Efficacy of pamidronate in breast cancer with bone metastases: A randomized, double-blind placebo-controlled multicenter study

Purpose: To evaluate the efficacy of pamidronate 60 mg i.v. q 4 weeks in wo men with advanced breast cancer with skeletal metastases. Patients and Meth ods: 404 woman with skeletal metastases from breast cancer in Sweden and No rway were included in a randomized, placebo-controlled, multicenter study. Except for the study medication, other palliative treatment was chosen at t he discretion of the physician. Skeletal related events, i.e. increased pai n, treatment of hypercalcemia, pathologic fractures of log bones or pelvis, paralyses due to vertebral compression, palliative radiotherapy for skelet al metastases, surgery on bone and change of antitumor therapy were recorde d every third month as well as a self-estimated pain-score using visual Ana log Scales and analgesic consumption. Results: There was a significantly in creased time to progression of pain (p<0.01), to hypercalcemic events (p<0. 05) as well as for the cumulative number of skeletal related events (p<0.01 ) in favor for the pamidronate group. No statistically significant reductio n of pathologic fractures of long bones or pelvis, or pareses due to verteb ral compression occured. No statistically significant differences were foun d for the need of radiotherapy and surgery on bone. The pamidronate group f aired better regarding performance status (p<0.05). There was a statistical ly not significant lower consumption of opioid analgesics in the pamidronat e group (p=0.14). Conclusion: Pamidronate 60 mg i.v. q 4 weeks reduces skel etal events and improves the quality of life in women with bone metastases from breast cancer.