Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Abiraterone Clinical Trials

Matthew Rashid, Eli Oldham, Griffin K. Hughes, Andriana M. Peña, Chase Ladd, Brooke Gardner, Ryan McIntire, Bradley Johnson, Jordan Tuia, Alyson Haslam, Vinay Prasad, Matt Vassar

Research output: Contribution to conferencePosterpeer-review

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Abstract

Objective: Our goal was to analyze the risk/benefit profiles of clinical trials involving abiraterone in cancer treatment.

Methods: On May 24, 2023, we searched Pubmed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov for clinical trials using abiraterone for cancer treatment. Data were extracted using Google Forms in a masked, duplicate fashion. We collected adverse event data, progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and prostate-specific antigen response rate (PSA-RR). The CTCAE grades were used to measure the risk, and the results of the ORR measured were used to determine benefit. The primary endpoints were deemed positive, negative, or indeterminate based on abiraterone's safety profile and the PSA-RR or OS values indicated in each of the clinical trials.

Results: Nearly all clinical trials testing abiraterone in prostate cancer showed promising outcomes with 89% of studies meeting their endpoint. Our study supports abiraterone's use in prostate cancer, its only FDA-approved indication to treat, with a median ORR of 20.0% and a median PSA-RR of 42.0%. However, when looking at the three novel indications tested, the risk-to-benefit profile was similar to that of its original approval. Even though most novel indications failed to meet their primary endpoint, the overall toxicity profile was similar to that found in prostate cancer.

Conclusion: Abiraterone showed an overall risk-to-benefit portfolio that supports the use of its treatment in prostate cancer. Although the primary endpoints in ovarian and breast cancer trials were not met, the use was appropriate when assessing how the mechanism of action for abiraterone could be beneficial in patients with these types of cancers.
Original languageAmerican English
StatePublished - 21 Jul 2023
Event7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States
Duration: 21 Jul 202321 Jul 2023

Conference

Conference7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics
Abbreviated title7th Joint Annual Research Meeting
Country/TerritoryUnited States
CityTulsa
Period21/07/2321/07/23

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