A phase i open-label trial evaluating the cardiovascular safety of regorafenib in patients with advanced cancer
Cancer Chemotherapy and Pharmacology, ISSN: 1432-0843, Vol: 76, Issue: 4, Page: 777-784
2015
- 17Citations
- 48Captures
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
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Metrics Details
- Citations17
- Citation Indexes17
- 17
- CrossRef9
- Captures48
- Readers48
- 48
Article Description
Purpose: To characterize the cardiovascular safety profile of regorafenib in patients with advanced cancer. Methods: Patients received regorafenib 160 mg/day for 21 days followed by a 7-day break. The primary endpoint was the change from baseline in QTcF at the regorafenib t (Day 21, Cycle 1 or 2) and changes in left ventricular ejection fraction (LVEF) from baseline on Cycle 2, Day 21. Secondary objectives were pharmacokinetics, safety, anti-tumor activity and effects on electrocardiogram intervals. QT intervals were corrected using the methods of Fridericia (QTcF) and Bazett (QTcB). LVEF was assessed by multigated acquisition scanning. Results: Fifty-three patients were enrolled, and all received at least one dose of regorafenib 160 mg. Twenty-five patients received regorafenib for 21 days without dose reduction. The mean change from baseline in QTcF at t was (-)2 ms (90 % CI -8, 3). No patient experienced a change from baseline in QTcF > 60 ms, and two had QTcF changes between 30 and 60 ms. No patient had a QTcF or QTcB > 480 ms. In 27 patients who received at least 80 mg of regorafenib, the mean change from baseline in LVEF% ± SD was 1.7 ± 7.8. In 14 patients without a dose reduction, the mean change from baseline in LVEF% was (-)0.1 ± 8.6 at Cycle 2, Day 21. Four patients experienced a LVEF decrease between 10 and 20 %. Conclusion: The effects of regorafenib on the QT/QTc interval and LVEF were modest and unlikely to be of clinical significance in the setting of advanced cancer therapy.
Bibliographic Details
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84942192960&origin=inward; http://dx.doi.org/10.1007/s00280-015-2827-3; https://clinicaltrials.gov/ct2/show/NCT01339104; http://www.ncbi.nlm.nih.gov/pubmed/26281907; http://link.springer.com/10.1007/s00280-015-2827-3; https://dx.doi.org/10.1007/s00280-015-2827-3; https://link.springer.com/article/10.1007/s00280-015-2827-3
Springer Science and Business Media LLC
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