Tamoxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study

Fisher, Bernard; Costantino, Joseph P.; Wickerham, D. Lawrence; Redmond, Carol; Kavanah, Maureen; Cronin, Walter M.; Vogel, Victor G.; Robidoux, André; Dimitrov, Nikolay V.; Atkins, James N.; Daly, Mary B.; Wieand, Samuel; Tan-Chiu, Elizabeth; Ford, Leslie G.; Wolmark, Norman

doi:10.1093/jnci/90.18.1371

Cited by 4,960 publications

(3,240 citation statements)

References 51 publications

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“…[9][10][11][12][13][14][15] As tamoxifen has been associated with increased incidence of thromboembolic events and endometrial cancer, it is necessary to evaluate risk versus benefit for each patient. 16 …”

Section: Discussionmentioning

confidence: 99%

Semi-quantitative immunohistochemical assay versus oncotype DX® qRT-PCR assay for estrogen and progesterone receptors: an independent quality assurance study

et al. 2012

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Estrogen receptor (ER) status is a strong predictor of response to hormonal therapy in breast cancer patients. Presence of ER and level of expression have been shown to correlate with time to recurrence in patients undergoing therapy with tamoxifen or aromatase inhibitors. Risk reduction is also known to occur in ERnegative, progesterone receptor (PR)-positive patients treated with hormonal therapy. Since the 1990s, immunohistochemistry has been the primary method for assessing hormone receptor status. Recently, as a component of its oncotype DX s assay, Genomic Health began reporting quantitative estrogen and PR results determined by quantitative reverse transcription polymerase chain reaction (qRT-PCR). As part of an ongoing quality assurance program at our institution, we reviewed 464 breast cancer cases evaluated by both immunohistochemistry and oncotype DX s assay for estrogen and PR. We found good correlation for ER status between both assays (98.9% concordance), with immunohistochemistry being slightly more sensitive. Concordance for PR was 94.2% between immunohistochemistry and qRT-PCR with immunohistochemistry again more sensitive than RT-PCR. The results also showed linear correlation between immunohistochemistry H-scores and qRT-PCR expression values for ER (correlation coefficient of 0.579), and PR (correlation coefficient of 0.685). Due to the higher sensitivity of hormone receptor immunohistochemistry and additional advantages (ie preservation of morphology, less expensive, faster, more convenient), we conclude immunohistochemistry is preferable to qRT-PCR for determination of estrogen and PR expression.

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Section: Discussionmentioning

confidence: 99%

Semi-quantitative immunohistochemical assay versus oncotype DX® qRT-PCR assay for estrogen and progesterone receptors: an independent quality assurance study

et al. 2012

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“…Tamoxifen has also been demonstrated to be of value in reducing the risk of primary invasive and pre-malignant breast cancer in high-risk women in North America (Fisher et al, 1998), and of contralateral breast cancer in unselected women (Early Breast Cancer Trialists' Collaborative Group, 1998). The large National Surgical Adjuvant Breast and Bowel Project (NSABP) breast cancer prevention trial reported a highly significant reduction in the incidence of invasive breast cancer among women randomized to tamoxifen, versus placebo (Fisher et al, 1998). In an subset analysis of the NSABP database, genetic mutation status was determined by DNA sequencing on 288 women with incident breast cancer (King et al, 2001).…”

Section: Tamoxifen and Raloxifenementioning

confidence: 99%

Modifiers of risk of hereditary breast cancer

Narod

2006

Oncogene

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Mutations in the BRCA1 and BRCA2 genes confer a high lifetime risk of breast and ovarian cancer. The risk varies from individual to individual, and it appears that the risk has increased in recent generations. These observations imply that non-genetic factors may modify the inherited risk. To date, the factors that appear most strongly to modify the risk include reproductive histories and exogenous hormones. Oral contraceptives are associated with a profound reduction in the risk of ovarian cancer, and with little or no increase in the risk of breast cancer. Other modifying factors include age of menarche, parity, breastfeeding and oophorectomy. The effect of parity is different in BRCA1 and BRCA2 carriers. Multiparity appears to be protective in BRCA1 carriers, but is associated with an increase in risk in BRCA2 carriers. Oophorectomy has been associated with reductions in both the risk of breast and ovarian cancer. Knowledge of these risk factors will be useful for managing risk and for developing prevention strategies.

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“…Tamoxifen administration is known to be associated with gynecological side effects such as endometrial hyperplasia, polyps and cancer [1][2][3][4]. Although most of these changes are benign, the wide range of abnormalities induced by tamoxifen has led to a number of gynecological interventions in symptomatic women to exclude malignant disease.…”

Section: Introductionmentioning

confidence: 99%

Prospective assessment of the endometrium in postmenopausal breast cancer patients treated with fulvestrant

Morales

Neven

Timmerman

et al. 2008

Breast Cancer Res Treat

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This prospective study assessed the endometrial effects of fulvestrant, a pure estrogen-receptor antagonist, in postmenopausal women with breast cancer. This singlecenter study enrolled postmenopausal patients who had an intact uterus at baseline with progressive metastatic breast cancer on tamoxifen followed by an oral aromatase inhibitor (AI). Fulvestrant (250 mg) was administered every 28 ± 3 days via IM injection. Transvaginal ultrasonography (TVUS) was performed at baseline and after 3 months of therapy. Primary and secondary endpoints were changes from baseline in double endometrial thickness (DET) and uterine volume (UV), respectively. No interventions were performed on any asymptomatic uterine abnormalities that were detected at baseline. In total, 32 women were enrolled. Five patients had no repeat TVUS because of early progression before 3 months, leaving 27 evaluable patients for final analysis. After 3 months therapy, mean DET had significantly decreased by 23.08% (P = 0.010). Mean UV also decreased by 10.88%, although this change was not significant (P = 0.119). After 3 months of therapy, none reported vaginal bleeding, there were no changes noted in most of the uterine pathologies present at baseline and no new uterine abnormalities were detected. We observed that 3 months of fulvestrant treatment resulted in a significant decrease in endometrial growth and a non-significant decrease in UV in postmenopausal women with metastatic breast cancer previously exposed to tamoxifen and AIs. Furthermore, no new uterine pathologies were detected, indicating that fulvestrant behaves as a pure antiestrogen at the uterine level.

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Tamoxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study

Abstract: Tamoxifen decreases the incidence of invasive and noninvasive breast cancer. Despite side effects resulting from administration of tamoxifen, its use as a breast cancer preventive agent is appropriate in many women at increased risk for the disease.

Cited by 4,960 publications

References 51 publications

Semi-quantitative immunohistochemical assay versus oncotype DX® qRT-PCR assay for estrogen and progesterone receptors: an independent quality assurance study

Semi-quantitative immunohistochemical assay versus oncotype DX® qRT-PCR assay for estrogen and progesterone receptors: an independent quality assurance study

Modifiers of risk of hereditary breast cancer

Prospective assessment of the endometrium in postmenopausal breast cancer patients treated with fulvestrant

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