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The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer.
Expert Rev Anticancer Ther. 2007 May; 7(5):627-34.ER

Abstract

As there is a risk for relapse in early breast cancer, especially at 1-3 years post surgery, the need for adjuvant therapy is clear. In terms of disease-free survival, aromatase inhibitors have emerged as superior to tamoxifen for the adjuvant treatment of hormone-sensitive breast cancer in several Phase III clinical trials. Of these trials, the Breast International Group (BIG) 1-98 trial stands out as unique in design, as it is the only trial to address whether an aromatase inhibitor is more effective as initial adjuvant therapy or as sequential therapy with an aromatase inhibitor and tamoxifen in either order and in rigor of end points and safety evaluations. When compared with tamoxifen, letrozole has been shown to significantly reduce recurrence risk in the overall population by 19% and also significantly reduced recurrence risk in the patient subgroups at increased risk: node-positive and previously chemotherapy-treated patients. Letrozole is the only aromatase inhibitor to demonstrate a significant 27% reduction in the risk of distant metastases (p = 0.001) in the clinically relevant, hormone receptor-positive population in the initial adjuvant setting. Recent results also suggest that letrozole in particular reduces the risk of distant metastases early on after initial surgery for breast cancer. This is important, as early distant metastatic events compose the majority of early recurrences and are a well-recognized predictor of breast cancer death. Letrozole has been found to be well tolerated in the initial adjuvant treatment setting, and these data have been confirmed by long-term safety data from the monotherapy analysis in the BIG 1-98 study. Thus far, the results from the BIG 1-98 trial provide clear support for the use of letrozole in the initial adjuvant treatment of breast cancer. Future studies will provide the definitive answer to questions of which initial adjuvant therapy is superior (i.e., anastrozole or letrozole) and information as to the optimal treatment strategy (i.e., initial adjuvant aromatase inhibitor therapy or sequential adjuvant aromatase inhibitor therapy).

Authors+Show Affiliations

Department of Medical Oncology, Centre Hospitalier A. Boulloche, Montbeliard Cedex, France. a.monnier@infonie.fr

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

17492927

Citation

Monnier, Alain M.. "The Breast International Group 1-98 Trial: Big Results for Women With Hormone-sensitive Early Breast Cancer." Expert Review of Anticancer Therapy, vol. 7, no. 5, 2007, pp. 627-34.
Monnier AM. The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer. Expert Rev Anticancer Ther. 2007;7(5):627-34.
Monnier, A. M. (2007). The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer. Expert Review of Anticancer Therapy, 7(5), 627-34.
Monnier AM. The Breast International Group 1-98 Trial: Big Results for Women With Hormone-sensitive Early Breast Cancer. Expert Rev Anticancer Ther. 2007;7(5):627-34. PubMed PMID: 17492927.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer. A1 - Monnier,Alain M, PY - 2007/5/12/pubmed PY - 2007/5/18/medline PY - 2007/5/12/entrez SP - 627 EP - 34 JF - Expert review of anticancer therapy JO - Expert Rev Anticancer Ther VL - 7 IS - 5 N2 - As there is a risk for relapse in early breast cancer, especially at 1-3 years post surgery, the need for adjuvant therapy is clear. In terms of disease-free survival, aromatase inhibitors have emerged as superior to tamoxifen for the adjuvant treatment of hormone-sensitive breast cancer in several Phase III clinical trials. Of these trials, the Breast International Group (BIG) 1-98 trial stands out as unique in design, as it is the only trial to address whether an aromatase inhibitor is more effective as initial adjuvant therapy or as sequential therapy with an aromatase inhibitor and tamoxifen in either order and in rigor of end points and safety evaluations. When compared with tamoxifen, letrozole has been shown to significantly reduce recurrence risk in the overall population by 19% and also significantly reduced recurrence risk in the patient subgroups at increased risk: node-positive and previously chemotherapy-treated patients. Letrozole is the only aromatase inhibitor to demonstrate a significant 27% reduction in the risk of distant metastases (p = 0.001) in the clinically relevant, hormone receptor-positive population in the initial adjuvant setting. Recent results also suggest that letrozole in particular reduces the risk of distant metastases early on after initial surgery for breast cancer. This is important, as early distant metastatic events compose the majority of early recurrences and are a well-recognized predictor of breast cancer death. Letrozole has been found to be well tolerated in the initial adjuvant treatment setting, and these data have been confirmed by long-term safety data from the monotherapy analysis in the BIG 1-98 study. Thus far, the results from the BIG 1-98 trial provide clear support for the use of letrozole in the initial adjuvant treatment of breast cancer. Future studies will provide the definitive answer to questions of which initial adjuvant therapy is superior (i.e., anastrozole or letrozole) and information as to the optimal treatment strategy (i.e., initial adjuvant aromatase inhibitor therapy or sequential adjuvant aromatase inhibitor therapy). SN - 1744-8328 UR - https://www.unboundmedicine.com/medline/citation/17492927/The_Breast_International_Group_1_98_trial:_big_results_for_women_with_hormone_sensitive_early_breast_cancer_ L2 - https://www.tandfonline.com/doi/full/10.1586/14737140.7.5.627 DB - PRIME DP - Unbound Medicine ER -