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

Research output: Contribution to conferencePosterpeer-review

Abstract

Objective: The goal of this study is to evaluate clinical trials to identify pertuzumab's drug development profile as well as the risks and benefits in its off-label use.

Background: Breast cancer is the most prevalent cancer among women, and its diagnosis leads to financial and health burdens. Pertuzumab is an anti-HER2 drug FDA approved for breast cancer, yet it is used for off-label indications. In order to better understand its off-label use, a drug development profile must be established for pertuzumab.

Methods: On May 25, 2023, a search through Pubmed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov was completed to gather clinical trials evaluating pertuzumab. Studies meeting inclusion criteria were screened in a masked duplicate fashion, followed by a full-text screen. Final included studies were evaluated for adverse events, trial characteristics, and endpoints such as objective response rate, progression-free survival, and overall survival.

Results: Since pertuzumab's FDA approval for breast cancer, it has been applied in clinical trials against several different indications. Pertuzumab's use in breast cancer notably showed the highest median objective response rate at 68.3% and median overall survival of 39.2 months. However, pertuzumab's risk/benefit profile has increased since 2012. Off-label use of pertuzumab increased patient risk of adverse events, and the majority failed to meet the study's primary-end-point.

Conclusion: Positive outcomes were seen with the use of pertuzumab in breast cancer trials, while negative results were observed when the drug was used outside of its primary indication. The risk-benefit analysis of pertuzumab in breast cancer revealed a high objective response rate and overall survival, but cumulative adverse events have steadily increased since 2012. Pertuzumab in other indications often failed to meet the study endpoints, and reported comparatively lower objective response rates and overall survival values to that of breast cancer.
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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