Title: Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer
Author: Philipp Harter, M.D., Ph.D.,, Jalid Sehouli, M.D., Ph.D.,, Ignace Vergote, M.D., Ph.D.,, Gwenael Ferron, M.D., Ph.D.,, Alexander Reuss, M.Sc.,, Werner Meier, M.D., Ph.D.,, Stefano Greggi, M.D., Ph.D.,, Berit J. Mosgard, M.D., Ph.D.,, Frederic Selle, M.D., Ph.D.,, Frédéric Guyon, M.D., Ph.D.,, Christophe Pomel, M.D., Ph.D.,, Fabrice Lécuru, M.D., Ph.D.,, Rongyu Zang, M.D., Ph.D.,, Elisabeth Avall-Lundqvist, M.D., Ph.D.,, Jae-Weon Kim, M.D., Ph.D.,, Jordi Ponce, M.D., Ph.D.,, Francesco Raspagliesi, M.D., Ph.D.,, Gunnar Kristensen, M.D., Ph.D.,, Jean-Marc Classe, M.D., Ph.D.,, Peter Hillemanns, M.D., Ph.D.,, Pernille Jensen, M.D., Ph.D.,, Annette Hasenburg, M.D., Ph.D.,, Sadaf Ghaem-Maghami, M.D., Ph.D.,, Mansoor R. Mirza, M.D., Ph.D.,, Bente Lund, M.D., Ph.D.,, Alexander Reinthaller, M.D., Ph.D.,, Ana Santaballa, M.D., Ph.D.,, Adeola Olaitan, M.D., Ph.D.,, Felix Hilpert, M.D., Ph.D.,, and Andreas du Bois, M.D., Ph.D.
Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear.
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 Gynkologische 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.
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.
In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overall survival than chemotherapy alone.