title: 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.
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.
authors.affiliation: Department of Hematology, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands. s.verelst@erasmusmc.nl
authors.forename: Silvia G R
authors.initials: SG
authors.lastname: Verelst
authors.forename: F
authors.initials: F
authors.lastname: Termorshuizen
authors.forename: C A
authors.initials: CA
authors.lastname: Uyl-de Groot
authors.forename: M R
authors.initials: MR
authors.lastname: Schaafsma
authors.forename: A H M
authors.initials: AH
authors.lastname: Ammerlaan
authors.forename: S
authors.initials: S
authors.lastname: Wittebol
authors.forename: H A M
authors.initials: HA
authors.lastname: Sinnige
authors.forename: S
authors.initials: S
authors.lastname: Zweegman
authors.forename: M
authors.initials: M
authors.lastname: van Marwijk Kooy
authors.forename: R
authors.initials: R
authors.lastname: van der Griend
authors.forename: H M
authors.initials: HM
authors.lastname: Lokhorst
authors.forename: P
authors.initials: P
authors.lastname: Sonneveld
authors.forename: P W
authors.initials: PW
authors.lastname: Wijermans
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008558:Melphalan / Q000627:therapeutic use*; D008875:Middle Aged; D015233:Models, Statistical; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000503:physiopathology; D011241:Prednisone / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013792:Thalidomide / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D013792:Thalidomide; D008558:Melphalan; D011241:Prednisone