Impact of body mass index (BMI) on the efficacy of zoledronic acid in premenopausal patients with hormone receptor positive breast cancer: An analysis of the ABCSG-12 trial.

Authors

Georg Pfeiler

Georg Pfeiler

Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria

Georg Pfeiler , Robert Konigsberg , Christian Fesl , Brigitte Mlineritsch , Herbert Stoger , Christian F. Singer , Sabine Poestlberger , Guenther G. Steger , Michael Seifert , Peter Christian Dubsky , Raimund Jakesz , Hellmut Samonigg , Vesna Bjelic-Radisic , Richard Greil , Christian Marth , Michael Gnant

Organizations

Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria, Applied Cancer Research – Institution for Translational Research Vienna (ACR-ITR VIEnna)/CEADDP, Vienna, Austria, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria, Paracelsus University of Salzburg, Salzburg, Austria, Medizinische Universitatsklinik Graz, Graz, Austria, Medical University of Vienna, Department of OB/GYN, Vienna, Austria, Hospital of the Sisters of Mercy, Linz, Austria, Medical University of Vienna, Vienna, Austria, Department of Surgery, Medical University of Vienna, Vienna, Austria, Department of Medical Oncology, Medical University of Graz, Graz, Austria, Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria, IIIrd Medical Department with Hematology, Medical Oncology, Paracelsus Medical University Hospital Salzburg and AGMT (Arbeitsgemeinschaft Medikamentöse Tumortherapie), Salzburg, Austria, Medical University of Innsbruck, Innsbruck, Austria, Comprehensive Cancer Center, Medical University of Vienna, Department of Surgery, Vienna, Austria

Research Funding

Pharmaceutical/Biotech Company
Background: Zoledronic acid (ZOL) improves disease outcome in premenopausal patients with breast cancer (BC), especially in those with low estrogen environment. Obesity is associated with increased estrogen serum levels, which might influence the efficacy of ZOL. We investigated the impact of BMI on the efficacy of ZOL in premenopausal patients with BC. Methods: ABCSG-12 examined the efficacy of ovarian suppression using goserelin (3.6 mg q28d SC) in combination with anastrozole (ANA) or tamoxifen (TAM) ± ZOL 4 mg IV q6mo) in premenopausal women with endocrine-responsive BC. BMI was calculated using the prospectively collected data on patients’ height and weight at study entry. BMI definitions of the WHO were used: normal 18.5-24.9 kg/m2, overweight: BMI 25-29.9 kg/m2, obese BMI ≥ 30 kg/m2). Disease-free survival (DFS) and overall survival (OS) were calculated by Kaplan-Meier method and results were compared by using the log-rank test and Cox proportional hazard modeling. Results: Two thirds of the patients were normal weight (1,111) and one third was overweight (391) or obese (182). Normal weight patients treated with ZOL experienced the same benefit as overweight/obese patients treated with ZOL compared to patients without ZOL regarding disease free survival (HR 0.75, 95%CI 0.53 1.05 p = 0.09 and HR 0.71, 95%CI 0.46 1.1, p=0.12, respectively) as well as overall survival (HR 0.67, 95% CI 0.37 1.22, p=0.19 and HR 0.64, 95%CI 0.32 1.28, p=0.19, respectively). No difference regarding DFS and OS could be detected between normal weight and overweight/ obese patients treated with ZOL (HR 1.05, 95%CI 0.69 1.59, p=0.83 and HR 1.27, 95%CI 0.62 2.61, p= 0.51). Comparing normal weight patients with ZOL to obese patients with ZOL, again no difference could be observed. Conclusions: The significant outcome benefit of adjuvant zoledronic acid in ABCSG-12 can be demonstrated both in normal weight and overweight/obese premenopausal patients with early breast cancer, indicating that the bone marrow microenvironment changing impact of adjuvant bisphopshonate treatment does not correlate with patients’ BMI.

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Abstract Details

Meeting

2012 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Breast Cancer - HER2/ER

Track

Breast Cancer

Sub Track

ER+

Clinical Trial Registration Number

NCT00295646

Citation

J Clin Oncol 30, 2012 (suppl; abstr 514)

DOI

10.1200/jco.2012.30.15_suppl.514

Abstract #

514

Poster Bd #

4

Abstract Disclosures