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Table 1 Baseline patient demographics and disease characteristics

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

Baseline parameters

Fulvestrant + dovitinib (n = 47)

Fulvestrant + placebo (n = 50)

All patients (n = 97)

Patient demographics

 Median age (range), years

63 (44–82)

63 (38–82)

63 (38–82)

 Median weight (range), kg

66.5 (38.0–95.0)

65.0 (41.0–135.5)

66.0 (38.0–135.5)

ECOG performance status, n (%)

 0

28 (59.6)

28 (56.0)

56 (57.7)

 1

18 (38.8)

20 (40.0)

38 (39.2)

 2

1 (2.1)

2 (4.0)

3 (3.1)

FGF pathway amplified, n (%)a

 No

32 (68.1)

33 (66.0)

65 (67.0)

 Yes

15 (31.9)

17 (34.0)

32 (33.0)

Presence of visceral disease, n (%)b

 No

12 (25.5)

20 (40.0)

32 (33.0)

 Yes

35 (74.5)

30 (60.0)

65 (67.0)

Disease characteristics, n (%)

 Primary site of cancer

  Breast

47 (100)

50 (100)

97 (100)

 Metastatic site of cancer

  Bone

39 (83.0)

36 (72.0)

75 (77.3)

  Lymph nodes

21 (44.7)

26 (52.0)

47 (48.5)

  Liver

22 (46.8)

16 (32.0)

38 (39.2)

  Other

19 (40.4)

8 (16.0)

27 (27.8)

  Adrenal

3 (6.4)

3 (6.0)

6 (6.2)

  Breast

0

1 (2.0)

1 (1.0)

 Time from initial diagnosis of primary site to start of study drug

  <6 months

0

0

0

  6 to <12 months

2 (4.3)

4 (8.0)

6 (6.2)

  12 to <24 months

5 (10.6)

8 (16.0)

13 (13.4)

  ≥24 months

40 (85.1)

38 (76.0)

78 (80.4)

 De novo stage IV

23 (48.9)

24 (48.0)

47 (48.5)

  FGF pathway–amplified

9 (19.1)

6 (16.0)

 

  FGF pathway–nonamplified

14 (29.8)

16 (32.0)

 

Prior therapies, n (%)

 Antineoplastic therapyc

47 (100)

50 (100)

97 (100)

  Surgery

47 (100)

50 (100)

97 (100)

  Hormone therapy

47 (100)

50 (100)

97 (100)

  Radiotherapy

37 (78.7)

38 (76.0)

75 (77.3)

  Chemotherapy

32 (68.1)

32 (64.0)

64 (66.0)

 Therapy type at last treatment

  Hormone therapy

43 (91.5)

48 (96.0)

91 (93.8)

  Chemotherapy

0

1 (2.0)

1 (1.0)

  Other

4 (8.5)

1 (2.0)

5 (5.2)

Prior hormone therapies, n (%)

 Number of prior hormone regimens

  1

28 (59.6)

36 (72.0)

64 (66.0)

  2

17 (36.2)

13 (26.0)

30 (30.9)

  3

2 (4.3)

1 (2.0)

3 (3.1)

 Settingd

  Adjuvant/neoadjuvant setting

38 (80.9)

37 (74.0)

75 (77.3)

  Therapeutic setting

23 (48.9)

24 (48.0)

47 (48.5)

  Prevention

4 (8.5)

3 (6.0)

7 (7.2)

 Regimen type

  Tamoxifen

27 (57.4)

21 (42.0)

48 (49.5)

  Letrozole

18 (38.3)

23 (46.0)

41 (42.3)

  Anastrozole

16 (34.0)

18 (36.0)

34 (35.1)

  Exemestane

8 (17.0)

9 (18.0)

17 (17.5)

  Othere

1 (2.1)

4 (8.0)

5 (5.2)

  1. ECOG European Cooperative Oncology Group, FGF Fibroblast growth factor
  2. aDerived from biomarker data and determined by the central laboratory to be positive for gene amplification of fibroblast growth factor receptor 1 (FGFR1), FGFR2, or FGF3
  3. bBased on electronic case report forms; visceral refers to lung, liver, pleural, or peritoneal involvement
  4. cIncludes patients who had medication, radiotherapy, or surgery
  5. dA patient may have been treated in multiple settings
  6. eOther prior hormone regimens included goserelin (n = 3), toremifene (n = 1), and triptorelin (n = 1)
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Breast Cancer Research

ISSN: 1465-542X

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