Phase Ii Study of Individualized Sunitinib As First-Line Therapy for Metastatic Clear Cell Renal Cell Cancer (Mrcc)

Aim: A high sunitinib area under the curve is associated with more toxicity, and a better response rate (RR), progression free (PFS) and overall survival (OS). Retrospective data (Urol Oncol 2014;32:480) show poorer PFS and OS in mRCC patients (pts) with minimum toxicity on the standard 28 day (d)/14 d schedule vs. pts with toxicity leading to schedule and/or dose changes. We hypothesized that toxicity (mucositis, diarrhea, hand foot syndrome, fatigue, hematological) could serve as a surrogate to individualize therapy (Rx) to optimize drug exposure and manage toxicity for each pt.