Journal of Clinical Oncology, Vol 16, 2038-2044, Copyright © 1998 by American Society of Clinical Oncology
Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate. Protocol 19 Aredia Breast Cancer Study Group
GN Hortobagyi, RL Theriault, A Lipton, L Porter, D Blayney, C Sinoff, H Wheeler, JF Simeone, JJ Seaman, RD Knight, M Heffernan, K Mellars and DJ Reitsma
Department of Breast Medical Oncology, University of Texas, M.D. Anderson Cancer Center, Houston 77030, USA. ghorto@notes.mdacc.tmc.edu
PURPOSE: Pamidronate, an aminobisphosphonate, has been shown to lower the
risk of skeletal complications associated with lytic bone lesions for up to
1 year in women with stage IV breast cancer who received chemotherapy. We
studied the long-term effectiveness and safety of continued treatment with
intravenous pamidronate infusions for up to 2 years. PATIENTS AND METHODS:
Three hundred eighty-two women with metastatic breast cancer and lytic bone
lesions who received chemotherapy were randomly assigned to receive either
90 mg of pamidronate or placebo intravenously every 3 to 4 weeks in this
double- blind, multicenter, parallel-group trial. Patients were evaluated
monthly for 2 years for skeletal complications, which included pathologic
fractures, need for radiation or surgery to treat bone complications,
spinal cord compression, and hypercalcemia. Bone pain, analgesic use, bone
biochemical markers, performance status, quality of life, radiologic
response in bone, and survival were also evaluated. RESULTS: As in the
first year of treatment, the proportion of patients with any skeletal
complication was significantly less for the pamidronate than the placebo
group at 15, 18, 21, and 24 months (P < .001). The proportions of
patients with any pathologic fracture (i.e., vertebral and nonvertebral
fractures), need for radiation or surgery to treat bone complications, and
hypercalcemia were also statistically less for the pamidronate than the
placebo group. The median time to the first skeletal complication was 13.9
months in the pamidronate-treated women and 7.0 months in the placebo group
(P < .001). Long-term treatment did not result in any unexpected adverse
events. Survival did not differ between the two groups. CONCLUSION: The
risk for osteolytic bone lesion complications in metastatic breast cancer
was significantly decreased with monthly infusions of 90 mg of pamidronate,
and this effect was maintained for at least 2 years. Pamidronate is a
useful adjunct to standard chemotherapy in the palliative treatment of
metastatic breast cancer.

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