ABSTRACT
In these two trials, women with stage IV breast cancer who were receiving either cytotoxic chemotherapy (382 randomized patients) or hormonal therapy (372 randomized patients) were randomized to receive either placebo or pamidronate 90 mg as a 2-hour intravenous infusion for 12 cycles (with chemotherapy) or 24 cycles (with hormonal therapy). In both cases, the median time to the occurrence of first skeletal complications was greater in the pamidronate group than in the placebo group: 13.1 months versus 7 months (p 0.005) for patients receiving chemotherapy and 10.4 months versus 6.9 months (p 0.049) for patients receiving hormonal therapy. The proportion of patients in whom any skeletal complication occurred was also lower: 43% versus 56% (p 0.008) with chemotherapy and 56% versus 67% (p 0.024) with hormonal therapy. There was also significantly less increase in bone pain (p 0.046 with chemotherapy and p 0.002 with hormonal therapy) and less deterioration of performance status (p 0.027 with chemotherapy) in the pamidronate group. In no instance was survival improved.
