TY - JOUR
T1 - Health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma
T2 - Findings from the phase III MAIA trial
AU - Perrot, Aurore
AU - Facon, Thierry
AU - Plesner, Torben
AU - Usmani, Saad Z.
AU - Kumar, Shaji
AU - Bahlis, Nizar J.
AU - Hulin, Cyrille
AU - Orlowski, Robert Z.
AU - Nahi, Hareth
AU - Mollee, Peter
AU - Ramasamy, Karthik
AU - Roussel, Murielle
AU - Jaccard, Arnaud
AU - Delforge, Michel
AU - Karlin, Lionel
AU - Arnulf, Bertrand
AU - Chari, Ajai
AU - He, Jianming
AU - Ho, Kai Fai
AU - van Rampelbergh, Rian
AU - Uhlar, Clarissa M.
AU - Wang, Jianping
AU - Kobos, Rachel
AU - Gries, Katharine S.
AU - Fastenau, John
AU - Weisel, Katja
N1 - Publisher Copyright:
© 2021 American Society of Clinical Oncology. All rights reserved.
PY - 2021
Y1 - 2021
N2 - PURPOSE To evaluate the effects of daratumumab, lenalidomide, and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) on patient-reported outcomes (PROs) in the phase III MAIA study. PATIENTS AND METHODS PROs were assessed on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item and the EuroQol 5-dimensional descriptive system at baseline and every 3 months during treatment. By mixed-effects model, changes from baseline are presented as least squares means with 95% CIs. RESULTS A total of 737 transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma were randomly assigned to D-Rd (n 5 368) or Rd (n 5 369). Compliance with PRO assessments was high at baseline (. 90%) through month 12 (. 78%) for both groups. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item global health status scores improved from baseline in both groups and were consistently greater with D-Rd at all time points. A global health status benefit was achieved with D-Rd, regardless of age (, 75 and $ 75 years), baseline Eastern Cooperative Oncology Group (ECOG) performance status score, or depth of response. D-Rd treatment resulted in significantly greater reduction in pain scores as early as cycle 3 (P 5.0007 v Rd); the magnitude of change was sustained through cycle 12. Reductions in pain with D-Rd were clinically meaningful in patients regardless of age, ECOG status, or depth of response. Similarly, PRO improvements were observed with D-Rd and Rd on the EuroQol 5-dimensional descriptive system visual analog scale score. CONCLUSION D-Rd compared with Rd was associated with faster and sustained clinically meaningful improvements in PROs, including pain, in transplant-ineligible patients with newly diagnosed multiple myeloma regardless of age, baseline ECOG status, or depth of treatment response.
AB - PURPOSE To evaluate the effects of daratumumab, lenalidomide, and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) on patient-reported outcomes (PROs) in the phase III MAIA study. PATIENTS AND METHODS PROs were assessed on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item and the EuroQol 5-dimensional descriptive system at baseline and every 3 months during treatment. By mixed-effects model, changes from baseline are presented as least squares means with 95% CIs. RESULTS A total of 737 transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma were randomly assigned to D-Rd (n 5 368) or Rd (n 5 369). Compliance with PRO assessments was high at baseline (. 90%) through month 12 (. 78%) for both groups. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item global health status scores improved from baseline in both groups and were consistently greater with D-Rd at all time points. A global health status benefit was achieved with D-Rd, regardless of age (, 75 and $ 75 years), baseline Eastern Cooperative Oncology Group (ECOG) performance status score, or depth of response. D-Rd treatment resulted in significantly greater reduction in pain scores as early as cycle 3 (P 5.0007 v Rd); the magnitude of change was sustained through cycle 12. Reductions in pain with D-Rd were clinically meaningful in patients regardless of age, ECOG status, or depth of response. Similarly, PRO improvements were observed with D-Rd and Rd on the EuroQol 5-dimensional descriptive system visual analog scale score. CONCLUSION D-Rd compared with Rd was associated with faster and sustained clinically meaningful improvements in PROs, including pain, in transplant-ineligible patients with newly diagnosed multiple myeloma regardless of age, baseline ECOG status, or depth of treatment response.
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U2 - 10.1200/JCO.20.01370
DO - 10.1200/JCO.20.01370
M3 - Article
C2 - 33326255
AN - SCOPUS:85100125176
SN - 0732-183X
VL - 39
SP - 227
EP - 237
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 3
ER -