Effect of age and frailty on the efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma.

Adult Age Factors Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols / adverse effects Bortezomib / administration & dosage Clinical Trials, Phase III as Topic / statistics & numerical data Dexamethasone / administration & dosage Drug Administration Schedule Female Frailty / complications Gastrointestinal Diseases / chemically induced Hematologic Diseases / chemically induced Humans Hydrazines / administration & dosage Kaplan-Meier Estimate Male Middle Aged Multicenter Studies as Topic / statistics & numerical data Multiple Myeloma / complications Peripheral Nervous System Diseases / chemically induced Progression-Free Survival Randomized Controlled Trials as Topic / statistics & numerical data Retrospective Studies Severity of Illness Index Triazoles / administration & dosage

Journal

American journal of hematology

ISSN: 1096-8652

Titre abrégé: Am J Hematol

Pays: United States

ID NLM: 7610369

Informations de publication

Date de publication:
01 06 2021

Historique:

revised: 16 03 2021

received: 09 03 2021

accepted: 22 03 2021

pubmed: 24 3 2021

medline: 25 6 2021

entrez: 23 3 2021

Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1002/ajh.26172 PMID: 33755235

pubmed: 33755235

doi: 10.1002/ajh.26172

doi:

Substances chimiques

Hydrazines 0

Triazoles 0

selinexor 31TZ62FO8F

Bortezomib 69G8BD63PP

Dexamethasone 7S5I7G3JQL

Banques de données

ClinicalTrials.gov

['NCT03110562']

Types de publication

Comparative Study Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

708-718

Informations de copyright

Références

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