Dovitinib + fulvestrant (n = 47) | Placebo + fulvestrant (n = 50) | |||
---|---|---|---|---|
All patients | ||||
Best overall response, n (%) | ||||
CR | 1 (2.1) | 1 (2.0) | ||
PR | 12 (25.5) | 4 (8.0) | ||
SD | 18 (38.3) | 16 (32.0) | ||
PD | 4 (8.5) | 13 (26.0) | ||
Non-CR/non-PD | 6 (12.8) | 9 (18.0) | ||
Unknown | 6 (12.8) | 7 (14.0) | ||
Overall response rate (CR + PR) [95% CI], n (%) | 13 (27.7) [15.6–42.6] | 5 (10.0) [3.3–21.8] | ||
Median time to first response [95% CI], months | 2.0 [1.5–18.8] | 3.7 [1.6–9.1] | ||
Median duration of response [95% CI], months | 13.5 [5.5–16.6] | 14.7 [3.3–NE] | ||
Patients stratified by FGF pathway amplification | FGF pathway–amplified (n = 15) | FGF pathway–nonamplified (n = 32) | FGF pathway–amplified (n = 16) | FGF pathway–nonamplified (n = 34) |
Best overall response, n (%) | ||||
CR | 0 | 1 (3.1) | 1 (6.3) | 0 |
PR | 3 (20.0) | 9 (28.1) | 1 (6.3) | 3 (8.8) |
SD | 7 (46.7) | 11 (34.4) | 4 (25.0) | 12 (35.3) |
PD | 1 (6.7) | 3 (9.4) | 2 (12.5) | 11 (32.4) |
Non-CR/non-PD | 2 (13.3) | 4 (12.5) | 6 (37.5) | 3 (8.8) |
Unknown | 2 (13.3) | 4 (12.5) | 2 (12.5) | 5 (14.7) |
Overall response rate (CR + PR) [95% CI], n (%) | 3 (20.0) [4.3–48.1] | 10 (31.3) [16.1–50.0] | 2 (12.5) [1.6–38.3] | 3 (8.8) [1.9–23.7] |
Median duration of response [95% CI], months | 5.5 [3.2–16.3] | 14.8 [5.5–NE] | 14.7 [NE–NE] | 10.9 [3.3–NE] |