Table 5.
Best response (efficacy analysis set)
| Study | PMS studya (JUA criteria) |
Japanese Phase II studyb (RECIST) | |||||
|---|---|---|---|---|---|---|---|
| Response | Overall | Metastatic organc |
Overall | ||||
| Lung | Kidneyd | Bone | Liver | Brain | |||
| n = 3171 | n = 2260 | n = 1021 | n = 988 | n = 477 | n = 165 | n = 129 | |
| CR | 43 (1.4) | 83 (3.7) | 10 (1.0) | 12 (1.2) | 3 (0.6) | 2 (1.2) | 0 (0) |
| PR | 764 (24.1) | 622 (27.5) | 151 (14.8) | 101 (10.2) | 79 (16.6) | 19 (11.5) | 25 (19.4) |
| NC/SD | 1669 (52.6) | 1198 (53.0) | 784 (76.8) | 645 (65.3) | 245 (51.4) | 74 (44.8) | 87 (67.4) |
| Disease progression | 429 (13.5) | 169 (7.5) | 76 (7.4) | 113 (11.4) | 87 (18.2) | 22 (13.3) | 13 (10.1) |
| Not evaluable | 266 (8.4) | 180 (8.3) | 0 (0) | 117 (11.8) | 63 (13.2) | 48 (29.1) | 4 (3.1) |
| Objective response | 807 (25.4) | 705 (31.2) | 161 (15.8) | 113 (11.4) | 82 (17.2) | 21 (12.7) | 25 (19.4) |
| Overall disease control | 2476 (78.1) | 1903 (84.2) | 945 (92.6) | 758 (76.7) | 327 (68.6) | 95 (57.6) | 95 (73.6) |
| Median time to response | 1.9 months | Not available | 2.8 months | ||||
| Median duration of response | 5.8 months | 13.8 months | |||||
Values represent number (%) of patients.
PMS, post-marketing surveillance; JUA, Japanese Urological Association; RECIST, response evaluation criteria in solid tumor; CR, complete response; PR, partial response; NC, no change; SD, stable disease.
aThe best overall response according to the Criteria for Non-invasive Evaluation of Therapeutic Effectiveness in the Japanese Urological Association's General Rules for Clinical and Pathological Studies of Renal Cell Carcinoma.
bThe best overall response according to RECIST.
cResponse of metastatic disease in each organ among the patients who had metastases in the organ at baseline, except for the response in kidney disease which was differently defined below (d).
dResponse of kidney disease was compiled among all patients who had tumor evaluation data for kidney disease regardless of primary or metastatic lesion.