N Engl J Med 2021 12;385(23):2123-2131
From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).
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 platinum-based 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. (Funded by the AGO Study Group and others; DESKTOP III ClinicalTrials.gov number, NCT01166737.).