Efficacy of Pamidronate in Reducing Skeletal Complications in Patients with Breast Cancer and Lytic Bone Metastases
Gabriel N. Hortobagyi, M.D., Richard L. Theriault, D.O., Lester Porter, M.D., Douglas Blayney, M.D., Allan Lipton, M.D., Clive Sinoff, M.D., Helen Wheeler, M.D., Joseph F. Simeone, M.D., John Seaman, Pharm.D., Robert D. Knight, M.D., Maika Heffernan, Ph.D., Dirk J. Reitsma, M.D., Ian Kennedy, Simon G. Allan, Kathleen Mellars, for The Protocol 19 Aredia Breast Cancer Study Group
Background Bisphosphonates such as pamidronate disodium inhibitosteoclast-induced bone resorption associated with cancer thathas metastasized to bone.
Methods Women with stage IV breast cancer who were receivingcytotoxic chemotherapy and had at least one lytic bone lesionwere given either placebo or pamidronate (90 mg) as a two-hourintravenous infusion monthly for 12 cycles. Skeletal complications,including pathologic fractures, the need for radiation to boneor bone surgery, spinal cord compression, and hypercalcemia(a serum calcium concentration above 12 mg per deciliter [3.0mmol per liter] or elevated to any degree and requiring treatment),were assessed monthly. Bone pain, use of analgesic drugs, performancestatus, and quality of life were assessed throughout the trial.
Results The efficacy of treatment was evaluated in 380 of 382randomized patients, 185 receiving pamidronate and 195 receivingplacebo. The median time to the occurrence of the first skeletalcomplication was greater in the pamidronate group than in theplacebo group (13.1 vs. 7.0 months, P = 0.005), and the proportionof patients in whom any skeletal complication occurred was lower(43 percent vs. 56 percent, P = 0.008). There was significantlyless increase in bone pain (P = 0.046) and deterioration ofperformance status (P = 0.027) in the pamidronate group thanin the placebo group. Pamidronate was well tolerated.
Conclusions Monthly infusions of pamidronate as a supplementto chemotherapy can protect against skeletal complications inwomen with stage IV breast cancer who have osteolytic bone metastases.
Source Information
From the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.N.H., R.L.T.); the Saint Thomas Medical Group, Saint Thomas Hospital, Nashville (L.P.); the Saint Vincent Medical Center, Los Angeles (D.B.); the Milton S. Hershey Medical Center, Hershey, Pa. (A.L.); the Northeastern Ontario Regional Cancer Center, Sudbury, Ont., Canada (C.S.); the Department of Clinical Oncology, Royal North Shore Hospital, St. Leonards, Australia (H.W.); the Department of Radiology, Massachusetts General Hospital, Boston (J.F.S.); and Ciba Pharmaceuticals, Summit, N.J. (J.S., R.D.K., M.H., D.J.R.). Other authors were Ian Kennedy, M.D. (Waikato Hospital, Hamilton, New Zealand), Simon G. Allan, M.D. (Palmerston North Hospital, Palmerston North, New Zealand), and Kathleen Mellars, M.S. (Ciba Pharmaceuticals, Summit, N.J.).
Address reprint requests to Dr. Hortobagyi at the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030.
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