Robert L Coleman1, Nick M Spirtos1, Danielle Enserro1, Thomas J Herzog1, Paul Sabbatini1, Deborah K Armstrong1, Jae-Weon Kim1, Sang-Yoon Park1, Byoung-Gie Kim1, Joo-Hyun Nam1, Keiichi Fujiwara1, Joan L Walker1, Ann C Casey1, Angeles Alvarez Secord1, Steve Rubin1, John K Chan1, Paul DiSilvestro1, Susan A Davidson1, David E Cohn1, Krishnansu S Tewari1, Karen Basen-Engquist1, Helen Q Huang1, Mark F Brady1, Robert S Mannel1. 1. 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.).
Abstract
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 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. 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.).
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 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. 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.).
Authors: Philipp Harter; Jalid Sehouli; Alexander Reuss; Annette Hasenburg; Giovanni Scambia; David Cibula; Sven Mahner; Ignace Vergote; Alexander Reinthaller; Alexander Burges; Lars Hanker; Martin Pölcher; Christian Kurzeder; Ulrich Canzler; Karl Ulrich Petry; Andreas Obermair; Edgar Petru; Barbara Schmalfeldt; Domenica Lorusso; Andreas du Bois Journal: Int J Gynecol Cancer Date: 2011-02 Impact factor: 3.437
Authors: Mansoor R Mirza; Bradley J Monk; Jørn Herrstedt; Amit M Oza; Sven Mahner; Andrés Redondo; Michel Fabbro; Jonathan A Ledermann; Domenica Lorusso; Ignace Vergote; Noa E Ben-Baruch; Christian Marth; Radosław Mądry; René D Christensen; Jonathan S Berek; Anne Dørum; Anna V Tinker; Andreas du Bois; Antonio González-Martín; Philippe Follana; Benedict Benigno; Per Rosenberg; Lucy Gilbert; Bobbie J Rimel; Joseph Buscema; John P Balser; Shefali Agarwal; Ursula A Matulonis Journal: N Engl J Med Date: 2016-10-07 Impact factor: 91.245
Authors: Robert L Dood; Yang Zhao; Shannon D Armbruster; Robert L Coleman; Shelley Tworoger; Anil K Sood; Keith A Baggerly Journal: JAMA Oncol Date: 2018-11-01 Impact factor: 31.777
Authors: R Y Zang; P Harter; D S Chi; J Sehouli; R Jiang; C G Tropé; A Ayhan; G Cormio; Y Xing; K M Wollschlaeger; E I Braicu; C A Rabbitt; H Oksefjell; W J Tian; C Fotopoulou; J Pfisterer; A du Bois; J S Berek Journal: Br J Cancer Date: 2011-08-30 Impact factor: 7.640
Authors: Robert L Coleman; Amit M Oza; Domenica Lorusso; Carol Aghajanian; Ana Oaknin; Andrew Dean; Nicoletta Colombo; Johanne I Weberpals; Andrew Clamp; Giovanni Scambia; Alexandra Leary; Robert W Holloway; Margarita Amenedo Gancedo; Peter C Fong; Jeffrey C Goh; David M O'Malley; Deborah K Armstrong; Jesus Garcia-Donas; Elizabeth M Swisher; Anne Floquet; Gottfried E Konecny; Iain A McNeish; Clare L Scott; Terri Cameron; Lara Maloney; Jeff Isaacson; Sandra Goble; Caroline Grace; Thomas C Harding; Mitch Raponi; James Sun; Kevin K Lin; Heidi Giordano; Jonathan A Ledermann Journal: Lancet Date: 2017-09-12 Impact factor: 79.321
Authors: Vito Andrea Capozzi; Andrea Rosati; Luigi Carlo Turco; Giulio Sozzi; Matteo Riccò; Benito Chiofalo; Giuseppe Vizzielli Journal: Gland Surg Date: 2020-08
Authors: Felipe Leonardo Estati; Rafaela Pirolli; Viviane Teixeira Loiola de Alencar; Adriana Regina Gonçalves Ribeiro; Maria Nirvana Formiga; Giovana Tardin Torrezan; Dirce Maria Carraro; Andrea Paiva Gadelha Guimarães; Glauco Baiocchi; Alexandre André Balieiro Anastácio da Costa Journal: Ann Surg Oncol Date: 2020-11-21 Impact factor: 5.344
Authors: Shama Virani; Glauco Baiocchi; David Bowtell; Citadel J Cabasag; Kathleen R Cho; Renée T Fortner; Keiichi Fujiwara; Jae-Weon Kim; Martin Köbel; Jean-Emmanuel Kurtz; Douglas A Levine; Usha Menon; Barbara M Norquist; Paul D P Pharoah; Anil K Sood; Shelley T Tworoger; Nicolas Wentzensen; Stephen J Chanock; Paul Brennan; Britton Trabert Journal: Carcinogenesis Date: 2021-06-21 Impact factor: 4.944
Authors: Philipp Horvath; Can Yurttas; Stefan Beckert; Alfred Königsrainer; Ingmar Königsrainer Journal: Cancers (Basel) Date: 2021-05-19 Impact factor: 6.639