AST / ALT 78 (39) 3 (2) 23 (23) 1 (1)
Lipase 50 (25) 20 (10) 17 (17) 7 (7)
Alkaline phosphatase 48 (24) 7 (4) 21 (21) 4 (4)
Amylase 35 (17) 10 (5) 12 (12) 3 (3)
Total bilirubin 32 (16) 2 (1) 8 (8) 0 (0)
Indirect bilirubin 20 (10) 0 (0) 4 (4) 0 (0)
Cardiac
Decreased LVEF 22 (11) 2 (1) 3 (3) 0 (0)
Renal/Metabolic
Creatinine 25 (12) 1 (1) 7 (7) 0 (0)
Potassium decreased 24 (12) 1 (1) 4 (4) 0 (0)
Sodium increased 20 (10) 0 (0) 4 (4) 1 (1)
Hematology
Neutrophils 107 (53) 20 (10) 4 (4) 0 (0)
Lymphocytes 76 (38) 0 (0) 16 (16) 0 (0)
Platelets 76 (38) 10 (5) 4 (4) 0 (0)
Hemoglobin 52 (26) 6 (3) 22 (22) 2 (2)
The as-treated patient population for the treatment-naive RCC study included 735 patients, 375 randomized to SUTENT and 360 randomized to IFN-α. The median duration of treatment was 11.1 months (range: 0.4 – 46.1) for SUTENT treatment and 4.1 months (range: 0.1 – 45.6) for IFN-α treatment. Dose interruptions occurred in 202 patients (54%) on SUTENT and 141 patients (39%) on IFN-α. Dose reductions occurred in 194 patients (52%) on SUTENT and 98 patients (27%) on IFN-α. Discontinuation rates due to adverse reactions were 20% for SUTENT and 24% for IFN-α. Most treatment-emergent adverse reactions in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 77% versus 55% of patients on SUTENT versus IFN-α, respectively.
Table 3 compares the incidence of common (≥10%) treatment-emergent adverse reactions for patients receiving SUTENT versus IFN-α.
Treatment-emergent Grade 3/4 laboratory abnormalities are presented in Table 4.
Table 3. Adverse Reactions Reported in at Least 10% of Patients with RCC Who Received SUTENT or IFN-αCommon Terminology Criteria for Adverse Events (CTCAE), Version 3.0 Adverse Reaction,
n (%) Treatment-Naïve RCC
SUTENT (n=375) IFN-α (n=360)
All Grades Grade 3/4Grade 4 ARs in patients on SUTENT included back pain (1%), arthralgia (<1%), dyspnea (<1%), asthenia (<1%), fatigue (<1%), limb pain (<1%) and rash (<1%). All Grades Grade 3/4Grade 4 ARs in patients on IFN-α included dyspnea (1%), fatigue (1%), abdominal pain (<1%) and depression (<1%).
Any 372 (99) 290 (77) 355 (99) 197 (55)
Constitutional
Fatigue 233 (62) 55 (15) 202 (56) 54 (15)
Asthenia 96 (26) 42 (11) 81 (22) 21 (6)
Fever 84 (22) 3 (1) 134 (37) 1 (<1)
Weight decreased 60 (16) 1 (<1) 60 (17) 3 (1)
Chills 53 (14) 3 (1) 111 (31) 0 (0)
Chest Pain 50 (13) 7 (2) 24 (7) 3 (1)
Influenza like illness 18 (5) 0 (0) 54 (15) 1 (<1)
Gastrointestinal
Diarrhea 246 (66) 37 (10) 76 (21) 1 (<1)
Nausea 216 (58) 21 (6) 147 (41) 6 (2)
Mucositis/stomatitis 178 (47) 13 (3) 19 (5) 2 (<1)
Vomiting 148 (39) 19 (5) 62 (17) 4 (1)
Dyspepsia 128 (34) 8 (2) 16 (4) 0 (0)
Abdominal painIncludes flank pain 113 (30) 20 (5) 42 (12) 5 (1)
Constipation 85 (23) 4 (1) 49 (14) 1 (<1)
Dry mouth 50 (13) 0 (0) 27 (7) 1 (<1)
GERD/reflux esophagitis 47 (12) 1 (<1) 3 (1) 0(0)
F
