Tamoxifen for early breast cancer: an overview of the randomised trials

doi:10.1016/s0140-6736(97)11423-4

Cited by 3,510 publications

(157 citation statements)

References 18 publications

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“…lymph node status, tumour diameter and histological grade) are moderately accurate in classifying breast tumours according to their clinical behaviour. The Oxford Overviews of systemic treatments demonstrate that a significant proportion of patients are long-term survivors without adjuvant systemic therapy [1,5,6]. Furthermore, there are patients that will develop metastatic disease despite this treatment.…”

Section: Introductionmentioning

confidence: 99%

Validation of 70-gene prognosis signature in node-negative breast cancer

Bueno-de-Mesquita

Linn

Keijzer

et al. 2008

Breast Cancer Res Treat

149

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International audienceThe 70-gene prognosis signature (van't Veer et al., Nature 415(6871):530–536, 2002) may improve the selection of lymph node-negative breast cancer patients for adjuvant systemic therapy. Optimal validation of prognostic classifiers is of great importance and we therefore wished to evaluate the prognostic value of the 70-gene prognosis signature in a series of relatively recently diagnosed lymph node negative breast cancer patients. We evaluated the 70-gene prognosis signature in an independent representative series of patients with invasive breast cancer ( = 123; <55 years; pT1-2N0; diagnosed between 1996 and 1999; median follow-up 5.8 years) by classifying these patients as having a good or poor prognosis signature. In addition, we updated the follow-up of the node-negative patients of the previously published validation-series (Van de Vijver et al., N Engl J Med 347(25):1999–2009, 2002; = 151; median follow-up 10.2 years). The prognostic value of the 70-gene prognosis signature was compared with that of four commonly used clinicopathological risk indexes. The endpoints were distant metastasis (as first event) free percentage (DMFP) and overall survival (OS). The 5-year OS was 82 ± 5% in poor (48%) and 97 ± 2% in good prognosis signature (52%) patients (HR 3.4; 95% CI 1.2–9.6; = 0.021). The 5-years DMFP was 78 ± 6% in poor and 98 ± 2% in good prognosis signature patients (HR 5.7; 95% CI 1.6–20; = 0.007). In the updated series ( = 151; 60% poor vs. 40% good), the 10-year OS was 51 ± 5% and 94 ± 3% (HR 10.7; 95% CI 3.9–30; < 0.01), respectively. The DMFP was 50 ± 6% in poor and 86 ± 5% in good prognosis signature patients (HR 5.5; 95% CI 2.5–12; < 0.01). In multivariate analysis, the prognosis signature was a strong independent prognostic factor in both series, outperforming the clinicopathological risk indexes. The 70-gene prognosis signature is also an independent prognostic factor in node-negative breast cancer patients for women diagnosed in recent years

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Section: Introductionmentioning

confidence: 99%

Validation of 70-gene prognosis signature in node-negative breast cancer

Bueno-de-Mesquita

Linn

Keijzer

et al. 2008

Breast Cancer Res Treat

149

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“…However, a number of clinical studies have shown that long-term use of tamoxifen is associated with some uncommon, but serious risks, including an increase in the incidence of endometrial cancer and thromboembolic events [2,4,5,6]. …”

Section: Safety Of Tamoxifenmentioning

confidence: 99%

“…A meta-analysis of 55 trials of adjuvant tamoxifen versus no adjuvant tamoxifen in 37,000 women with early breast cancer found that tamoxifen doubled the risk of endometrial cancer after 1 or 2 years of treatment, and quadrupled the risk after 5 years of treatment [2]. A total of 8,349 women were available for assessment at a mean scheduled duration of adjuvant tamoxifen treatment of ≥3 years.…”

Section: Safety Of Tamoxifenmentioning

confidence: 99%

“…In breast cancer patients, approximately two thirds of the tumors are estrogen receptor (ER)-positive [1, 2]. Endocrine therapy therefore represents an important treatment for these women and may include agents that reduce the effects of estrogen at the receptor level, such as tamoxifen or fulvestrant, or inhibit estrogen formation, such as the aromatase inhibitors (AIs).…”

Section: Introductionmentioning

confidence: 99%

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Safety Considerations of Adjuvant Therapy in Early Breast Cancer in Postmenopausal Women

Gradishar

2005

Oncology

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Because of its proven efficacy profile based on long-term data, tamoxifen has been the standard adjuvant endocrine therapy for hormone-sensitive early breast cancer for the past 30 years. However, there is well-established evidence that long-term use of tamoxifen is associated with serious side effects. As adjuvant endocrine therapy is generally administered for long periods of time, the safety and tolerability of agents used in this setting are of particular importance. Due to their superior efficacy over tamoxifen, newer agents, such as the third-generation aromatase inhibitors (AIs), are already established therapies for the treatment of advanced breast cancer. In addition, recent trials indicate that the AI anastrozole (‘Arimidex’) has improved efficacy compared with tamoxifen in the adjuvant setting in postmenopausal women. The other third-generation AIs have reported disease-free survival benefits but not in the absence of prior treatment with tamoxifen; letrozole (‘Femara’) has been compared with placebo following 5 years of tamoxifen therapy and exemestane (‘Aromasin’) has been compared with tamoxifen following 2–3 years of prior treatment with tamoxifen. Long-term safety data show that anastrozole also has a more favorable overall safety profile compared with tamoxifen, particularly in terms of life-threatening events such as endometrial cancer and thromboembolism. Anastrozole alone, therefore, provides a new option for adjuvant therapy in postmenopausal women with hormone-receptor-positive early breast cancer. The AIs have differing pharmacological profiles, which may translate into dissimilar adverse event profiles in the adjuvant treatment setting, but patient follow-up in most trials is relatively short to make a valid comparison. It cannot, therefore, be assumed that all AIs will be equally well tolerated in the adjuvant setting. Further data on the long-term safety of AIs other than anastrozole are therefore required to allow overall risk:benefit assessments on these agents to be made.

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“…Involvement of the regional lymph nodes is a major predictive factor of metastatic disease. Adjuvant therapies such as chemotherapy, radiotherapy, hormone therapy, and monoclonal antibodies reduce the incidence of metastasis greatly (8)(9)(10).…”

Section: Introductionmentioning

confidence: 99%

Comparison of Estrogen, Progesterone and Her2 Receptors in Primary Breast Cancer and Paired Metastatic Lymph Nodes: An Immunohistochemical Study

et al. 2017

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Background: Immunohistochemistry (IHC) of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (Her2) are important prognostic factors of breast cancer. However, discordance between IHC findings of primary tumor and ipsilateral metastatic lymph nodes (IMLNs) has been reported that might affect the criteria for adjuvant therapies in breast cancer in the future. Methods: Sample size of the current study was estimated 50 (Macnemar test). We performed IHC for ER, PR, and Her2 on IMLNs of 50 paraffin embedded blocks of breast cancer patients with regional lymphadenopathy during the period. All-red score 2 was regarded as negative and 3 as positive for ER/PR. Her2 results were classified to 1+ ( 0 and 1+), 2+, and 3+. We used SPSS 16 to insert and analyze the data.

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Tamoxifen for early breast cancer: an overview of the randomised trials

Cited by 3,510 publications

References 18 publications

Validation of 70-gene prognosis signature in node-negative breast cancer

Validation of 70-gene prognosis signature in node-negative breast cancer

Safety Considerations of Adjuvant Therapy in Early Breast Cancer in Postmenopausal Women

Comparison of Estrogen, Progesterone and Her2 Receptors in Primary Breast Cancer and Paired Metastatic Lymph Nodes: An Immunohistochemical Study

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