Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Philipp Harter*, Jalid Sehouli, Ignace Vergote, Gwenael Ferron, Alexander Reuss, Werner Meier, Stefano Greggi, Berit J Mosgard, Frederic Selle, Frédéric Guyon, Christophe Pomel, Fabrice Lécuru, Rongyu Zang, Elisabeth Avall-Lundqvist, Jae-Weon Kim, Jordi Ponce, Francesco Raspagliesi, Gunnar Kristensen, Jean-Marc Classe, Peter HillemannsPernille Jensen, Annette Hasenburg, Sadaf Ghaem-Maghami, Mansoor R Mirza, Bente Lund, Alexander Reinthaller, Ana Santaballa, Adeola Olaitan, Felix Hilpert, Andreas du Bois, DESKTOP III Investigators

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

63 Citations (Scopus)

Abstract

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.).

Original languageEnglish
JournalThe New England Journal of Medicine
Volume385
Issue number23
Pages (from-to)2123-2131
Number of pages9
ISSN0028-4793
DOIs
Publication statusPublished - 2 Dec 2021

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Copyright © 2021 Massachusetts Medical Society.

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