Long-term Safety of Sunitinib in Metastatic Renal Cell Carcinoma

摘要: Abstract 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 in mRCC patients. Design, setting, and participants Data were pooled from 5739 nine trials, comprising seven phase II studies, a III study, an expanded-access trial various settings (e.g. cytokine refractory or treatment-naive). Outcome measurements statistical analysis Interval cumulative time-period analyses evaluated the incidence of treatment-related adverse events (TRAEs) for up 6 overall population those (≥2 yr) treatment. Results limitations Among ( n =807), most TRAEs occurred initially first year then decreased frequency; following this pattern included appetite, diarrhea, dysgeusia, dyspepsia, fatigue, hypertension, mucosal inflammation, nausea, stomatitis. However, hypothyroidism increased by interval 6% at 0– Conclusions Prolonged was not associated new types severity TRAEs. Except hypothyroidism, toxicity cumulative. Patient summary More than 800 received between 2 yr without experiencing more severe toxicity. Clinicians may be able prescribe as long continue derive clinical benefit, untoward additional risk.