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Table 1 Patient demographics and baseline disease characteristics

From: Natural history of malignant bone disease in breast cancer and the use of cumulative mean functions to measure skeletal morbidity

Characteristics

Placebo group

(n = 195)

Age, mean years ± SD

56 ± 12

   Patients < 50 years of age, n (%)

67 (34)

ECOG performance status, n (%)

 

   0 – 1

128 (66)

   2 – 3

67 (34)

Estrogen- and progesterone-receptor status, n (%)

 

   Positive for at least 1

120 (62)

   Other

75 (38)

Sites of metastasis, patients, n (%)

 

   Bone, any

195 (100)

   Bone as only metastatic site

117 (60)

   Lung

30 (15)

   Liver

29 (15)

   Brain

1 (1)

   Other

27 (14)

Time from primary to bone metastases diagnosis, median years ± SD

3.8 ± 4.5

Time from bone metastases to study entry, mean years ± SD

1.6 ± 1.7

Patients with bone lesions ≥ 1 cm in diameter, n (%)

 

   1 lesion

82 (42)

   2 lesions

71 (36)

   ≥ 3 lesions

42 (22)

Lesion types and numbers

 

   1 – 2 osteolytic

104 (53)

   ≥ 3 osteolytic

91 (47)

   0 osteoblastic

146 (75)

   1 – 2 osteoblastic

37 (19)

   ≥ 3 osteoblastic

12 (6)

   0 mixed lesions

28 (14)

1 – 2 mixed lesions

≥ 3 mixed lesions

61 (31)

106 (54)

Patients with SREs during the 3 months before study entry, n (%)

 

   Palliative radiotherapy

57 (29)

   Fracture

35 (18)

Pain scores, n (%)

 

   0

27 (14)

   1 – 3

76 (39)

   4 – 9

92 (47)

Prior therapy regimens, n (%)

 

   0 – 1 chemotherapy

80 (41)

   2 – 3 chemotherapy

104 (53)

   ≥ 4 chemotherapy

11 (6)

   0 – 1 hormonal therapy

102 (52)

   2 – 3 hormonal therapy

77 (39)

   ≥ 4 hormonal therapy

16 (8)

  1. SD = Standard deviation, ECOG = Eastern Cooperative Oncology Group, SRE = Skeletal-related event.
  2. Adapted with permission from Hortobagyi et al. Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. Protocol 19 Aredia Breast Cancer Study Group. N Engl J Med. 1996;335:1785–1791. Copyright© 1996 Massachusetts Medical Society. All rights reserved[15]