NEW YORK (Reuters Health) - Adding the drug lenalidomide, a less-toxic relative of the drug thalidomide, to standard dexamethasone therapy can improve survival in patients with relapsed or hard-to-treat multiple myeloma — a cancer of the blood.
That’s according to the results of two phase III trials published in The New England Journal of Medicine this week.
In a study conducted in North America, Dr. Donna M. Weber, from M. D. Anderson Cancer Center in Houston, and colleagues assessed 353 patients who were randomly allocated to receive lenalidomide (25 mg) or placebo, in addition to dexamethasone.
They report that 61 percent of patients who added lenalidomide to dexamethasone responded to treatment compared with only about 20 percent of patients who added placebo. Moreover, 14 percent of lenalidomide-treated patients had a complete response compared with only 0.6 percent of placebo-treated patients.
The median time to disease progression was longer in the lenalidomide group (11.1 vs. 4.7 months), as was survival. Lenalidomide-treated patients survived a median of 29.6 months compared with 20.2 months for placebo patients. These differences were statistically significant.
“Lenalidomide-dexamethasone is a highly active regimen which provides survival benefit for patients with relapsed or refractory multiple myeloma,” Weber told Reuters Health.
In a similar study, conducted in Europe, Israel, and Australia, Dr. Meletios Dimopoulos, from the University of Athens School of Medicine in Greece, and colleagues examined the effects of lenalidomide in 351 patients. The findings largely echoed those seen in the North American study, with lenalidomide enhancing treatment response and survival rates.
“Lenalidomide and the immunomodulatory drugs stand as prime examples of potentially dangerous chemical compounds that have been granted a second life with powerful therapeutic applicability,” Dr. Alan F. List, from the University of South Florida College of Medicine in Tampa, comments in a related editorial. “Like the mythical phoenix that was reborn from its own ashes, lenalidomide and the immunomodulatory drugs carry exciting potential.”
SOURC: The New England Journal of Medicine, November 22, 2007.