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Journal of Clinical Oncology, Vol 17, Issue 3 (March), 1999: 846
© 1999 American Society for Clinical Oncology

Pamidronate Reduces Skeletal Morbidity in Women With Advanced Breast Cancer and Lytic Bone Lesions: A Randomized, Placebo-Controlled Trial

Richard L. Theriault, Allan Lipton, Gabriel N. Hortobagyi, Richard Leff, Stefan Glück, John F. Stewart, Sean Costello, Ian Kennedy, Joseph Simeone, John J. Seaman, Robert D. Knight, Kathleen Mellars, Maika Heffernan, Dirk J. Reitsma, for the Protocol 18 Aredia Breast Cancer Study Group

From the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX; the Milton S. Hershey Medical Center, Hershey, PA; Georgia Cancer Specialists, Decatur, GA; Northeastern Ontario Regional Centre, Sudbury, Ontario, Canada; Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia; Dunedin Hospital, Dunedin, New Zealand; Waikato Hospital, Hamilton, New Zealand; Massachusetts General Hospital, Boston, MA; and Novartis Pharmaceuticals, East Hanover, NJ.

Address reprint requests to Richard L. Theriault, DO, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 56, Houston, TX 77030; email rtheriau{at}mdanderson.org

PURPOSE: To assess whether pamidronate can reduce the frequency of skeletal morbidity in women with lytic bone metastases from breast cancer treated with hormone therapy.

PATIENTS AND METHODS: Three hundred seventy-two women with breast cancer who had at least one lytic bone lesion and who were receiving hormonal therapy were randomized to receive 90 mg of pamidronate or placebo as a 2-hour intravenous infusion given in double-blind fashion every 4 weeks for 24 cycles. Patients were evaluated for skeletal complications: pathologic fractures, spinal cord compression, irradiation of or surgery on bone, or hypercalcemia. The skeletal morbidity rate (the ratio of the number of skeletal complications to the time on trial) was the primary efficacy variable. Bone pain, use of analgesics, quality of life, performance status, bone tumor response, and biochemical parameters were also evaluated.

RESULTS: One hundred eighty-two patients who received pamidronate and 189 who received placebo were assessable. The skeletal morbidity rate was significantly reduced at 12, 18, and 24 cycles in patients treated with 90 mg of pamidronate (P = .028, .023, and .008, respectively). At 24 cycles, the proportion of patients having had any skeletal complication was 56% in the pamidronate group and 67% in the placebo group (P = .027). The time to the first skeletal complication was longer for patients receiving pamidronate than for those given placebo (P = .049). There was no statistical difference in survival or in objective bone response rate. Pamidronate was well tolerated.

CONCLUSION: Treatment with 90 mg of pamidronate as a 2-hour intravenous infusion every 4 weeks in addition to hormonal therapy significantly reduces skeletal morbidity from osteolytic metastases.

This study was supported by a grant from Novartis Pharmaceuticals, East Hanover, NJ.


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