sp;
Anorexia# 182 (48) 11 (3) 153 (42) 7 (2)
Hemorrhage/Bleeding
Bleeding, all sites 140 (37) 16 (4)Þ 35 (10) 3 (1)
Psychiatric
Insomnia 57 (15) 3 (<1) 37 (10) 0 (0)
Depressionß 40 (11) 0 (0) 51 (14) 5 (1)
Treatment-emergent Grade 3/4 laboratory abnormalities are presented in Table 4.
Table 4. Laboratory Abnormalities Reported in at Least 10% of Treatment-Naïve RCC Patients Who Received SUTENT or IFN-α Laboratory Parameter, n (%) Treatment-Naïve RCC
SUTENT (n=375) IFN-α (n=360)
All Grades* Grade 3/4*† All Grades* Grade 3/4*
Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
Grade 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%).
Grade 4 laboratory abnormalities in patients on IFN-α included uric acid (8%), lymphocytes (2%), lipase (1%), neutrophils (1%), amylase (<1%), calcium increased (<1%), glucose decreased (<1%), potassium increased (<1%), and hemoglobin (<1%).
Gastrointestinal
AST 211 (56) 6 (2) 136 (38) 8 (2)
ALT 192 (51) 10 (3) 144 (40) 9 (2)
Lipase 211 (56) 69 (18) 165 (46) 29 (8)
Alkaline phosphatase 171 (46) 7 (2) 132 (37) 6 (2)
Amylase 130 (35) 22 (6) 114 (32) 12 (3)
Total bilirubin 75 (20) 3 (1) 8 (2) 0 (0)
Indirect bilirubin 49 (13) 4 (1) 3 (1) 0 (0)
Renal/Metabolic
Creatinine 262 (70) 2 (<1) 183 (51) 1 (<1)
Creatine kinase 183 (49) 9 (2) 40 (11) 4 (1)
Uric acid 173 (46) 54 (14) 119 (33) 29 (8)
Calcium decreased 156 (42) 4 (1) 145 (40) 4 (1)
Phosphorus 116 (31) 22 (6) 87 (24) 23 (6)
Albumin 106 (28) 4 (1) 72 (20) 0 (0)
Glucose increased 86 (23) 21 (6) 55 (15) 22 (6)
Sodium decreased 75 (20) 31 (8) 55 (15) 13 (4)
Glucose decreased 65 (17) 0 (0) 43 (12) 1 (<1)
Potassium increased 61 (16) 13 (3) 61 (17) 15 (4)
Calcium increased 50 (13) 2 (<1) 35 (10) 5 (1)
Potassium decreased 49 (13) 3 (1) 7 (2) 1 (<1)
Sodium increased 48 (13) 0 (0) 38 (10) 0 (0)
Hematology
Neutrophils 289 (77) 65 (17) 178 (49) 31 (9)
Hemoglobin 298 (79) 29 (8) 250 (69) 18 (5)
Platelets 255 (68) 35 (9) 85 (24) 2 (1)
Lymphocytes 256 (68) 66 (18) 245 (68) 93 (26)
Leukocytes 293 (78) 29 (8) 202 (56) 8 (2)
6.3Adverse Reactions in the Phase 3 pNET Study
The median number of days on treatment was 139 days (range 13–532 days) for patients on SUTENT and 113 days (range 1–614 days) for patients on placebo. Nineteen patients (23%) on SUTENT and 4 patients (5%) on placebo were on study for >1 year. Dose interruptions occurred in 25 patients (30%) on SUTENT and 10 patients (12%) on placebo. Dose reductions occurred in 26 patients (31%) on SUTENT and 9 patients (11%) on placebo. Discontinuation rates due to adverse reactions were 22% for SUTENT and 17% for placebo.
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 54% versus 50% of patients on SUTENT versus placebo, respectively. Table 5 compares the incidence of common (≥10 |
