TY - JOUR
T1 - Secondary surgical cytoreduction for recurrent ovarian cancer
AU - Coleman, Robert L.
AU - Spirtos, Nick M.
AU - Enserro, Danielle
AU - Herzog, Thomas J.
AU - Sabbatini, Paul
AU - Armstrong, Deborah K.
AU - Kim, Jae Weon
AU - Park, Sang Yoon
AU - Kim, Byoung Gie
AU - Nam, Joo Hyun
AU - Fujiwara, Keiichi
AU - Walker, Joan L.
AU - Casey, Ann C.
AU - Secord, Angeles Alvarez
AU - Rubin, Steve
AU - Chan, John K.
AU - DiSilvestro, Paul
AU - Davidson, Susan A.
AU - Davidson, Susan A.
AU - Cohn, David E.
AU - Basen-Engquist, Karen
AU - Huang, Helen Q.
AU - Brady, Mark F.
AU - Mannel, Robert S.
AU - Tewari, Krishnansu S.
N1 - Publisher Copyright:
© 2019 Massachussetts Medical Society. All rights reserved.
PY - 2019/11/14
Y1 - 2019/11/14
N2 - BACKGROUND Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-Tube ("ovarian") cancer is widely practiced but has not been evaluated in phase 3 investigation. METHODS We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinumbased chemotherapy alone. Adjuvant chemotherapy (paclitaxel carboplatin or gemcitabine carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. RESULTS A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. CONCLUSIONS In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).
AB - BACKGROUND Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-Tube ("ovarian") cancer is widely practiced but has not been evaluated in phase 3 investigation. METHODS We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinumbased chemotherapy alone. Adjuvant chemotherapy (paclitaxel carboplatin or gemcitabine carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. RESULTS A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. CONCLUSIONS In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).
UR - http://www.scopus.com/inward/record.url?scp=85075078979&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85075078979&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1902626
DO - 10.1056/NEJMoa1902626
M3 - Article
C2 - 31722153
AN - SCOPUS:85075078979
SN - 0028-4793
VL - 381
SP - 1929
EP - 1939
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 20
ER -