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Table 2 Best overall response per local investigator review in the full analysis set

From: Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR+, HER2 breast cancer that had progressed during or after prior endocrine therapy

 

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]

  1. Abbreviations: CR Complete response, FGF Fibroblast growth factor, NE Not estimable, PD Progressive disease, PR Partial response, SD Stable disease