POWERPIINC (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

Adam L. Cohen, Rachel E. Factor, Kathi Mooney, Mohamed E. Salama, Mark Wade, Victoria Serpico, Emily Ostrander, Edward Nelson, Jane Porretta, Cindy Matsen, Philip Bernard, Ken Boucher, Leigh A Neumayer

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objectives 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.

Original languageEnglish (US)
Pages (from-to)219-223
Number of pages5
JournalBreast
Volume31
DOIs
StatePublished - Feb 1 2017
Externally publishedYes

Fingerprint

Tamoxifen
Compliance
Quality of Life
Neoplasms
Therapeutics
Breast Neoplasms
Ambulatory Surgical Procedures
Preoperative Period
Neoadjuvant Therapy
Immunohistochemistry
Clinical Trials

Keywords

  • Breast neoplasms
  • Ki-67 antigen
  • Neoadjuvant therapy
  • Tamoxifen

ASJC Scopus subject areas

  • Surgery

Cite this

POWERPIINC (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. / Cohen, Adam L.; Factor, Rachel E.; Mooney, Kathi; Salama, Mohamed E.; Wade, Mark; Serpico, Victoria; Ostrander, Emily; Nelson, Edward; Porretta, Jane; Matsen, Cindy; Bernard, Philip; Boucher, Ken; Neumayer, Leigh A.

In: Breast, Vol. 31, 01.02.2017, p. 219-223.

Research output: Contribution to journalArticle

Cohen, Adam L. ; Factor, Rachel E. ; Mooney, Kathi ; Salama, Mohamed E. ; Wade, Mark ; Serpico, Victoria ; Ostrander, Emily ; Nelson, Edward ; Porretta, Jane ; Matsen, Cindy ; Bernard, Philip ; Boucher, Ken ; Neumayer, Leigh A. / POWERPIINC (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. In: Breast. 2017 ; Vol. 31. pp. 219-223.
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title = "POWERPIINC (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",
abstract = "Objectives 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.",
keywords = "Breast neoplasms, Ki-67 antigen, Neoadjuvant therapy, Tamoxifen",
author = "Cohen, {Adam L.} and Factor, {Rachel E.} and Kathi Mooney and Salama, {Mohamed E.} and Mark Wade and Victoria Serpico and Emily Ostrander and Edward Nelson and Jane Porretta and Cindy Matsen and Philip Bernard and Ken Boucher and Neumayer, {Leigh A}",
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T2 - Changes in tumor proliferation index and quality of life with 7 days of preoperative tamoxifen

AU - Cohen, Adam L.

AU - Factor, Rachel E.

AU - Mooney, Kathi

AU - Salama, Mohamed E.

AU - Wade, Mark

AU - Serpico, Victoria

AU - Ostrander, Emily

AU - Nelson, Edward

AU - Porretta, Jane

AU - Matsen, Cindy

AU - Bernard, Philip

AU - Boucher, Ken

AU - Neumayer, Leigh A

PY - 2017/2/1

Y1 - 2017/2/1

N2 - Objectives 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.

AB - Objectives 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.

KW - Breast neoplasms

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KW - Neoadjuvant therapy

KW - Tamoxifen

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