Combination of three drugs is a step forward in myeloma treatment
posted in Cancer |The study results have led to the approval of the use of Bortezomib for myeloma patients by the Food and Drug Administration (FDA).
The Cancer Center The University of Salamanca Spanish today introduced a new treatment for myeloma, based on the combination of three drugs for patients newly diagnosed over 65 years that until now could only be treated with chemotherapy.
Bortezomib, Melphalan and Prednisone are drugs indicated for the treatment of this cancer, which affects the growth of bone marrow cells that produce proteins of various kinds.
The results of the study, coordinated by the Spanish investigator Jesus San Miguel, Center for Cancer Research and head of the department of Hematology, University Hospital of Salamanca, have led to the approval of the use of Bortezomib for myeloma patients by the Food and Drug Administration (FDA).
The European Medicines Agency (EMEA) has also expressed a positive opinion.
Speaking to EFE, San Miguel said the implementation of this new treatment “constitutes a significant hope for patients with myeloma.
“We are confident that with these new drugs, we can continue to prolong the survival of myeloma for more chronic disease,” said the scientist.
According to research, implementation of more Bortezomib melphalan and prednisone achieved a higher rate of complete remission of myeloma and a significant prolongation in survival compared to standard treatment.
These results make the combination of three drugs in a new standard procedure for patients with newly diagnosed myeloma who are not transplant candidates.
The study, published today in the New England Journal of Medicine, presents the results of a randomized trial which involved 151 hospitals in 22 countries in Europe, America, Asia and Oceania, in which 682 patients participated.
To date, the standard treatment for these patients was chemotherapy with melphalan and prednisone.
However, adding the Bortezomib treatment has been lowered by 52 percent the risk of disease progression, to which must be added a 40 percent reduction in risk of death and increased the time lag since the treatment ended up receiving a new one.
In this sense, while at two years 57 percent of patients treated with Melphalan-Prednisone and have required a second line of treatment, only 35 percent of patients treated with this new combination of drugs had to re - be treated within that period of time.
In addition, San Miguel said the time between the patient is diagnosed and the disease has happened to the new treatment of 16 months to 24, equivalent to “a 40 percent reduction in risk of death.”
San Miguel said that the new formula, at 2 years, 82 percent of patients were “still alive” compared to 69 percent of those who had followed the usual treatment.
It was also found that treatment is a more effective “in high risk patients such as those suffering from renal failure or genetic disorders,” said San Miguel.
However, the experimental treatment had some complications, since 46 percent of patients had side effects compared with 36 percent of those that suffered the usual treatment.
Despite this setback, there were no differences in mortality by treatment toxicity, which is 1 per cent in both cases, the major side effect is “peripheral neuropathy, but patients in a couple of months can improve or reverse.
In this regard, San Miguel said that 86% of patients could complete the procedure.
The combination therapy more Bortezomib Melphalan-Prednisone had its origin in a preclinical research developed in 2006 by the Spanish group of myeloma, showing a positive synergy of this triple drug combination.