The Breast : official journal of the European Society of Mastology
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Randomized Controlled Trial Multicenter Study
Update of the BIG 1-98 Trial: where do we stand?
There is accumulating data on the clinical benefit of aromatase inhibitors in the adjuvant treatment of early-stage breast cancer in postmenopausal women. The Breast International Group (BIG) 1-98 study is a randomized, phase 3, double-blind trial comparing four adjuvant endocrine treatments of 5 years duration in postmenopausal women with hormone-receptor-positive breast cancer: letrozole or tamoxifen monotherapy, sequential treatment with tamoxifen followed by letrozole, or vice versa. This article summarizes data presented at the 2009 St. Gallen early breast cancer conference: an update on the monotherapy arms of the BIG 1-98 study, and results from the sequential treatment arms. Implications for daily practice from BIG 1-98 and from other adjuvant trials will be discussed. ⋯ The BIG 1-98 study update with median follow up of 76 months confirms a significant reduction in the risk of breast cancer recurrence and a trend towards improved overall survival with letrozole as compared to tamoxifen, and no unexpected safety concerns with letrozole. Adjuvant endocrine treatment should preferentially be initiated with letrozole. For patients unable to continue letrozole, switching to tamoxifen appears to be an acceptable alternative.
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Recent studies have shown a dramatic increase in the use of contralateral prophylactic mastectomy (CPM). The choice of surgical procedure is primarily influenced by the recommendations of physicians and surgeons. As smaller breast cancers are detected by improved breast screening, and larger breast cancers are reduced in size by neo-adjuvant chemo- and endocrine therapy, breast conservation therapy (BCT) has been applicable to more women. ⋯ Some women elect CPM rather than biopsy or further imaging of the contralateral breast. The case can be made that CPM should be on the decline. Its increase raises questions of the awareness of breast oncologists, medical and surgical, of the true risk data.
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The role of immune surveillance in controlling the spread of breast cancer to the regional nodes is poorly understood. In theory regional nodal irradiation (RNI) might compromise this host function. However the clinical evidence suggests that the risk of regional recurrence is lower in patients with early breast cancer whose axilla has been irradiated compared to no axillary treatment. ⋯ The role of internal mammary nodal irradiation is unclear. The individualisation of RNI based on molecular and genetic factors should be a priority for research. The benefits of RNI need to be carefully balanced against the risks of cardiotoxicity, pneumonitis, lymphoedema, brachial plexopathy and secondary malignancy.