In continuation of my update on lenalidomide...
Data from the first large U.S. study assessing the effectiveness of
long-term "maintenance" therapy with lenalidomide for patients with
multiple myeloma show that the drug significantly improves the time to
progression and overall survival for patients with this often-deadly
hematologic cancer.
Among 460 patients aged 18 to 70 (median age 59), 321 were randomly
assigned to the lenalidomide arm, and 229 to the placebo group. All
participants had received prior autologous hematopoietic stem-cell
transplantation and had stable (non-progressing) disease. The
participants' assignments and responses to date were unblinded in
December 2009 when the primary endpoint of the study (time to disease
progression) showed a statistically significant difference between the
two study groups. After January 2010, 86 of 128 eligible patients
crossed over from the placebo arm to the active arm.
The researchers found that the therapy extended the time to disease
progression by 19 months overall, even with the majority of placebo
patients without progression crossing over to lenalidomide. The
treatment was fairly well-tolerated particularly as compared to other
treatments for multiple myeloma, such as thalidomide. There was more
hematologic toxicity, particularly neutropenia, in the lenalidomide
group. When the study data was analyzed again in October 2011, at a
median follow-up of 34 months, 37% of participants receiving
lenalidomide had disease progression or had died, compared to 58% of
those in the placebo group.
"These findings fill a gap that existed previously in terms of data on whether maintenance therapy with lenalidomide prolongs the time to disease progression after initial therapy. We now have evidence that it does, in this and the two other lenalidomide studies that are presented in this issue of the Journal," said Dr. McCarthy. "This shows that patients with multiple myeloma now have options for prolonging the response to initial therapy. The next steps will be trying to improve on these responses by adding new agents that may prove even more effective in combination with lenalidomide following transplant."
