ObjectiveNeratinib plus capecitabine (Ner+Cap) were proved to be clinically beneficial as a third-line treatment for women with human epidermal growth factor receptor-2 (HER2) positive metastatic breast cancer (MBC). The objective of this study was to evaluate the cost-effectiveness of Ner+Cap from the Chinese healthcare perspective.DesignA three-state Markov simulation model was performed based on the results of NALA trial. The utilities of health state and disutilities of adverse events were derived from the published literature. Direct costs of anticancer agents, drug administration, routine follow-up and serious adverse events management were calculated in the model. Uncertainty was evaluated through univariate and probability sensitivity analysis.ParticipantsPatients with confirmed HER2-positive MBC who previously received at least two HER2-targeted treatments and were aged ≥18 years with an Eastern Cooperative Oncology Group performance status 0 or 1. A total of 621 patients were enrolled in the NALA trial.InterventionsThird-line treatment with Ner+Cap or lapatinib plus capecitabine (Lap+Cap).Main outcome measuresThe primary health outcomes of the model were costs, expected life-years (LYs), quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs).ResultsWhen compared with Lap+Cap, Ner+Cap provided an additional 0.431 LYs and 0.339 QALYs, and increased the cost by $4299.2. The corresponding ICERs were 9970.1/LY and $12 670.2/QALY. Univariate sensitivity analyses suggested that the results were generally robust. Besides, Ner+Cap had a 100% probability of being cost-effective according to probabilistic sensitivity analysis.ConclusionsNer+Cap was likely to be a cost-effective regimen as the third-line therapy for women with HER2-positive MBC at the willingness-to-pay threshold of $37 653.0/QALY in China.
Background
Abemaciclib is currently the most active Cyclin4/6-dependent kinase inhibitor (CDKI) for the treatment of estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative(HER2−) advanced breast cancer. We explored the potential adverse reactions of Abemaciclib by mining the relevant reported data and tried to provide information for the clinical safe medication.
Methods
Reporting odds ratio (ROR) was used to detect adverse event signals from the data in the US Food and Drug Administration (FDA) adverse event reporting system database (FAERS). The definition depended on preferred terms (PTs) and system organ class (SOCs) by the Medical Dictionary for Regulatory Activities (MedDRA).
Results
A total of 5680 reports and 12170 adverse events were retrieved, 55 alert signals were excavated. Among them, the strong signals were "weight decreased”, “blood creatinine increased”, “constipation”, “stomatitis”, “pleural effusion”, “pneumothorax”, ”hot flashes”, ”hypokalemia”, “blood potassium decreased”, “taste disorder”, “eating disorder”, ”renal impairment”, “kidney disease” and “lacrimation increased”. We found that “eating disorder”, “hot flush” and ”pleural effusion” are some new safety signals. The system organ class (SOC) involved in the highest frequency signals mainly focused on abnormal examination parameters and gastrointestinal system diseases.
Conclusions
Overall, by using the FDA FAERS the present study suggested some new safety signals, which deserve more careful monitoring in clinic.
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