2011
DOI: 10.1186/bcr2837
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Interpreting breast international group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer

Abstract: The Breast International Group (BIG) 1-98 study is a four-arm trial comparing 5 years of monotherapy with tamoxifen or with letrozole or with sequences of 2 years of one followed by 3 years of the other for postmenopausal women with endocrine-responsive early invasive breast cancer. From 1998 to 2003, BIG -98 enrolled 8,010 women. The enhanced design f the trial enabled two complementary analyses of efficacy and safety. Collection of tumor specimens further enabled treatment comparisons based on tumor biology.… Show more

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Cited by 62 publications
(39 citation statements)
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“…Hormonal therapies, such as aromatase inhibitors (AI) and tamoxifen, significantly increase disease-free survival and reduce the risk of recurrence in breast cancer patients [13]. However, patients and survivors often experience unpleasant side effects from these therapies including musculoskeletal symptoms (joint pain and stiffness), bone loss, and menopausal symptoms [4].…”
Section: Introductionmentioning
confidence: 99%
“…Hormonal therapies, such as aromatase inhibitors (AI) and tamoxifen, significantly increase disease-free survival and reduce the risk of recurrence in breast cancer patients [13]. However, patients and survivors often experience unpleasant side effects from these therapies including musculoskeletal symptoms (joint pain and stiffness), bone loss, and menopausal symptoms [4].…”
Section: Introductionmentioning
confidence: 99%
“…Additionally, markers are usually measured in excised primary tumours whereas the measured endpoints are largely dependent upon the behaviour of micro-metastatic disease. Most clinical trials comparing the adjuvant use of AIs versus tamoxifen have consistently shown clinical benefit in favour of AIs [12][13][14]. Effects on disease recurrence are usually statistically significant whereas those on survival are rarely so, unless trials are combined in a meta-analysis [20,21].…”
Section: Adjuvant Settingmentioning
confidence: 98%
“…In principle, these models are being updated according to accumulated evidence and include some data for patients treated with AIs [137]. However, in practice the current breast cancer version of Adjuvant!online (version 8.0) is dated by 2005, which is before publication of the long-term outcomes of the major adjuvant AI trials [12][13][14]. At the same time, the Adjvuant!online web site says that an updated breast cancer version is undergoing checking and will be released in future (version 9.0).…”
Section: Pepi and Other Multicomponent Clinical Indicesmentioning
confidence: 99%
See 1 more Smart Citation
“…Aromatase inhibitors such as exemestane, letrozole, and anastrozole work by inhibiting CYP19Al to stop the production of estrogens. In a five year study of 8,010 women, treatment with letrozole resulted in improved disease-free survival, overall survival, and time to distant recurrence for postmenopausal women, as compared to treatment with tamoxifen or a sequence of tamoxifen and letrozole [55], highlighting the clinical efficacy of aromatase inhibitors as a treatment of choice in postmenopausal women.…”
Section: Another Methods Of Targeting the Estrogen Receptor Is Throughmentioning
confidence: 99%