Long-Term Safety With Axitinib in Previously Treated Patients With Metastatic Renal Cell Carcinoma

Clinical Genitourinary Cancer
Brian I RiniRobert J Motzer

Abstract

Axitinib is an approved treatment for advanced renal cell carcinoma (RCC) after failure of 1 systemic therapy. Long-term safety with single-agent axitinib was analyzed using pooled data from clinical trials in 672 previously treated patients with metastatic RCC (mRCC) and in 1304 patients with different advanced solid tumors. In all studies, except the phase I first-in-human, dose-finding study, the starting dose of oral axitinib was 5 mg twice daily continuously. Common long-term treatment-emergent adverse events (AEs) were identified in patients who received axitinib for ≥ 2 years, then evaluated in all patients, and assessed using interval, cumulative, and latency analyses. In all, 108 (16%) previously treated patients with mRCC received axitinib for ≥ 2 years. In interval analysis, most AEs occurred during the first 6 months of treatment, with rates stable or decreased over time; rates increased for proteinuria, peripheral edema, and increased blood creatinine. Common Grade ≥ 3 AE rates declined or plateaued over time, except for increased amylase and myocardial infarction. Results were similar in cumulative analysis in this population, and in interval and cumulative analyses in all patients with mRCC and those with advance...Continue Reading

Citations

Dec 13, 2016·International Journal of Molecular Sciences·Aleksandra Semeniuk-WojtaśStanisław Niemczyk
Apr 1, 2017·Targeted Oncology·Brian I RiniThomas E Hutson
Jul 15, 2017·Future Oncology·Yoshiko UmeyamaHideyuki Akaza
Dec 22, 2017·Future Oncology·Manuela SchmidingerSylvie Négrier
Oct 22, 2015·Drugs·Gillian M Keating
Aug 5, 2016·British Journal of Cancer·Basma Greef, Tim Eisen
May 5, 2016·Expert Opinion on Drug Safety·Lisa DerosaBernard Escudier
Mar 2, 2021·Bioorganic & Medicinal Chemistry·Shruti ChoudharyAleem Gangjee

❮ Previous
Next ❯

Related Concepts

Related Feeds

Cardiovascular Disease Pathophysiology

Cardiovascular disease involves several different processes that contribute to the pathological mechanism, including hyperglycemia, inflammation, atherosclerosis, hypertension and more. Vasculature stability plays a critical role in the development of the disease. Discover the latest research on cardiovascular disease pathophysiology here.