Background
Methods
Patients
Study design
Endpoints and assessments
Statistical methods and analysis
Results
Patients
Asian patients | Non-Asian patients | |||
---|---|---|---|---|
Pazopanib (n = 188) | Sunitinib (n = 179) | Pazopanib (n = 349) | Sunitinib (n = 358) | |
Age, median years (range) | 59.0 (18–81) | 58.0 (23–82) | 62.0 (35–88) | 63.0 (33–86) |
Male sex, n (%) | 137 (73) | 137 (77) | 247 (71) | 265 (74) |
Race, n (%) | ||||
Asian—Central/South Asian heritage | 2 (1) | 1 (< 1) | 0 | 0 |
Asian—East Asian heritage | 154 (82) | 144 (80) | 0 | 0 |
Asian—Japanese heritage | 29 (15) | 31 (17) | 0 | 0 |
Asian—South East Asian heritage | 3 (2) | 3 (2) | 0 | 0 |
Non-Asian—White/Caucasian/European heritage | 0 | 0 | 346 (99) | 356 (99) |
Non-Asian—Arabic/North African heritage | 0 | 0 | 2 (< 1) | 2 (< 1) |
Non-Asian—mixed race | 0 | 0 | 1 (< 1) | 0 |
Time since initial diagnosis, median days (range) | 93.5 (1–6039) | 145.5 (2–6239) | 287.0 (10–9117) | 252.0 (9–7922) |
Histology, n (%) | ||||
Clear cell | 183 (97) | 165 (92) | 322 (92) | 331 (92) |
Predominantly clear cell | 5 (3) | 10 (6) | 20 (6) | 20 (6) |
Other | 0 | 4 (2) | 7 (2) | 6 (2) |
Missing | 0 | 0 | 0 | 1 (< 1) |
Karnofsky performance scale, n (%) | ||||
70 or 80 | 37 (20) | 20 (11) | 96 (28) | 103 (29) |
90 or 100 | 151 (80) | 159 (89) | 253 (72) | 255 (71) |
Prior nephrectomy, n (%) | 152 (81) | 152 (85) | 292 (84) | 300 (84) |
Baseline levels of LDH, n (%) | ||||
> 1.5 × ULN | 10 (5) | 6 (3) | 28 (8) | 22 (6) |
≤ 1.5 × ULN | 178 (95) | 173 (97) | 321 (92) | 336 (94) |
Number of organs involved, n (%) | ||||
1 | 53 (28) | 50 (28) | 61 (17) | 54 (15) |
2 | 71 (38) | 67 (37) | 127 (36) | 131 (37) |
≥ 3 | 63 (34) | 62 (35) | 161 (46) | 173 (48) |
Missing | 1 (< 1) | 0 | 0 | 0 |
Location of disease at baseline, n (%) | ||||
Lung | 146 (78) | 143 (80) | 262 (75) | 270 (75) |
Lymph nodes | 62 (33) | 68 (38) | 153 (44) | 172 (48) |
Kidney | 57 (30) | 43 (24) | 101 (29) | 105 (29) |
Bone | 36 (19) | 33 (18) | 65 (19) | 49 (14) |
Other | 27 (14) | 27 (15) | 45 (13) | 50 (14) |
Liver | 24 (13) | 30 (17) | 60 (17) | 78 (22) |
MSKCC risk category, n (%) | ||||
Favorable risk | 47 (25) | 55 (31) | 97 (28) | 90 (25) |
Intermediate risk | 119 (63) | 112 (63) | 192 (55) | 209 (58) |
Poor risk | 18 (10) | 9 (5) | 48 (14) | 41 (11) |
Unknown | 4 (2) | 3 (2) | 12 (3) | 18 (5) |
Heng risk category, n (%) | ||||
Favorable risk | 43 (23) | 50 (28) | 92 (26) | 82 (23) |
Intermediate risk | 112 (60) | 98 (55) | 177 (51) | 203 (57) |
Poor risk | 30 (16) | 27 (15) | 74 (21) | 63 (18) |
Unknown | 3 (2) | 4 (2) | 6 (2) | 10 (3) |
Number of metastatic sites, n (%) | ||||
0 | 1 (< 1) | 3 (2) | 2 (< 1) | 2 (< 1) |
1 | 77 (41) | 57 (32) | 91 (26) | 77 (22) |
2 | 58 (31) | 72 (40) | 130 (37) | 146 (41) |
≥ 3 | 51 (27) | 47 (26) | 126 (36) | 133 (37) |
Missing | 1 (< 1) | 0 | 0 | 0 |
Asian patients | Non-Asian patients | |||
---|---|---|---|---|
Pazopanib | Sunitinib | Pazopanib | Sunitinib | |
Study discontinuation, n (%) | 146 (78) | 139 (79) | 320 (92) | 331 (93) |
Died, n (%) | 66 (35) | 59 (33) | 171 (49) | 190 (53) |
Safety
Treatment exposure
Dose modifications and discontinuations
Common adverse events
Asian patients, n (%) | Non-Asian patients, n (%) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pazopanib (n = 186) | Sunitinib (n = 177) | Pazopanib (n = 348) | Sunitinib (n = 355) | |||||||||
Preferred Term | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 |
Neutropenia | 44 (24) | 11 (6) | 1 (< 1) | 77 (44) | 25 (14) | 5 (3) | 15 (4) | 4 (1) | 1 (< 1) | 68 (19) | 26 (7) | 1 (< 1) |
Neutrophil count decreased | 27 (15) | 2 (1) | 2 (1) | 47 (27) | 17 (10) | 0 | 1 (< 1) | 0 | 0 | 14 (4) | 7 (2) | 0 |
Neutropenia/neutrophil count decreaseda | 71 (38) | 13 (7) | 3 (2) | 124 (70) | 42 (24) | 5 (3) | 16 (5) | 4 | 1 | 82 (23) | 33 (9) | 1 |
Leukopenia | 40 (22) | 5 (3) | 0 | 59 (33) | 10 (6) | 0 | 11 (3) | 0 | 0 | 38 (11) | 4 (1) | 0 |
WBC count decreased | 24 (13) | 1 (< 1) | 0 | 52 (29) | 4 (2) | 0 | 4 (1) | 0 | 0 | 19 (5) | 4 (1) | 0 |
Leukopenia/ WBC count decreaseda | 64 (34) | 6 (3) | 0 | 111 (63) | 14 (8) | 0 | 15 (4) | 0 | 0 | 57 (16) | 8 | 0 |
Platelet count decreased | 30 (16) | 5 (3) | 0 | 62 (35) | 25 (14) | 5 (3) | 5 (1) | 0 | 0 | 38 (11) | 7 (2) | 1 (< 1) |
Thrombocytopenia | 31 (17) | 8 (4) | 2 (1) | 81 (46) | 39 (22) | 12 (7) | 24 (7) | 0 | 1 (< 1) | 100 (28) | 23 (6) | 7 (2) |
Thrombocytopenia/platelet count decreaseda | 61 (33) | 13 (7) | 2 (1) | 143 (81) | 64 (36) | 17 (10) | 29 (8) | 0 | 1 | 138 (39) | 30 | 8 |
Hemoglobin decreased | 21 (11) | 0 | 0 | 48 (27) | 8 (5) | 1 (< 1) | 12 (3) | 4 (1) | 0 | 21 (6) | 4 (1) | 0 |
Anemia | 13 (7) | 1 (< 1) | 3 (2) | 51 (29) | 10 (6) | 3 (2) | 24 (7) | 2 (< 1) | 3 (< 1) | 50 (14) | 11 (3) | 3 (< 1) |
Anemia/hemoglobin decreaseda | 34 (18) | 1 (< 1) | 3 (2) | 99 (56) | 18 (10) | 4 | 36 (10) | 6 | 3 | 71 (20) | 15 | 3 |
Treatment-related adverse events
Asian patients, n (%) | Non-Asian patients, n (%) | |||
---|---|---|---|---|
Preferred term | Pazopanib (n = 186) | Sunitinib (n = 177) | Pazopanib (n = 348) | Sunitinib (n = 355) |
Neutropenia | 41 (22) | 74 (42) | 15 (4) | 62 (17) |
Neutrophil count decreased | 26 (14) | 46 (26) | 1 (< 1) | 13 (4) |
Neutropenia/neutrophil count decreaseda | 67 (36) | 120 (68) | 16 (5) | 75 (21) |
Leukopenia | 37 (20) | 58 (33) | 9 (3) | 38 (11) |
WBC count decreased | 23 (12) | 51 (29) | 3 (< 1) | 16 (5) |
Leukopenia/WBC count decreaseda | 60 (32) | 109 (62) | 12 (4) | 54 (15) |
Platelet count decreased | 29 (16) | 62 (35) | 5 (1) | 30 (8) |
Thrombocytopenia | 29 (16) | 81 (46) | 23 (7) | 94 (26) |
Thrombocytopenia/platelet count decreaseda | 58 (31) | 143 (81) | 28 (8) | 124 (35) |
Hemoglobin decreased | 19 (10) | 42 (24) | 5 (1) | 13 (4) |
Anemia | 12 (6) | 46 (26) | 15 (4) | 38 (11) |
Anemia/hemoglobin decreaseda | 31 (17) | 88 (50) | 20 (6) | 51 (14) |