AZURE results --"do not support the routine use of zoledronic acid adjuv mngmt of bc

[Lani]

N Engl J Med. 2011 Oct 13;365(15):1396-1405. Epub 2011 Sep 25.
Breast-Cancer Adjuvant Therapy with Zoledronic Acid.
Coleman RE, Marshall H, Cameron D, Dodwell D, Burkinshaw R, Keane M, Gil M, Houston SJ, Grieve RJ, Barrett-Lee PJ, Ritchie D, Pugh J, Gaunt C, Rea U, Peterson J, Davies C, Hiley V, Gregory W, Bell R; the AZURE Investigators.
Source
The authors' affiliations are listed in the Appendix.
Abstract
Background Data suggest that the adjuvant use of bisphosphonates reduces rates of recurrence and death in patients with early-stage breast cancer. We conducted a study to determine whether treatment with zoledronic acid, in addition to standard adjuvant therapy, would improve disease outcomes in such patients. Methods In this open-label phase 3 study, we randomly assigned 3360 patients to receive standard adjuvant systemic therapy either with or without zoledronic acid. The zoledronic acid was administered every 3 to 4 weeks for 6 doses and then every 3 to 6 months to complete 5 years of treatment. The primary end point of the study was disease-free survival. A second interim analysis revealed that a prespecified boundary for lack of benefit had been crossed. Results At a median follow-up of 59 months, there was no significant between-group difference in the primary end point, with a rate of disease-free survival of 77% in each group (adjusted hazard ratio in the zoledronic acid group, 0.98; 95% confidence interval [CI], 0.85 to 1.13; P=0.79). Disease recurrence or death occurred in 377 patients in the zoledronic acid group and 375 of those in the control group. The numbers of deaths - 243 in the zoledronic acid group and 276 in the control group - were also similar, resulting in rates of overall survival of 85.4% in the zoledronic acid group and 83.1% in the control group (adjusted hazard ratio, 0.85; 95% CI, 0.72 to 1.01; P=0.07). In the zoledronic acid group, there were 17 confirmed cases of osteonecrosis of the jaw (cumulative incidence, 1.1%; 95% CI, 0.6 to 1.7; P<0.001) and 9 suspected cases; there were no cases in the control group. Rates of other adverse effects were similar in the two study groups. Conclusions These findings do not support the routine use of zoledronic acid in the adjuvant management of breast cancer. (Funded by Novartis Pharmaceuticals and the National Cancer Research Network; AZURE Current Controlled Trials number, ISRCTN79831382 .).

PMID: 21995387

[tricia keegan]

Thanks Lani, I'm in the control group of this study and I believe it's continuing for ten years. I was sorry to see it did'nt help avoid mets but I'm now being given the drug yearly to due to osteopenia from five years on arimidex so maybe its worth taking anyway to help counteract that!

[Rich66]

Commentary on the same study:
http://www.cancernetwork.com/breast-.../10165/1959178

In a prespecified analysis, our finding of a possible benefit of [ZA] in patients who had undergone menopause more than 5 years before study entry is intriguing…and showed a small but significant survival advantage for patients who received [ZA]. Furthermore, the use of [ZA] appeared to have divergent effects on metastasis to visceral and locoregional sites according to menopausal status.” Analyses of the findings “suggest a systemic effect of [ZA] that operates differently according to menopausal status and that is distinct from any effect in bone,” they said, hypothesizing that “perhaps bone provides a sanctuary for cancer cells, and after treatment with [ZA], the ability of cancer cells to disseminate to other body sites is dependent on the presence of reproductive hormones.

[pibikay]

Interesting Lani.Hema has her dose IV once in 3 Months