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1.
Expert Opin Drug Saf ; 22(3): 243-252, 2023 Mar.
Article in English | MEDLINE | ID: mdl-35998294

ABSTRACT

BACKGROUND: Several therapies directed at novel targets and also immunotherapies have recently shown promising results in advanced or metastatic TNBC. We aimed to compare the efficacy and safety of these new regimens for advanced or metastatic TNBC (mTNBC). METHODS: The PubMed, Embase, and Cochrane Library electronic databases were searched for phase III randomized trials. We conducted a network meta-analysis to compare the efficacy and safety of new targeted and immunotherapy regimens. Trial quality was assessed using the GRADE method. The comparative outcomes were progression-free survival, overall survival, and G3-4 adverse drug events (ADEs). RESULTS: Thirteen phase III randomized controlled trials were identified in the network meta-analysis. Olaparib significantly improved PFS in comparison with the pembrolizumab plus chemotherapy 1, atezolizumab plus nab-paclitaxel and pembrolizumab regimens. Sacituzumab yielded a significant improvement in OS over immunotherapies, veliparib, and chemotherapy alone, but no significantly superiority over pembrolizumab, olaparib, and talazoparib. The risk of ≥grade 3 ADEs associated with olaparib was significantly lower than the risks associated with the other regimens. CONCLUSION: For mTNBC, sacituzumab had a better effect on overall survival, with comparatively high risk of SAE, whereas olaparib improved progression-free survival with a lower risk of SAE, particularly in those patients with BRCA mutations.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Triple Negative Breast Neoplasms , Humans , Network Meta-Analysis , Triple Negative Breast Neoplasms/drug therapy , Immunotherapy/adverse effects , Antibodies, Monoclonal
2.
Breast ; 65: 91-97, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35870421

ABSTRACT

BACKGROUND: The rising cost of cancer drug therapy threatens the long-term sustainability of Taiwan National Health Insurance. Cost savings can be achieved through various strategies, e.g., using smaller vial sizes, sharing vials, weight-based dosing, or switching to biosimilars. Here we aimed to examine the cost-effectiveness of a trastuzumab biosimilar combined with docetaxel (TDbiol) for treatment-naïve HER2+ metastatic breast cancer (MBC), and the financial impact of drug wastage. METHODS: A Markov model with three health states was developed to assess the cost-effectiveness of trastuzumab biosimilars plus docetaxel over a 40-month time horizon in patients with HER2+ MBC. Based on the literature and our expert opinion, we assumed similar efficacy between the trastuzumab biosimilar and its reference product. The primary clinical input for the biosimilar was the same as for the reference product in the Catastrophic Patient Database (HV). Health state utilities were derived from the literature, and direct medical costs were obtained from the National Health Insurance Administration (NHIA). RESULTS: In the base-case scenario, the incremental cost-effectiveness ratio (ICER) was NTD 811,050 per QALY gained. One-way sensitivity analyses showed that the model was sensitive to utilities and transition probabilities, but not particularly sensitive to the wastage assumption. In scenario analyses, the ICER was higher when applying the price for trastuzumab reference biologic (branded), than for trastuzumab biosimilar. CONCLUSION: The trastuzumab biosimilar combination regimen is cost-effective and offers significant drug cost savings in Taiwan.


Subject(s)
Biosimilar Pharmaceuticals , Breast Neoplasms , Neoplasms, Second Primary , Biosimilar Pharmaceuticals/therapeutic use , Breast Neoplasms/pathology , Cost-Benefit Analysis , Docetaxel/therapeutic use , Female , Humans , Markov Chains , Pharmaceutical Preparations , Quality-Adjusted Life Years , Receptor, ErbB-2 , Trastuzumab/therapeutic use
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