Pernille Tine Jensen

Randomized trial of cytoreductive surgery for relapsed ovarian cancer

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Philipp Harter, Kliniken Essen-Mitte, Philipps-University Marburg
  • ,
  • Jalid Sehouli, Charité-Universitätsmedizin Berlin
  • ,
  • Ignace Vergote, KU Leuven
  • ,
  • Gwenael Ferron, Institut Claudius Regaud
  • ,
  • Alexander Reuss, The Coordinating Center for Clinical Trials
  • ,
  • Werner Meier, Heinrich Heine University Düsseldorf
  • ,
  • Stefano Greggi, IRCCS Istituto nazionale tumori Fondazione Giovanni Pascale - Napoli
  • ,
  • Berit J. Mosgard, Københavns Universitet
  • ,
  • Frederic Selle, Diaconesses Cross Saint-Simon Hospital Group
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  • Frédéric Guyon, Comprehensive Cancer Center, Bordeaux
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  • Christophe Pomel, Jean Perrin Cancer Center
  • ,
  • Fabrice Lécuru, Université de Paris
  • ,
  • Rongyu Zang, Fudan University
  • ,
  • Elisabeth Avall-Lundqvist, Karolinska Institutet
  • ,
  • Jae Weon Kim, Seoul National University
  • ,
  • Jordi Ponce, University of Barcelona
  • ,
  • Francesco Raspagliesi, IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano
  • ,
  • Gunnar Kristensen, University of Oslo
  • ,
  • Jean Marc Classe, Université de Médecine
  • ,
  • Peter Hillemanns, Hannover Medical School
  • ,
  • Pernille Jensen
  • Annette Hasenburg, Johannes Gutenberg University Mainz
  • ,
  • Sadaf Ghaem-Maghami, Imperial College London
  • ,
  • Mansoor R. Mirza, Københavns Universitet
  • ,
  • Bente Lund, Aalborg Universitet
  • ,
  • Alexander Reinthaller, Medical University of Vienna
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  • Ana Santaballa, Hospital Universitario La Fe
  • ,
  • Adeola Olaitan, UCL Hospitals NHS Foundation Trust
  • ,
  • Felix Hilpert, Mammazentrum Hamburg
  • ,
  • Andreas Du Bois, Kliniken Essen-Mitte

BACKGROUND Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear. METHODS We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinumbased chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival. RESULTS A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery. CONCLUSIONS In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overall survival than chemotherapy alone.

OriginalsprogEngelsk
TidsskriftNew England Journal of Medicine
Vol/bind385
Nummer23
Sider (fra-til)2123-2131
Antal sider9
ISSN0028-4793
DOI
StatusUdgivet - dec. 2021

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