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Surgical versus clinical staging prior to primary chemoradiation in patients with cervical cancer FIGO stages IIB–IVA: oncologic results of a prospective randomized international multicenter (Uterus-11) intergroup study
  1. Simone Marnitz1,
  2. Audrey Tieko Tsunoda2,
  3. Peter Martus3,
  4. Marcelo Vieira4,
  5. Renato Jose Affonso Junior5,
  6. João Nunes2,6,
  7. Volker Budach7,
  8. Hermann Hertel8,
  9. Alexander Mustea9,
  10. Jalid Sehouli10,
  11. Jens-Peter Scharf11,
  12. Uwe Ulrich12,
  13. Andreas Ebert13,
  14. Iris Piwonski14 and
  15. Christhardt Kohler15,16
  1. 1 Department of Radiooncology, Medical Faculty of the University of Cologne, Cologne, Germany
  2. 2 Gynecologic Oncology Department, Hospital Erasto Gaertner, Curitiba, Brazil
  3. 3 Institute for Clinical Epidemiology and Biometry, Eberhard Karls University Tübingen Faculty of Medicine, Tubingen, Germany
  4. 4 Department for Gynecologic Oncology, Hospital de Amor de Barretos, Barretos, Brazil
  5. 5 Department of Radiooncology, Hospital de Amor de Barretos, Barretos, Brazil
  6. 6 Gynecologic Oncology Department, Instituto de Oncologia do Paraná, Curitiba, Brazil
  7. 7 Department of Radiooncology, Charité Universitätsmedizin Berlin, Berlin, Germany
  8. 8 Department of Obstetrics and Gynecology, Hannover Medical School, Hannover, Germany
  9. 9 Department of Gynecology and Gynecologic Oncology, University of Bonn, Bonn, Germany
  10. 10 Department of Gynecology with Center for Oncological Surgery, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany
  11. 11 Department of Gynecology and Obstetrics, Sana-Clinics Berlin Lichtenberg, Berlin, Germany
  12. 12 Department of Gynecology and Obstetrics, Martin-Luther-Hospital Berlin, Berlin, Germany
  13. 13 Outpatient Clinics for Women’s Health, Berlin, Germany
  14. 14 Institute of Pathology, Charite Medical Faculty Berlin, Berlin, Germany
  15. 15 Department of Gynecology, University of Cologne, Koln, Germany
  16. 16 Department of Special Operative and Oncologic Gynecology, Asklepios-Clinic Hamburg-Altona, Asklepios Hospital Group, Hamburg, Germany
  1. Correspondence to Professor Simone Marnitz, Department of Radiooncology, Medical Faculty of the University of Cologne, Cologne 50937, Germany; simone.marnitz-schulze{at}uk-koeln.de

Abstract

Objective Revised staging of patients with locally advanced cervical cancer is based on clinical examination, imaging, and potential surgical findings. A known limitation of imaging techniques is an appreciable rate of understaging. In contrast, surgical staging may provide more accurate information on lymph node involvement. The aim of this prospective study was to evaluate the impact of pre-treatment surgical staging, including removal of bulky lymph nodes, on disease-free survival in patients with locally advanced cervical cancer.

Methods Uterus-11 was a prospective international multicenter study including patients with locally advanced cervical cancer who were randomized 1:1 to surgical staging (experimental arm) or clinical staging (control arm) followed by primary platinum-based chemoradiation. Patients with histologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous cancer International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IIB–IVA underwent gynecologic examination and pre-treatment imaging including abdominal computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI). Patients had chest imaging (any of the following: X-ray, CT, or PET-CT). The primary endpoint was disease-free survival and the secondary endpoint was overall survival. An ad hoc analysis was performed after trial completion for cancer-specific survival. Randomization was conducted from February 2009 to August 2013.

Results A total of 255 patients (surgical arm, n=130; clinical arm, n=125) with locally advanced cervical cancer were randomized. Of these, 240 patients were eligible for analysis. The two groups were comparable with respect to patient characteristics. The surgical approach was transperitoneal laparoscopy in most patients (96.6%). Laparoscopic staging led to upstaging in 39 of 120 (33%) patients. After a median follow-up of 90 months (range 1–123) in both arms, there was no difference in disease-free survival between the groups (p=0.084). For patients with FIGO stage IIB, surgical staging is superior to clinical staging with respect to disease-free survival (HR 0.51, 95% CI 0.30 to 0.86, p=0.011). In the post-hoc analysis, surgical staging was associated with better cancer-specific survival (HR 0.61, 95% CI 0.40 to 0.93, p=0.020).

Conclusion Our study did not show a difference in disease-free survival between surgical and clinical staging in patients with locally advanced cervical cancer. There was a significant benefit in disease-free survival for patients with FIGO stage IIB and, in a post-hoc analysis, a cancer-specific survival benefit in favor of laparoscopic staging. The high risk of distant metastases in both arms emphasizes the need for further evaluation.

  • cervical cancer
  • radiation oncology
  • surgical procedures
  • operative
  • laparoscopes
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Footnotes

  • Contributors All authors contributed substantially to this manuscript.

  • Funding This study was funded by Deutsche Krebshilfe.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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