Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study

Lk Nielsen, C Stege, B Witte, B Holt, U-H Mellqvist, M Salomo, M-D Levin, M Hansson, T Plesner, D Szatkowski, E Haukas, P Gimsing, P Sonneveld, N Abildgaard, A Waage, S Zweegman

Research output: Book/ReportBookAcademicpeer-review

Abstract

Aims: The aim is to evaluate the health-related quality of life (HRQoL) results of HOVON87/NMSG18 study (Zweegman et al., Blood 2016;127(9):1109-1116). Non-transplant eligible, newly diagnosed multiple myeloma patients were randomized between melphalan/prednisolone plus either thalidomide or lenalidomide for nine induction cycles, followed by thalidomide or lenalidomide maintenance (MPT-T or MRP-R). The study showed comparable efficacy of treatment. Methods: The validated instruments, EORTC QLQ-C30 and EORTC QLQ-MY20, were used for HRQoL measurement and were optional in the study. The patients answered the questionnaires at baseline, after 3 and 9 induction cycles and after 6 and 12 months of maintenance. Changes in HRQoL score over time during treatment and between groups were evaluated according to previously published levels of minimal important difference. Results: 613 of the total of 637 randomized patients chose to participate in the HRQoL reporting, and the baseline questionnaire was available from 553 patients (90.2%). Patient drop-out during follow-up was due to progressive disease, toxicity, death and other, and reduced the number of patients completing the therapy to 42 (15%) patients in the MPT-T and 93 (33%) in the MPR-R group. Both groups reported clinically meaningful improvement in global quality of life (QoL), physical functioning, pain, disease symptoms and insomnia. In the evaluation of difference between groups, the patients receiving MPR-R reported increasing diarrhea, better controlled pain at induction phase and increased global QoL and physical functioning during maintenance phase compared to MPT-T. The patients receiving MPT-T reported increasing constipation, better controlled pain during maintenance phase, better controlled fatigue during induction treatment and decreased insomnia compared to MPR-R. Conclusions: HRQoL during treatment is important to myeloma patients, especially when treatment efficacy of the treatment regimens is comparable. MPR-R and MPT-T both demonstrated improvements in global QoL, physical functioning and pain. Fatigue and insomnia were better controlled in the MPT-T group, which can be attributed to the thalidomide side effect of sleepiness. For interpretation of the HRQoL results patient drop-out rate must be taken in account, and we will recommend a HRQoL study design with high focus on data completeness and registration of reasons for missing data. (Figure Presented).
Original languageEnglish
Number of pages2
Volume26
DOIs
Publication statusPublished - 2017

Publication series

NameQuality of life research. Conference: 24th annual conference of the international society for quality of life research, ISOQOL 2017. United states
Volume26

Cite this

Nielsen, L., Stege, C., Witte, B., Holt, B., Mellqvist, U-H., Salomo, M., ... Zweegman, S. (2017). Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study. (Quality of life research. Conference: 24th annual conference of the international society for quality of life research, ISOQOL 2017. United states; Vol. 26). https://doi.org/10.1007/s11136-017-1658-6
Nielsen, Lk ; Stege, C ; Witte, B ; Holt, B ; Mellqvist, U-H ; Salomo, M ; Levin, M-D ; Hansson, M ; Plesner, T ; Szatkowski, D ; Haukas, E ; Gimsing, P ; Sonneveld, P ; Abildgaard, N ; Waage, A ; Zweegman, S. / Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study. 2017. 2 p. (Quality of life research. Conference: 24th annual conference of the international society for quality of life research, ISOQOL 2017. United states).
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title = "Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study",
abstract = "Aims: The aim is to evaluate the health-related quality of life (HRQoL) results of HOVON87/NMSG18 study (Zweegman et al., Blood 2016;127(9):1109-1116). Non-transplant eligible, newly diagnosed multiple myeloma patients were randomized between melphalan/prednisolone plus either thalidomide or lenalidomide for nine induction cycles, followed by thalidomide or lenalidomide maintenance (MPT-T or MRP-R). The study showed comparable efficacy of treatment. Methods: The validated instruments, EORTC QLQ-C30 and EORTC QLQ-MY20, were used for HRQoL measurement and were optional in the study. The patients answered the questionnaires at baseline, after 3 and 9 induction cycles and after 6 and 12 months of maintenance. Changes in HRQoL score over time during treatment and between groups were evaluated according to previously published levels of minimal important difference. Results: 613 of the total of 637 randomized patients chose to participate in the HRQoL reporting, and the baseline questionnaire was available from 553 patients (90.2{\%}). Patient drop-out during follow-up was due to progressive disease, toxicity, death and other, and reduced the number of patients completing the therapy to 42 (15{\%}) patients in the MPT-T and 93 (33{\%}) in the MPR-R group. Both groups reported clinically meaningful improvement in global quality of life (QoL), physical functioning, pain, disease symptoms and insomnia. In the evaluation of difference between groups, the patients receiving MPR-R reported increasing diarrhea, better controlled pain at induction phase and increased global QoL and physical functioning during maintenance phase compared to MPT-T. The patients receiving MPT-T reported increasing constipation, better controlled pain during maintenance phase, better controlled fatigue during induction treatment and decreased insomnia compared to MPR-R. Conclusions: HRQoL during treatment is important to myeloma patients, especially when treatment efficacy of the treatment regimens is comparable. MPR-R and MPT-T both demonstrated improvements in global QoL, physical functioning and pain. Fatigue and insomnia were better controlled in the MPT-T group, which can be attributed to the thalidomide side effect of sleepiness. For interpretation of the HRQoL results patient drop-out rate must be taken in account, and we will recommend a HRQoL study design with high focus on data completeness and registration of reasons for missing data. (Figure Presented).",
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author = "Lk Nielsen and C Stege and B Witte and B Holt and U-H Mellqvist and M Salomo and M-D Levin and M Hansson and T Plesner and D Szatkowski and E Haukas and P Gimsing and P Sonneveld and N Abildgaard and A Waage and S Zweegman",
year = "2017",
doi = "10.1007/s11136-017-1658-6",
language = "English",
volume = "26",
series = "Quality of life research. Conference: 24th annual conference of the international society for quality of life research, ISOQOL 2017. United states",

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Nielsen, L, Stege, C, Witte, B, Holt, B, Mellqvist, U-H, Salomo, M, Levin, M-D, Hansson, M, Plesner, T, Szatkowski, D, Haukas, E, Gimsing, P, Sonneveld, P, Abildgaard, N, Waage, A & Zweegman, S 2017, Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study. Quality of life research. Conference: 24th annual conference of the international society for quality of life research, ISOQOL 2017. United states, vol. 26, vol. 26. https://doi.org/10.1007/s11136-017-1658-6

Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study. / Nielsen, Lk; Stege, C; Witte, B; Holt, B; Mellqvist, U-H; Salomo, M; Levin, M-D; Hansson, M; Plesner, T; Szatkowski, D; Haukas, E; Gimsing, P; Sonneveld, P; Abildgaard, N; Waage, A; Zweegman, S.

2017. 2 p. (Quality of life research. Conference: 24th annual conference of the international society for quality of life research, ISOQOL 2017. United states; Vol. 26).

Research output: Book/ReportBookAcademicpeer-review

TY - BOOK

T1 - Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study

AU - Nielsen, Lk

AU - Stege, C

AU - Witte, B

AU - Holt, B

AU - Mellqvist, U-H

AU - Salomo, M

AU - Levin, M-D

AU - Hansson, M

AU - Plesner, T

AU - Szatkowski, D

AU - Haukas, E

AU - Gimsing, P

AU - Sonneveld, P

AU - Abildgaard, N

AU - Waage, A

AU - Zweegman, S

PY - 2017

Y1 - 2017

N2 - Aims: The aim is to evaluate the health-related quality of life (HRQoL) results of HOVON87/NMSG18 study (Zweegman et al., Blood 2016;127(9):1109-1116). Non-transplant eligible, newly diagnosed multiple myeloma patients were randomized between melphalan/prednisolone plus either thalidomide or lenalidomide for nine induction cycles, followed by thalidomide or lenalidomide maintenance (MPT-T or MRP-R). The study showed comparable efficacy of treatment. Methods: The validated instruments, EORTC QLQ-C30 and EORTC QLQ-MY20, were used for HRQoL measurement and were optional in the study. The patients answered the questionnaires at baseline, after 3 and 9 induction cycles and after 6 and 12 months of maintenance. Changes in HRQoL score over time during treatment and between groups were evaluated according to previously published levels of minimal important difference. Results: 613 of the total of 637 randomized patients chose to participate in the HRQoL reporting, and the baseline questionnaire was available from 553 patients (90.2%). Patient drop-out during follow-up was due to progressive disease, toxicity, death and other, and reduced the number of patients completing the therapy to 42 (15%) patients in the MPT-T and 93 (33%) in the MPR-R group. Both groups reported clinically meaningful improvement in global quality of life (QoL), physical functioning, pain, disease symptoms and insomnia. In the evaluation of difference between groups, the patients receiving MPR-R reported increasing diarrhea, better controlled pain at induction phase and increased global QoL and physical functioning during maintenance phase compared to MPT-T. The patients receiving MPT-T reported increasing constipation, better controlled pain during maintenance phase, better controlled fatigue during induction treatment and decreased insomnia compared to MPR-R. Conclusions: HRQoL during treatment is important to myeloma patients, especially when treatment efficacy of the treatment regimens is comparable. MPR-R and MPT-T both demonstrated improvements in global QoL, physical functioning and pain. Fatigue and insomnia were better controlled in the MPT-T group, which can be attributed to the thalidomide side effect of sleepiness. For interpretation of the HRQoL results patient drop-out rate must be taken in account, and we will recommend a HRQoL study design with high focus on data completeness and registration of reasons for missing data. (Figure Presented).

AB - Aims: The aim is to evaluate the health-related quality of life (HRQoL) results of HOVON87/NMSG18 study (Zweegman et al., Blood 2016;127(9):1109-1116). Non-transplant eligible, newly diagnosed multiple myeloma patients were randomized between melphalan/prednisolone plus either thalidomide or lenalidomide for nine induction cycles, followed by thalidomide or lenalidomide maintenance (MPT-T or MRP-R). The study showed comparable efficacy of treatment. Methods: The validated instruments, EORTC QLQ-C30 and EORTC QLQ-MY20, were used for HRQoL measurement and were optional in the study. The patients answered the questionnaires at baseline, after 3 and 9 induction cycles and after 6 and 12 months of maintenance. Changes in HRQoL score over time during treatment and between groups were evaluated according to previously published levels of minimal important difference. Results: 613 of the total of 637 randomized patients chose to participate in the HRQoL reporting, and the baseline questionnaire was available from 553 patients (90.2%). Patient drop-out during follow-up was due to progressive disease, toxicity, death and other, and reduced the number of patients completing the therapy to 42 (15%) patients in the MPT-T and 93 (33%) in the MPR-R group. Both groups reported clinically meaningful improvement in global quality of life (QoL), physical functioning, pain, disease symptoms and insomnia. In the evaluation of difference between groups, the patients receiving MPR-R reported increasing diarrhea, better controlled pain at induction phase and increased global QoL and physical functioning during maintenance phase compared to MPT-T. The patients receiving MPT-T reported increasing constipation, better controlled pain during maintenance phase, better controlled fatigue during induction treatment and decreased insomnia compared to MPR-R. Conclusions: HRQoL during treatment is important to myeloma patients, especially when treatment efficacy of the treatment regimens is comparable. MPR-R and MPT-T both demonstrated improvements in global QoL, physical functioning and pain. Fatigue and insomnia were better controlled in the MPT-T group, which can be attributed to the thalidomide side effect of sleepiness. For interpretation of the HRQoL results patient drop-out rate must be taken in account, and we will recommend a HRQoL study design with high focus on data completeness and registration of reasons for missing data. (Figure Presented).

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DO - 10.1007/s11136-017-1658-6

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T3 - Quality of life research. Conference: 24th annual conference of the international society for quality of life research, ISOQOL 2017. United states

BT - Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study

ER -

Nielsen L, Stege C, Witte B, Holt B, Mellqvist U-H, Salomo M et al. Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study. 2017. 2 p. (Quality of life research. Conference: 24th annual conference of the international society for quality of life research, ISOQOL 2017. United states). https://doi.org/10.1007/s11136-017-1658-6