Abstract
Objective: To examine oncological clinical trials using enzalutamide in order to generate a comprehensive assessment of the drugs risks and benefits for approved and non-approved indications.
Background: Developing novel chemotherapy drugs is time consuming and expensive. To compensate for this expense, drug manufacturers attempt to expand the drug indications by conducting clinical trials. To effectively assess the risk/benefit profile as it relates to clinical efficacy, a complete analysis is required.
Methods: On May 25th, 2023 we conducted a search of Pubmed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov for clinical trials of enzalutamide in the treatment of solid tumors. Per our inclusion criteria, we selected trials using RECIST criteria, published in English, included adult participants, and treated solid tumors. Data extraction and screening was conducted in a blinded, duplicate fashion. We compiled study demographics, PSA response, median progression-free survival (PFS) and overall survival (OS) in months, adverse events and objective response for each trial. The results of the study were classified as positive, negative or indeterminate based on trial predetermined primary endpoints and tolerability.
Results: Enzalutamide, approved for treating prostate cancer in 2012, has since undergone trials in 5 off-label indications. Following its approval, enzalutamide has been attributed to 4,733 grade 3-5 adverse events in 9,475 patients. It has shown a positive profile and moderate objective response (12.9%) in FDA approved indications. However, when comparing enzalutamide's impact on other histologies, a similar profile exists, with lacking ability to produce significant benefits in PFS, OS, or objective response.
Conclusions: Despite positive outcomes in trials outside of enzalutamide's primary indication, little evidence exists to support the benefit or efficacy of its use in alternative histologies. Furthermore, given that enzalutamide has shown the propensity to cause adverse events, physicians should consider the risk-to-benefit profile of enzalutamide before recommending treatment.
Background: Developing novel chemotherapy drugs is time consuming and expensive. To compensate for this expense, drug manufacturers attempt to expand the drug indications by conducting clinical trials. To effectively assess the risk/benefit profile as it relates to clinical efficacy, a complete analysis is required.
Methods: On May 25th, 2023 we conducted a search of Pubmed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov for clinical trials of enzalutamide in the treatment of solid tumors. Per our inclusion criteria, we selected trials using RECIST criteria, published in English, included adult participants, and treated solid tumors. Data extraction and screening was conducted in a blinded, duplicate fashion. We compiled study demographics, PSA response, median progression-free survival (PFS) and overall survival (OS) in months, adverse events and objective response for each trial. The results of the study were classified as positive, negative or indeterminate based on trial predetermined primary endpoints and tolerability.
Results: Enzalutamide, approved for treating prostate cancer in 2012, has since undergone trials in 5 off-label indications. Following its approval, enzalutamide has been attributed to 4,733 grade 3-5 adverse events in 9,475 patients. It has shown a positive profile and moderate objective response (12.9%) in FDA approved indications. However, when comparing enzalutamide's impact on other histologies, a similar profile exists, with lacking ability to produce significant benefits in PFS, OS, or objective response.
Conclusions: Despite positive outcomes in trials outside of enzalutamide's primary indication, little evidence exists to support the benefit or efficacy of its use in alternative histologies. Furthermore, given that enzalutamide has shown the propensity to cause adverse events, physicians should consider the risk-to-benefit profile of enzalutamide before recommending treatment.
| Original language | American English |
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| State | Published - 21 Jul 2023 |
| Event | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States Duration: 21 Jul 2023 → 21 Jul 2023 |
Conference
| Conference | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics |
|---|---|
| Abbreviated title | 7th Joint Annual Research Meeting |
| Country/Territory | United States |
| City | Tulsa |
| Period | 21/07/23 → 21/07/23 |