According to the study, patients who take a reduced dose of abiraterone with a low-fat meal may cut costs by as much as $300,000.
Treatment with abiraterone acetate, a standard first-line therapy for metastatic castration-resistant prostate cancer, can cause significant financial burden for patients. According to a recently-published study in the Journal of Clinical Oncology, the current regimen for the drug can be inconvenient for patients, as well as wasteful.1
Approved in 2011, a 1-month supply of the recommended dose of abiraterone costs from $8000 to $11,000 when purchased wholesale, according to the study authors. Many patients take the drug for 2 to 3 years.
Typically, patients who are prescribed abiraterone are told to take 4 of the 250-mg pills first thing in the morning, and must wait at least 1 hour before consuming food. According to the authors, taking abiraterone with a low-fat meal—consisting of approximately 300 calories and 7% fat—can boost its “food effect,” allowing the amount of the drug that is absorbed to be multiplied by 4 or 5 times, which can then increase to 10 times with a high-fat meal of 825 calories and 57% fat.
The authors conducted a clinical trial to compare the cost, risks, and benefits of taking abiraterone with or without breakfast. Launched in 2012, the study included 72 patients with advanced prostate cancer who were divided into 2 separate groups: a low-dose food group and a standard-dose fasting group. Patients in the low-dose food group took one-fourth of the standard dose, a single 250-mg pill, with a low-fat breakfast such as cereal with skim milk. They were advised to avoid high-fat items, such as bacon or sausage.
In the other group, patients took the recommended dose of 1000 milligrams — 4 pills each morning with water on an empty stomach – and were told to wait an additional hour afterwards before they could eat breakfast. Four patients, 2 from each group, dropped out before the study began.
The authors found that the low-dose food group kept the disease under control as well as the standard-dose fasting group. In patients in the low-dose food group, abiraterone demonstrated a slightly greater ability to lower levels of prostate-specific antigen, a surrogate marker for prostate cancer, when measured at 12 weeks.
Progression-free survival for patients in both groups was identical at approximately 8.6 months. The authors noted that, despite the small study size, they were confident of the comparable results between the low-dose and the standard-dose arm.
“Although it should be validated with a larger trial with more robust clinical endpoints, given the pharmacoeconomic implications, these data warrant consideration by prescribers, payers, and patients,” the study’s lead author Russell Szmulewitz, MD, associate professor of medicine at the University of Chicago and a prostate cancer specialist, said in a press release.2
The low-dose regimen with food was also slightly more convenient for patients and much less expensive, cutting costs by as much as $300,000 per patient, the authors noted.
1. Szmulewitz RZ, Peer CJ, Ibraheem A, et al. Prospective international randomized phase II study of low-dose abiraterone with food versus standard dose abiraterone in castration-resistant prostate cancer. Journal of Clinical Oncology. Published March 28, 2018. Doi: 10.1200/JCO.2017.76.4381
2. Taking a standard prostate cancer drug with food boosts impact, lowers cost [news release]. University of Chicago Medicine’s website. https://www.uchicagomedicine.org/cancer-articles/taking-a-standard-prostate-cancer-drug-with-food-boosts-impact-lowers-cost. Accessed April 2, 2018.