Lenalidomide (Revlimid®) in addition to dexamethasone compared to dexamethasone alone delivers significant gains in survival for patients with multiple myeloma, finds a new statistical methodology presented at the 13th European Hematology Association Meeting (Copenhagen, Denmark , June 12-15). The study is the first in multiple myeloma to apply a new statistical methodology that makes adjustments for the patients who cross over to different treatment arms at the end of trials.
“The study reveals extraordinary gains in survival for the combination arm, particularly bearing in mind that these are relapsed/refractory multiple myeloma patients,” commented Professor Brian Durie (Cedars Sinai Medical Centre, Los Angeles CA). “The advantage of this technique is that it allows you to get a better handle on treatment outcomes without having to wait 5 to 10 years for survival data.”
The analysis stemmed from the phase III randomised controlled studies, MM-009 and MM-010, published in the NEJM, which demonstrated high response rates and durable remissions resulting in the longest median survival in a phase III trial ever seen in relapsed/refractory patients.
In the study 47 % of patients allocated to dexamethasone alone switched to combination treatment following disease progression or unblinding.
In the current study Professor Gareth Morgan and colleagues, from the Institute of Cancer Research (London, UK) used a life time simulation equation to predict what the survival would have been without crossover. The methodology allows comparison of long term survival of lenalidomide plus dexamethasone compared to dexamethasone alone.
Results of the life time simulation yielded an estimated mean survival rate of 5.6 life years with the combination treatment compared to 2.2 life years with dexamethasone alone for patients who had received one prior therapy. For patients who had received multiple prior therapies the estimated mean survival was 4.2 life years for combination treatment, compared to 1.5 life-years for dexamethasone alone.
“This analysis shows that lenalidomide has the potential to more than double the years of survival for patients,” commented Professor Morgan. “This is a milestone in the treatment of multiple myeloma that is helping to turn this critical blood cancer into a chronic manageable disease.”
Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. It is the second most prevalent blood cancer after non-Hodgkin's lymphoma.
Lenalidomide is a derivative of thalidomide which is an immunomodulatory agent that also interferes with angiogenesis.
Abstract 0441: Overall survival with dexamethasone in phase III multiple myeloma trias after adjustment for cross-over to lenalidomide. Gareth Morgan.
(Picture: Wellcome Images)
