Τίτλος:
Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Objectives: Health-related quality of life (HRQoL) is particularly important during maintenance therapy (MT) in newly diagnosed multiple myeloma post-transplant, when disease symptoms are limited. Methods: We assessed HRQoL in patients randomised to 26 cycles of MT (ixazomib vs placebo) in TOURMALINE-MM3 (NCT02181413). Results: The characteristics at study entry were well-balanced between ixazomib (n = 386) and placebo (n = 251) arms. At study entry, EORTC QLQ-C30 and MY20 scores were high for functional scales and low for symptom scales and were comparable with those of the general population. Changes in subscale scores across intervals, analysed over 30 four-week intervals using a linear mixed-effects model, were generally small and similar between arms for the EORTC QLQ-C30 Global Health Status/QoL, Physical Functioning, and Pain subscales and EORTC QLQ-MY20 Disease Symptoms subscale and Peripheral Neuropathy item. EORTC QLQ-C30 Nausea/Vomiting and Diarrhoea subscales were consistently worse for ixazomib than for placebo, in line with the ixazomib toxicity profile. Even when least-squares mean differences between arms were statistically significant, none reached the established minimal important clinical difference of 10 in multiple myeloma. Conclusions: In addition to improvement in progression-free survival with ixazomib, HRQoL was maintained in both arms. Active treatment with ixazomib did not have an adverse impact on HRQoL. © 2019 Takeda Pharmaceuticals. European Journal of Haematology published by John Wiley & Sons Ltd
Συγγραφείς:
Schjesvold, F.
Goldschmidt, H.
Maisnar, V.
Spicka, I.
Abildgaard, N.
Rowlings, P.
Cain, L.
Romanus, D.
Suryanarayan, K.
Rajkumar, V.
Odom, D.
Gnanasakthy, A.
Dimopoulos, M.
Περιοδικό:
European Journal of Haematology
Εκδότης:
Wiley-Blackwell Publishing Ltd
Λέξεις-κλειδιά:
immunomodulating agent; ixazomib; melphalan; placebo; proteasome inhibitor; antineoplastic agent; boron derivative; glycine; ixazomib, adult; Article; autologous stem cell transplantation; cancer patient; cognition; constipation; controlled study; diarrhea; drug megadose; drug safety; dyspnea; emotionality; EORTC QLQ MY20; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; fatigue; female; Global Health Status; human; insomnia; loss of appetite; maintenance therapy; major clinical study; male; multiple cycle treatment; multiple myeloma; nausea and vomiting; pain; patient-reported outcome; peripheral neuropathy; physical capacity; priority journal; progression free survival; quality of life; quality of life assessment; randomized controlled trial; social interaction; transplantation conditioning; treatment withdrawal; aged; clinical trial; hematopoietic stem cell transplantation; maintenance chemotherapy; medication compliance; middle aged; mortality; multimodality cancer therapy; multiple myeloma; phase 3 clinical trial; treatment outcome, Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Boron Compounds; Combined Modality Therapy; Female; Glycine; Hematopoietic Stem Cell Transplantation; Humans; Maintenance Chemotherapy; Male; Medication Adherence; Middle Aged; Multiple Myeloma; Patient Reported Outcome Measures; Quality of Life; Treatment Outcome
