(Wednesday, 9 may HealthDay News) - three new studies confirm that drug lenalidomide can significantly increase time than multiple myeloma patients did experience any worsening of their disease, is after a transplant of stem cells or to chemotherapy.
However, what is not clearly studies is or not the improvement in survival time "without progress" will result in a longer overall survival.
"They are very promising, early studies," said the author of an accompanying editorial, Dr. Ashraf Badros, Professor in the Department of medicine at the University of Maryland School of Medicine in Baltimore. "I think that these studies will generate much discussion."
Potential areas of debate, he said, include or non-progression-free survival is sufficient if it is not a benefit in overall survival. He said that progression-free survival may well justify this treatment if the quality of life improved considerably. However, none of the studies reviewed measures of quality of life. Another important factor is cost; This drug is estimated at about $163 381 per year to treat a patient, according to the editorial of the Badros costs.
Studies and writing are published in the issue of the New England Journal of Medicine on May 10.
Multiple myeloma is a cancer that affects plasma cells in the blood. Each year, approximately 22,000 Americans receive a diagnosis of multiple myeloma, according to the American Cancer Society. The current rate of survival at 5 years for multiple myeloma is only 40 percent. However, recent advances will likely increase the survival rate for people who are diagnosed to move forward, according to the cancer society.
Lenalidomide (Revlimid) modifies the immune response and direct toxic effects on tumors, according to background information in one of these studies.
Among younger people, the standard treatment is usually a stem cell transplantation to replace the many cancer cells from plasma. However, many older patients are ineligible for this treatment.
The first study looked at treatment lenalidomide in people who were not candidates for transplantation of stem cells, and it included slightly more than 450 people more than 65 years old, who was recently diagnosed with multiple myeloma. A group received initial chemotherapy which included lenalidomide also followed by treatment of maintenance by lenalidomide, while the second group has just received the initial chemotherapy, including lenalidomide. The latter group received standard chemotherapy without lenalidomide.
After an average 30-month follow-up period, the researchers found that the first group had an average of progression-free survival of 31 months, compared to only 14 months for the second group, only 13 months for the final group. This study was not designed to evaluate overall survival.
"This approach is approximately double the duration of remission of 15 to 30 months old therapies," said author Dr. Antonio Palumbo, of the study of the Department of Hematology at the University of Turin in Italy.
Palumbo, stated that the cost has always to be considered in the treatment. He said that there are some costs associated with lenalidomide because economies it is an oral medication, which must be administered intravenously. In addition, if it prevents complications, such as bone fractures, it can help prevent them disability and hospital costs.
The second study, conducted by researchers from the Roswell Park Institute in New York, included 468 persons less than 71 years who received transplants of stem cells. From 100 days after their transplants, half of the Group was given daily lenalidomide and half received either a placebo. Once the progression of the disease, study participants said what treatment they received, and if they were to a placebo, they were allowed to begin to lenalidomide.
At the time, the results were decoded, only 20% of people lenalidomide progression of the disease compared with 44% of those receiving placebo.
The third study, reported by French researchers, was also considered in the maintenance treatment of lenalidomide in those who have had a stem cell transplant. This study included 614 people aged under 65. The group taking lenalidomide was progression-free survival an average of 41 months, compared to 23 months in the placebo group. Four years after the start of the study, the average overall survival was similar in the two groups, according to the study.
Secondary effect the most important and what has been an increase in the risk of a second cancer. In the three studies, the rate of cancers of the second was more than doubled in people taking lenalidomide. Low white blood cells were also commonly related to lenalidomide therapy.
Badros said that all cancer treatments have secondary, and that for the most part, lenalidomide did appear to have unexpected effects, except for the increase in the rate of cancers of the second. This finding, he said, deserves further study.
More information
Learn more about multiple myeloma of the American Cancer Society.
SOURCES: Ashraf Badros, M.B., Ch.B., Professor, Department of medicine, University of Maryland School of medicine and the University of Maryland Medical Center, Baltimore; Antonio Palumbo, MD, Department of Hematology, University of Turin, Italy; May 10, 2012, New England Journal of Medicine
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