If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Long-Term Aredia Reduces Bone Complications In Multiple Myeloma Patients LOS ANGELES, CA -- February 5, 1998 -- A report published in this month’s Journal of Clinical Oncology shows that long-term (21-month cycle) infusion of panmidronate disodium for injection (Aredia(R)) significantly reduces skeletal complications among multiple myeloma patients. The study was led by James Berenson, M.D., a U.S. Department of Veterans Affairs (VA) West Los Angeles Medical Center researcher. "A previous study showed the benefits of pamidronate disodium after nine monthly doses. This recent study demonstrates that pamidronate disodium continues to reduce skeletal complications after 21 monthly doses," said Dr. Berenson, chief of medical oncology at the West Los Angeles VA Medical Center. "In addition, the trial warrants further investigation of pamidronate disodium as the results indicate it may help prolong the lives of certain multiple myeloma patients." Multiple myeloma is a complex, currently incurable form of bone marrow cancer that produces an uncontrolled growth of plasma cells. One common characteristic of multiple myeloma is osteolytic bone destruction, which occurs when plasma cells release factors that activate specific bone cells -- osteoclasts -- to resorb, or dissolve, bone. This bone destruction is not accompanied by increased bone formation and the result is loss of bone density, bone pain, fractures and spinal cord compression. The study was an international, randomised, double-blind trial of 392 patients with advanced multiple myeloma and at least one osteolytic lesion. Before randomisation, patients were divided according to their antimyeloma therapy at the beginning of the trial. Two groups were created: Group 1 consisted of patients who responded to initial treatment or whose disease was controlled after single regimen chemotherapy; and Group 2 included patients who required second-line therapy to control their disease. Within each group, patients were randomised to receive either pamidronate disodium 90 mg or placebo (500mL of five percent dextrose in water), each administered as a four-hour intravenous infusion. Of the 392 randomised patients, the proportion of patients who developed any skeletal event was lower in the pamidronate disodium group (38 percent compared to 51 percent of patients in the placebo group). The mean number of skeletal events per year was also less in the pamidronate disodium group than the placebo group (1.3 versus 2.2, respectively). Among patients in Group 2, the survival time of pamidronate disodium treated patients was prolonged to 21 months, compared with 14 months of placebo patients. Pamidronate disodium was generally well tolerated and adverse effects were similar for both pamidronate disodium treated and placebo treated patients. The most common adverse effects with pamidronate disodium were bone pain, anemia, fever, nausea, upper respiratory tract infection, fatigue and constipation. The disease affects more than 50,000 people in the U.S. and according to the International Myeloma Foundation, approximately 12,000 new cases are diagnosed each year, making multiple myeloma one of the most rapidly increasing types of cancer in the Western world. Standard treatment consists of agents that directly combat the cancer, as well as those agents that treat disease-related complications. In 1995, Aredia became the first and only therapy indicated for the treatment of osteolytic bone lesions of multiple myeloma in conjunction with standard antimyeloma chemotherapy. In 1996, Aredia was cleared for marketing by the FDA for the treatment of osteolytic bone metastases of breast cancer in conjunction with standard antineoplastic therapy. More information on: Aredia
|
