LUXEMBOURG-The bisphos-phonate pamidronate(Drug information on pamidronate) (Aredia) not only reduced skeletal morbidity but also relieved pain, reduced analgesic use, and improved quality of life in a multicenter study reported at the 7th International Symposium of the Multinational Association of Supportive Care in Cancer.
Harold Harvey, MD, described the randomized, double-blind, placebo-controlled trial, which involved 377 patients with stage III multiple myeloma and lytic bone metastases. He said that, prior to randomization, patients were stratified according to whether they were undergoing their first course of chemotherapy (stratum-1) or had received previous chemotherapy (stratum-2).
The 90-mg dose of pamidronate was administered as a 4-hour infusion every 4 weeks. "This 4-hour regimen was safe and associated with minimal side effects, and those deaths that occurred in the study were related to disease progression, not therapy," said Dr. Harvey of the Hershey Medical Center, Pennsylvania.
Zeroing in on the primary study endpoint, Dr. Harvey observed that the incidence of skeletal events, including pathologic fractures, spinal cord compression, radiation therapy, and the need for orthopedic intervention, was significantly lower in pamidronate-treated patients than in the placebo group.
More than 50% of stratum-2 patients, and 33% of stratum-1 patients who received placebo experienced a skeletal event, as contrasted with 29% and 22%, respectively, of their pamidronate-treated counterparts, he pointed out.
"The time to development of any skeletal event was also significantly decreased in the group receiving pamidronate, as compared to placebo," he added. "If one looks at individual events-fractures, radiation to bone, hypercalcemia, spinal cord compression, and bone pain-one sees consistently, across the board, that the frequency and time to development of these events were far less with pamid-ronate treatment."
Pamidronate-treated patients showed a significant decrease in pain score, while narcotic consumption rose markedly in the placebo group, Dr. Harvey said. In addition, he reported, quality of life deteriorated in the placebo group, as measured by the ECOG scale, but improved in the pamidronate group, as measured by the Spitzer index.