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
Jan 1, 2017·Cardio-Oncology·Daniel PinkhasSakima Smith
Aug 5, 2016·British Journal of Cancer·Basma Greef, Tim Eisen
Jul 1, 2020·Expert Opinion on Drug Metabolism & Toxicology·Liyu JiangPeihua Luo
Jan 27, 2019·Medicine·Pengfei CuiZiling Liu
Nov 10, 2015·Case Reports in Oncological Medicine·Bo ZhaoBrian I Rini
May 5, 2016·Expert Opinion on Drug Safety·Lisa DerosaBernard Escudier
Oct 25, 2020·Investigational New Drugs·Masahide FukudoYoshikazu Tasaki
Dec 4, 2020·Cancer Control : Journal of the Moffitt Cancer Center·Haoran ZhangPengfei Shen
Mar 2, 2021·Bioorganic & Medicinal Chemistry·Shruti ChoudharyAleem Gangjee