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... from 4 clinical trials indicate that zoledronic acid prevents AI-associated bone loss Recommendations for Women With Breast Cancer ... The Zometa -Femara Adjuvant ... – PowerPoint PPT presentation

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Title: ????? ?????????????


1
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2
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4
Adjuvant Zomera
5
Adjuvant Zomera
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Zomera For Adjuvant Treatment
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Recommendations for Women With Breast Cancer
Initiating AI Therapy
T-score lt 2.0
  • Any 2 of the following risk factors
  • T-score lt 1.5
  • Age gt 65 years
  • Low BMI (lt 20 kg/m2)
  • Family history of hip fracture
  • Personal history of fragility fracture after age
    50
  • Oral corticosteroid use of gt 6 months
  • Smoking (current or history of)

T-score 2.0, No risk factors
Zoledronic acid (4 mg / 6 months)calcium and
vitamin D supplements
Calcium and vitamin D supplements
Monitor risk status and BMD every 1 to 2 years
Monitor BMD every 2 years
  • Data for oral bisphosphonates are emerging
  • Evidence from 4 clinical trials indicate that
    zoledronic acid prevents AI-associated bone loss

5 drop in BMD should trigger zoledronic acid
treatment (4 mg / 6 months). Use lowest T-score
from 3 sites. Hadji P, et al. Presented at SABCS
2007. Abstract 504.
13
All Aromatase Inhibitors Increase Fracture Risk
Exemestane
Letrozole
Placebo
Tamoxifen
Anastrozole
P lt .0001
11
P .003
7.7
P lt .001
7.0
P .25
Fractures,
5.7
5.3
5.0
4.6
4.0
ATAC2 (68 months)
IES3 (58 months)
BIG 1-984 (26 months)
MA.175 (30 months)
1. Adapted from Hadji P, et al. US Oncological
Disease 2007. 2007118-21 2. Howell A, et al.
Lancet. 200536560-62 3. Coleman RE, et al.
Lancet Oncol. 20078119-127 4. Thurlimann B,
et al. N Engl J Med. 20053532747-2757 5. Goss
PE, et al. J Natl Cancer Inst. 2005971262-1271.
14
Z-FAST,1 ZO-FAST2, and E-ZO-FAST3 Study Design
R A N DO M I Z E D
  • Eligibility
  • ER/PR BC
  • PMW withT-score 2
  • Stratification
  • Adjuvant CT(yes or no)
  • T score (gt 1 or between 1 and 2 )

LET (2.5 mg/day) UPFRONT ZOL 4 mg q 6 mo
LET (2.5 mg/day) DELAYED ZOL 4 mg q 6 mo
0
5 yearsFinal analysis
3 years
1 year
Accrual completed Z-FAST N
602 ZO-FAST N 1,066
E-ZO-FAST N 527 Total N 2,195
ER Estrogen receptor PR Progesterone
receptor BC Breast cancer PMW
Postmenopausal women CT Chemotherapy LET
LetrozoleZOL Zoledronic acid.Initiation of
zoledronic acid determined by postbaseline BMD
T-score lt 2.0, any clinical fracture, or any
asymptomatic fracture at 36 months. 1. Brufsky ,
et al. Presented at 30th Annual SABCS December
13-16, 2007 San Antonio, Texas. Abstract 272.
DeBoer R, et al. Presented at 30th Annual SABCS
December 13-16, 2007 San Antonio, Texas.
Abstract 501 3. Llombart A, et al. Presented
at 14th ECCO Conference September 23-27, 2007
Barcelona, Spain. Abstract 2044.
15
Conclusions
  • Upfront Zoledronic acid (4 mg IV q6mo) prevents
    bone loss in women with early stage BC receiving
    adjuvant letrozole
  • Zoledronic acid has potential to have an impact
    on clinical outcomes other than bone health

16
Local and Distant recurrences
Upfront group Delayed group P value
12 months 1(0.3) 6(2) 0.056
24 months 7(2.3) 12 (4) 0.207
36 months 9(3) 16 (5.3) 0.127
The Zometa-Femara Adjuvant Synergy Trial (Z-FAST)
17
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    ??????.

18
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20
Bisphosphonates in patients with Breast cancer
Bone metastases
  • Delay in the onset of skeletal events
  • Reduction in bone pain
  • Decrease need for radiation therapy
  • Reduction in skeletal morbidity rate
  • No effect on overall survival

21
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30
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