This article is more than 5 years old. Information may no longer be current.
Lenalidomide extends myeloma survival after stem cell transplantation
Click Here to Manage Email Alerts
Maintenance therapy with lenalidomide following autologous hematopoietic stem cell transplantation reduced mortality rates by 25% compared with placebo or observation among patients with newly diagnosed multiple myeloma, according to results of a meta-analysis.
“With new, highly active, triplet induction, as well as ongoing studies evaluating the optimal timing of autologous stem cell transplantation, the use of lenalidomide [Revlimid, Celgene] maintenance for transplantation-eligible patients can be considered a standard of care,” Philip L. McCarthy, MD, director of the Blood and Marrow Transplant Center at Roswell Park Cancer Institute, and colleagues wrote.
Previous studies demonstrated improved PFS with lenalidomide maintenance over placebo or observation after treatment with high-dose melphalan and autologous HSCT. However, these studies were not powered to show an improvement in OS, and some patients developed second primary malignances.
To better understand the effect of lenalidomide maintenance in this patient population — following a request from the FDA — McCarthy and colleagues analyzed patient-level data from three randomized clinical trials from the United States (CALGB 100104), France (IFM 05-2) and Italy (GIMEMA RV-MM-PI-209). The studies included patients with newly diagnosed multiple myeloma (median age, 58 years) who received autologous HSCT and underwent lenalidomide maintenance (n = 1,208), or placebo or observation (n = 603).
OS served as the primary endpoint. Additional analyses measured PFS and safety parameters.
Median follow-up was 79.5 months (range, 0-114.3) for surviving patients.
Patients treated with lenalidomide demonstrated improved PFS compared with those who received placebo or observation (52.8 months vs. 23.5 months; HR = 0.48; 95% CI, 0.41-0.55).
A total of 490 patients died. Median OS was not reached among patients in the lenalidomide group and was 86 months in the placebo or observation group (HR = 0.75; 95% CI, 0.63-0.9), indicating a significant OS benefit.
Researchers also observed higher 7-year OS rates in the lenalidomide group (62% vs. 50%).
A greater proportion of patients in the lenalidomide group experienced a hematologic second primary malignancy (before progression, 5.3% vs. 0.8%; before and after progression, 6.1% vs. 2.8%) and solid tumor second primary malignancy (before progression, 5.8% vs. 2%; before and after progression, 7.3% vs. 4.2%).
However, the cumulative incidence rates of progression, mortality or mortality as a result of myeloma all were greater in the placebo or observation group.
The researchers noted the costs of maintenance therapy should be considered when determining this as an option for patients.
“Understanding the role of minimal residual disease detection and immune reconstitution after autologous HSCT, we well as developing early endpoints as surrogates for long-term outcomes, should allow us to develop clinical strategies to further improve OS,” the researchers wrote. – by Melinda Stevens
Disclosures: McCarthy reports he receives honoraria from The Binding Site, Bristol-Myers Squibb, Celgene, Karyopharm Therapeutics, Sanofi and Takeda; research funding to his institution from Celgene; and is a consultant/adviser for Bristol-Myers Squibb, Celgene, Janssen, Karyopharm Therapeutics and Sanofi. Please see the full study for a list of all other researchers’ relevant financial disclosures.
Click Here to Manage Email Alerts