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dc.contributor.authorCohen, Adam L.
dc.contributor.authorFactor, Rachel E.
dc.contributor.authorMooney, Kathi
dc.contributor.authorSalama, Mohamed E.
dc.contributor.authorWade, Mark
dc.contributor.authorSerpico, Victoria
dc.contributor.authorOstrander, Emily
dc.contributor.authorNelson, Edward
dc.contributor.authorPorretta, Jane
dc.contributor.authorMatsen, Cindy
dc.contributor.authorBernard, Philip
dc.contributor.authorBoucher, Ken
dc.contributor.authorNeumayer, Leigh
dc.date.accessioned2017-02-23T22:34:55Z
dc.date.available2017-02-23T22:34:55Z
dc.date.issued2017-02
dc.identifier.citationPOWERPIINC (PreOperative Window of Endocrine TheRapy Provides Information to Increase Compliance) trial: Changes in tumor proliferation index and quality of life with 7 days of preoperative tamoxifen 2017, 31:219 The Breasten
dc.identifier.issn09609776
dc.identifier.doi10.1016/j.breast.2016.11.016
dc.identifier.urihttp://hdl.handle.net/10150/622653
dc.description.abstractObjectives: A decrease in Ki67 during neoadjuvant therapy predicts response to tamoxifen. Previous trials have shown a decreased Ki67 in breast tumors with as little as two or more weeks of preoperative tamoxifen. Shortening the preoperative treatment time in window of opportunity clinical trials makes these trials more attractive to women. POWERPIINC examined the effect of 7 days of preoperative tamoxifen on breast tumor proliferation and patient symptoms. Methods: Women with untreated stage I/II, ER-positive, invasive breast cancer with no contraindications to tamoxifen were enrolled. Women received 20 mg of tamoxifen for 7 days up to the day of surgery. Proliferation was assessed by Ki67 immunohistochemistry before and after 7 days of tamoxifen. Symptoms and QOL were assessed by the FACT-ES and MENQOL. Adherence was measured by pill counts. Results: 52 women were enrolled, and 44 were evaluable for Ki67. The median age was 58.5 years, and the median tumor diameter was 1.2 cm. Most women (73%) were post-menopausal. Most tumors were PR positive (88%) and HER2-negative (92%). The Ki67 decreased by a geometric mean of 40% (95% CI 29%-63%), and 73% (95% CI 57%-85%) of women had tumors with decreased proliferation (p = 0.0001 by paired t-test). Adherence to taking tamoxifen during the preoperative period was 100%. Women reported minimal bother from psychosocial or physical symptoms at baseline or on the day of surgery. Conclusion: Seven days of tamoxifen showed a similar relative decrease in Ki67 as that reported for longer courses, was acceptable to women, and could be considered for window of opportunity studies.
dc.description.sponsorshipNational Institutes of Health [P30CA042014]en
dc.language.isoenen
dc.publisherCHURCHILL LIVINGSTONEen
dc.relation.urlhttp://linkinghub.elsevier.com/retrieve/pii/S0960977616302508en
dc.rights© 2016 The Authors. Published by Elsevier Ltd.en
dc.subjectTamoxifenen
dc.subjectKi-67 antigenen
dc.subjectNeoadjuvant therapyen
dc.subjectBreast neoplasmsen
dc.titlePOWERPIINC (PreOperative Window of Endocrine TheRapy Provides Information to Increase Compliance) trial: Changes in tumor proliferation index and quality of life with 7 days of preoperative tamoxifenen
dc.typeArticleen
dc.contributor.departmentDepartment of Surgery, University of Arizonaen
dc.identifier.journalThe Breasten
dc.description.notePublished open access.en
dc.description.collectioninformationThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
refterms.dateFOA2016-12-06T00:00:00Z
html.description.abstractObjectives: A decrease in Ki67 during neoadjuvant therapy predicts response to tamoxifen. Previous trials have shown a decreased Ki67 in breast tumors with as little as two or more weeks of preoperative tamoxifen. Shortening the preoperative treatment time in window of opportunity clinical trials makes these trials more attractive to women. POWERPIINC examined the effect of 7 days of preoperative tamoxifen on breast tumor proliferation and patient symptoms. Methods: Women with untreated stage I/II, ER-positive, invasive breast cancer with no contraindications to tamoxifen were enrolled. Women received 20 mg of tamoxifen for 7 days up to the day of surgery. Proliferation was assessed by Ki67 immunohistochemistry before and after 7 days of tamoxifen. Symptoms and QOL were assessed by the FACT-ES and MENQOL. Adherence was measured by pill counts. Results: 52 women were enrolled, and 44 were evaluable for Ki67. The median age was 58.5 years, and the median tumor diameter was 1.2 cm. Most women (73%) were post-menopausal. Most tumors were PR positive (88%) and HER2-negative (92%). The Ki67 decreased by a geometric mean of 40% (95% CI 29%-63%), and 73% (95% CI 57%-85%) of women had tumors with decreased proliferation (p = 0.0001 by paired t-test). Adherence to taking tamoxifen during the preoperative period was 100%. Women reported minimal bother from psychosocial or physical symptoms at baseline or on the day of surgery. Conclusion: Seven days of tamoxifen showed a similar relative decrease in Ki67 as that reported for longer courses, was acceptable to women, and could be considered for window of opportunity studies.


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