SUTENT Has an Established Safety Profile
Reference: 1. Data on file. Pfizer Inc, New York, NY.
Treatment-Emergent Adverse Reactions (ARs)
*Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
aGrade 4 ARs in patients on SUTENT included back pain (1%), arthralgia (<1%), dyspnea (<1%), asthenia (<1%), fatigue (<1%), limb pain (<1%), and rash (<1%).
bGrade 4 ARs in patients on IFNα included dyspnea (1%), fatigue (1%), abdominal pain (<1%), and depression (<1%).
cIncludes decreased appetite.
dIncludes ageusia, hypogeusia, and dysgeusia.
eIncludes 1 patient with Grade 5 gastric hemorrhage.
fIncludes flank pain.
Results of the phase 3, randomized, multicenter trial of treatment-naïve patients with metastatic renal cell carcinoma (RCC) (N=750). Patients were treated with either 50-mg SUTENT once daily in cycles of 4 weeks on/2 weeks off, or 9 MIU interferon alfa (IFNα) 3 times per week until disease progression or study withdrawal.
SUTENT Laboratory Abnormalities
*Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
aGrade 4 laboratory abnormalities in patients on SUTENT included uric acid (14%), lipase (3%), neutrophils (2%), lymphocytes (2%), hemoglobin (2%), platelets (1%), amylase (1%), ALT (<1%), creatine kinase (<1%), creatinine (<1%), glucose increased (<1%), calcium decreased (<1%), phosphorous (<1%), potassium increased (<1%), and sodium decreased (<1%).
bGrade 4 laboratory abnormalities in patients on IFNα included uric acid (8%), lymphocytes (2%), lipase (1%), neutrophils (1%), amylase (<1%), calcium increased (<1%), glucose decreased (<1%), potassium increased (<1%), and hemoglobin (<1%).
Results of the phase 3, randomized, multicenter trial of treatment-naïve patients with metastatic renal cell carcinoma (RCC) (N=750). Patients were treated with either 50-mg SUTENT once daily in cycles of 4 weeks on/2 weeks off, or 9 MIU interferon alfa (IFNα) 3 times per week until disease progression or study withdrawal.
The Majority of Patients Did Not Discontinue Due to ARs
Dose interruptions and dose reductions may have helped to prevent treatment discontinuations
- 54% of SUTENT patients had a dose interruption (vs 39% with IFNα)
- 52% of SUTENT patients had a dose reduction (vs 27% with IFNα)
Other reasons for discontinuation included decision of sponsor, protocol violation, withdrawal of consent, completion of study crossover, and failure to take study drug.1
Results of the phase 3, randomized, multicenter trial of treatment-naïve patients with metastatic renal cell carcinoma (RCC) (N=750). Patients were treated with either 50-mg SUTENT once daily in cycles of 4 weeks on/2 weeks off, or 9 MIU interferon alfa (IFNα) 3 times per week until disease progression or study withdrawal.
