TY - JOUR
T1 - Long-term Safety of Sunitinib in Metastatic Renal Cell Carcinoma
AU - Porta, Camillo
AU - Gore, Martin E.
AU - Rini, Brian I.
AU - Escudier, Bernard
AU - Hariharan, Subramanian
AU - Charles, Lorna P.
AU - Yang, Liqiang
AU - Deannuntis, Liza
AU - Motzer, Robert J.
PY - 2016/2/1
Y1 - 2016/2/1
N2 - 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-
AB - 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-
KW - Long-term safety
KW - Renal cell carcinoma
KW - Sunitinib
KW - Toxicity
KW - Treatment-related adverse events
UR - http://www.scopus.com/inward/record.url?scp=84952873380&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84952873380&partnerID=8YFLogxK
U2 - 10.1016/j.eururo.2015.07.006
DO - 10.1016/j.eururo.2015.07.006
M3 - Article
AN - SCOPUS:84952873380
VL - 69
SP - 345
EP - 351
JO - European Urology
JF - European Urology
SN - 0302-2838
IS - 2
ER -