Long-term Safety of Sunitinib in Metastatic Renal Cell Carcinoma

Camillo Porta, Martin E. Gore, Brian I. Rini, Bernard Escudier, Subramanian Hariharan, Lorna P. Charles, Liqiang Yang, Liza Deannuntis, Robert J. Motzer

Research output: Contribution to journalArticlepeer-review


Background Metastatic renal cell carcinoma (mRCC) patients receiving first-line sunitinib typically survive >2 yr, with chronic treatment sometimes extending to ≥6 yr. Objective To analyze long-term safety with sunitinib in mRCC patients. Design, setting, and participants Data were pooled from 5739 patients in nine trials, comprising seven phase II studies, a phase III study, and an expanded-access trial in various treatment settings (e.g. cytokine refractory or treatment-naïve). Outcome measurements and statistical analysis Interval and cumulative time-period analyses evaluated the incidence of treatment-related adverse events (TRAEs) for up to 6 yr, in the overall population and in those with long-term (≥2 yr) sunitinib treatment. Results and limitations Among long-term patients (n=807), most TRAEs occurred initially in the first year and then decreased in frequency; TRAEs following this pattern included decreased appetite, diarrhea, dysgeusia, dyspepsia, fatigue, hypertension, mucosal inflammation, nausea, and stomatitis. However, hypothyroidism increased by interval analysis from 6% at 0-

Original languageEnglish
Pages (from-to)345-351
Number of pages7
JournalEuropean Urology
Issue number2
Publication statusPublished - Feb 1 2016


  • Long-term safety
  • Renal cell carcinoma
  • Sunitinib
  • Toxicity
  • Treatment-related adverse events

ASJC Scopus subject areas

  • Urology


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