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

R. Hunter Hall, Carson L. Wright, Griffin K. Hughes, Andriana M. Peña, Chase Ladd, Brooke Gardner, Ryan McIntire, Jane Rubenstein, Jordan Tuia, Alyson Haslam, Vinay Prasad, Matt Vassar

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Abstract

Objective: The objective of this study is to examine the total benefit/burden portfolio for published clinical trials using afatinib.

Background: Lung cancer remains the leading cause of cancer-related deaths in the United States. The high prevalence of lung cancer has played a role in the expansion of drug development. Afatinib was developed as a therapy for lung cancer which has been expanded to other indications in hope for more viable treatment for other indications.

Methods: In this cross-sectional investigation, we screened PubMed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov for clinical trials of afatinib as monotherapy or in combination with other interventions for solid cancer treatment. We extracted adverse event rates, median progression free survival, median overall survival, and objective response rate for each included trial. Studies were considered positive if they met their primary endpoint and retained safety, negative if neither criteria were met, and indeterminate if no endpoint was prespecified.

Results: Our search yielded 2,444 articles for initial consideration. We excluded this number to 92 included trials with 8,859 patients. Our sample had 49 (53%) positive trials, 27 (29%) negative trials, and 16 (17%) indeterminate trials. Afatinib was most commonly indicated for non-small cell lung cancer, 48.9%, and squamous cell carcinoma of head and neck, 21.7%. The median OS was 8.4 months, median PFS 3.4 months, and total ORR of 29.6%.

Conclusion: Our study found that beyond its primary indication for lung cancer there was little success. The recurring breast cancer trials consistently show negative results with more adverse events when compared to other indications. We recommend that in clinical practice, physicians closely consider the risk/benefit portfolio when considering afatinib as treatment.
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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