• Robert L Coleman, Nick M Spirtos, Danielle Enserro, Thomas J Herzog, Paul Sabbatini, Deborah K Armstrong, Jae-Weon Kim, Sang-Yoon Park, Byoung-Gie Kim, Joo-Hyun Nam, Keiichi Fujiwara, Joan L Walker, Ann C Casey, Angeles Alvarez Secord, Steve Rubin, John K Chan, Paul DiSilvestro, Susan A Davidson, David E Cohn, Krishnansu S Tewari, Karen Basen-Engquist, Helen Q Huang, Mark F Brady, and Robert S Mannel.
• From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).
• N. Engl. J. Med. 2019 Nov 14; 381 (20): 192919391929-1939.

BackgroundSecondary 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.MethodsWe 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 platinum-based 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.ResultsA 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.ConclusionsIn 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.).Copyright © 2019 Massachusetts Medical Society.

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