Endocrine Therapy plus Zoledronic Acid in Premenopausal Breast Cancer Export

@article{citeulike:4043619, abstract = {Background Ovarian suppression plus tamoxifen is a standard adjuvant treatment in premenopausal women with endocrine-responsive breast cancer. Aromatase inhibitors are superior to tamoxifen in postmenopausal patients, and preclinical data suggest that zoledronic acid has antitumor properties. Methods We examined the effect of adding zoledronic acid to a combination of either goserelin and tamoxifen or goserelin and anastrozole in premenopausal women with endocrine-responsive early breast cancer. We randomly assigned 1803 patients to receive goserelin (3.6 mg given subcutaneously every 28 days) plus tamoxifen (20 mg per day given orally) or anastrozole (1 mg per day given orally) with or without zoledronic acid (4 mg given intravenously every 6 months) for 3 years. The primary end point was disease-free survival; recurrence-free survival and overall survival were secondary end points. Results After a median follow-up of 47.8 months, 137 events had occurred, with disease-free survival rates of 92.8\% in the tamoxifen group, 92.0\% in the anastrozole group, 90.8\% in the group that received endocrine therapy alone, and 94.0\% in the group that received endocrine therapy with zoledronic acid. There was no significant difference in disease-free survival between the anastrozole and tamoxifen groups (hazard ratio for disease progression in the anastrozole group, 1.10; 95\% confidence interval [CI], 0.78 to 1.53; P=0.59). The addition of zoledronic acid to endocrine therapy, as compared with endocrine therapy without zoledronic acid, resulted in an absolute reduction of 3.2 percentage points and a relative reduction of 36\% in the risk of disease progression (hazard ratio, 0.64; 95\% CI, 0.46 to 0.91; P=0.01); the addition of zoledronic acid did not significantly reduce the risk of death (hazard ratio, 0.60; 95\% CI, 0.32 to 1.11; P=0.11). Adverse events were consistent with known drug-safety profiles. Conclusions The addition of zoledronic acid to adjuvant endocrine therapy improves disease-free survival in premenopausal patients with estrogen-responsive early breast cancer. (ClinicalTrials.gov number, NCT00295646 .) 10.1056/NEJMoa0806285}, author = {Gnant, Michael and Mlineritsch, Brigitte and Schippinger, Walter and Luschin-Ebengreuth, Gero and Postlberger, Sabine and Menzel, Christian and Jakesz, Raimund and Seifert, Michael and Hubalek, Michael and Bjelic-Radisic, Vesna and Samonigg, Hellmut and Tausch, Christoph and Eidtmann, Holger and Steger, Gunther and Kwasny, Werner and Dubsky, Peter and Fridrik, Michael and Fitzal, Florian and Stierer, Michael and Rucklinger, Ernst and Greil, Richard and The abcsg-12 Trial Investigators}, citeulike-article-id = {4043619}, citeulike-linkout-0 = {http://dx.doi.org/10.1056/NEJMoa0806285}, citeulike-linkout-1 = {http://content.nejm.org/cgi/content/abstract/360/7/679?query=TOC}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/19213681}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=19213681}, day = {12}, doi = {10.1056/NEJMoa0806285}, journal = {N Engl J Med}, keywords = {biphosphonates, cancer, estrogen, femalegonadal, osteoporosis, therapy}, month = {February}, number = {7}, pages = {679--691}, posted-at = {2009-02-13 15:00:55}, priority = {2}, title = {Endocrine Therapy plus Zoledronic Acid in Premenopausal Breast Cancer}, url = {http://dx.doi.org/10.1056/NEJMoa0806285}, volume = {360}, year = {2009} }

TY - JOUR ID - citeulike:4043619 L3 - citeulike-article-id:4043619 N2 - Background Ovarian suppression plus tamoxifen is a standard adjuvant treatment in premenopausal women with endocrine-responsive breast cancer. Aromatase inhibitors are superior to tamoxifen in postmenopausal patients, and preclinical data suggest that zoledronic acid has antitumor properties. Methods We examined the effect of adding zoledronic acid to a combination of either goserelin and tamoxifen or goserelin and anastrozole in premenopausal women with endocrine-responsive early breast cancer. We randomly assigned 1803 patients to receive goserelin (3.6 mg given subcutaneously every 28 days) plus tamoxifen (20 mg per day given orally) or anastrozole (1 mg per day given orally) with or without zoledronic acid (4 mg given intravenously every 6 months) for 3 years. The primary end point was disease-free survival; recurrence-free survival and overall survival were secondary end points. Results After a median follow-up of 47.8 months, 137 events had occurred, with disease-free survival rates of 92.8% in the tamoxifen group, 92.0% in the anastrozole group, 90.8% in the group that received endocrine therapy alone, and 94.0% in the group that received endocrine therapy with zoledronic acid. There was no significant difference in disease-free survival between the anastrozole and tamoxifen groups (hazard ratio for disease progression in the anastrozole group, 1.10; 95% confidence interval [CI], 0.78 to 1.53; P=0.59). The addition of zoledronic acid to endocrine therapy, as compared with endocrine therapy without zoledronic acid, resulted in an absolute reduction of 3.2 percentage points and a relative reduction of 36% in the risk of disease progression (hazard ratio, 0.64; 95% CI, 0.46 to 0.91; P=0.01); the addition of zoledronic acid did not significantly reduce the risk of death (hazard ratio, 0.60; 95% CI, 0.32 to 1.11; P=0.11). Adverse events were consistent with known drug-safety profiles. Conclusions The addition of zoledronic acid to adjuvant endocrine therapy improves disease-free survival in premenopausal patients with estrogen-responsive early breast cancer. (ClinicalTrials.gov number, NCT00295646 .) 10.1056/NEJMoa0806285 IS - 7 JF - N Engl J Med EP - 691 TI - Endocrine Therapy plus Zoledronic Acid in Premenopausal Breast Cancer VL - 360 SP - 679 KW - biphosphonates KW - cancer KW - estrogen KW - femalegonadal KW - osteoporosis KW - therapy AU - Gnant, Michael AU - Mlineritsch, Brigitte AU - Schippinger, Walter AU - Luschin-Ebengreuth, Gero AU - Postlberger, Sabine AU - Menzel, Christian AU - Jakesz, Raimund AU - Seifert, Michael AU - Hubalek, Michael AU - Bjelic-Radisic, Vesna AU - Samonigg, Hellmut AU - Tausch, Christoph AU - Eidtmann, Holger AU - Steger, Gunther AU - Kwasny, Werner AU - Dubsky, Peter AU - Fridrik, Michael AU - Fitzal, Florian AU - Stierer, Michael AU - Rucklinger, Ernst AU - Greil, Richard AU - The abcsg-12 Trial Investigators PY - 2009/02/12/ UR - http://dx.doi.org/10.1056/NEJMoa0806285 ER -