= Zometa zoledronic acid immediately after surgery in women with early breast cancer who Femara - Letrozole use provides better protection against bone loss and disease-free time than when Zometa is given only after significant bone loss or fracture occurs. Thus 3-year evaluation of Phase III trial of Z-FAST 602 breast cancer patients. Article updated October 1, 2009.

October 1, 2009: By popular demand, two recent major studies into the effect of Zometa highlighted. Please ask your oncologist instead Zometa APD.

May 14, 2009: Source: 1: Clin Breast Cancer. March 2009, 9 (2) :77-85.

Zometa - zoledronic acid prevents aromatase inhibitor-associated bone loss in postmenopausal women with breast cancer stage I and II Femara - Letrozole used. Thus the results of a 3-year evaluation of a randomized phase III study called Z-FAST study in 301 patients in each group. Group 1 started immediately after surgery with Femara and Zometa, Zometa group 2 received only after the total BMD of the lumbar spine (LS) or total hip (TH) T score below -2.0 was whether the first fracture was created. Immediately after surgery seems important to begin with Zometa in addition to Femara. Because once fractures were created and only then start Zometa Zometa it seems little or no effect it. Thus, the conclusions from the study. Here almost literally the study abstract translated with the help of google translation. Original abstract is below this article

Background: Postmenopausal women with breast cancer that additional aromatase inhibitors (AIS) use have an increased risk of accelerated bone loss and subsequent fractures. The current Zometa Femara Adjuvant Synergy Trial (Z-FAST) is evaluating the efficacy and safety of zoledronic acid (Zometa) in the prevention of such bone loss.

Patients and Methods: In this multicenter study, postmenopausal women with early hormone receptor-positive breast cancer receiving adjuvant letrozole - Femara and were randomized to receive surgery (upfront) or delayed start Zometa - zoledronic acid (ZA, 4 mg intravenously every 6 months) for 5 years. The delayed start ZA was administered at the lumbar spine (LS) or total hip (TH) T score below -2.0 or a nontraumatic fracture occurred. The primary endpoint was the comparison with the change of BMD = bone mineral density from baseline values between groups after 1 year; Secondary endpoints, measured at other predetermined times, were the comparison of changes in TH BMD, LS BMD and markers of bone density, fracture incidence, and time to disease progression or recurrence. Herein, we report the results of 36 months interim analysis.

Results: A total of 301 patients were randomized to each group. After three years, the absolute difference in mean LS and TH BMDs between the upfront and delayed groups was 6.7% and 5.2% respectively (P <.0001 for both). Although this study was not designed to show the effect on fractures to show the incidence of fractures was slightly higher in the delayed group (up-front, 17 [5.7%] vs delayed, 19 [6, 3%]) but not statistically significant (p =. 8638). Pyrexia (27 [9%] vs 6 [2]%, P = .0002) and bone pain (39 [13%] vs 20 [6.7%], P = .01) were more common in up-front patients, cough (13 [4.3%] vs 27 [9%], P = .03) was more common in the delayed patients. No serious renal dysfunction, or confirmed cases of osteonecrosis of the jaw were reported. Disease recurrence was reported in 9 upfront (3.0%) and 16 delayed (5.3%) patients (Kaplan-Meier analysis, P = .127), with a decrease of 2.3%.

Conclusion: Up-front ZA effectively prevents AI-associated bone loss in postmenopausal women with early breast cancer than delaying treatment until significant bone loss or failure.

Zoledronic Acid Effectively Prevents Aromatase Inhibitor-Associated Bone Loss in postmenopausal Women with Early Breast Cancer Receiving Adjuvant Letrozole: Z-FAST Study 36-Month Follow-up Results.

Magee-Women's Hospital, University of Pittsburgh Cancer Institute, Pittsburgh, PA.

Background: postmenopausal women with breast cancer receiving adjuvant aromatase inhibitors (AIs) are at risk for accelerated bone loss and fractures subsequent component. The ongoing Femara Adjuvant Synergy Trial Zometa (Z-FAST) is Evaluating the efficacy and safety of zoledronic acid in Preventing Such bone loss.

Patients and Methods: In this multicenter study, postmenopausal women with hormone receptor-positive early breast cancer receiving adjuvant letrozole Were randomized to receive upfront or delayed-start zoledronic acid (ZA, 4 mg intravenously everytime 6 months) for 5 years. Delayed-start SA was Administered if the lumbar spine (LS) or total hip (TH) T score below -2.0 Fell or a nontraumatic fracture occurred. The primary endpoint was to compare the change from baseline in LS bone mineral density (BMD) Between groups at month 12, secondary endpoints, Measured at Other predetermined time points, included Comparing changes in TH BMD, LS BMD, and markers of bone turnover, fracture incidence, and time to disease Recurrence. Herein, we report the results of the 36-month interim analysis.

Results: Overall, 301 patients randomized to Were Each group. At month 36, the mean absolute difference in LS and TH BMDs Between the upfront and delayed groups were 6.7% and 5.2%, respectively (P <.0001 for both). Although this study was not designed to show antifracture efficacy, the incidence of fractures was Slightly higher in the delayed group (up-front, 17 [5.7%] vs. Delayed, 19 [6.3%]) but not statistically significant (P =. 8638). Pyrexia (27 [9%] vs. 6 [2%], P = .0002) and bone pain (39 [13%] vs. 20 [6.7%], P = .01) Were more common in upfront patiënten , cough (13 [4.3%] vs. 27 [9%], P = .03) was more common in delayed patient. No severe renal dysfunction or CONFIRMED cases of osteonecrosis of the jaw Were reported. Recurrence Disease Reported in September was up-front (3.0%) and 16 delayed (5.3%) patients (Kaplan-Meier analysis, P = .127), with an absolute Decrease of 2.3%.

Conclusion: Up-front ZA more effectively Prevents AI-associated bone loss in postmenopausal women with early breast cancer therapy Than Delay Until Substantial bone loss or fracture occurring.

PMID: 19433387 [PubMed - in process]