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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]