Abstract
Objective: Our study analyzed all oncologic clinical trials using the drug lapatinib to create a risk/benefit profile of this drug.
Background: Drug manufacturers allocate large amounts of time and capital to the development of novel chemotherapies. To make up these costs, companies may seek to repurpose their medications to extended indications via clinical trials. Thus, a portfolio should be created to better understand the risk/benefit.
Methods: On May 25th, 2023, we conducted a search for studies of lapatinib treating solid cancers in Pubmed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. Eligible articles were required to be adult clinical trials, use RECIST criteria, be published in English, and involve solid tumors. Screening and data collection was completed in a masked, duplicate manner. We extracted trial characteristics, median progression-free survival (PFS) and overall survival (OS) in months, adverse event rates, and objective response rate for each study. We labeled studies positive, negative, or indeterminate based on their pre-specified endpoints and tolerability.
Results: Lapatinib was approved in advanced and metastatic breast cancer but has since been tested in 15 other cancer indications. A total of 6,922 grade 3-5 adverse events were experienced in 12,908 patients. The objective response for combination therapy was generally higher in breast cancer, with minor discrepancies. OS and PFS were significantly higher for breast cancer when lapatinib was used as a combination therapy. Lapatinib showed positive outcomes around FDA approval, but became negative and indeterminate.
Conclusions: Lapatinib showed effectiveness for its approved indication as a combination therapy while showing limited benefit in off-label indications. The risk-benefit analysis of lapatinib confirmed its efficacy. Although efficacious in breast cancer, the adverse event rates increased across clinical trials. Future trials using lapatinib should evaluate the risk-benefit profile before utilizing this measure.
Background: Drug manufacturers allocate large amounts of time and capital to the development of novel chemotherapies. To make up these costs, companies may seek to repurpose their medications to extended indications via clinical trials. Thus, a portfolio should be created to better understand the risk/benefit.
Methods: On May 25th, 2023, we conducted a search for studies of lapatinib treating solid cancers in Pubmed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. Eligible articles were required to be adult clinical trials, use RECIST criteria, be published in English, and involve solid tumors. Screening and data collection was completed in a masked, duplicate manner. We extracted trial characteristics, median progression-free survival (PFS) and overall survival (OS) in months, adverse event rates, and objective response rate for each study. We labeled studies positive, negative, or indeterminate based on their pre-specified endpoints and tolerability.
Results: Lapatinib was approved in advanced and metastatic breast cancer but has since been tested in 15 other cancer indications. A total of 6,922 grade 3-5 adverse events were experienced in 12,908 patients. The objective response for combination therapy was generally higher in breast cancer, with minor discrepancies. OS and PFS were significantly higher for breast cancer when lapatinib was used as a combination therapy. Lapatinib showed positive outcomes around FDA approval, but became negative and indeterminate.
Conclusions: Lapatinib showed effectiveness for its approved indication as a combination therapy while showing limited benefit in off-label indications. The risk-benefit analysis of lapatinib confirmed its efficacy. Although efficacious in breast cancer, the adverse event rates increased across clinical trials. Future trials using lapatinib should evaluate the risk-benefit profile before utilizing this measure.
| 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 |
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| Abbreviated title | 7th Joint Annual Research Meeting |
| Country/Territory | United States |
| City | Tulsa |
| Period | 21/07/23 → 21/07/23 |