title: Role of tumour-free margin distance for loco-regional control in vulvar cancer-a subset analysis of the Arbeitsgemeinschaft Gynäkologische Onkologie CaRE-1 multicenter study.
abstract: A tumour-free pathological resection margin of ≥8 mm is considered state-of-the-art. Available evidence is based on heterogeneous cohorts. This study was designed to clarify the relevance of the resection margin for loco-regional control in vulvar cancer.
  
  
  
  AGO-CaRE-1 is a large retrospective study. Patients (n = 1618) with vulvar cancer ≥ FIGO stage IB treated at 29 German gynecologic-cancer-centres 1998-2008 were included. This subgroup analysis focuses on solely surgically treated node-negative patients with complete tumour resection (n = 289).
  
  
  
  Of the 289 analysed patients, 141 (48.8%) had pT1b, 140 (48.4%) pT2 and 8 (2.8%) pT3 tumours. One hundred twenty-five (43.3%) underwent complete vulvectomy, 127 (43.9%) partial vulvectomy and 37 (12.8%) radical local excision. The median minimal resection margin was 5 mm (1 mm-33 mm); all patients received groin staging, in 86.5% with full dissection. Median follow-up was 35.1 months. 46 (15.9%) patients developed recurrence, thereof 34 (11.8%) at the vulva, after a median of 18.3 months. Vulvar recurrence rates were 12.6% in patients with a margin <8 mm and 10.2% in patients with a margin ≥8 mm. When analysed as a continuous variable, the margin distance had no statistically significant impact on local recurrence (HR per mm increase: 0.930, 95% CI: 0.849-1.020; p = 0.125). Multivariate analyses did also not reveal a significant association between the margin and local recurrence neither when analysed as continuous variable nor categorically based on the 8 mm cutoff. Results were consistent when looking at disease-free-survival and time-to-recurrence at any site (HR per mm increase: 0.949, 95% CI: 0.864-1.041; p = 0.267).
  
  
  
  The need for a minimal margin of 8 mm could not be confirmed in the large and homogeneous node-negative cohort of the AGO-CaRE database.
authors.affiliation: Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: lwoelber@uke.de.
authors.forename: Linn
authors.initials: L
authors.lastname: Woelber
authors.affiliation: Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Lis-Femke
authors.initials: LF
authors.lastname: Griebel
authors.affiliation: Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Epidemiology, Medical Statistics and Decision Making, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Christine
authors.initials: C
authors.lastname: Eulenburg
authors.affiliation: Department of Gynecology, Charité, University Medicine Berlin, Berlin, Germany.
authors.forename: Jalid
authors.initials: J
authors.lastname: Sehouli
authors.affiliation: Department of Gynecology and Obstetrics, University of Munich, Munich, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Jueckstock
authors.affiliation: University Medical Center Kiel, Kiel, Germany; Jerusalem Hospital, Hamburg, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Hilpert
authors.affiliation: Department of Gynecology, University of Ulm, Ulm, Germany.
authors.forename: Nikolaus
authors.initials: N
authors.lastname: de Gregorio
authors.affiliation: Department of Gynecology and Gynecologic Oncology, University Hospital Freiburg, Freiburg, Germany; Department of Gynecology and Obstetrics, University Hospital Mainz, Mainz, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Hasenburg
authors.affiliation: Department of Gynecology, University of Magdeburg, Magdeburg, Germany.
authors.forename: Atanas
authors.initials: A
authors.lastname: Ignatov
authors.affiliation: Department of Gynecology, Hannover Medical School, Hannover, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Hillemanns
authors.affiliation: Department of Gynecology, University of Munich (LMU), Munich, Germany.
authors.forename: Sophie
authors.initials: S
authors.lastname: Fuerst
authors.affiliation: Department of Gynecology, University of Halle, Halle, Germany.
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Strauss
authors.affiliation: Department of Gynecology and Gynecologic Oncology, Philipps University Marburg, Marburg, Germany; Department of Gynecology, Klinikum Ludwigshafen, Ludwigshafen, Germany.
authors.forename: Klaus H
authors.initials: KH
authors.lastname: Baumann
authors.affiliation: Department of Gynecology and Obstetrics, Erlangen University Hospital, Erlangen, Germany; Department of Gynecology, Alb Fils Kliniken, Klinik am Eichert, Goeppingen, Germany.
authors.forename: Falk C
authors.initials: FC
authors.lastname: Thiel
authors.affiliation: Department of Gynecology, University Medicine Greifswald, Greifswald, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Mustea
authors.affiliation: Department of Gynecology, Evangelisches Krankenhaus Duesseldorf, Duesseldorf, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Meier
authors.affiliation: Department of Gynecology, Kliniken Essen Mitte, Essen, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Harter
authors.affiliation: Department of Gynecology and Obstetrics, Technische Universität Dresden, Dresden, Germany.
authors.forename: Pauline
authors.initials: P
authors.lastname: Wimberger
authors.affiliation: Department of Gynecology, University Hospital Frankfurt, Frankfurt, Germany; Department of Gynecology, UKSH Campus Lübeck, Lübeck, Germany.
authors.forename: Lars Christian
authors.initials: LC
authors.lastname: Hanker
authors.affiliation: Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Gynecology, University Hospital Technical University of Munich, Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Schmalfeldt
authors.affiliation: Department of Gynecology and Obstetrics, Technische Universität Dresden, Dresden, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Canzler
authors.affiliation: Department of Gynecology, Düsseldorf University Hospital, Düsseldorf, Germany; Department of Gynecology and Obstetrics, University of Tuebingen, Tuebingen, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Fehm
authors.affiliation: Department of Gynecology, Obstetrics and Gynecologic Oncology, Wolfsburg Hospital, Wolfsburg, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Luyten
authors.affiliation: Department of Gynecology, Georg-August-University Goettingen, Goettingen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Hellriegel
authors.affiliation: Department of Gynecology, Offenbach Hospital, Offenbach, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Kosse
authors.affiliation: Department of Gynecology, Alb Fils Kliniken, Klinik am Eichert, Goeppingen, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Heiss
authors.affiliation: Department of Gynecology, Hospital Altoettingen, Altoettignen, Germany.
authors.forename: Peer
authors.initials: P
authors.lastname: Hantschmann
authors.affiliation: Department of Gynecology, University Hospital Cologne, Cologne, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Mallmann
authors.affiliation: Oberhavel Hospital, Oranienburg, Germany.
authors.forename: Berno
authors.initials: B
authors.lastname: Tanner
authors.affiliation: Gynecologic Oncology Center, Kiel, Germany.
authors.forename: Jacobus
authors.initials: J
authors.lastname: Pfisterer
authors.affiliation: Elbland Hospital Meißen-Radebeul, Radebeul Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Richter
authors.affiliation: KKS Philipps University Marburg, Marburg; Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Neuser
authors.affiliation: Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Gynecology and Obstetrics, University of Munich, Munich, Germany; Department of Gynecology, University of Munich (LMU), Munich, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Mahner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000601:surgery*; D018572:Disease-Free Survival; D005260:Female; D005858:Germany; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology; D000072662:Margins of Excision; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology*; D009367:Neoplasm Staging; D011379:Prognosis; D012189:Retrospective Studies; D047368:Tumor Burden; D014846:Vulvar Neoplasms / Q000473:pathology / Q000601:surgery*; D055815:Young Adult
keywords: Margin distance; Prognosis; Recurrence; Resection margin; Surgery; Vulvar cancer