in randomised controlled trials in multiple myeloma: a critical review of methodology and impact on treatment recommendations. Eur J Haematol 83(4):279–289. doi:10.1111/j.1600-0609.2009.01303.x PubMedCrossRef Kvam AK, Fayers P, Hjermstad M, Gulbrandsen N, Wisloff F (2009) Health-related quality of life assessment in randomised controlled trials in multiple myeloma: a critical review of methodology and impact on treatment recommendations. Eur J Haematol 83(4):279–289. doi:10.​1111/​j.​1600-0609.​2009.​01303.​x PubMedCrossRef
16.
17.
Zurück zum Zitat Palumbo A, Davies F, Kropff M, Blade J, Delforge M, Leal da Costa F, Garcia Sanz R, Schey S, Facon T, Morgan G, Moreau P (2010) Consensus guidelines for the optimal management of adverse events in newly diagnosed, transplant-ineligible patients receiving melphalan and prednisone in combination with thalidomide (MPT) for the treatment of multiple myeloma. Ann Hematol 89(8):803–811. doi:10.1007/s00277-010-0925-1 PubMedCrossRef Palumbo A, Davies F, Kropff M, Blade J, Delforge M, Leal da Costa F, Garcia Sanz R, Schey S, Facon T, Morgan G, Moreau P (2010) Consensus guidelines for the optimal management of adverse events in newly diagnosed, transplant-ineligible patients receiving melphalan and prednisone in combination with thalidomide (MPT) for the treatment of multiple myeloma. Ann Hematol 89(8):803–811. doi:10.​1007/​s00277-010-0925-1 PubMedCrossRef
19.
Zurück zum Zitat Nout RA, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, van Bunningen BN, Smit VT, Nijman HW, van den Tol PP, Creutzberg CL (2009) Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial. J Clin Oncol 27(21):3547–3556. doi:10.1200/JCO.2008.20.2424 PubMedCrossRef Nout RA, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, van Bunningen BN, Smit VT, Nijman HW, van den Tol PP, Creutzberg CL (2009) Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial. J Clin Oncol 27(21):3547–3556. doi:10.​1200/​JCO.​2008.​20.​2424 PubMedCrossRef
Metadaten
Titel
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
verfasst von
Silvia G. R. Verelst
F. Termorshuizen
C. A. Uyl-de Groot
M. R. Schaafsma
A. H. M. Ammerlaan
S. Wittebol
H. A. M. Sinnige
S. Zweegman
M. van Marwijk Kooy
R. van der Griend
H. M. Lokhorst
P. Sonneveld
P. W. Wijermans
Dutch-Belgium Hemato-Oncology Cooperative Group (HOVON)
Publikationsdatum
01.12.2011
Verlag
Springer-Verlag
Erschienen in
Annals of Hematology / Ausgabe 12/2011
Print ISSN: 0939-5555
Elektronische ISSN: 1432-0584
DOI
https://doi.org/10.1007/s00277-011-1224-1

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