Adjuvant tamoxifen in postmenopausal breast cancer: Preliminary results of a randomized trial

Delozier, T.; Julien, J.P.; Juret, P; Veyret, Corinne; Couette, J.E.; Graic, Y.; Ollivier, J. M.; Ranieri, E

doi:10.1007/bf01806795

Cited by 44 publications

(18 citation statements)

References 6 publications

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“…Delozier and coworkers [76] compared three years of adjuvant tamoxifen therapy vs no treatment in a small randomized clinical study. The tamoxifen-treated patients who were receptor-positive had a survival advantage when compared with either receptor-negative patients or those not receiving tamoxifen.…”

Section: Long-term Adjuvant Tamoxifen Therapymentioning

confidence: 99%

Long-term adjuvant tamoxifen therapy for breast cancer

Jordan¹

1990

Breast Cancer Res Tr

113

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Tamoxifen (ICI46,474) is a competitive inhibitor of estrogen action which has found ubiquitous application in the treatment of breast cancer. The drug is the front line endocrine therapy for breast cancer and is the proven treatment of choice for the adjuvant therapy of postmenopausal women with node-positive disease. Tamoxifen is available for the treatment of premenopausal patients with advanced disease, and is being evaluated in clinical trials as an adjuvant therapy for premenopausal patients with either node-positive or node-negative disease. Laboratory studies demonstrate that tamoxifen is a tumoristatic agent and long-term treatment strategies (chemosuppression) should be considered to apply the antiestrogen to its maximal therapeutic advantage. Optimal therapy with tamoxifen may also be achieved by treatment strategies to lower circulating estrogen levels in the premenopausal patient. Tamoxifen is a well tolerated drug, and long-term therapy does not appear to induce metabolic tolerance. Concerns about premature osteoporosis or cardiovascular disease appear to be unfounded because tamoxifen has an appropriate level of target site-directed estrogenic activity. Isolated reports about the growth or appearance of endometrial carcinoma during long-term adjuvant tamoxifen therapy must be balanced against the risks of withholding treatment to patients with a fatal disease.

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Section: Long-term Adjuvant Tamoxifen Therapymentioning

confidence: 99%

Long-term adjuvant tamoxifen therapy for breast cancer

Jordan¹

1990

Breast Cancer Res Tr

113

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Section: Methodsmentioning

confidence: 99%

“…(3) To find randomized trials of tamoxifen administration for at least 3 years in breast cancer patients for prevention of recurrences or new primary breast cancers, with published results stratified by ER status. Five such studies were found (Delozier et al, 1986; Breast Cancer Trials Committee, 1987;Falkson et al, 1990;Tormey et al, 1992;Rutqvist et al, 1996).Results of each of the above three types of study were first synthesized using random effects meta-analysis methods, details of which are given by Nixon and Duffy (2002). Results of the trials were then combined with those of the BRCA1 and BRCA2 tumour surveys in turn, as follows: let R 7 be the percentage reduction conferred by tamoxifen in ER7 tumours, as observed in the combined randomized trials.…”

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confidence: 99%

Estimates of the likely prophylactic effect of tamoxifen in women with high risk BRCA1 and BRCA2 mutations

Duffy

Nixon

2002

Br J Cancer

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The development of breast cancer control strategies in women at high genetic risk of breast cancer is an important issue. The likely benefit of chemopreventive approaches is of particular interest. Tamoxifen tends to be more effective in both prevention and treatment of oestrogen receptor positive tumours than oestrogen receptor negative. In this study, we combine the oestrogen-receptor specific effects of tamoxifen from randomized preventive or therapeutic trials with the oestrogen receptor status of tumours in BRCA1 and BRCA2 mutation positive women from published tumour surveys to obtain estimates of the likely effect of tamoxifen administration in mutation carriers. We used a simple two-stage procedure to estimate the benefit as a weighted average of the effect on oestrogen receptor positive tumours and oestrogen receptor negative, and using a more complex hierarchical modelling approach. Using the simple procedure and deriving the estimates of benefit from both primary prevention and therapeutic trials, we obtain an estimated reduction in risk of breast cancer from administration of tamoxifen in BRCA1 mutation positive women of 13% (RR=0.87, 95% CI 0.68 -1.11). The corresponding estimated reduction in BRCA2 mutation positive women was 27% (RR=0.73, 95% CI 0.59 -0.90). Using the more complex models gave essentially the same results. Using only the primary prevention trials gave smaller estimates of benefit in BRCA1 carriers but larger estimates in BRCA2, in both cases with wider confidence intervals. The benefit of prophylactic use of tamoxifen in BRCA1 mutation carriers is likely to be modest, and the effect in BRCA2 mutation carriers somewhat greater. In randomized trials, tamoxifen has been shown to be effective in treatment of oestrogen receptor positive (ER+) tumours but not of oestrogen receptor negative (ER7), in terms of prevention of recurrences, new primary tumours and fatality (Early Breast Cancer Trialists' Collaborative Group, 1998). One primary prevention trial in the USA found that tamoxifen substantially reduced incidence of ER+ tumours but had no such effect on ER7 (Fisher et al, 1998). In sporadic breast cancer, the majority of tumours are ER positive (Early Breast Cancer Trialists' Collaborative Group, 1998), whereas the opposite is the case in cancers diagnosed in women with high risk mutations in the BRCA1 and BRCA2 genes (Johannsson et al, 1997;Armes et al, 1999).In this study we synthesize the results on oestrogen receptor (ER) status from tumour series in mutation carriers with subgroup analyses by ER status in primary and secondary prevention trials of long-term tamoxifen use. From this, we derive an estimate of the likely preventive benefit of long-term tamoxifen administration in women with high risk BRCA1 and BRCA2 mutations. MATERIALS AND METHODSFirst, three computerized literature searches augmented with studies brought to our attention by personal communication were performed: (1) To find surveys of ER status in breast cancer patients with a high risk mutation in the BRCA1 or ...

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“…The value of ER status in predicting the benefit from adjuvant endocrine treatment is controversial. Thus, adjuvant tamoxifen treatment has been reported in some studies (16)(17)(18) to benefit only patients with ER-positive tumors, whereas the NATO trial found that the ER status had no such importance (78). However, the Scottish trial demonstrated that all women benefitted, but mostly those with the highest ER content (79).…”

Section: Prediction Of Benefit Of Adjuvant Hormonal Treatment In Earlmentioning

confidence: 99%

Determination of Estrogen Receptors in Paraffin-Embedded Tissue: Techniques and the value in breast cancer treatment

Andersen

1992

Acta Oncologica

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Adjuvant tamoxifen in postmenopausal breast cancer: Preliminary results of a randomized trial

Cited by 44 publications

References 6 publications

Long-term adjuvant tamoxifen therapy for breast cancer

Long-term adjuvant tamoxifen therapy for breast cancer

Estimates of the likely prophylactic effect of tamoxifen in women with high risk BRCA1 and BRCA2 mutations

Determination of Estrogen Receptors in Paraffin-Embedded Tissue: Techniques and the value in breast cancer treatment

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