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  • Ray-Coquard, I.GINECO and Medical Oncology Department, Centre Léon Bérard, University Claude Bernard Lyon, Lyon, France (author)

Final results from GCIG/ENGOT/AGO-OVAR 12, a randomised placebo-controlled phase III trial of nintedanib combined with chemotherapy for newly diagnosed advanced ovarian cancer

  • Article/chapterEnglish2020

Publisher, publication year, extent ...

  • 2019-09-06
  • John Wiley & Sons,2020
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:liu-161315
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-161315URI
  • https://doi.org/10.1002/ijc.32606DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding agencies:  AGO; Boehringer Ingelheim, Ingelheim, GermanyBoehringer Ingelheim
  • AGO-OVAR 12 investigated the effect of adding the oral triple angiokinase inhibitor nintedanib to standard front-line chemotherapy for advanced ovarian cancer. At the primary analysis, nintedanib demonstrated significantly improved progression-free survival (PFS; primary endpoint) compared with placebo. We report final results, including overall survival (OS). Patients with primary debulked International Federation of Gynaecology and Obstetrics (FIGO) stage IIB–IV newly diagnosed ovarian cancer were randomised 2:1 to receive carboplatin (area under the curve 5 or 6) plus paclitaxel (175 mg/m2) on day 1 every 3 weeks for six cycles combined with either nintedanib 200 mg or placebo twice daily on days 2–21 every 3 weeks for up to 120 weeks. Between December 2009 and July 2011, 1,366 patients were randomised (911 to nintedanib, 455 to placebo). Disease was considered as high risk (FIGO stage III with amp;gt;1 cm residuum, or any stage IV) in 39%. At the final analysis, 605 patients (44%) had died. There was no difference in OS (hazard ratio 0.99, 95% confidence interval [CI] 0.83–1.17, p = 0.86; median 62.0 months with nintedanib vs. 62.8 months with placebo). Subgroup analyses according to stratification factors, clinical characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75–0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports. © 2019 UICC

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Cibula, D.AGO and Oncogynecologic Center, Department of Obstetrics and Gynecology, General Faculty Hospital, Charles University of Prague, Prague, Czech Republic (author)
  • Mirza, M.R.NSGO and Department of Oncology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark (author)
  • Reuss, A.AGO and Coordinating Center for Clinical Trials, Philipps-University of Marburg, Marburg, Germany (author)
  • Ricci, C.MITO and Division of Gynecologic Oncology, Department of Women and Childrens Health and Public Health, Fondazione Policlinico Gemelli IRCCS, Rome, Italy (author)
  • Colombo, N.MaNGO and European Institute of Oncology and University of Milan Bicocca, Milan, Italy (author)
  • Koch, H.AGO Austria and Department of Obstetrics and Gynecology, Paracelsus Medical University, Salzburg, Austria (author)
  • Goffin, F.BGOG and CHU de Liège, University of Liège, Liège, Belgium (author)
  • González-Martin, A.GEICO and Medical Oncology Department, Clínica Universidad de Navarra, Madrid, Spain (author)
  • Ottevanger, P.B.DGOG and Department of Medical Oncology, Radboud University Medical Centre, Nijmegen, Netherlands (author)
  • Baumann, K.AGO and Department of Gynecology, Klinikum der Stadt Ludwigshafen GmbH, Ludwigshafen, Germany (author)
  • Bjørge, L.NSGO and Department of Gynecology, Haukeland Universitetssykehus, Bergen, Norway; Center for Cancer Biomarkers CCBIO, Department of Clinical Science, University of Bergen, Bergen, Norway (author)
  • Lesoin, A.GINECO and Department of Gynecologic Cancer and Medical Oncology, Centre Oscar Lambret, Lille, France (author)
  • Burges, A.AGO and Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Germany (author)
  • Rosenberg, Per,1951-Linköpings universitet,Institutionen för biomedicinska och kliniska vetenskaper,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US(Swepub:liu)perro95 (author)
  • Gropp-Meier, M.AGO and Department of Gynecology and Obstetrics, Oberschwabenklinik, Krankenhaus St. Elisabeth, Ravensburg, Germany (author)
  • Harrela, M.NSGO and Department of Gynoncology and Gynecology and Obstetrics, Kymenlaakso Central Hospital, Kotka, Finland (author)
  • Harter, P.AGO and Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany (author)
  • Frenel, J.-S.GINECO and Centre René Gauducheau, Institut de Cancerologie de lOuest, Saint Herblain, France (author)
  • Minarik, T.NSGO and National Institute of Oncology, Bratislava, Slovakia (author)
  • Pisano, C.MITO and Department of Uro-Gynecologic Oncology, Istituto Nazionale per Io Studio e la Cura dei Tumori ‘Fondazione G. Pascale’ IRCCS, Naples, Italy (author)
  • Hasenburg, A.AGO and Department of Obstetrics and Gynecology, University Medical Center, Mainz, Germany (author)
  • Merger, M.Oncology Medicine, Boehringer Ingelheim International GmbH, Biberach, Germany (author)
  • du, Bois A.AGO and Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany (author)
  • GINECO and Medical Oncology Department, Centre Léon Bérard, University Claude Bernard Lyon, Lyon, FranceAGO and Oncogynecologic Center, Department of Obstetrics and Gynecology, General Faculty Hospital, Charles University of Prague, Prague, Czech Republic (creator_code:org_t)

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  • In:International Journal of Cancer: John Wiley & Sons146:2, s. 439-4480020-71361097-0215

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