Journal of Clinical Oncology, Vol 14, 2552-2559, Copyright © 1996 by American Society of Clinical Oncology
Delay in progression of bone metastases in breast cancer patients treated with intravenous pamidronate: results from a multinational randomized controlled trial. The Aredia Multinational Cooperative Group
PF Conte, J Latreille, L Mauriac, F Calabresi, R Santos, D Campos, J Bonneterre, G Francini and JM Ford
Division of Medical Oncology, St Chiara Hospital, Pisa, Italy.
PURPOSE: Bone metastases are a major cause of morbidity in breast cancer,
resulting in complications that include pain, loss of mobility, pathologic
fracture, and tumor-induced hypercalcemia (TIH). Inhibition of
osteoclast-mediated bone destruction using bisphosphonates represents a
promising new management approach. PATIENTS AND METHODS: Breast cancer
patients with bone metastases were randomly allocated to receive
chemotherapy alone (152 patients) or chemotherapy plus pamidronate 45 mg in
250 mL of saline as a 1-hour intravenous infusion every 3 weeks (143
patients). Whenever possible, treatment continued until progression of
disease (PD) in bone appeared on radiographs or bone scan. Time to PD in
bone and pain reduction according to a self- assessment six-point scale
were selected as primary end points. PD in bone was verified during
extramural review (EMR) of all imaging studies by blinded observers, and
these data were used as the main efficacy criterion. Analgesic intake,
World Health Organization (WHO) performance status, and complications of
bone metastases (radiotherapy, TIH, fractures, orthopedic surgery) were
also compared in the two groups. RESULTS AND CONCLUSION: At EMR, median
time to PD in bone was increased by 48% in patients who received
pamidronate (249 v 168 days; P = .02, Wilcoxon test). Marked pain relief,
defined as a two-point decrease lasting for > or = 6 weeks, was reported
by 44% of pamidronate patients and by 30% of controls (P = .025, chi 2
test). The infusions (median, nine per patient; range, 0 to 39) were well
tolerated, with no major toxicities reported. Pamidronate by repeated
infusion can significantly slow the progression of bone metastases and
reduce attendant morbidity.
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