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: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Internal Medicine, College of Medicine, University of Utah, USA; Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA. Electronic address: adam.cohen@hci.utah.edu.
authors.forename: Adam L
authors.initials: AL
authors.lastname: Cohen
authors.affiliation: Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA; Department of Pathology, University of Utah, School of Medicine, ARUP Laboratories, 15 North Medical Drive East, Ste #1100, Salt Lake City, UT 84112, USA.
authors.forename: Rachel E
authors.initials: RE
authors.lastname: Factor
authors.affiliation: Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA; College of Nursing, University of Utah, 10 South 2000 East, Salt Lake City, UT 84112, USA.
authors.forename: Kathi
authors.initials: K
authors.lastname: Mooney
authors.affiliation: Department of Pathology, University of Utah, School of Medicine, ARUP Laboratories, 15 North Medical Drive East, Ste #1100, Salt Lake City, UT 84112, USA.
authors.forename: Mohamed E
authors.initials: ME
authors.lastname: Salama
authors.affiliation: Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Wade
authors.affiliation: Department of Internal Medicine, College of Medicine, University of Utah, USA; Department of Surgery, College of Medicine, University of Utah, 30 North 1900 East, Salt Lake City, UT 84124, USA.
authors.forename: Victoria
authors.initials: V
authors.lastname: Serpico
authors.affiliation: Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA.
authors.forename: Emily
authors.initials: E
authors.lastname: Ostrander
authors.affiliation: Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA; Department of Surgery, College of Medicine, University of Utah, 30 North 1900 East, Salt Lake City, UT 84124, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Nelson
authors.affiliation: Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA; Department of Surgery, College of Medicine, University of Utah, 30 North 1900 East, Salt Lake City, UT 84124, USA.
authors.forename: Jane
authors.initials: J
authors.lastname: Porretta
authors.affiliation: Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA; Department of Surgery, College of Medicine, University of Utah, 30 North 1900 East, Salt Lake City, UT 84124, USA.
authors.forename: Cindy
authors.initials: C
authors.lastname: Matsen
authors.affiliation: Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA; Department of Pathology, University of Utah, School of Medicine, ARUP Laboratories, 15 North Medical Drive East, Ste #1100, Salt Lake City, UT 84112, USA.
authors.forename: Philip
authors.initials: P
authors.lastname: Bernard
authors.affiliation: Department of Internal Medicine, College of Medicine, University of Utah, USA; Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84124, USA.
authors.forename: Ken
authors.initials: K
authors.lastname: Boucher
authors.affiliation: Department of Surgery, College of Medicine, University of Utah, 30 North 1900 East, Salt Lake City, UT 84124, USA.
authors.forename: Leigh
authors.initials: L
authors.lastname: Neumayer
mesh_terms: D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D049109:Cell Proliferation / Q000187:drug effects; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D019394:Ki-67 Antigen / Q000032:analysis; D055118:Medication Adherence; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011788:Quality of Life; D013629:Tamoxifen / Q000008:administration & dosage*; D013997:Time Factors; D047368:Tumor Burden
chemical_list: D018931:Antineoplastic Agents, Hormonal; D019394:Ki-67 Antigen; D013629:Tamoxifen
keywords: Breast neoplasms; Ki-67 antigen; Neoadjuvant therapy; Tamoxifen