title: Do margins matter? The influence of positive surgical margins on prostate cancer-specific mortality.
abstract: BACKGROUND
  Positive surgical margins (PSMs) in radical prostatectomy (RP) specimens are a frequent indication for adjuvant radiotherapy and are used as a measure of surgical quality. However, the association between PSMs and prostate cancer-specific mortality (CSM) is poorly defined.
  
  
  OBJECTIVE
  Analyze the association of PSMs with CSM, adjusting for fixed and time-dependent parameters.
  
  
  METHODS
  Fine and Gray competing risk regression analysis was used to model the clinical data and follow-up information of 11,521 patients treated by RP between 1987 and 2005. Two extended models were used that adjusted for the use of postoperative radiotherapy, which was handled as a time-dependent covariate. Postoperative radiotherapy was modeled as a single parameter and also as early and late therapy, based on the prostate-specific antigen level at the start of treatment (≤0.5 vs >0.5 ng/ml).
  
  
  METHODS
  RP for clinically localized prostate cancer and selective use of secondary local and/or systemic therapy.
  
  
  METHODS
  The outcome measure was prostate cancer-specific mortality.
  
  
  CONCLUSIONS
  The 15-yr CSM rates for patients with PSMs and negative surgical margins were 10% and 6%, respectively (p<0.001). No significant association between PSM and CSM was observed in the conventional model with fixed covariates (hazard ratio [HR]: 1.04; 95% confidence interval [CI], 0.7-1.5; p=0.8) or in the two extended models that adjusted for postoperative radiotherapy (HR: 0.96; 95% CI, 0.7-1.4; p=0.9), or early and late postoperative radiotherapy (HR: 1.01; 95% CI, 0.7-1.4; p=0.9).
  
  
  CONCLUSIONS
  PSMs alone are not associated with a significantly increased risk of CSM within 15 yr of RP. However, urologists should continue to strive to avoid PSMs, as they increase a man's risk of biochemical recurrence and need for secondary therapy and may be a source of considerable patient anxiety.
authors.affiliation: Glickman Urological & Kidney Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: stephea2@ccf.org.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Stephenson
authors.affiliation: Section of Urology, University of Chicago Medical Center, Chicago, IL, USA.
authors.forename: Scott E
authors.initials: SE
authors.lastname: Eggener
authors.affiliation: Glickman Urological & Kidney Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Adrian V
authors.initials: AV
authors.lastname: Hernandez
authors.affiliation: Glickman Urological & Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Eric A
authors.initials: EA
authors.lastname: Klein
authors.affiliation: Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Kattan
authors.affiliation: Department of Urology, University of Michigan, Ann Arbor, MI, USA.
authors.forename: David P
authors.initials: DP
authors.lastname: Wood
authors.affiliation: Division of Urology, Department of Surgery, Princess Johara Alibrahim Center for Cancer Research, King Saud University, Riyadh, Saudi Arabia.
authors.forename: Danny M
authors.initials: DM
authors.lastname: Rabah
authors.affiliation: Urology Service, Department of Surgery, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: James A
authors.initials: JA
authors.lastname: Eastham
authors.affiliation: Urology Service, Department of Surgery, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: Peter T
authors.initials: PT
authors.lastname: Scardino
mesh_terms: D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000401:mortality* / Q000473:pathology* / Q000601:surgery*
keywords: Models; Prostatectomy; Prostatic neoplasms; Statistical; Surgical margins; Treatment outcome