Περίληψη:
BackgroundIn 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.MethodsThe 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 3months (year 1) and every 6months
(until progression). Treatment effects were assessed using a
repeated-measures, mixed-effects model.ResultsCompliance 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.ConclusionsPatients 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
registrationClinicalTrials.gov identifier NCT02195479, registered
September 21, 2014
Συγγραφείς:
Knop, Stefan
Mateos, Maria-Victoria
Dimopoulos, Meletios A. and
Suzuki, Kenshi
Jakubowiak, Andrzej
Doyen, Chantal
Lucio,
Paulo
Nagy, Zsolt
Usenko, Ganna
Pour, Ludek
Cook, Mark
and Grosicki, Sebastian
Crepaldi, Andre
Liberati, Anna Marina
and Campbell, Philip
Shelekhova, Tatiana
Yoon, Sung-Soo and
Losava, Genadi
Fujisaki, Tomoaki
Garg, Mamta
Wang, Jianping
and Wroblewski, Susan
Kudva, Anupa
Gries, Katharine S. and
Fastenau, John
San-Miguel, Jesus
Cavo, Michele
