I can’t believe it’s not butter.
Top Line: The pharmacokinetics of abiraterone appear to be extremely sensitive to concurrent food intake.
The Study: At around $10,000 per month, abiraterone is expensive. But in LATITUDE and STAMPEDE, it worked, improving survival over androgen deprivation (ADT) alone in men with metastatic castration sensitive prostate cancer. In these trials, abiraterone was given at 1000 mg qAM following overnight fast. So what does it mean if you live in a more “progressive” state and get the munchies before it’s time for your meds? A low-fat meal (think Jenny Craig) can increase abiraterone concentrations by a factor of 5-7 and a high fat meal (think Jimmy Dean) by a factor of 10-15. This study hypothesized low-dose abiraterone of 250 mg with a low-fat meal would have a noninferior reduction in PSA in men with castration resistant prostate cancer compared to standard dosing of 1000 mg fasting, all with hopes of lowering cost. The results demonstrate a noninferior reduction in PSA at 12 weeks as well as a similar median progression free survival (PFS) time of about 9 months. That’s not without criticisms, though. First, there was no standardized PSA measurement (any lab was used). Plus PSA change at 12 weeks has questionable clinical significance, in any case. Finally, both groups had abiraterone concentrations that were lower than expected (read: lower than what’s believed to be optimal), with the low-dose group achieving particularly low concentrations. Ultimately, while dreamt up with the best of intentions, this study may not have been performed with the best of methods.
Bottom Line: Lower dose abiraterone taken with a low-fat meal was “noninferior” to standard doses while fasting, but some folks don’t believe it. | Szmulewitz, J Clin Oncol 2018
The Study: At around $10,000 per month, abiraterone is expensive. But in LATITUDE and STAMPEDE, it worked, improving survival over androgen deprivation (ADT) alone in men with metastatic castration sensitive prostate cancer. In these trials, abiraterone was given at 1000 mg qAM following overnight fast. So what does it mean if you live in a more “progressive” state and get the munchies before it’s time for your meds? A low-fat meal (think Jenny Craig) can increase abiraterone concentrations by a factor of 5-7 and a high fat meal (think Jimmy Dean) by a factor of 10-15. This study hypothesized low-dose abiraterone of 250 mg with a low-fat meal would have a noninferior reduction in PSA in men with castration resistant prostate cancer compared to standard dosing of 1000 mg fasting, all with hopes of lowering cost. The results demonstrate a noninferior reduction in PSA at 12 weeks as well as a similar median progression free survival (PFS) time of about 9 months. That’s not without criticisms, though. First, there was no standardized PSA measurement (any lab was used). Plus PSA change at 12 weeks has questionable clinical significance, in any case. Finally, both groups had abiraterone concentrations that were lower than expected (read: lower than what’s believed to be optimal), with the low-dose group achieving particularly low concentrations. Ultimately, while dreamt up with the best of intentions, this study may not have been performed with the best of methods.
Bottom Line: Lower dose abiraterone taken with a low-fat meal was “noninferior” to standard doses while fasting, but some folks don’t believe it. | Szmulewitz, J Clin Oncol 2018
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