TY - JOUR
T1 - Daratumumab plus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma
T2 - frailty subgroup analysis of MAIA
AU - Facon, Thierry
AU - Cook, Gordon
AU - Usmani, Saad Z.
AU - Hulin, Cyrille
AU - Kumar, Shaji
AU - Plesner, Torben
AU - Touzeau, Cyrille
AU - Bahlis, Nizar J.
AU - Basu, Supratik
AU - Nahi, Hareth
AU - Goldschmidt, Hartmut
AU - Quach, Hang
AU - Mohty, Mohamad
AU - Venner, Christopher P.
AU - Weisel, Katja
AU - Raje, Noopur
AU - Hebraud, Benjamin
AU - Belhadj-Merzoug, Karim
AU - Benboubker, Lotfi
AU - Decaux, Olivier
AU - Manier, Salomon
AU - Caillot, Denis
AU - Ukropec, Jon
AU - Pei, Huiling
AU - Van Rampelbergh, Rian
AU - Uhlar, Clarissa M.
AU - Kobos, Rachel
AU - Zweegman, Sonja
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2022/4
Y1 - 2022/4
N2 - In the phase 3 MAIA study of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM), daratumumab plus lenalidomide/dexamethasone (D-Rd) improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd). We present a subgroup analysis of MAIA by frailty status. Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit, intermediate, non-frail (fit + intermediate), or frail. Of the randomized patients (D-Rd, n = 368; Rd, n = 369), 396 patients were non-frail (D-Rd, 196 [53.3%]; Rd, 200 [54.2%]) and 341 patients were frail (172 [46.7%]; 169 [45.8%]). After a 36.4-month median follow-up, non-frail patients had longer PFS than frail patients, but the PFS benefit of D-Rd versus Rd was maintained across subgroups: non-frail (median, not reached [NR] vs 41.7 months; hazard ratio [HR], 0.48; P < 0.0001) and frail (NR vs 30.4 months; HR, 0.62; P = 0.003). Improved rates of complete response or better and minimal residual disease (10–5) negativity were observed for D-Rd across subgroups. The most common grade 3/4 treatment-emergent adverse event in non-frail and frail patients was neutropenia (non-frail, 45.4% [D-Rd] and 37.2% [Rd]; frail, 57.7% and 33.1%). These findings support the clinical benefit of D-Rd in transplant-ineligible NDMM patients enrolled in MAIA, regardless of frailty status.
AB - In the phase 3 MAIA study of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM), daratumumab plus lenalidomide/dexamethasone (D-Rd) improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd). We present a subgroup analysis of MAIA by frailty status. Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit, intermediate, non-frail (fit + intermediate), or frail. Of the randomized patients (D-Rd, n = 368; Rd, n = 369), 396 patients were non-frail (D-Rd, 196 [53.3%]; Rd, 200 [54.2%]) and 341 patients were frail (172 [46.7%]; 169 [45.8%]). After a 36.4-month median follow-up, non-frail patients had longer PFS than frail patients, but the PFS benefit of D-Rd versus Rd was maintained across subgroups: non-frail (median, not reached [NR] vs 41.7 months; hazard ratio [HR], 0.48; P < 0.0001) and frail (NR vs 30.4 months; HR, 0.62; P = 0.003). Improved rates of complete response or better and minimal residual disease (10–5) negativity were observed for D-Rd across subgroups. The most common grade 3/4 treatment-emergent adverse event in non-frail and frail patients was neutropenia (non-frail, 45.4% [D-Rd] and 37.2% [Rd]; frail, 57.7% and 33.1%). These findings support the clinical benefit of D-Rd in transplant-ineligible NDMM patients enrolled in MAIA, regardless of frailty status.
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U2 - 10.1038/s41375-021-01488-8
DO - 10.1038/s41375-021-01488-8
M3 - Article
C2 - 34974527
AN - SCOPUS:85122085157
SN - 0887-6924
VL - 36
SP - 1066
EP - 1077
JO - Leukemia
JF - Leukemia
IS - 4
ER -