LUXEMBOURG-The bisphos-phonate 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.
LUXEMBOURG-The bisphos-phonate pamidronate (Aredia) not only reducedskeletal morbidity but also relieved pain, reduced analgesic use,and improved quality of life in a multicenter study reported atthe 7th International Symposium of the Multinational Associationof Supportive Care in Cancer.
Harold Harvey, MD, described the randomized, double-blind, placebo-controlledtrial, which involved 377 patients with stage III multiple myelomaand lytic bone metastases. He said that, prior to randomization,patients were stratified according to whether they were undergoingtheir first course of chemotherapy (stratum-1) or had receivedprevious chemotherapy (stratum-2).
The 90-mg dose of pamidronate was administered as a 4-hour infusionevery 4 weeks. "This 4-hour regimen was safe and associatedwith minimal side effects, and those deaths that occurred in thestudy 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 observedthat the incidence of skeletal events, including pathologic fractures,spinal cord compression, radiation therapy, and the need for orthopedicintervention, was significantly lower in pamidronate-treated patientsthan in the placebo group.
More than 50% of stratum-2 patients, and 33% of stratum-1 patientswho received placebo experienced a skeletal event, as contrastedwith 29% and 22%, respectively, of their pamidronate-treated counterparts,he pointed out.
"The time to development of any skeletal event was also significantlydecreased in the group receiving pamidronate, as compared to placebo,"he added. "If one looks at individual events-fractures, radiationto bone, hypercalcemia, spinal cord compression, and bone pain-onesees consistently, across the board, that the frequency and timeto development of these events were far less with pamid-ronatetreatment."
Pamidronate-treated patients showed a significant decrease inpain score, while narcotic consumption rose markedly in the placebogroup, Dr. Harvey said. In addition, he reported, quality of lifedeteriorated in the placebo group, as measured by the ECOG scale,but improved in the pamidronate group, as measured by the Spitzerindex.
"Interestingly, there was no difference between the pamidronategroup and the placebo group with respect to the radiologic appearanceof bone lesions," Dr. Harvey said.
"We now have a group of compounds, the bisphosphonates, thatare proven to be highly effective in inhibiting osteoclast-drivenosteolysis, and these compounds ought to be considered as adjunctsin the supportive care of patients with bone metastases,"Dr. Harvey said.
He noted that two similar randomized placebo-controlled trialsof pamidro-nate are currently underway, each enrolling 300 womenwith stage IV breast cancer and lytic lesions who are receivingeither chemotherapy or hormonal therapy.