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Tamoxifen

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1. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and Tamoxifen Therapy

Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and Tamoxifen Therapy ClinicalPharmacogeneticsImplementation Consortium(CPIC)GuidelineforCYP2D6 andTamoxifenTherapy MatthewP.Goetz 1 ,KatrinSangkuhl 2 ,Henk-JanGuchelaar 3 ,MatthiasSchwab 4,5,6 ,MichaelProvince 7 , MichelleWhirl-Carrillo 2 ,W.FraserSymmans 8 ,HowardL.McLeod 9 ,MarkJ.Ratain 10 , HitoshiZembutsu 11 ,AndreaGaedigk 12 ,RonH.vanSchaik 13,14 ,JamesN.Ingle 1 , KellyE.Caudle 15 andTeriE.Klein 2 Tamoxifen (...) is biotransformed by CYP2D6 to 4-hydroxytamoxifen and 4-hydroxy N-desmethyl tamoxifen (endoxifen), both with greater antiestrogenic potency than the parent drug. Patients with certain CYP2D6 genetic polymorphisms and patients who receive strong CYP2D6 inhibitors exhibit lower endoxifen concentrations and a higher risk of disease recurrence in some studies of tamoxi- fen adjuvant therapy of early breast cancer. We summarize evidence from the literature and provide therapeutic recommenda

2018 Clinical Pharmacogenetics Implementation Consortium

2. Tamoxifen and SSRI or SNRI antidepressants ? is there an interaction?

Tamoxifen and SSRI or SNRI antidepressants ? is there an interaction? Tamoxifen and SSRI or SNRI antidepressants – is there an interaction? – SPS - Specialist Pharmacy Service – The first stop for professional medicines advice Menu · · 15th February 2019 This updated Medicines Q&A reviews the evidence for an interaction between tamoxifen and selective serotonin reuptake inhibitors (SSRIs)/serotonin noradrenaline reuptake inhibitors (SNRIs) resulting in reduced tamoxifen efficacy. Tamoxifen (...) is extensively metabolised via cytochrome P450 2D6 (CYP2D6) to active metabolites, the most significant of which is endoxifen. CYP2D6 is highly polymorphic, therefore capacity to metabolise tamoxifen varies according to individual CYP2D6 genotype. Different SSRIs/SNRIs inhibit the action of CYP2D6 to varying degrees. Epidemiological data are conflicting and inconclusive with regard to the interaction between tamoxifen and SSRIs or SNRIs. As the mechanism of effect is biologically plausible, caution

2019 Specialist Pharmacy Services

3. Aromatase inhibitors alone or sequentially combined with tamoxifen in postmenopausal early breast cancer compared with tamoxifen or placebo - Meta-analyses on efficacy and adverse events based on randomized clinical trials. (PubMed)

Aromatase inhibitors alone or sequentially combined with tamoxifen in postmenopausal early breast cancer compared with tamoxifen or placebo - Meta-analyses on efficacy and adverse events based on randomized clinical trials. Tamoxifen (TAM) and aromatase inhibitors (AI) are adjuvant therapy options for postmenopausal women with estrogen receptor positive (ER+) breast cancer. This systematic review of seven randomized controlled studies comparing TAM and AI, and one study comparing extended (...) therapy with an AI with placebo after about 5 years of tamoxifen, aims to assess long-term clinical efficacy and adverse events. The literature review was performed according to the principles of the Cochrane Collaboration. The search included common databases up to 2013-01-14. Studies of high or moderate quality were used for grading of evidence. Revman™ software was utilized for meta-analyses of published data. Disease free survival (DFS) and overall survival (OS) were improved with AI monotherapy

2016 Breast (Edinburgh, Scotland)

4. Taking tamoxifen to reduce the chance of developing breast cancer: premenopausal women at moderately increased risk

Taking tamoxifen to reduce the chance of developing breast cancer: premenopausal women at moderately increased risk Taking a medicine to reduce the chance of developing breast cancer: patient decision aid (premenopausal moderate risk) Copyright © NICE 2017. All rights reserved. Last updated March 2017 Page 1 of 11 Taking tamoxifen to reduce the chance of developing breast cancer Decision aid for premenopausal women at moderately increased risk Published: March 2017 About this decision aid (...) This decision aid can help you to decide whether or not to take a medicine called tamoxifen to reduce your chance of developing breast cancer. It is not intended for women who have had breast cancer in the past. Your decision depends on several things that this information will help to explain. Different women will feel that some of these things are more important to them than others, so it is important that you make a decision that is right for you. This decision aid is designed for you to work through

2017 Health Information and Quality Authority

5. Taking tamoxifen to reduce the chance of developing breast cancer: premenopausal women at high risk

Taking tamoxifen to reduce the chance of developing breast cancer: premenopausal women at high risk Taking a medicine to reduce the chance of developing breast cancer: patient decision aid (premenopausal high risk women) Copyright © NICE 2017. All rights reserved. Last updated March 2017 Page 1 of 11 Taking tamoxifen to reduce the chance of developing breast cancer Decision aid for premenopausal women at high risk Published: March 2017 About this decision aid This decision aid can help you (...) to decide whether or not to take a medicine called tamoxifen to reduce your chance of developing breast cancer. It is not intended for women who have had breast cancer in the past. Your decision depends on several things that this information will help to explain. Different women will feel that some of these things are more important to them than others, so it is important that you make a decision that is right for you. This decision aid is designed for you to work through with your healthcare

2017 Health Information and Quality Authority

6. Therapeutic Effects of a Traditional Chinese Medicine Formula Plus Tamoxifen vs. Tamoxifen for the Treatment of Mammary Gland Hyperplasia: A Meta-Analysis of Randomized Trials. (PubMed)

Therapeutic Effects of a Traditional Chinese Medicine Formula Plus Tamoxifen vs. Tamoxifen for the Treatment of Mammary Gland Hyperplasia: A Meta-Analysis of Randomized Trials. As a common disorder that accounts for over 70% of all breast disease cases, mammary gland hyperplasia (MGH) causes a severe problem for the quality of patients' life, and confers an increased risk of breast carcinoma. However, the etiology and pathogenesis of MGH remain unclear, and the safety and efficacy of current (...) western drug therapy for MGH still need to be improved. Therefore, a meta-analysis was conducted by our team to determine whether a TCM formula named Ru-Pi-Xiao in combination with tamoxifen or Ru-Pi-Xiao treated alone can show more prominent therapeutic effects against MGH with fewer adverse reactions than that of tamoxifen. Studies published before June 2017 were searched based on standardized searching rules in several mainstream medical databases. A total of 27 articles with 4,368 patients were

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2018 Frontiers in pharmacology

7. The tamoxifen paradox-influence of adjuvant tamoxifen on fracture risk in pre- and postmenopausal women with breast cancer. (PubMed)

The tamoxifen paradox-influence of adjuvant tamoxifen on fracture risk in pre- and postmenopausal women with breast cancer. Our data demonstrate that tamoxifen does not reduce fracture risk. Close surveillance is necessary to prevent bone loss in premenopausal women with breast cancer upon treatment initiation.Endocrine treatment of breast cancer may interfere with bone turnover and influence fracture risk.Out of a cohort of almost 5 million patients in total, we identified 5520 women between (...) 18 and 90 years of age with breast cancer receiving tamoxifen, matched them with 5520 healthy controls using the Disease Analyzer Database, and investigated the fracture risk.We found a cumulative incidence of fractures of 6.3% in patients aged between 18 and 50 years (n = 3634) treated with tamoxifen versus a cumulative incidence of 3.6% in the control group (p < 0.001). As such, the risk of fracture was 75% higher for patients receiving tamoxifen than that for healthy controls (HR 1.75; 95% CI

2018 Osteoporosis International

8. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia

Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia Tamoxifen administered for 5 years at 20 mg/d is effective in breast cancer treatment and prevention, but toxicity has limited its broad use. Biomarker trials showed that 5 mg/d is not inferior to 20 mg/d in decreasing breast cancer proliferation. We hypothesized that a lower dose given for a shorter period could be as effective in preventing recurrence (...) from breast intraepithelial neoplasia but have a lower toxicity than the standard dose.We conducted a multicenter randomized trial of tamoxifen, 5 mg/d or placebo administered for 3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ. The primary end point was the incidence of invasive breast cancer or ductal carcinoma in situ.Five hundred women 75 years of age or younger were

2019 EvidenceUpdates

9. Tamoxifen with radiotherapy compared with Tamoxifen alone in elderly women with early-stage breast cancer treated with breast conserving surgery: A systematic review and meta-analysis. (PubMed)

Tamoxifen with radiotherapy compared with Tamoxifen alone in elderly women with early-stage breast cancer treated with breast conserving surgery: A systematic review and meta-analysis. Our aim was to assess the effect of adjuvant radiotherapy on recurrence and survival for elderly women (≥70) with early-stage hormone receptor-positive breast cancer treated with breast conserving surgery (BCS) and Tamoxifen.MEDLINE, EMBASE, and Evidence-Based Medicine Reviews were systematically searched through (...) August 12, 2016 for randomized controlled trials (RCTs) comparing radiotherapy to no radiotherapy and presenting outcomes for women ≥70years. Two investigators screened citations, abstracted results, and appraised studies using Cochrane Risk of Bias tool. Pooled risk ratios (RR) for breast, axillary, and distant recurrence, and overall survival were determined using weights from fixed-effects models.Four RCTs with low risk of bias were identified (2387 elderly women). Tamoxifen plus radiotherapy

2017 Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

10. CYP2C19*2 and CYP2C19*17 variants and effect of tamoxifen on breast cancer recurrence: Analysis of the International Tamoxifen Pharmacogenomics Consortium dataset (PubMed)

CYP2C19*2 and CYP2C19*17 variants and effect of tamoxifen on breast cancer recurrence: Analysis of the International Tamoxifen Pharmacogenomics Consortium dataset The role of cytochrome P450 drug metabolizing enzymes in the efficacy of tamoxifen treatment of breast cancer is subject to substantial interest and controversy. CYP2D6 have been intensively studied, but the role of CYP2C19 is less elucidated, and we studied the association of CYPC19 genotype and recurrence of breast cancer. We used (...) outcome and genotyping data from the large publicly available International Tamoxifen Pharmacogenomics Consortium (ITPC) dataset. Cox regression was used to compute the hazard ratios (HRs) for recurrence. CYP2C19 genotype data was available for 2 423 patients and the final sample cohort comprised 2 102 patients. CYP2C19*2 or *19 alleles did not influence DFS. For the CYP2C19*2 allele, the HR was 1.05 (CI 0.78-1.42) and 0.79 (CI 0.32-1.94) for hetero- and homozygote carriers, respectively

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2017 Scientific reports

11. Discovery of Tamoxifen and N-Desmethyl Tamoxifen Protein Targets in MCF-7 Cells Using Large-Scale Protein Folding and Stability Measurements (PubMed)

Discovery of Tamoxifen and N-Desmethyl Tamoxifen Protein Targets in MCF-7 Cells Using Large-Scale Protein Folding and Stability Measurements The proteins in an MCF-7 cell line were probed for tamoxifen (TAM) and n-desmethyl tamoxifen (NDT) induced stability changes using the Stability of Proteins from Rates of Oxidation (SPROX) technique in combination with two different quantitative proteomics strategies, including one based on SILAC and one based on isobaric mass tags. Over 1000 proteins were

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2017 Journal of proteome research

12. Agoraphobia and Follicle-Stimulating Hormone Levels between Tamoxifen and Goserelin versus Tamoxifen Alone in Premenopausal Hormone Receptor-Positive Breast Cancer: A 12-Month Prospective Randomized Study (PubMed)

Agoraphobia and Follicle-Stimulating Hormone Levels between Tamoxifen and Goserelin versus Tamoxifen Alone in Premenopausal Hormone Receptor-Positive Breast Cancer: A 12-Month Prospective Randomized Study Tamoxifen is an estrogen receptor antagonist used to prevent recurrence of breast cancer, which may provoke depression and anxiety and increase follicle-stimulating hormone (FSH) to patients. We compared anxiety and depression symptoms and FSH levels who received conventional tamoxifen alone (...) and combination treatment of goserelin, a gonadotropin-releasing hormone (GnRH) analogue, with tamoxifen.Sixty-four premenopausal women with hormone receptor-positive early-stage breast cancer were included and were assigned randomly to receive either tamoxifen and goserelin combination or tamoxifen alone for 12 months. The participants were evaluated blindly using the Hamilton Depression and Anxiety Rating Scale, the Beck Depression Rating Scale, and the Albany Panic and Phobia Questionnaire (APPQ). Blood

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2017 Psychiatry investigation

13. Variations in plasma concentrations of tamoxifen metabolites and the effects of genetic polymorphisms on tamoxifen metabolism in Korean patients with breast cancer (PubMed)

Variations in plasma concentrations of tamoxifen metabolites and the effects of genetic polymorphisms on tamoxifen metabolism in Korean patients with breast cancer Inter-individual variation in tamoxifen metabolism in breast cancer patients is caused by various genetic and clinical factors. We measured the plasma concentrations of tamoxifen and its metabolites and investigated genetic polymorphisms influencing those concentrations. We measured the concentrations of tamoxifen, endoxifen, N (...) -desmethyltamoxifen (NDM), and 4-hydroxytamoxifen (4-OH tamoxifen) in 550 plasma specimens from 281 breast cancer patients treated with tamoxifen. Duplicate or triplicate specimens were obtained from 179 patients at 3-month intervals. In 80 patients, genotyping for tamoxifen metabolizing enzymes was performed using the DMET Plus array and long-range PCR. Plasma concentrations of tamoxifen and its metabolites showed wide variations among patients. The following genetic polymorphisms were associated with the plasma

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2017 Oncotarget

14. Incidence of Comorbidities in Women with Breast Cancer Treated with Tamoxifen or an Aromatase Inhibitor: An Australian Population-Based Cohort Study (PubMed)

Incidence of Comorbidities in Women with Breast Cancer Treated with Tamoxifen or an Aromatase Inhibitor: An Australian Population-Based Cohort Study The development of comorbidities has become increasingly relevant with longer-term cancer survival.To assess the pattern of comorbidities among Australian women with breast cancer treated with tamoxifen or an aromatase inhibitor.Retrospective cohort study using Pharmaceutical Benefits Scheme (PBS) data (10% sample) from January 2003 to December (...) 2014. Dispensing claims data were used to identify comorbidities and classified with the Rx-Risk-V model. The breast cancer cohort had tamoxifen or an aromatase inhibitor dispensed between 2004 and 2011 with no switching between types of endocrine therapy. Comparisons were made between the breast cancer cohort and specific control groups (age- and sex-matched at 1:10 ratio without any dispensing of anti-neoplastic agents during the study period) for the development of five individual comorbidities

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2018 Journal of comorbidity

15. Norcantharidin regulates ERα signaling and tamoxifen resistance via targeting miR-873/CDK3 in breast cancer cells. (PubMed)

Norcantharidin regulates ERα signaling and tamoxifen resistance via targeting miR-873/CDK3 in breast cancer cells. MiR-873/CDK3 has been shown to play a critical role in ERα signaling and tamoxifen resistance. Thus, targeting this pathway may be a potential therapeutic approach for the treatment of ER positive breast cancer especially tamoxifen resistant subtype. Here we report that Norcantharidin (NCTD), currently used clinically as an ani-cancer drug in China, regulates miR-873/CDK3 axis (...) in breast cancer cells. NCTD decreases the transcriptional activity of ERα but not ERβ through the modulation of miR-873/CDK3 axis. We also found that NCTD inhibits cell proliferation and tumor growth and miR-873/CDK3 axis mediates cell proliferation suppression of NCTD. More important, we found that NCTD sensitizes resistant cells to tamoxifen. NCTD inhibits tamoxifen induced the transcriptional activity as well ERα downstream gene expressions in tamoxifen resistant breast cancer cells. In addition, we

2019 PLoS ONE

16. Levonorgestrel intrauterine system for endometrial protection in women with breast cancer on adjuvant tamoxifen. (PubMed)

Levonorgestrel intrauterine system for endometrial protection in women with breast cancer on adjuvant tamoxifen. Adjuvant tamoxifen reduces the risk of breast cancer recurrence in women with oestrogen receptor-positive breast cancer. Tamoxifen also increases the risk of postmenopausal bleeding, endometrial polyps, hyperplasia, and endometrial cancer. The levonorgestrel-releasing intrauterine system (LNG-IUS) causes profound endometrial suppression. This systematic review considered the evidence (...) that the LNG-IUS prevents the development of endometrial pathology in women taking tamoxifen as adjuvant endocrine therapy for breast cancer.To determine the effectiveness and safety of levonorgestrel intrauterine system (LNG-IUS) in pre- and postmenopausal women taking adjuvant tamoxifen following breast cancer for the outcomes of endometrial and uterine pathology including abnormal vaginal bleeding or spotting, and secondary breast cancer events.We searched the following databases: Cochrane Menstrual

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2015 Cochrane

17. Meta-analysis of the cumulative risk of endometrial malignancy and systematic review of endometrial surveillance in extended tamoxifen therapy

Meta-analysis of the cumulative risk of endometrial malignancy and systematic review of endometrial surveillance in extended tamoxifen therapy Optimal management of the endometrium in patients with oestrogen receptor-positive breast cancer taking extended tamoxifen therapy (for 10 years) remains uncertain. A meta-analysis was performed to determine the cumulative risk ratio (RR) for endometrial malignancy following extended compared with standard tamoxifen treatment. A systematic review (...) was undertaken to identify whether routine endometrial surveillance in patients receiving tamoxifen is associated with earlier detection and reduced incidence of endometrial malignancy.Two independent searches were undertaken in the Cochrane Library, PubMed and MEDLINE. A meta-analysis was performed of RCTs reporting on endometrial malignancy risk in extended tamoxifen therapy. A systematic review included prospective studies investigating the benefit of endometrial surveillance during tamoxifen therapy.Four

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2018 EvidenceUpdates

18. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant (...) disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised

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2018 EvidenceUpdates

19. How do we increase uptake of tamoxifen and other anti-estrogens for breast cancer prevention? (PubMed)

How do we increase uptake of tamoxifen and other anti-estrogens for breast cancer prevention? Several randomized controlled trials of anti-estrogens, such as tamoxifen and aromatase inhibitors, have demonstrated up to a 50-65% decrease in breast cancerincidence among high-risk women. Approximately 15% of women, age 35-79 years, in the U.S. meet criteria for breast cancer preventive therapies, but uptake of these medications remain low. Explanations for this low uptake includelack of awareness

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2017 NPJ breast cancer

20. Tamoxifen and aromatase inhibitor treatment and incident type 2 diabetes: a systematic review and meta-analysis of observational studies

Tamoxifen and aromatase inhibitor treatment and incident type 2 diabetes: a systematic review and meta-analysis of observational studies Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content of this registration

2019 PROSPERO

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