ArticleCancer chemotherapy and pharmacology2019
Population pharmacokinetic and covariate analyses of intravenous trastuzumab (Herceptin
Article in Cancer chemotherapy and pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.
- Pooled it
- Evaluation of Innate Immune System, Body Habitus, and Sex on the Pharmacokinetics and Pharmacodynamics of Anetumab Ravtansine in Patients With Cancer.Clinical and translational science · 2025Trial
- A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (HerceptinEuropean journal of drug metabolism and pharmacokinetics · 2024Trial
- Trial
- Population pharmacokinetics and exposure-response relationship of trastuzumab and bevacizumab in early-stage breast cancer.European journal of clinical pharmacology · 2021Trial
- Associations between obesity and outcomes in pembrolizumab-treated endometrial cancer.Gynecologic oncology · 2026Article
- Article
- A recombinant fragment antigen-binding (Fab) of trastuzumab displays low cytotoxic profile in adult human cardiomyocytes: first evidence and the key implication of FcγRIIA receptor.Acta pharmacologica Sinica · 2025Article
- Ultrasound-based radiomics for the evaluation of breast cancer.Frontiers in oncology · 2025Review
- Article
- Pharmacokinetics of trastuzumab and its efficacy and safety in HER2-positive cancer patients.Cancer chemotherapy and pharmacology · 2024Review
- Machine learning-based model constructed from ultrasound radiomics and clinical features for predicting HER2 status in breast cancer patients with indeterminate (2+) immunohistochemical results.Cancer medicine · 2024Article
- Alternative Trastuzumab Dosing Schedules Are Associated With Reductions in Health Care Greenhouse Gas Emissions.JCO oncology practice · 2023Article
- HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial.Investigational new drugs · 2023Article
- Population pharmacokinetics of zanidatamab, an anti-HER2 biparatopic antibody, in patients with advanced or metastatic cancer.Cancer chemotherapy and pharmacology · 2022Article
- Alternative trastuzumab dosing strategies in HER2-positive early breast cancer are associated with patient out-of-pocket savings.NPJ breast cancer · 2022Article
- Predicting HER2 Status in Breast Cancer on Ultrasound Images Using Deep Learning Method.Frontiers in oncology · 2022Article
- Impact of Dose Delays and Alternative Dosing Regimens on Pertuzumab Pharmacokinetics.Journal of clinical pharmacology · 2021Article
- Is weight-based IV dosing of trastuzumab preferable to SC fixed-dose in some patients? A systematic scoping review.Breast (Edinburgh, Scotland) · 2021Article
- Drug Exposure to Establish Pharmacokinetic-Response Relationships in Oncology.Clinical pharmacokinetics · 2020Review
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of the study was to characterize the population pharmacokinetics (PK) of the intravenous formulation of trastuzumab, assess the impact of patient and pathological covariates on trastuzumab PK, and perform simulations to support dosing recommendations in special situations.
methodsSerum trastuzumab concentrations were obtained from 1582 patients with metastatic breast cancer (MBC), early breast cancer (EBC), advanced gastric cancer (AGC), or other tumor types/healthy volunteers in 18 phase I, II, and III trials and analyzed by nonlinear mixed-effects modeling.
resultsA two-compartment model with parallel linear and nonlinear elimination best described the data. During treatment, linear clearance (CL) dominated, resulting in a total CL of 0.173-0.337 L/day, which is similar to other IgG1 monoclonal antibodies. Covariates influencing CL were baseline body weight, aspartate aminotransferase, albumin, gastric cancer, and the presence of liver metastases. MBC and EBC had similar PK parameters, while CL was higher in AGC. Simulations indicated that at least 95% of patients with BC reach concentrations < 1 µg/mL (~ 97% washout) by 7 months. A dose delay in BC or AGC patients of > 1 week would take approximately 6 weeks to get back within steady-state exposure range.
conclusionsTrastuzumab PK for the intravenous formulation was well-described across cancer types, disease status, and regimens. No dose adjustment is required for any of the identified patient covariates. A 7-month serum washout period for trastuzumab is recommended. A reloading dose is required if a maintenance dose is missed by > 1 week.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.