Zometa for reducing chance of recurrence

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orange1 Member Posts: 930

Something to consider....Since women with Her2+ breast cancer may consider themselves at increased risk for recurrence - they may want to consider taking zometa 2x per year as was done in the ABCSG-12 study described below.  Zometa reduced recurrence by about 36%.  Many of us diagnosed Her2+ BC take it (or a participating in a trial with similar drugs)

This is a repost. 

Multiple studies are now demonstrating significant reduction in recurrence rates with zoledronic acid (brand name Zometa).

In premenopausal women, in study ABCSG-12, zoledronic acid reduced recurrence by 36%.

In postmenopausal women, in the integrated anaysis of the Z-fast and Zo-fast trials, zoldronic acid reduced recurrence by 43%

In the neoadjuvant subset of the AZURE trial zoledronic acid reduced tumor volume by 33% and doubled the pathologic complete response rate

From an article in Medscape 1/5/2010

http://www.medscape.com/viewarticle/713259_4

The ABCSG-12 trial compared tamoxifen with anastrozole and endocrine therapy alone with endocrine therapy plus ZOL (4 mg IV q6mo) in 1,803 premenopausal women with early stage endocrine-responsive breast cancer receiving ovarian suppression therapy with goserelin. The primary endpoint of ABCSG-12 was DFS for the comparison of anastrozole versus tamoxifen and ZOL versus no ZOL [Gnant et al. 2009]. At a median follow-up of 48 months, there was no significant difference in DFS for anastrozole versus tamoxifen (hazard ratio [HR]=1.10; p = 0.59) [Gnant et al. 2009]. In contrast, adding ZOL to adjuvant endocrine therapy significantly improved DFS by 36% compared with adjuvant endocrine therapy alone (54 versus 83 events; HR=0.64; log-rank p = 0.01; Figure 3) [Gnant et al. 2009]. Similarly, the secondary endpoint of recurrence-free survival was improved by 35% with ZOL treatment compared with endocrine therapy alone (54 versus 82 events; HR=0.65; log-rank p = 0.01) and produced a trend toward improved overall survival (16 versus 26 events; HR = 0.60; log-rank p = 0.10) [Gnant et al. 2009]. ZOL treatment reduced the incidence of bone metastases and decreased recurrence at all sites compared with adjuvant therapy alone. Moreover, ZOL was not significantly associated with serious adverse events, there were no confirmed cases of osteonecrosis of the jaw, and no renal tolerability issues were noted. Overall, adding ZOL to adjuvant endocrine therapy was generally well tolerated, reduced endocrine therapy-associated bone loss, and effectively improved clinical outcomes in pre-menopausal women with early stage breast cancer [Gnant et al. 2009; 2008; 2007].

Figure 3.

Bisphosphonates Improve Disease-free Survival in Premenopausal Women Receiving Adjuvant Endocrine Therapy with Goserelin Plus Tamoxifen or Anastrozole ± Zoledronic Acid. Adapted from Gnant et al. Copyright © 2009 Massachusetts Medical Society. All rights reserved [Gnant et al. 2009].

The effect of ZOL on disease recurrence and DFS in postmenopausal women with breast cancer was evaluated as a secondary endpoint in the three companion trials Z-FAST, ZO-FAST, and E-ZO-FAST [Frassoldati et al. 2009; Brufsky et al. 2008]. The 24-month integrated analysis of Z-FAST and ZO-FAST (total n = 1,667) demonstrated that upfront ZOL significantly improved DFS compared with delayed ZOL (HR= 0.573; p = 0.0183) [Frassoldati et al. 2009]. Similarly, the 36-month analysis of ZO-FAST (n = 1,064) found that patients in the upfront-ZOL group experienced reduced disease recurrence and improved DFS compared with patients in the delayed-ZOL group (HR = 0.588; p = 0.0314) [Eidtmann et al. 2008]. These exploratory data suggest that adding ZOL to AI therapy in postmenopausal women can improve disease outcomes beyond bone health.

In addition to the potential role in adjuvant therapy for breast cancer, the efficacy of bisphosphonates has been examined in combination with neoadjuvant chemotherapy. The neoadjuvant subset analysis (n = 205) from the ongoing AZURE trial (n = 3,360) examined the effect of neoadjuvant chemotherapy with or without ZOL on residual invasive tumor size and pathologic complete response in patients with stage II or III breast cancer. Patients who received neoadjuvant chemotherapy plus ZOL had a significant 33% reduction in residual invasive tumor size (p = 0.002) at the time of surgery and a nearly two-fold increase in pathologic complete response (p = 0.03) compared with standard therapy [Winter et al. 2008]. Furthermore, patients who received ZOL were less likely to require a mastectomy.

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