title: A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer.
abstract: BACKGROUND
  Routine resection of cavity shave margins (additional tissue circumferentially around the cavity left by partial mastectomy) may reduce the rates of positive margins (margins positive for tumor) and reexcision among patients undergoing partial mastectomy for breast cancer.
  
  
  METHODS
  In this randomized, controlled trial, we assigned, in a 1:1 ratio, 235 patients with breast cancer of stage 0 to III who were undergoing partial mastectomy, with or without resection of selective margins, to have further cavity shave margins resected (shave group) or not to have further cavity shave margins resected (no-shave group). Randomization occurred intraoperatively after surgeons had completed standard partial mastectomy. Positive margins were defined as tumor touching the edge of the specimen that was removed in the case of invasive cancer and tumor that was within 1 mm of the edge of the specimen removed in the case of ductal carcinoma in situ. The rate of positive margins was the primary outcome measure; secondary outcome measures included cosmesis and the volume of tissue resected.
  
  
  RESULTS
  The median age of the patients was 61 years (range, 33 to 94). On final pathological testing, 54 patients (23%) had invasive cancer, 45 (19%) had ductal carcinoma in situ, and 125 (53%) had both; 11 patients had no further disease. The median size of the tumor in the greatest diameter was 1.1 cm (range, 0 to 6.5) in patients with invasive carcinoma and 1.0 cm (range, 0 to 9.3) in patients with ductal carcinoma in situ. Groups were well matched at baseline with respect to demographic and clinicopathological characteristics. The rate of positive margins after partial mastectomy (before randomization) was similar in the shave group and the no-shave group (36% and 34%, respectively; P=0.69). After randomization, patients in the shave group had a significantly lower rate of positive margins than did those in the no-shave group (19% vs. 34%, P=0.01), as well as a lower rate of second surgery for margin clearance (10% vs. 21%, P=0.02). There was no significant difference in complications between the two groups.
  
  
  CONCLUSIONS
  Cavity shaving halved the rates of positive margins and reexcision among patients with partial mastectomy. (Funded by the Yale Cancer Center; ClinicalTrials.gov number, NCT01452399.).
authors.affiliation: From the Departments of Surgery (A.B.C., B.K.K., M.B., K.S., D.R.L., N.R.H.), Pathology (V.B., M.H.), and Medicine (L.P.), Yale Cancer Center (A.B.C., B.K.K., M.B., K.S., F.L., X.Y., D.R.L., L.P., N.R.H.), and Yale Center for Analytical Sciences (F.L., X.Y.), Yale University School of Medicine, New Haven, CT; and the Department of Surgery, Thomas Jefferson University, Philadelphia (T.N.T.).
authors.forename: Anees B
authors.initials: AB
authors.lastname: Chagpar
authors.forename: Brigid K
authors.initials: BK
authors.lastname: Killelea
authors.forename: Theodore N
authors.initials: TN
authors.lastname: Tsangaris
authors.forename: Meghan
authors.initials: M
authors.lastname: Butler
authors.forename: Karen
authors.initials: K
authors.lastname: Stavris
authors.forename: Fangyong
authors.initials: F
authors.lastname: Li
authors.forename: Xiaopan
authors.initials: X
authors.lastname: Yao
authors.forename: Veerle
authors.initials: V
authors.lastname: Bossuyt
authors.forename: Malini
authors.initials: M
authors.lastname: Harigopal
authors.forename: Donald R
authors.initials: DR
authors.lastname: Lannin
authors.forename: Lajos
authors.initials: L
authors.lastname: Pusztai
authors.forename: Nina R
authors.initials: NR
authors.lastname: Horowitz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000473:pathology / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000601:surgery*; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000473:pathology / Q000601:surgery; D018275:Carcinoma, Lobular / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental / Q000379:methods*; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D012086:Reoperation