title: Perioperative morbidity and rate of upstaging after laparoscopic staging for patients with locally advanced cervical cancer: results of a prospective randomized trial.
abstract: OBJECTIVE
  The International Federation of Gynecology and Obstetrics (FIGO) staging for cervical cancer is based on clinical examination. Previous studies have demonstrated significant upstaging with surgical staging. However, no randomized trial has ever shown a survival benefit when radiation combined with chemoradiation (RCTX) is modified according to surgical staging. The objective of the study was to evaluate the feasibility and outcomes of surgical staging prior to radical RCTX treatment among patients with locally advanced cervical cancer in the setting of a larger, prospective, randomized study (the Uterus-11 study of the German Gynecologic Oncology Group).
  
  
  METHODS
  Between 2009 and 2013, 255 patients with advanced cervical cancer (FIGO IIB-IVA) were randomized to surgical staging and RCTX (arm A) or RCTX (arm B). RCTX in both arms included pelvic external beam radiotherapy with weekly cisplatin at 40 mg/m(2) and brachytherapy. Extended-field radiation was performed in cases of confirmed paraaortic metastases.
  
  
  RESULTS
  One hundred thirty patients were randomized to surgical staging; 121 were eligible for this analysis. The mean patient age was 47.2 years, and the mean body mass index was 26.2 kg/m(2); the FIGO stages were IIB, IIIA, IIIB, and IVA in 85 (70.2%), 4 (3.3%), 29 (24%), and 3 (2.5%) patients, respectively. Arm A and arm B were similar with respect to Karnofsky performance status, histology, comorbidities, and lymphovascular space involvement. The surgical approach was transperitoneal laparoscopy in nearly all patients (93.4%), with no operative mortality. One patient (0.8%) had a conversion to laparotomy; 2 patients had more than 500 mL blood loss; the early postoperative complication rate was 7.3%. A mean of 19 pelvic and 17 paraaortic nodes were removed, with means of 2.4 and 1.3 positive nodes, respectively. RCTX began between 7 and 21 days after surgery. Operative staging led to upstaging in 40 of 121 (33%).
  
  
  CONCLUSIONS
  Surgical staging in patients with locally advanced cervical cancer is safe and does not delay primary RCTX in a randomized study.
authors.affiliation: Department of Advanced Operative and Oncologic Gynecology, Asklepios Hospital, Hamburg, Germany.
authors.forename: Christhardt
authors.initials: C
authors.lastname: Köhler
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital, Greifswald, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Mustea
authors.affiliation: Department of Radiology-Oncology, Charité-Universitätsmedizin, Berlin, Germany.
authors.forename: Simone
authors.initials: S
authors.lastname: Marnitz
authors.affiliation: Institute for Cytology and Dysplasia, Fürstenberg-Carree, Berlin, Germany.
authors.forename: Achim
authors.initials: A
authors.lastname: Schneider
authors.affiliation: Department of Gynecologic Oncology, Universita Cattolica del Sacro Coure, Campobasso, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Chiantera
authors.affiliation: Department of Gynecology and Obstetrics, Martin-Luther-Krankenhaus, Berlin, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Ulrich
authors.affiliation: Department of Gynecology, Sana-Klinik, Berlin, Germany.
authors.forename: Jens-Peter
authors.initials: JP
authors.lastname: Scharf
authors.affiliation: Institute for Clinical Epidemiology and Applied Biostatistics, Eberhard-Karls-Universität Tübingen, Tübingen, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Martus
authors.affiliation: Department of Gynecologic Oncology, Hospital de Cancer de Barretos, São Paulo, Brazil.
authors.forename: Marcelo Andrade
authors.initials: MA
authors.lastname: Vieira
authors.affiliation: Department of Gynecologic Oncology, Hospital de Cancer de Barretos, São Paulo, Brazil. Electronic address: atsunoda@gmail.com.
authors.forename: Audrey
authors.initials: A
authors.lastname: Tsunoda
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery* / Q000628:therapy; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001918:Brachytherapy; D018196:Carcinoma, Adenosquamous / Q000473:pathology / Q000601:surgery* / Q000628:therapy; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000601:surgery* / Q000628:therapy; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000627:therapeutic use; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D010535:Laparoscopy; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology*; D008875:Middle Aged; D009367:Neoplasm Staging; D010388:Pelvis; D011183:Postoperative Complications / Q000453:epidemiology*; D011878:Radiotherapy; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000601:surgery* / Q000628:therapy; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin
keywords: laparoscopic staging; locally advanced cervical cancer; operative morbidity; randomized trial