The evidence supporting this protocol is provided by a phase III, multicentre, randomised trial involving 769 patients comparing exemestane with megestrol acetate in postmenopausal women with progressive advanced breast cancer who experienced failure with tamoxifen.r
Between October 1995 and May 1998, 366 patients were randomised to receive exemestane 25 mg daily and 403 patients were randomised to receive megestrol 40 mg four times daily.r
The primary efficacy end point was OR rate and secondary end points included overall success rate, overall success duration, time to OR, duration of OR, duration of SD greater than or equal to 24 weeks, time to tumor progression (TTP), time to treatment failure (TTF), survival time, subjective response, and effects on circulating oestrogen levels.r
Efficacy
The overall objective response (OR) rates were higher in patients treated with exemestane than in those treated with megestrol (15.0% vs 12.4%). Median survival time was significantly longer with exemestane (median not reached) than with megestrol (123.4 weeks; P =0.039), as were the median duration of overall success (OR or stable disease > 24 weeks; 60.1 vs 49.1 weeks; P =0.025), time to tumor progression (20.3 vs 16.6 weeks; P =0.037), and time to treatment failure (16.3 vs 15.7 weeks; P = 0.042).r
© Journal of Clinical Oncology 2000
Toxicity
Compared with megestrol, there were similar or greater improvements in pain, TRSS, and QOL with exemestane. Both drugs were well tolerated. Grade 3 or 4 weight changes were more common with megestrol (17.1% vs 7.6%; P = 0.001).r
Adverse events r
© Journal of Clinical Oncology 2000