lenalidomide (Revlimid) with reduced doses of the steroid dexamethasone in the treatment of multiple myeloma.
Findings from a phase III study by the Eastern Cooperative Oncology Group (ECOG 4A03), presented at the recent American Society of Clinical Oncology (ASCO) meeting held June 2–5 in Chicago, demonstrate the benefits of using lenalidomide (Revlimid) with reduced doses of the steroid dexamethasone in the treatment of multiple myeloma.
Key Trial Data
Findings from the ECOG study were reported in May, when the trial closed early based on 1-year data showing a greater survival advantage for patients receiving low-dose dexamethasone compared to those receiving the standard high dose of the steroid. Due to the potential risk of side effects related to dexamethasone, researchers decided that it was best to switch all patients in the trial onto the lower dose.
However, for the first time at ASCO, the complete data were presented by lead investigator Dr. Vincent Rajkumar of the Mayo Clinic. The results show that patients in all age ranges benefit from lenalidomide with low-dose dexamethasone (LDD).
• Patients under age 65 had the greatest 1-year survival: 98% with lenalidomide/LDD vs 90% with lenalidomide/high-dose dexamethasone (HDD).
• But patients over age 65 had the greatest degree of benefit from lenalidomide/LDD, 95% survival vs 83% for lenalidomide/HDD.
• The combined survival rate at 1 year was 96.5% with lenalidomide/LDD vs 86% with lenalidomide/HDD, more than a 10% improvement in survival.
Based on these data, the US Myeloma Forum, a committee of leading myeloma researchers including Dr. Mohamad Hussein, clinical director of the malignant hematology division and head of the myeloma section at the H. Lee Moffitt Cancer Center & Research Institute, met to discuss and develop plans for further medical studies.
At the meeting, which was organized by the International Myeloma Foundation, the researchers approved plans to study novel therapeutic options for newly diagnosed myeloma patients, without first offering bone marrow (stem cell) transplants that have been the standard of care up until now.
"Because of the strong 1-year survival data seen in the ECOG trial, we think there is a need to continue to evaluate novel treatment options," said Dr. Hussein. "The development of new therapeutic agents which are very effective combined with the model of changing myeloma into a chronic disease process is making us rethink our traditional treatment paradigm, where therapy is decided on if or if not the patient qualifies for high-dose therapy and bone marrow (stem cell) transplant."