Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial.
Aged
Antibodies, Monoclonal
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Bortezomib
/ administration & dosage
Disease Progression
Drug Administration Schedule
Female
Humans
Male
Melphalan
/ administration & dosage
Middle Aged
Multiple Myeloma
/ complications
Patient Reported Outcome Measures
Prednisone
/ administration & dosage
Quality of Life
Treatment Outcome
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
02 Jun 2021
02 Jun 2021
Historique:
received:
29
09
2020
accepted:
09
05
2021
entrez:
3
6
2021
pubmed:
4
6
2021
medline:
21
10
2021
Statut:
epublish
Résumé
In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) from ALCYONE. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire were administered at baseline, every 3 months (year 1) and every 6 months (until progression). Treatment effects were assessed using a repeated-measures, mixed-effects model. Compliance with PRO assessments was comparable at baseline (> 90%) and throughout study (> 76%) for both treatment groups. Improvements from baseline were observed in both groups for EORTC QLQ-C30 Global Health Status (GHS), most functional scales, symptom scales and EQ-5D-5L visual analog scale (VAS). Between-group differences were significant for GHS (p = 0.0240) and VAS (p = 0.0160) at month 3. Improvements in pain were clinically meaningful in both groups at all assessment time points. Cognitive function declined in both groups, but the magnitude of the decline was not clinically meaningful. Patients with transplant-ineligible NDMM demonstrated early and continuous improvements in health-related quality of life, including improvements in functioning and symptoms, following treatment with D-VMP or VMP. ClinicalTrials.gov identifier NCT02195479 , registered September 21, 2014.
Sections du résumé
BACKGROUND
BACKGROUND
In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) from ALCYONE.
METHODS
METHODS
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire were administered at baseline, every 3 months (year 1) and every 6 months (until progression). Treatment effects were assessed using a repeated-measures, mixed-effects model.
RESULTS
RESULTS
Compliance with PRO assessments was comparable at baseline (> 90%) and throughout study (> 76%) for both treatment groups. Improvements from baseline were observed in both groups for EORTC QLQ-C30 Global Health Status (GHS), most functional scales, symptom scales and EQ-5D-5L visual analog scale (VAS). Between-group differences were significant for GHS (p = 0.0240) and VAS (p = 0.0160) at month 3. Improvements in pain were clinically meaningful in both groups at all assessment time points. Cognitive function declined in both groups, but the magnitude of the decline was not clinically meaningful.
CONCLUSIONS
CONCLUSIONS
Patients with transplant-ineligible NDMM demonstrated early and continuous improvements in health-related quality of life, including improvements in functioning and symptoms, following treatment with D-VMP or VMP.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov identifier NCT02195479 , registered September 21, 2014.
Identifiants
pubmed: 34078314
doi: 10.1186/s12885-021-08325-2
pii: 10.1186/s12885-021-08325-2
pmc: PMC8170980
doi:
Substances chimiques
Antibodies, Monoclonal
0
daratumumab
4Z63YK6E0E
Bortezomib
69G8BD63PP
Melphalan
Q41OR9510P
Prednisone
VB0R961HZT
Banques de données
ClinicalTrials.gov
['NCT02195479']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
659Références
Eur J Haematol. 2011 Oct;87(4):330-7
pubmed: 21668504
Br J Haematol. 2016 Aug;174(3):368-81
pubmed: 27265837
N Engl J Med. 2018 Feb 8;378(6):518-528
pubmed: 29231133
Eur J Cancer. 2001 Jul;37(11):1345-51
pubmed: 11435063
Eur J Cancer. 2019 Jan;107:153-163
pubmed: 30576971
Support Care Cancer. 2014 Feb;22(2):417-26
pubmed: 24122403
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Haematologica. 2015 Jun;100(6):826-33
pubmed: 25769541
Ann Oncol. 2017 Jul 1;28(suppl_4):iv52-iv61
pubmed: 28453614
Clin Adv Hematol Oncol. 2018 Aug;16(8):564-574
pubmed: 30148829
CA Cancer J Clin. 2018 Nov;68(6):394-424
pubmed: 30207593
Health Qual Life Outcomes. 2007 Dec 21;5:70
pubmed: 18154669
Haematologica. 2015 Oct;100(10):1254-66
pubmed: 26432383
Support Care Cancer. 2015 Sep;23(9):2789-97
pubmed: 25708126
J Clin Oncol. 2011 Jan 1;29(1):89-96
pubmed: 21098316
Eur J Haematol. 2017 Jul;99(1):3-17
pubmed: 28322018
Br J Haematol. 2001 Jun;113(4):1020-34
pubmed: 11442498
Blood. 2015 May 14;125(20):3076-84
pubmed: 25838345
Blood Cancer J. 2019 Mar 18;9(4):36
pubmed: 30886139
Cancer Nurs. 2011 May-Jun;34(3):219-27
pubmed: 21522061
Eur J Haematol. 2016 Nov;97(5):416-429
pubmed: 27528496
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
PLoS One. 2020 Feb 21;15(2):e0229469
pubmed: 32084254
Leuk Lymphoma. 2014 Jul;55(7):1489-97
pubmed: 24144308
Eur J Haematol. 2012 Jul;89(1):16-27
pubmed: 22469559
Expert Rev Pharmacoecon Outcomes Res. 2011 Apr;11(2):171-84
pubmed: 21476819
Eur J Cancer. 2008 Sep;44(13):1793-8
pubmed: 18599286
Eur J Cancer. 2012 Jul;48(11):1713-21
pubmed: 22418017
Br J Haematol. 1996 Mar;92(3):604-13
pubmed: 8616024
Lancet. 2020 Jan 11;395(10218):132-141
pubmed: 31836199
Eur J Haematol. 2012 Dec;89(6):437-57
pubmed: 22985406
Biomed Res Int. 2018 Oct 25;2018:6416378
pubmed: 30498759