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Effect of age and frailty on the efficacy and tolerability of once‐weekly selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma
Author(s) -
Auner Holger W.,
Gavriatopoulou Maria,
Delimpasi Sosana,
Simonova Maryana,
Spicka Ivan,
Pour Ludek,
Dimopoulos Meletios A.,
Kriachok Iryna,
Pylypenko Halyna,
Leleu Xavier,
Doronin Vadim,
Usenko Ganna,
Hajek Roman,
Benjamin Reuben,
Dolai Tuphan Kanti,
Sinha Dinesh Kumar,
Venner Christopher P.,
Garg Mamta,
Stevens Don Ambrose,
Quach Hang,
Jagannath Sundar,
Moreau Phillipe,
Levy Moshe,
Badros Ashraf,
Anderson Larry D.,
Bahlis Nizar J.,
Facon Thierry,
Mateos Maria Victoria,
Cavo Michele,
Chai Yi,
Arazy Melina,
Shah Jatin,
Shacham Sharon,
Kauffman Michael G.,
Richardson Paul G.,
Grosicki Sebastian
Publication year - 2021
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.26172
Subject(s) - medicine , bortezomib , tolerability , dexamethasone , multiple myeloma , incidence (geometry) , post hoc analysis , gastroenterology , surgery , adverse effect , physics , optics
Abstract Elderly and frail patients with multiple myeloma (MM) are more vulnerable to the toxicity of combination therapies, often resulting in treatment modifications and suboptimal outcomes. The phase 3 BOSTON study showed that once‐weekly selinexor and bortezomib with low‐dose dexamethasone (XVd) improved PFS and ORR compared with standard twice‐weekly bortezomib and moderate‐dose dexamethasone (Vd) in patients with previously treated MM. This is a retrospective subgroup analysis of the multicenter, prospective, randomized BOSTON trial. Post hoc analyses were performed to compare XVd versus Vd safety and efficacy according to age and frailty status (<65 and ≥65 years, nonfrail and frail). Patients ≥65 years with XVd had higher ORR (OR 1.77, p = .024), ≥VGPR (OR, 1.68, p = .027), PFS (HR 0.55, p = .002), and improved OS (HR 0.63, p = .030), compared with Vd. In frail patients, XVd was associated with a trend towards better PFS (HR 0.69, p = .08) and OS (HR 0.62, p = .062). Significant improvements were also observed in patients <65 (ORR and TTNT) and nonfrail patients (PFS, ORR, ≥VGPR, and TTNT). Patients treated with XVd had a lower incidence of grade ≥ 2 peripheral neuropathy in ≥65 year‐old (22% vs. 37%; p = .0060) and frail patients (15% vs. 44%; p = .0002). Grade ≥3 TEAEs were not observed more often in older compared to younger patients, nor in frail compared to nonfrail patients. XVd is safe and effective in patients <65 and ≥65 and in nonfrail and frail patients with previously treated MM.