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Recommendations for use of Bisphosphonates

Details of Trials or Studies

Table 1. Summary of trials

Study

Follow-up

Quality

Population Intervention* Comparator*
Clodronate

Diel 200821,35

Median 8.5yr follow-up

Fair

Women with T1-4, N0-2 breast cancer, no distant metastases who received adjuvant endocrine therapy or chemotherapy with or without radiotherapy Clodronate 1600mg/d for 2yrs (N=157) Standard care for 2yrs (N=145)

McCloskey 20105

2yr follow-up

Fair

Women with primary breast cancer without metastasis having chemotherapy, endocrine therapy and/or radiotherapy, according to local protocols Clodronate 1600mg/d for 2yrs (N=419) Placebo for 2yrs (N=432)

Saarto 20086

10yr follow-up

Fair

Pre/postmenopausal women with breast cancer who received postoperative radiotherapy; premenopausal women who received chemotherapy

Premenopausal:
Clodronate 1600mg/d for 3yrs (N=20)

Postmenopausal:
Clodronate 1600mg/d for 3yrs & tamoxifen 20mg (N=14) or toremifene 60mg/d (N=10) for 3yrs

Premenopausal:
Standard care for 3yrs (N=35)

Postmenopausal:
Tamoxifen  20mg (N=11) or toremifene 60mg/d (N=6) for 3yrs

Ibandronate

ARIBON7

2yr follow-up

Fair

Osteopenic, postmenopausal women with ER+ breast cancer who received anastrozole Ibandronate 150mg every 4wks for 2yrs (N=25) Placebo every 4wks for 2yrs (N=25)
Pamidronate

Kristensen 20088

10yr follow-up (4yr BMD)

Fair

Women with no distant metastases and either:

1) premenopausal, grade 2-3 breast cancer ≤5cm without lymph node metastasis; 2) premenopausal, HR-ve/ unknown breast cancer & axillary lymph node metastases or primary tumour >5cm; 3) postmenopausal, HR-ve breast cancer & axillary lymph node metastasis or primary tumour >5cm

Patients received adjuvant chemotherapy; locoregional radiotherapy was given according to local guidelines, and endocrine therapy was avoided

Pamidronate 150mg twice daily for 4yrs (N=460) Standard care for 4yrs (N=493)
Risedronate

Hines 2009a25

1yr follow-up

Good

Premenopausal women with stage I-IIIb breast cancer with adjuvant/neoadjuvant chemotherapy scheduled with or without tamoxifen Risedronate 35mg weekly for 1yr (N=108) Placebo weekly for 1yr (N=108)

REBBeCa9,26-28

2yr follow-up

Good

Women with breast cancer, <8yrs postmenopausal, after chemotherapy with or without endocrine therapy Risedronate 35mg weekly for 2yrs (N=43) Placebo weekly for 2yrs (N=44)

SABRE10

2yr follow-up

Good

Postmenopausal women with non-metastatic breast cancer, moderate fracture risk with anastrozole scheduled Risedronate 35mg weekly for 2yrs (N=77) Placebo weekly for 2yrs (N=77)
Zoledronic acid

ABCSG-1211,22-23

Median 5yr follow-up (5yr BMD)

Fair

Premenopausal women with stage I-II ER+/PR+ breast cancer, <10 positive lymph nodes, standard therapy with goserelin scheduled

Preoperative chemotherapy was allowed however no patients received adjuvant chemotherapy; postoperative radiotherapy was given according to local guidelines

GTZ: Goserelin 3.6mg s.c. every 4wks & tamoxifen  20mg/d & ZA IV 8mg every 4wks for 3yrs (N=449)§

GAZ: Goserelin 3.6mg s.c. every 4 wks & anastrozole 1mg/d & ZA IV 8mg every 4wks for 3yrs (N=450)§

GT: Goserelin 3.6mg s.c. every 4 wks & tamoxifen 20mg/d for 3yrs (N=451)

GA: Goserelin 3.6mg s.c. every 4wks & anastrozole 1mg/d for 3yrs (N=453)

Hershman 201012

2yr BMD follow-up; 1yr AEs, recurrence

Fair

Premenopausal women with non-metastatic breast cancer receiving chemotherapy ZA IV 4mg every 3mths for 1yr (N=57) Placebo for 1yr (N=57)

Hines 2009b24

2yr follow-up

Fair

Postmenopausal women with stage I-IIIa ER+/PR+ breast cancer without metastasis, ≤6yrs tamoxifen completed Letrozole 2.5mg/d for 5yrs + upfront ZA IV 4mg every 6mths for 5yrs or until recurrence (N=279) Letrozole 2.5mg/d for 5yrs + delayed ZA IV 4mg every 6mths for 5yrs or until recurrence (N=279)

Z-FAST17

3yr follow-up

Fair

Postmenopausal women with stage I-IIIa ER+/PR+ breast cancer Letrozole 2.5mg/d for 5yrs + upfront ZA IV 4mg every 6mths for 5yrs (N=301) Letrozole 2.5mg/d for 5yrs + delayed ZA IV 4mg every 6mths for 5yrs (N=301)

ZO-FAST18

1yr follow-up

Fair

Postmenopausal women with stage I-IIIa ER+/PR+ breast cancer Letrozole 2.5mg/d for 5yrs + upfront ZA IV 4mg every 6mths for 5yrs (N=532) Letrozole 2.5mg/d for 5yrs + delayed ZA IV 4mg every 6mths for 5yrs (N=533)

Abbreviations: AE = adverse event; BMD = bone mineral density; ER+ = oestrogen receptor-positive; GA = goserelin & anastrozole; GAZ = goserelin & anastrozole & zoledronic acid; GT = goserelin & tamoxifen; GTZ = goserelin & tamoxifen & zoledronic acid; HR- = hormone receptor-negative; IV = intravenous; PR+ = progesterone receptor-positive; s.c. = subcutaneous; ZA = zoledronic acid
*administered orally unless otherwise specified; §protocol amendments, after 254 patients had been enrolled, reduced the dose of intravenous zoledronic acid from 8mg every 4 weeks to 4mg every 6 months; administered immediately after random assignment; administered when either post-baseline lumbar spine or total hip T score decreased to less than -2.0 or a non-traumatic clinical fracture occurred

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