Randomized, open-label, phase 3 trials of sorafenib in RCC published following the TARGET trial.

Abbreviations: AE = adverse event; AX = axitinib; CI = confidence interval; CR = complete response; ECOG PS = Eastern Cooperative Oncology Group performance status; DOV = dovitinib; HFSR = hand-foot skin reaction; HR = hazard ratio; MSKCC = Memorial Sloan-Kettering Cancer Center; NR = not reported; OS = overall survival; PFS = progression-free survival; PR = partial response; SAE = serious adverse event; SD = stable disease; SOR = sorafenib; SU = sunitinib; TEM = temsirolimus; TIV = tivozanib.a Data reported only for first-line sorafenib.b Unless otherwise noted, baseline characteristics refer to the overall SU-SO population at study entry (n = 176); characteristics of patients who crossed over are NRc Except adjuvant IFNa.d 1-sided CI.e HR for progression of death.f Occurring in >20% of patients in any phase 3 study.g Data missing for 1 pt.h Reported as grade ≥3.i Data missing for 5 pts.j 18 (7%) had normal thyroid-stimulating hormone levels prior to dosing that increased to >10 IU/mL after treatment; 5 (2%) had low T3 and 2 (1%) had low T4 on or after the date that the increases in thyroid-stimulating hormone were observed.Randomized, open-label, phase 3 trials of sorafenib in RCC published following the TARGET trial.