ArticleInvestigational new drugs2021
Pharmacokinetics of the oral multikinase inhibitor regorafenib and its association with real-world treatment outcomes.
Article in Investigational new drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Efficacy and safety comparison of small molecule anti-angiogenic drugs in the treatment of bone and soft tissue sarcomas : a network meta-analysis.BMC cancer · 2025Pooled it
- Impact of trough concentrations of regorafenib and its major metabolites M-2 and M-5 on overall survival of chemorefractory metastatic colorectal cancer patients: Results from a multicentre GERCOR TEXCAN phase II study.European journal of cancer (Oxford, England : 1990) · 2022Trial
- Development of a UPLC-MS/MS method and its application for the pharmacokinetic analysis of regorafenib in rats.Scientific reports · 2026Article
- Early Higher Plasma Regorafenib Concentration Predicts Shorter PFS in Japanese Patients With mCRC.Clinical and translational science · 2025Article
- Pharmacokinetic Interaction Between Olaparib and Regorafenib in an Animal Model.Pharmaceutics · 2024Article
- Pharmacokinetic interaction between regorafenib and atorvastatin in rats.Pharmacological reports : PR · 2024Article
- Association between albumin-bilirubin grade and plasma trough concentrations of regorafenib and its metabolites M-2 and M-5 at steady-state in Japanese patients.Investigational new drugs · 2024Article
- Therapeutic Drug Monitoring of Kinase Inhibitors in Oncology.Clinical pharmacokinetics · 2023Review
- Targeting PSAT1 to mitigate metastasis in tumors with p53-72Pro variant.Signal transduction and targeted therapy · 2023Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose Despite the established activity of regorafenib in metastatic colorectal cancer (CRC), gastrointestinal stromal tumor (GIST), and hepatocellular carcinoma (HCC), its toxicity profile has limited clinical use. We aimed to evaluate the pharmacokinetics of regorafenib and its active metabolites M-2/M-5, and to clarify the relationships between total drug-related exposure and clinical outcomes in real-world practice. Methods Blood samples at steady state were obtained during Cycle 1 from patients treated with regorafenib. Plasma concentrations of regorafenib and its metabolites were measured by liquid chromatography-tandem mass spectrometry. The efficacy and safety endpoints were progression-free survival (PFS) and dose-limiting toxicities (DLTs), respectively. The exposure-response relationships were assessed. Results Thirty-four Japanese patients with advanced cancers were enrolled (CRC, n = 26; GIST and HCC, each n = 4). Nine patients started regorafenib treatment at the recommended dose of 160 mg once daily (3 weeks on / 1 week off), while the other patients received a reduced starting dose to minimize toxicities. The median PFS was significantly longer in patients achieving total trough concentrations (C
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