In results of a phase III trial reported at the 2014 American Society of Clinical Oncologists, treatment with Xtandi® (enzalutamide) was found to significantly delay the need for chemotherapy in metastatic prostate cancer patients previously treated with hormone therapy.
The trial, led by researchers at the Oregon Health and Sciences University, enrolled 1717 patients and randomly assigned them to a daily dose of Xtandi or a placebo. All patients had been treated previously with hormone therapy but had not received chemotherapy. Scientists were measuring progression-free survival and overall survival.
Results indicated that the Xtandi group had a time to the start of chemotherapy of 28 months. The same measure for the placebo group was 10.8 months. At 12 months, 65% of the Xtandi patients had no disease progression. Only 14% of the placebo group was without progression.
At the conclusion of data collection, 72% of the Xtandi patients were still alive, compared to 63% in the placebo group.
The rate of adverse events with the two groups was comparable. Forty-three percent of the Xtandi arm and 37% of the placebo arm reported grade 3 or higher adverse events. However, the time to onset of the adverse events was longer in the Xtandi group (22.3 months). The corresponding time for placebo patients was 13.3 months.
Reference: Beer TM, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. New Engl J Med 2014; DOI: 10.1056/NEJMoa1405095.
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