Table 1 Zoledronic acid trials and disease-free survival
Trial | Hormonal status | ZA/hormonal intervention | Effect of ZA |
|---|---|---|---|
Z-Fast [7] (n = 602) | Postmenopausal women | Immediate versus delayed ZA plus adjuvant letrazole | Decreased recurrence at 12 to 48 months, not at 60 months |
ZO-Fast [6] (n = 868) | Postmenopausal women | Immediate versus delayed ZA plus adjuvant letrazole | Reduction in DFS (HR = 0.59) at 36 and 48 months. Disease recurrence reduced at bone and at nonbone sites |
ABCSG12 [4] (n = 1,803) | Premenopausal ER/PR-positive stage 1/2 breast cancer | Phase 3 2×2 trial, goserelin ± tamoxifen or anastrozole ± ZA | Reduction in DFS (HR = 0.68) at 48 and 62 months. Disease recurrence reduced at bone and at nonbone sites |
AZURE [5] (n = 3,360) | Premenopausal and postmenopausal stage 2/3 breast cancer | Phase 3 trial, standard adjuvant systemic therapy including hormonal ± ZA | Lack of effect on invasive DFS. Subgroup analysis indicated benefit in women ≥5 years postmenopausal (HR = 0.75) |
AZURE subgroup [72] (n = 205) | Premenopausal and postmenopausal stage 2/3 breast cancer | Neoadjuvant chemotherapy ± ZA | Reduced residual invasive tumor size by 44% |