Findings from a Phase III study by the Eastern Cooperative Oncology Group (ECOG 4A03) were presented yesterday at the American Society of Clinical Oncology (ASCO) meeting in Chicago and demonstrate the benefits of using Revlimid (lenalidomide) with reduced doses of the steroid dexamethasone.
Based upon these data, the U.S. Myeloma Forum, a committee of leading myeloma researchers including Dr. Mohamad Hussein, Clinical Director of the Malignant Hematology Division & Head of 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 one-year survival data seen in the ECOG trial, we think there is a need to continue to evaluate novel treatment options. 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. With the current knowledge of disease biology and new effective therapy with a large safety margin, the myeloma community is able to reorganize the role of transplant in patients with multiple myeloma," said Dr. Hussein, "Stem cell harvest and saving after inducing response/remission should be the standard in all patients not receiving transplant to allow for this option as our knowledge advances. Oral therapies as first-line treatment would be a major advance in how we care for myeloma patients."
About ECOG 4A03 Trial
Top line findings from the ECOG study were reported last month, when the trial closed early based on one-year data which showed 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 and show that patients in all age ranges benefit from Revlimid with the low dose dexamethasone (LDD).
- Patients under age 65 had the greatest one year survival: 98% with Revlimid/LDD vs 90% with Revlimid/high dose dexamethasone (HDD).
- But patients over age 65 had the greatest degree of benefit from Revlimid/LDD, 95% survival vs 83% for Revlimid/HDD.
- The combined survival rate at one year was 96.5% with Revlimid/LDD vs 86% with Revlimid/HDD, more than a ten percent improvement in survival.
About Multiple Myeloma
Myeloma, also called multiple myeloma, is a cancer of the bone marrow that affects production of red cells, white cells and stem cells. It is the second most prevalent of the blood cancers, affecting an estimated 750,000 people worldwide, and in industrialized countries it is being diagnosed in growing in numbers and in increasingly younger people. The Revlimid/dexamethasone combination is approved for use in the United States by the FDA for patients who have received at least one prior therapy, and a similar approval is pending in Europe.