title: Surgical Excision Without Radiation for Ductal Carcinoma in Situ of the Breast: 12-Year Results From the ECOG-ACRIN E5194 Study.
abstract: OBJECTIVE
  To determine the 12-year risk of developing an ipsilateral breast event (IBE) for women with ductal carcinoma in situ (DCIS) of the breast treated with surgical excision (lumpectomy) without radiation.
  
  
  METHODS
  A prospective clinical trial was performed for women with DCIS who were selected for low-risk clinical and pathologic characteristics. Patients were enrolled onto one of two study cohorts (not randomly assigned): cohort 1: low- or intermediate-grade DCIS, tumor size 2.5 cm or smaller (n = 561); or cohort 2: high-grade DCIS, tumor size 1 cm or smaller (n = 104). Protocol specifications included excision of the DCIS tumor with a minimum negative margin width of at least 3 mm. Tamoxifen (not randomly assigned) was given to 30% of the patients. An IBE was defined as local recurrence of DCIS or invasive carcinoma in the treated breast. Median follow-up time was 12.3 years.
  
  
  RESULTS
  There were 99 IBEs, of which 51 (52%) were invasive. The IBE and invasive IBE rates increased over time in both cohorts. The 12-year rates of developing an IBE were 14.4% for cohort 1 and 24.6% for cohort 2 (P = .003). The 12-year rates of developing an invasive IBE were 7.5% and 13.4%, respectively (P = .08). On multivariable analysis, study cohort and tumor size were both significantly associated with developing an IBE (P = .009 and P = .03, respectively).
  
  
  CONCLUSIONS
  For patients with DCIS selected for favorable clinical and pathologic characteristics and treated with excision without radiation, the risks of developing an IBE and an invasive IBE increased through 12 years of follow-up, without plateau. These data help inform the treatment decision-making process for patients and their physicians.
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY. solin@einstein.edu.
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Solin
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Robert
authors.initials: R
authors.lastname: Gray
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Lorie L
authors.initials: LL
authors.lastname: Hughes
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: William C
authors.initials: WC
authors.lastname: Wood
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Lowen
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Sunil S
authors.initials: SS
authors.lastname: Badve
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Frederick L
authors.initials: FL
authors.lastname: Baehner
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: James N
authors.initials: JN
authors.lastname: Ingle
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Edith A
authors.initials: EA
authors.lastname: Perez
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Abram
authors.initials: A
authors.lastname: Recht
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Sparano
authors.affiliation: Lawrence J. Solin, Albert Einstein Healthcare Network, Philadelphia; Nancy E. Davidson, University of Pittsburgh, Pittsburgh, PA; Robert Gray, Dana-Farber Cancer Institute; Abram Recht, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Mary Ann Lowen, Baystate Medical Center, Springfield, MA; Lorie L. Hughes, Harris Radiation Therapy Center at Gordon Hospital, Calhoun; William C. Wood, Emory University, Atlanta, GA; Sunil S. Badve, Indiana University, Indianapolis, IN; Frederick L. Baehner, University of California, San Francisco, San Francisco, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Edith A. Perez, Mayo Clinic, Jacksonville, FL; and Joseph A. Sparano, Montefiore Medical Center, Bronx, NY.
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Davidson
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology* / Q000601:surgery*; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000188:drug therapy / Q000401:mortality / Q000473:pathology* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D053208:Kaplan-Meier Estimate; D015412:Mastectomy, Segmental / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D015999:Multivariate Analysis; D009361:Neoplasm Invasiveness / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000473:pathology*; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018570:Risk Assessment; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D013629:Tamoxifen