Role of pamidronate in the management of bone metastases from breast cancer: results of a non-comparative multicenter phase II trial. Aredia Multinational Cooperative Group.

摘要: Bone metastases are a common cause of morbidity in patients with breast cancer. In an open, phase II, non-comparative trial to investigate the effects repeated infusions pamidronate (Aredia) on pain, mobility, analgesic consumption, bone healing and metabolism, 69 cancer received 60 mg intravenously 250 ml normal saline over 1 or 4 hours every 2 weeks for total 13 infusions, until either progressive disease serious adverse event. Improvement pain score was seen 33 54 evaluable (61%) as measured by linear analogue scale, 28 56 (50%) 6-point scale: 18 (30%) showed reduction score, while some improvement assessed questionnaire. Sclerosis appeared > 25% lesions < 12 patients. Urinary calcium/creatinine ratios fell dramatically during therapy. One patient developed symptomatic hypocalcemia, deterioration pre-existing renal insufficiency. Fever occurred 19% patients, less than 20% flu-like symptoms. We conclude that intravenous at dose produces marked extensive from