Efficacy and Tolerability of High- versus Low-dose Lenalidomide Maintenance Therapy of Multiple Myeloma after Autologous Blood Stem Cell Transplantation.
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Consolidation Chemotherapy
Disease-Free Survival
Dose-Response Relationship, Drug
Female
Hematopoietic Stem Cell Transplantation
/ adverse effects
Humans
Lenalidomide
/ administration & dosage
Male
Maximum Tolerated Dose
Middle Aged
Multiple Myeloma
/ drug therapy
Peripheral Blood Stem Cell Transplantation
/ adverse effects
Progression-Free Survival
Quality of Life
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
15 11 2020
15 11 2020
Historique:
received:
04
03
2020
revised:
28
05
2020
accepted:
14
08
2020
pubmed:
21
8
2020
medline:
23
11
2021
entrez:
21
8
2020
Statut:
ppublish
Résumé
For multiple myeloma, high-dose chemotherapy and autologous blood stem-cell transplantation (ASCT) followed by lenalidomide maintenance (LenMT) at 10-15 mg/day is considered standard of care. However, dose reductions due to side effects are common and median LenMT doses achieved over time may remain lower. Dose response during LenMT has never been investigated. In a multicenter, randomized, open-label trial, patients with multiple myeloma after ASCT and high-dose lenalidomide consolidation therapy (CT) at 25 mg/day were randomized to receive LenMT at either 25 or 5 mg/day. Primary endpoint was progression-free survival (PFS). Ninety-four patients (median age, 58 years) were randomized to either arm, with 22% having International Staging System (ISS) stage 3 and 22% being in complete remission (CR). After median follow-up of 46.7 months, median doses of 14.5 and 5 mg/day were achieved in the two arms; 53% of dose reductions occurring during CT. In the high- and the low-dose arm, median PFS was 44.8 and 33.0 months (HR, 0.65; 95% CI, 0.44-0.97; LenMT dose correlated with efficacy and toxicity. High rates of dose reductions during CT argue against a high starting dose. However, continuous up- and down-titration for each patient to the current maximum tolerated dose is prudent.
Identifiants
pubmed: 32817078
pii: 1078-0432.CCR-20-0841
doi: 10.1158/1078-0432.CCR-20-0841
doi:
Substances chimiques
Lenalidomide
F0P408N6V4
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
5879-5886Informations de copyright
©2020 American Association for Cancer Research.
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