Comparison of out-of-pocket costs and adherence between the two arms of the prospective, randomized abiraterone food effect trial.

Abiraterone acetate, prescribed for metastatic prostate cancer, has enhanced absorption with food. This effect was exploited in a randomized trial which showed noninferiority of PSA decline for 250 mg abiraterone with a low-fat meal (LOW) compared to 1,000 mg abiraterone fasting (STD). Drug was obtained via patient insurance. Patient out-of-pocket costs and adherence were surveyed.

Trial participants were randomized to STD or LOW, and surveys of adherence and out-of-pocket costs were administered at baseline and just before coming off study (follow-up).

Out-of-pocket costs were available from 20 of 36 STD and 21 of 36 LOW patients. Median out-of-pocket costs for a month of drug were $0 (LOW) and $5 (STD); mean costs were $43.61 (LOW) and $393.83 (STD). The two groups did not differ significantly (p = 0.421). Maximum out-of-pocket cost was $1,000 (LOW) and $4,000 (STD). Monthly out-of-pocket costs > $500 were found in 1 LOW and 5 STD patients. For adherence, only 11 STD and 19 LOW patients had questionnaires completed at both baseline and follow-up. STD adherence was 98.18% at baseline and 91.69% at follow-up, differing significantly (p = 0.0078). LOW adherence was 96.52% at baseline and 97.86% at follow-up, not differing significantly (p = 0.3511). Adherence did not correlate with demographics. At follow-up, increasing adherence correlated significantly with decreasing dose (p = 0.013; rho =  - 0.458).

Out-of-pocket costs did not differ significantly in this limited analysis. Adherence was significantly different in STD as the trial progressed, which was not found in LOW.

ClinicalTrials.gov NCT01543776; registered March 5, 2012.

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021 Nov 29 [Epub ahead of print]

Brian L Heiss, Daniel M Geynisman, Elia Martinez, Alvin S C Wong, Wei Peng Yong, Russell Z Szmulewitz, Walter M Stadler

Department of Medicine, Section of Hematology/Oncology, The University of Chicago, 5841 S. Maryland Ave, MC 2115, Chicago, IL, 60637, USA. ., Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA., Department of Medicine, Section of Hematology/Oncology, The University of Chicago, 5841 S. Maryland Ave, MC 2115, Chicago, IL, 60637, USA., Department of Haematology-Oncology, National University Cancer Institute, Singapore, Singapore.

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