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Showing content from https://pubmed.ncbi.nlm.nih.gov/19196674/ below:

Breast cancer after use of estrogen plus progestin in postmenopausal women

Randomized Controlled Trial

Collaborators, Affiliations

• WHI Investigators: E Nabel, J Rossouw, S Ludlam, J McGowan, N Geller, L Ford, R Prentice, G L Anderson, A LaCroix, R Patterson, A McTiernan, B Cochrane, J Hunt, L Tinker, C Kooperberg, M McIntosh, C Y Wang, C Chen, D Bowen, A Kristal, J Stanford, N Urban, N Weiss, E White, E Stein, P Laskarzewski, S R Cummings, M Nevitt, L Palermo, L Harnack, F Cammarata, S Lindenfelser, B Psaty, S Heckbert, S Wassertheil-Smoller, W Frishman, J Wylie-Rosett, D Barad, R Freeman, A Rajkovic, J Hays, R Young, H Sangi-Haghpeykar, J E Manson, K M Rexrode, B Walsh, J M Gaziano, M Bueche, C B Eaton, M Cyr, G Sloane, L Phillips, V Butler, V Porter, S A A Beresford, V M Taylor, N F Woods, M Henderson, R Andersen, L Martin, J Hsia, N Gaba, R Katz, R Chlebowski, R Detrano, A Nelson, M Geller, Y Michael, E Whitlock, V Stevens, N Karanja, B Caan, S Sidney, G B J Hirata, J Morley Kotchen, V Barnabei, T A Kotchen, M A C Gilligan, J Neuner, B V Howard, L Adams-Campbell, L Lessin, C Iglesia, L K Mickel, L Van Horn, P Greenland, J Khandekar, K Liu, C Rosenberg, H Black, L Powell, E Mason, M Gulati, M L Stefanick, M A Hlatky, B Chen, R S Stafford, S Mackey, D Lane, I Granek, W Lawson, C Messina, G San Roman, R Jackson, R Harris, E Paskett, W J Mysiw, M Blumenfeld, C E Lewis, A Oberman, J M Shikany, M Safford, C A Thomson, T Bassford, C Ritenbaugh, Z Chen, M Ko, J Wactawski-Wende, M Trevisan, E Smit, S Graham, J Chang, J Robbins, S Yasmeen, F A Hubbell, G Frank, N Wong, N Greep, B Monk, L Nathan, D Heber, R Elashoff, S Liu, R D Langer, M H Criqui, G T Talavera, C F Garland, M A Allison, M Gass, N Watts, M Limacher, M Perri, A Kaunitz, R S Williams, Y Brinson, J D Curb, H Petrovitch, B Rodriguez, K Masaki, P Blanchette, R Wallace, J Torner, S Johnson, L Snetselaar, J Robinson, J Ockene, M Rosal, I Ockene, R Yood, P Aronson, N Lasser, B Singh, V Lasser, J Kostis, P McGovern, M J O'Sullivan, L Parker, J Potter, D Fernandez, P Caralis, K L Margolis, R H Grimm, M F Perron, C Bjerk, S Kempainen, R Brunner, W Graettinger, V Oujevolk, M Bloch, G Heiss, P Haines, D Ontjes, C Sueta, E Wells, L Kuller, J Cauley, N C Milas, K C Johnson, S Satterfield, R Li, S Connelly, F Tylavsky, R Brzyski, R Schenken, G E Sarto, D Laube, P McBride, J Mares, B Loevinger, M Vitolins, G Burke, R Crouse, S Washburn, M Simon, S Shumaker, S Rapp, C Legault, M Espeland, L Coker, J Hays, J Foreyt, A R Assaf, D Hall, V Miller, B Valanis, R Hiatt, C Clifford, L Pottern, F Meyskens Jr, H Judd, J Liu, N Watts, M Baum, R Grimm, S Daugherty, D Sheps, B Hulka, W Applegate, C Allen, D Bonds

• ¹ Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA 90502, USA. rchlebowski@gmail.com

• PMID: 19196674
• PMCID: PMC3963492
• DOI: 10.1056/NEJMoa0807684

Item in Clipboard

Randomized Controlled Trial

Rowan T Chlebowski et al. N Engl J Med. 2009.

• WHI Investigators: E Nabel, J Rossouw, S Ludlam, J McGowan, N Geller, L Ford, R Prentice, G L Anderson, A LaCroix, R Patterson, A McTiernan, B Cochrane, J Hunt, L Tinker, C Kooperberg, M McIntosh, C Y Wang, C Chen, D Bowen, A Kristal, J Stanford, N Urban, N Weiss, E White, E Stein, P Laskarzewski, S R Cummings, M Nevitt, L Palermo, L Harnack, F Cammarata, S Lindenfelser, B Psaty, S Heckbert, S Wassertheil-Smoller, W Frishman, J Wylie-Rosett, D Barad, R Freeman, A Rajkovic, J Hays, R Young, H Sangi-Haghpeykar, J E Manson, K M Rexrode, B Walsh, J M Gaziano, M Bueche, C B Eaton, M Cyr, G Sloane, L Phillips, V Butler, V Porter, S A A Beresford, V M Taylor, N F Woods, M Henderson, R Andersen, L Martin, J Hsia, N Gaba, R Katz, R Chlebowski, R Detrano, A Nelson, M Geller, Y Michael, E Whitlock, V Stevens, N Karanja, B Caan, S Sidney, G B J Hirata, J Morley Kotchen, V Barnabei, T A Kotchen, M A C Gilligan, J Neuner, B V Howard, L Adams-Campbell, L Lessin, C Iglesia, L K Mickel, L Van Horn, P Greenland, J Khandekar, K Liu, C Rosenberg, H Black, L Powell, E Mason, M Gulati, M L Stefanick, M A Hlatky, B Chen, R S Stafford, S Mackey, D Lane, I Granek, W Lawson, C Messina, G San Roman, R Jackson, R Harris, E Paskett, W J Mysiw, M Blumenfeld, C E Lewis, A Oberman, J M Shikany, M Safford, C A Thomson, T Bassford, C Ritenbaugh, Z Chen, M Ko, J Wactawski-Wende, M Trevisan, E Smit, S Graham, J Chang, J Robbins, S Yasmeen, F A Hubbell, G Frank, N Wong, N Greep, B Monk, L Nathan, D Heber, R Elashoff, S Liu, R D Langer, M H Criqui, G T Talavera, C F Garland, M A Allison, M Gass, N Watts, M Limacher, M Perri, A Kaunitz, R S Williams, Y Brinson, J D Curb, H Petrovitch, B Rodriguez, K Masaki, P Blanchette, R Wallace, J Torner, S Johnson, L Snetselaar, J Robinson, J Ockene, M Rosal, I Ockene, R Yood, P Aronson, N Lasser, B Singh, V Lasser, J Kostis, P McGovern, M J O'Sullivan, L Parker, J Potter, D Fernandez, P Caralis, K L Margolis, R H Grimm, M F Perron, C Bjerk, S Kempainen, R Brunner, W Graettinger, V Oujevolk, M Bloch, G Heiss, P Haines, D Ontjes, C Sueta, E Wells, L Kuller, J Cauley, N C Milas, K C Johnson, S Satterfield, R Li, S Connelly, F Tylavsky, R Brzyski, R Schenken, G E Sarto, D Laube, P McBride, J Mares, B Loevinger, M Vitolins, G Burke, R Crouse, S Washburn, M Simon, S Shumaker, S Rapp, C Legault, M Espeland, L Coker, J Hays, J Foreyt, A R Assaf, D Hall, V Miller, B Valanis, R Hiatt, C Clifford, L Pottern, F Meyskens Jr, H Judd, J Liu, N Watts, M Baum, R Grimm, S Daugherty, D Sheps, B Hulka, W Applegate, C Allen, D Bonds

• ¹ Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA 90502, USA. rchlebowski@gmail.com

• PMID: 19196674
• PMCID: PMC3963492
• DOI: 10.1056/NEJMoa0807684

Item in Clipboard

Background: Following the release of the 2002 report of the Women's Health Initiative (WHI) trial of estrogen plus progestin, the use of menopausal hormone therapy in the United States decreased substantially. Subsequently, the incidence of breast cancer also dropped, suggesting a cause-and-effect relation between hormone treatment and breast cancer. However, the cause of this decrease remains controversial.

Methods: We analyzed the results of the WHI randomized clinical trial--in which one study group received 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate daily and another group received placebo--and examined temporal trends in breast-cancer diagnoses in the WHI observational-study cohort. Risk factors for breast cancer, frequency of mammography, and time-specific incidence of breast cancer were assessed in relation to combined hormone use.

Results: In the clinical trial, there were fewer breast-cancer diagnoses in the group receiving estrogen plus progestin than in the placebo group in the initial 2 years of the study, but the number of diagnoses increased over the course of the 5.6-year intervention period. The elevated risk decreased rapidly after both groups stopped taking the study pills, despite a similar frequency of mammography. In the observational study, the incidence of breast cancer was initially about two times as high in the group receiving menopausal hormones as in the placebo group, but this difference in incidence decreased rapidly in about 2 years, coinciding with year-to-year reductions in combined hormone use. During this period, differences in the frequency of mammography between the two groups were unchanged.

Conclusions: The increased risk of breast cancer associated with the use of estrogen plus progestin declined markedly soon after discontinuation of combined hormone therapy and was unrelated to changes in frequency of mammography.

2009 Massachusetts Medical Society

PubMed Disclaimer

No other potential conflict of interest relevant to this article was reported.

Time-varying linear hazard ratios and 95% confidence intervals (solid and dashed lines, respectively) are shown for the effect of conjugated equine estrogens plus medroxyprogesterone acetate on the risk of breast cancer as compared with placebo during the intervention and postintervention phases of the study. The shaded areas indicate the overall mean and 95% confidence intervals for the hazard ratios in the intervention and postintervention phases. The I bars show hazard ratios and 95% confidence intervals according to an analysis based on events accumulated at 6-month intervals. The P value of 0.28 for a difference in trend is for the comparison of the hazard-ratio slopes in the two study phases in the primary, unadjusted analysis, and the P value of 0.005 is for a difference in trend from an analysis adjusted for adherence status, with censoring of events that occurred 6 months after a woman became nonadherent (defined as consuming <80% of study pills or starting hormone therapy). The thin solid lines show the adherence-adjusted, time-varying linear hazard ratios.

Smoothed time-varying, multivariable-adjusted hazard ratios and 95% confidence intervals (solid and dashed blue lines, respectively) for the comparison of participants who were taking estrogen plus progestin at study entry with those who were not are shown with the corresponding multivariable-adjusted hazard ratios and 95% confidence intervals from an analysis based on accumulated events at 6-month intervals (I bars). The variables used in this analysis are listed in the Methods section. The vertical line indicates the announcement of the results of the clinical trial in July 2002. The bar graph shows the year-to-year percentages of participants who were taking hormones and those who were not.

Time-varying linear hazard ratios and 95% confidence intervals for the risk of breast cancer (solid and dashed lines, respectively) are shown for a multivariable-adjusted proportional-hazards model comparing women who were using hormones at study entry with those who were not, with censoring of follow-up data for women whose status with regard to hormone use changed after enrollment and before July 2002. The I bars show hazard ratios and 95% confidence intervals according to the use or nonuse of hormones in an analysis based on events accumulated at 6-month intervals. Inverse probability weights according to time were used to adjust for changing characteristics of the study sample over time. The vertical line indicates the announcement of the results of the clinical trial in July 2002.

• Estrogen-plus-progestin use and mammographic density in postmenopausal women: Women's Health Initiative randomized trial.

  McTiernan A, Martin CF, Peck JD, Aragaki AK, Chlebowski RT, Pisano ED, Wang CY, Brunner RL, Johnson KC, Manson JE, Lewis CE, Kotchen JM, Hulka BS; Women's Health Initiative Mammogram Density Study Investigators. McTiernan A, et al. J Natl Cancer Inst. 2005 Sep 21;97(18):1366-76. doi: 10.1093/jnci/dji279. J Natl Cancer Inst. 2005. PMID: 16174858 Clinical Trial.

• Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative Randomized Trial.

  Chlebowski RT, Hendrix SL, Langer RD, Stefanick ML, Gass M, Lane D, Rodabough RJ, Gilligan MA, Cyr MG, Thomson CA, Khandekar J, Petrovitch H, McTiernan A; WHI Investigators. Chlebowski RT, et al. JAMA. 2003 Jun 25;289(24):3243-53. doi: 10.1001/jama.289.24.3243. JAMA. 2003. PMID: 12824205 Clinical Trial.

• Breast Cancer After Use of Estrogen Plus Progestin and Estrogen Alone: Analyses of Data From 2 Women's Health Initiative Randomized Clinical Trials.

  Chlebowski RT, Rohan TE, Manson JE, Aragaki AK, Kaunitz A, Stefanick ML, Simon MS, Johnson KC, Wactawski-Wende J, O'Sullivan MJ, Adams-Campbell LL, Nassir R, Lessin LS, Prentice RL. Chlebowski RT, et al. JAMA Oncol. 2015 Jun;1(3):296-305. doi: 10.1001/jamaoncol.2015.0494. JAMA Oncol. 2015. PMID: 26181174 Free PMC article. Clinical Trial.

• The Women's Health Initiative trial and related studies: 10 years later: a clinician's view.

  Gurney EP, Nachtigall MJ, Nachtigall LE, Naftolin F. Gurney EP, et al. J Steroid Biochem Mol Biol. 2014 Jul;142:4-11. doi: 10.1016/j.jsbmb.2013.10.009. Epub 2013 Oct 27. J Steroid Biochem Mol Biol. 2014. PMID: 24172877 Review.

• The Women's Health Initiative Randomized Trials and Clinical Practice: A Review.

  Manson JE, Crandall CJ, Rossouw JE, Chlebowski RT, Anderson GL, Stefanick ML, Aragaki AK, Cauley JA, Wells GL, LaCroix AZ, Thomson CA, Neuhouser ML, Van Horn L, Kooperberg C, Howard BV, Tinker LF, Wactawski-Wende J, Shumaker SA, Prentice RL. Manson JE, et al. JAMA. 2024 May 28;331(20):1748-1760. doi: 10.1001/jama.2024.6542. JAMA. 2024. PMID: 38691368 Review.

• Employment after a breast cancer diagnosis: a qualitative study of ethnically diverse urban women.

  Blinder VS, Murphy MM, Vahdat LT, Gold HT, de Melo-Martin I, Hayes MK, Scheff RJ, Chuang E, Moore A, Mazumdar M. Blinder VS, et al. J Community Health. 2012 Aug;37(4):763-72. doi: 10.1007/s10900-011-9509-9. J Community Health. 2012. PMID: 22109386

• Modeling of the growth kinetics of occult breast tumors: role in interpretation of studies of prevention and menopausal hormone therapy.

  Santen RJ, Yue W, Heitjan DF. Santen RJ, et al. Cancer Epidemiol Biomarkers Prev. 2012 Jul;21(7):1038-48. doi: 10.1158/1055-9965.EPI-12-0043. Epub 2012 May 14. Cancer Epidemiol Biomarkers Prev. 2012. PMID: 22586072 Free PMC article.

• Oral bisphosphonate use and breast cancer incidence in postmenopausal women.

  Chlebowski RT, Chen Z, Cauley JA, Anderson G, Rodabough RJ, McTiernan A, Lane DS, Manson JE, Snetselaar L, Yasmeen S, O'Sullivan MJ, Safford M, Hendrix SL, Wallace RB. Chlebowski RT, et al. J Clin Oncol. 2010 Aug 1;28(22):3582-90. doi: 10.1200/JCO.2010.28.2095. Epub 2010 Jun 21. J Clin Oncol. 2010. PMID: 20567009 Free PMC article.

• Association of Over-Expressed Estrogen Receptor Alpha with Development of Tamoxifen Resistant Hyperplasia and Adenocarcinomas in Genetically Engineered Mice.

  Miermont AM, Cabrera MC, Frech SM, Nakles RE, Diaz-Cruz ES, Shiffert MT, Furth PA. Miermont AM, et al. Anat Physiol. 2012 Jun 25;Suppl 12:001. doi: 10.4172/2161-0940.s12-001. Anat Physiol. 2012. PMID: 24575359 Free PMC article.

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