EHA Library - The official digital education library of European Hematology Association (EHA)

QUALITY OF LIFE WITH MELPHALAN/PREDNISONE PLUS EITHER THALIDOMIDE (MPT-T) OR LENALIDOMIDE (MPR-R) IN NON-TRANSPLANT ELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA; RESULTS OF THE HOVON87/NMSG18 STUDY
Author(s): ,
Claudia Stege
Affiliations:
Department of Hematology,VU University Medical Center,Amsterdam,Netherlands
,
Lene Kongsgaard Nielsen
Affiliations:
Quality of life Research Center,Odense University Hospital,Odense,Denmark
,
Birgit Witte
Affiliations:
Department of Epidemiology and Biostatistics,VU University Medical Center,Amsterdam,Netherlands
,
Bronno van der Holt
Affiliations:
HOVON Data Center,Erasmus MCCancer Institute,Rotterdam,Netherlands
,
Ulf-Henrik Mellqvist
Affiliations:
Section of Hematology and Coagulation, Department of Medicine,Sahlgrenska University Hospital,Gotheborg,Sweden
,
Morten Salomo
Affiliations:
Department of Hematology,Rigshospitalet,Copenhagen,Denmark
,
Gerard Bos
Affiliations:
Department of Hematology,Maastricht University Medical Center,Maastricht,Netherlands
,
Mark-David Levin
Affiliations:
Department of Internal Medicine,Albert Schweitzer Hospital,Dordrecht,Netherlands
,
Heleen Visser-Wisselaar
Affiliations:
HOVON Data Center,Erasmus MCCancer Institute,Rotterdam,Netherlands
,
Markus Hansson
Affiliations:
Division of Hematology and Transfusion Medicine,Skane University Hospital,Lund,Sweden
,
Annette van der Velden
Affiliations:
Department of Internal Medicine,Martini Ziekenhuis,Groningen,Netherlands
,
Wendy Deenik
Affiliations:
Department of Internal Medicine,Tergooi Ziekenhuizen,Blaricum,Netherlands
,
Astrid Gruber
Affiliations:
Center of Hematology,Karolinska Institute,Stockholm,Sweden
,
Juleon Coenen
Affiliations:
Department of Internal Medicine,Isala,Zwolle,Netherlands
,
Torben Plesner
Affiliations:
Department of Hematology,Vejle Hopital,Vejle,Denmark
,
Saskia Klein
Affiliations:
Department of Internal Medicine,Meander Medisch Centrum,Amersfoort,Netherlands
,
Bea Tanis
Affiliations:
Department of Internal Medicine,GroeneHart Ziekenhuis,Gouda,Netherlands
,
Damian Szatkowski
Affiliations:
Department of Oncology, Hematology and Palliative Care,Førde Central Hospital,Førde,Norway
,
Rolf Brouwer
Affiliations:
Department of Internal Medicine,Reinier de Graaf Ziekenhuis,Delft,Netherlands
,
Matthijs Westerman
Affiliations:
Department of Internal Medicine,Medisch Centrum Alkmaar,Alkmaar,Netherlands
,
Rineke Leys
Affiliations:
Department of Internal Medicine,Maasstad Ziekenhuis,Rotterdam,Netherlands
,
Harm Sinnige
Affiliations:
Department of Internal Medicine,Jeroen Bosch Ziekenhuis,Den Bosch,Netherlands
,
Einar Hauk°as
Affiliations:
Department of Hematology,Stavanger University Hospital,Stavanger,Norway
,
Klaas van der Hem
Affiliations:
Department of Internal Medicine,Zaans Medisch Centrum,Zaandam,Netherlands
,
Marc Durian
Affiliations:
Department of Internal Medicine,Tweesteden Ziekenhuis,Tilburg,Netherlands
,
Vera Mattijssen
Affiliations:
Department of Internal Medicine,Rijnstate Ziekenhuis,Arnhem,Netherlands
,
Peter Gimsing
Affiliations:
Department of Hematology,Rigshospitalet,Copenhagen,Denmark
,
Niels van de Donk
Affiliations:
Department of Hematology,VU medical center,Amsterdam,Netherlands
,
Marian Stevens-Kroef
Affiliations:
Department of Genetics,Radboud University,Nijmegen,Netherlands
,
Pieter Sonneveld
Affiliations:
Department of Hematology,Erasmus Medical Center Cancer Center,Rotterdam,Netherlands
,
Anders Waage
Affiliations:
Department of Hematology,St Olavs Hospital and Norwegian University of Science and Technology and KG Jebsen Myeloma Research Center,Trondheim,Norway
,
Sonja Zweegman
Affiliations:
Department of Hematology,VU University Medical Center,Amsterdam,Netherlands
Niels Abildgaard
Affiliations:
Quality of life Research Center,Odense University Hospital,Odense,Denmark
(Abstract release date: 05/18/17) EHA Library. Stege C. 06/24/17; 181788; S501
Claudia Stege
Claudia Stege
Contributions
Abstract

Abstract: S501

Type: Oral Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 16:00 - 16:15

Location: Room N109

Background
We recently reported the results of the phase III randomized HOVON87/NMSG18 study showing comparable efficacy of treatment with melphalan, prednisolone and thalidomide following by thalidomide maintenance (MPT-T) versus melphalan, prednisolone and lenalidomide followed by lenalidomide maintenance (MPR-R) (Zweegman S et al. Blood 2016;127(9):1109-1116). As not only efficacy but also potential toxicity affecting quality of life (QoL) guides the choice of treatment, health-related (HR) QoL is important.

Aims

To evaluate the HRQoL results of the HOVON87/NMSG18 study.

Methods

Two validated HRQoL instruments (EORTC QLQ-C30 and MY20) were obtained at baseline, after 3 and 9 induction cycles (3ID and 9ID) and after 6 and 12 months of maintenance therapy (6MT and 12MT). The subscales global QoL, physical functioning, pain, fatigue, constipation, diarrhea, nausea/vomiting, insomnia, disease symptoms, side effects of treatment and neuropathy were analysed. Change in HRQoL score over time between treatment arms was assessed by linear mixed models. Independent sample t-tests were used to determine changes from baseline. Minimal important difference (MID) within arms was defined as a difference in score of ≥1 standard error of measurement (SEM) or, if a subscale consisted of one parameter only, MID-levels described in previous literature were used. To determine clinically relevant superiority of one arm, a difference in score of ≥5 was used and in addition significance level was calculated.

Results

From 553 (90.2%) of the 613 patients who participated in the HRQoL part of the study a baseline questionnaire was available. Forty (15%) of patients randomized to MPT-T versus 68 (24%) of patients randomized to MPR-R completed therapy until 12 months of maintenance therapy.
Change in HRQoL between arms over time: in MPT-T improvement of HRQoL over time as compared to MPR-R was found for the subscales diarrhea and insomnia. In contrast, MPR-R showed improvement over time for the subscales pain, constipation, side effects of treatment and neuropathy, as compared to MPT-T.
Change in HRQoL per arm: In MPT-T MID was reached for the following subscales; global QoL increased after 9ID until 12MT (MID range 7-13), pain decreased at every time point (MID range -21 to -23), disease symptoms deceased after 9ID (MID -12), fatigue decreased during MT (MID 12) and insomnia decreased at each time point (MID range -11 to -21). In MPR-R the MID was reached for the following subscales; global QoL increased after 9ID until 12MT (MID range 8-14), physical functioning increased at 12MT (MID 13), pain decreased at every time point (MID range -14 to -26) and insomnia decreased at 6MT (MID -10).
Difference between MPT-T and MPR-R:
In the MPT-T arm significantly (p<0.05) and/or clinically (mean score difference (MSD) ≥5 points) less pain and disease symptoms at 3ID, less fatigue at 3ID and 9ID, less diarrhea and less insomnia at all time points were observed. In contrast, patients on MPR-R reported better global QoL, better physical functioning and less pain at 12MT, in general less side effects of treatment, and less constipation and neuropathy separately, at all time points than patients treated with MPT-T.

Conclusion

Both treatment with MPT-T and MPR-R controlled pain and resulted in an improvement in global QoL as compared to baseline after 9ID and during maintenance. Treatment with thalidomide initially resulted in less pain and disease symptoms. At all treatment stages thalidomide caused less diarrhea, fatigue and insomnia as compared to treatment with lenalidomide. In contrast, therapy with lenalidomide resulted in less side effects of treatment, less constipation and less neuropathy as compared to thalidomide at all stages of treatment. In addition, long term maintenance therapy with lenalidomide resulted in better global QoL, better physical functioning and less pain.

Session topic: 35. Quality of life, palliative care, ethics and health economics

Keyword(s): Thalidomide, Quality of Life, Multiple Myeloma

Abstract: S501

Type: Oral Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 16:00 - 16:15

Location: Room N109

Background
We recently reported the results of the phase III randomized HOVON87/NMSG18 study showing comparable efficacy of treatment with melphalan, prednisolone and thalidomide following by thalidomide maintenance (MPT-T) versus melphalan, prednisolone and lenalidomide followed by lenalidomide maintenance (MPR-R) (Zweegman S et al. Blood 2016;127(9):1109-1116). As not only efficacy but also potential toxicity affecting quality of life (QoL) guides the choice of treatment, health-related (HR) QoL is important.

Aims

To evaluate the HRQoL results of the HOVON87/NMSG18 study.

Methods

Two validated HRQoL instruments (EORTC QLQ-C30 and MY20) were obtained at baseline, after 3 and 9 induction cycles (3ID and 9ID) and after 6 and 12 months of maintenance therapy (6MT and 12MT). The subscales global QoL, physical functioning, pain, fatigue, constipation, diarrhea, nausea/vomiting, insomnia, disease symptoms, side effects of treatment and neuropathy were analysed. Change in HRQoL score over time between treatment arms was assessed by linear mixed models. Independent sample t-tests were used to determine changes from baseline. Minimal important difference (MID) within arms was defined as a difference in score of ≥1 standard error of measurement (SEM) or, if a subscale consisted of one parameter only, MID-levels described in previous literature were used. To determine clinically relevant superiority of one arm, a difference in score of ≥5 was used and in addition significance level was calculated.

Results

From 553 (90.2%) of the 613 patients who participated in the HRQoL part of the study a baseline questionnaire was available. Forty (15%) of patients randomized to MPT-T versus 68 (24%) of patients randomized to MPR-R completed therapy until 12 months of maintenance therapy.
Change in HRQoL between arms over time: in MPT-T improvement of HRQoL over time as compared to MPR-R was found for the subscales diarrhea and insomnia. In contrast, MPR-R showed improvement over time for the subscales pain, constipation, side effects of treatment and neuropathy, as compared to MPT-T.
Change in HRQoL per arm: In MPT-T MID was reached for the following subscales; global QoL increased after 9ID until 12MT (MID range 7-13), pain decreased at every time point (MID range -21 to -23), disease symptoms deceased after 9ID (MID -12), fatigue decreased during MT (MID 12) and insomnia decreased at each time point (MID range -11 to -21). In MPR-R the MID was reached for the following subscales; global QoL increased after 9ID until 12MT (MID range 8-14), physical functioning increased at 12MT (MID 13), pain decreased at every time point (MID range -14 to -26) and insomnia decreased at 6MT (MID -10).
Difference between MPT-T and MPR-R:
In the MPT-T arm significantly (p<0.05) and/or clinically (mean score difference (MSD) ≥5 points) less pain and disease symptoms at 3ID, less fatigue at 3ID and 9ID, less diarrhea and less insomnia at all time points were observed. In contrast, patients on MPR-R reported better global QoL, better physical functioning and less pain at 12MT, in general less side effects of treatment, and less constipation and neuropathy separately, at all time points than patients treated with MPT-T.

Conclusion

Both treatment with MPT-T and MPR-R controlled pain and resulted in an improvement in global QoL as compared to baseline after 9ID and during maintenance. Treatment with thalidomide initially resulted in less pain and disease symptoms. At all treatment stages thalidomide caused less diarrhea, fatigue and insomnia as compared to treatment with lenalidomide. In contrast, therapy with lenalidomide resulted in less side effects of treatment, less constipation and less neuropathy as compared to thalidomide at all stages of treatment. In addition, long term maintenance therapy with lenalidomide resulted in better global QoL, better physical functioning and less pain.

Session topic: 35. Quality of life, palliative care, ethics and health economics

Keyword(s): Thalidomide, Quality of Life, Multiple Myeloma

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies