TY - JOUR
T1 - Randomized trial of cytoreductive surgery for relapsed ovarian cancer
AU - Harter, Philipp
AU - Sehouli, Jalid
AU - Vergote, Ignace
AU - Ferron, Gwenael
AU - Reuss, Alexander
AU - Meier, Werner
AU - Greggi, Stefano
AU - Mosgard, Berit J.
AU - Selle, Frederic
AU - Guyon, Frédéric
AU - Pomel, Christophe
AU - Lécuru, Fabrice
AU - Zang, Rongyu
AU - Avall-Lundqvist, Elisabeth
AU - Kim, Jae Weon
AU - Ponce, Jordi
AU - Raspagliesi, Francesco
AU - Kristensen, Gunnar
AU - Classe, Jean Marc
AU - Hillemanns, Peter
AU - Jensen, Pernille
AU - Hasenburg, Annette
AU - Ghaem-Maghami, Sadaf
AU - Mirza, Mansoor R.
AU - Lund, Bente
AU - Reinthaller, Alexander
AU - Santaballa, Ana
AU - Olaitan, Adeola
AU - Hilpert, Felix
AU - Du Bois, Andreas
N1 - Publisher Copyright:
Copyright © 2021 Massachusetts Medical Society.
PY - 2021/12/2
Y1 - 2021/12/2
N2 - 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.).
AB - 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.).
UR - http://www.scopus.com/inward/record.url?scp=85120804203&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2103294
DO - 10.1056/NEJMoa2103294
M3 - Journal article
C2 - 34874631
AN - SCOPUS:85120804203
VL - 385
SP - 2123
EP - 2131
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 23
ER -