Dataset Information

Adherence to Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma.

ABSTRACT:

Introduction

One of the most common orally administered antimyeloma agents, lenalidomide, has significantly improved outcomes in multiple myeloma, including in older patients. However, despite its utilization and cost, the rates and factors related to adherence to lenalidomide in older adults with newly diagnosed multiple myeloma remain unknown.

Patients and methods

Data were collected from adults with newly diagnosed multiple myeloma over age 65 years being treated with lenalidomide therapy between the years 2007 and 2014 in the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked databases. Adherence was measured as medication possession ratio (MPR), which was defined as the ratio of the number of days the patient had pills in their possession to the number of days in the observation period in the first year after myeloma diagnosis. MPR of < 90% was considered poor adherence.

Results

A total of 793 patients were included in the analysis. The mean MPR in our cohort was 89.5 ± 9.3%. Overall, 38% (n = 302) of the patients were considered to have poor adherence. Factors associated with poor adherence included increasing age (adjusted odds ratio [aOR] = 1.03 per year; 95% confidence interval [CI], 1.00-1.05; P = .024), black race (aOR = 1.72; 95% CI, 1.08-2.73; P = .022), and polypharmacy (aOR = 1.04 per medication; 95% CI, 1.01-1.08; P = .008).

Conclusion

Over a third of older adults with newly diagnosed multiple myeloma were considered to have poor adherence to lenalidomide, using the MPR as a surrogate for adherence. This highlights the need to further understand factors and devise strategies to support adherence in this patient cohort.

SUBMITTER: Mian H

PROVIDER: S-EPMC7564009 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adherence to Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma.

Mian Hira H Fiala Mark M Wildes Tanya M TM

Clinical lymphoma, myeloma & leukemia 20191009 2

<h4>Introduction</h4>One of the most common orally administered antimyeloma agents, lenalidomide, has significantly improved outcomes in multiple myeloma, including in older patients. However, despite its utilization and cost, the rates and factors related to adherence to lenalidomide in older adults with newly diagnosed multiple myeloma remain unknown.<h4>Patients and methods</h4>Data were collected from adults with newly diagnosed multiple myeloma over age 65 years being treated with lenalidom ...[more]

PMID: 31843543

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Project description:ImportanceCarfilzomib-lenalidomide-dexamethasone therapy yields deep responses in patients with newly diagnosed multiple myeloma (NDMM). It is important to gain an understanding of this combination's tolerability and impact on minimal residual disease (MRD) negativity because this end point has been associated with improved survival.ObjectiveTo assess the safety and efficacy of carfilzomib-lenalidomide-dexamethasone therapy in NDMM and high-risk smoldering multiple myeloma (SMM).Design, setting, and participantsClinical and correlative pilot study at the National Institutes of Health Clinical Center. Patients with NDMM or high-risk SMM were enrolled between July 11, 2011, and October 9, 2013. Median follow-up was 17.3 (NDMM) and 15.9 months (SMM).InterventionsEight 28-day cycles were composed of carfilzomib 20/36 mg/m2 on days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on days 1 through 21; and dexamethasone 20/10 mg (cycles 1-4/5-8) on days 1, 2, 8, 9, 15, 16, 22, and 23. Patients who achieved at least stable disease subsequently received 24 cycles of lenalidomide extended dosing.Main outcomes and measuresPrimary end points were neuropathy of grade 3 or greater (NDMM) and at least very good partial response rates (SMM). Minimal residual disease was also assessed.ResultsOf 45 patients with NDMM, none had neuropathy of grade 3 or greater. Of 12 patients with high-risk SMM, the most common of any-grade adverse events were lymphopenia (12 [100%]) and gastrointestinal disorders (11 [92%]). All patients with SMM achieved at least a very good partial response during the study period. Among the 28 patients with NDMM and the 12 with SMM achieving at least a near-complete response, MRD negativity was found in 28 of 28 (100% [95% CI, 88%-100%]), 11 of 12 (92% [95% CI, 62%-100%]) (multiparametric flow cytometry), 14 of 21 (67% [95% CI, 43%-85%]), and 9 of 12 (75% [95% CI, 43%-94%]) (next-generation sequencing), respectively. In patients with NDMM, 12-month progression-free survival for MRD-negative vs MRD-positive status by flow cytometry and next-generation sequencing was 100% vs 79% (95% CI, 47%-94%; P < .001) and 100% vs 95% (95% CI, 75%-99%; P = .02), respectively.Conclusions and relevanceCarfilzomib-lenalidomide-dexamethasone therapy is tolerable and demonstrates high rates of MRD negativity in NDMM, translating into longer progression-free survival in patients achieving MRD negativity. Carfilzomib-lenalidomide-dexamethasone therapy also demonstrates efficacy in high-risk SMM.

Project description:Purpose Lenalidomide maintenance therapy after autologous stem-cell transplantation (ASCT) demonstrated prolonged progression-free survival (PFS) versus placebo or observation in several randomized controlled trials (RCTs) of patients with newly diagnosed multiple myeloma (NDMM). All studies had PFS as the primary end point, and none were powered for overall survival (OS) as a primary end point. Thus, a meta-analysis was conducted to better understand the impact of lenalidomide maintenance in this setting. Patients and Methods The meta-analysis was conducted using primary-source patient-level data and documentation from three RCTs (Cancer and Leukemia Group B 100104, Gruppo Italiano Malattie Ematologiche dell'Adulto RV-MM-PI-209, and Intergroupe Francophone du Myélome 2005-02) that met the following prespecified inclusion criteria: an RCT in patients with NDMM receiving ASCT followed by lenalidomide maintenance versus placebo or observation with patient-level data available and achieved database lock for primary efficacy analysis. Results Overall, 1,208 patients were included in the meta-analysis (605 patients in the lenalidomide maintenance group and 603 in the placebo or observation group). The median PFS was 52.8 months for the lenalidomide group and 23.5 months for the placebo or observation group (hazard ratio, 0.48; 95% CI, 0.41 to 0.55). At a median follow-up time of 79.5 months for all surviving patients, the median OS had not been reached for the lenalidomide maintenance group, whereas it was 86.0 months for the placebo or observation group (hazard ratio, 0.75; 95% CI, 0.63 to 0.90; P = .001). The cumulative incidence rate of a second primary malignancy before disease progression was higher with lenalidomide maintenance versus placebo or observation, whereas the cumulative incidence rates of progression, death, or death as a result of myeloma were all higher with placebo or observation versus lenalidomide maintenance. Conclusion This meta-analysis demonstrates a significant OS benefit and confirms the PFS benefit with lenalidomide maintenance after ASCT in patients with NDMM when compared with placebo or observation.

Dataset Information

Adherence to Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma.

Introduction

Patients and methods

Results

Conclusion

Publications

Adherence to Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma.

Similar Datasets

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