Axitinib safety in metastatic renal cell carcinoma: Suggestions for daily clinical practice based on case studies

Sergio Bracarda, Daniel Castellano, Giuseppe Procopio, Juan M. Sepúlveda, Michele Sisani, Elena Verzoni, Manuela Schmidinger

Research output: Contribution to journalArticlepeer-review


Introduction: Axitinib, a highly selective inhibitor of vascular endothelial growth factor receptors taken orally, is approved for second-line treatment of advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. We review data for axitinib and discuss strategies to manage or prevent adverse events (AEs) and maximize clinical benefit. Areas covered: A literature search identified key advanced RCC trials of axitinib and other targeted therapies. Each author also contributed a clinical case study to illustrate management approaches in patients who received axitinib following sunitinib in the AXIS Phase III trial. Axitinib has demonstrated a predictable and manageable AE profile in clinical trials; most commonly reported treatment-related events are diarrhea, hypertension, fatigue, nausea, vomiting and dysphonia. Case studies demonstrate that successful management requires patient awareness of potential AEs, regular monitoring and dose modification for specific AEs. Expert opinion: Improvement in progression-free survival with axitinib versus sorafenib in a Phase III trial supports preferred selection of axitinib in the second-line setting. The safety profile of axitinib versus mammalian target of rapamycin inhibitors and sorafenib also provides the opportunity to personalize treatment in advanced RCC based on the likelihood for specific AEs to occur and on prior toxicities in the first-line setting.

Original languageEnglish
Pages (from-to)497-510
Number of pages14
JournalExpert Opinion on Drug Safety
Issue number4
Publication statusPublished - 2014


  • Adverse events
  • AXIS
  • Axitinib
  • Renal cell carcinoma
  • Therapy management

ASJC Scopus subject areas

  • Pharmacology (medical)


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