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.
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
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