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I chose the TRANSFORMER protocol published in JCO in April of this year as my Story of the Year.1 This paper was selected due to its sort of paradoxical nature and what may be considered unexpected results.
This was a prospective phase II study wherein men with metastatic castration-resistant prostate cancer (mCRPC) who were asymptomatic and had progressed on abiraterone were randomized to receive testosterone at a dose of 400 mg every 28 days (the bipolar androgen therapy [BAT] group) or enzalutamide. Upon progression, patients received the opposite therapy, and PSA response was again evaluated. There was a 50% PSA reduction in 28.2% of men on BAT therapy compared with 25.5% of men taking enzalutamide. There was similar progression-free survival of 5.7 months in the two arms, and overall survival of 32.9 and 29 months in the BAT arm and enzalutamide arm, respectively. Interestingly, 77.8% of patients who received BAT followed by enzalutamide had a PSA50 response compared with 21.3% among those who received BAT after enzalutamide. The patients who underwent BAT followed by enzalutamide also had an improved progression-free survival response of 28.2 months versus 19.6 months with enzalutamide followed by BAT.
It is interesting that patients who received BAT prior to enzalutamide seemed to continue to respond or to have renewed response to enzalutamide. This suggests that BAT may “re-sensitize” prostate cancer cells to next-generation hormonal therapies.