Early breast cancer (preventing recurrence and improving survival): adjuvant bisphosphonates

Bisphosphonates

Control

Analysis

Total n=18,766

n=9,856

n=8,910

Primary outcomes

Rate of recurrence of breast cancer

16.3% at 5 years

24.9% at 10 years

17.4% at 5 years

25.9% at 10 years

Difference at 10 years 1.1% (95% CI −0.7% to 2.9%), NSS

Rate ratio 0.94 (95% CI 0.87 to 1.01) p=0.08, NSS

Rate of distant recurrence

13.5% at 5 years

20.4% at 10 years

14.8% at 5 years

21.8% at 10 years

Difference at 10 years 1.4% (95% CI −0.3% to 3.1%), NSS

Rate ratio 0.92 (95% CI 0.85 to 0.99) p=0.03

Rate of breast cancer mortality

8.9% at 5 years

16.6% at 10 years

9.7% at 5 years

18.4% at 10 years

Difference at 10 years 1.7% (95% CI 0.0% to 3.5%)

Rate ratio 0.91 (95% CI 0.83 to 0.99) p=0.04

Selected secondary outcome

Bone recurrence

4.7% at 5 years

7.8% at 10 years

5.9% at 5 years

9.0% at 10 years

Difference at 10 years 1.1% (95% CI −0.1% to 2.3%), NSS

Rate ratio 0.83 (95% CI 0.73 to 0.94) p=0.004

All-cause mortality

10.6% at 5 years

20.8% at 10 years

11.4% at 5 years

22.3% at 10 years

Difference at 10 years 1.6% (95% CI −0.36 to 3.56), NSS

Rate ratio 0.92, 95% CI 0.85 to 1.00, p=0.06

Prespecified subgroup analyses in postmenopausal women

Total n=11,767

n=6,099

n=5,668

Rate of recurrence of breast cancer

13.4% at 5 years

22.8% at 10 years

15.8% at 5 years

25.8% at 10 years

Difference at 10 years 3.0% (95% CI 0.5% to 5.5%)

Rate ratio 0.86 (95% CI 0.78 to 0.94) p=0.002

Rate of distant recurrence

11.1% at 5 years

17.9% at 10 years

13.6% at 5 years

21.2% at 10 years

Difference at 10 years 3.4% (95% CI 1.0% to 5.8%)

Rate ratio 0.82 (95% CI 0.74 to 0.91) p=0.0003

Rate of breast cancer mortality

7.5% at 5 years

14.7% at 10 years

8.7% at 5 years

18.0% at 10 years

Difference at 10 years 3.3% (95% CI 0.8% to 5.7%)

Rate ratio 0.82 (95% CI 0.73 to 0.93) p=0.002

Bone recurrence

3.6% at 5 years

6.6% at 10 years

5.4% at 5 years

8.8% at 10 years

Difference at 10 years 2.2% (95% CI 0.6% to 3.8%)

Rate ratio 0.72 (95% CI 0.60 to 0.86) p=0.0002

All-cause mortality

9.5% at 5 years

21.1% at 10 years

10.8% at 5 years

23.5% at 10 years

Difference at 10 years 2.3% (95% CI −0.64 to 5.24), NSS

Rate ratio 0.86, 95% CI 0.77 to 0.96, p=0.005

Safety and tolerability outcomes

Although data on safety outcomes was collected, results are not reported in the paper. From the data obtained, it was not possible to assess the incidence of osteonecrosis of the jaw

Abbreviations: CI, confidence interval; NSS, not statistically significant; p, p value