| A phase 3 trial of bevacizumab in ovarian cancer. | |
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MedLine Citation:
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PMID: 22204725 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Angiogenesis plays a role in the biology of ovarian cancer. We examined the effect of bevacizumab, the vascular endothelial growth factor inhibitor, on survival in women with this disease. METHODS: We randomly assigned women with ovarian cancer to carboplatin (area under the curve, 5 or 6) and paclitaxel (175 mg per square meter of body-surface area), given every 3 weeks for 6 cycles, or to this regimen plus bevacizumab (7.5 mg per kilogram of body weight), given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease. Outcome measures included progression-free survival, first analyzed per protocol and then updated, and interim overall survival. RESULTS: A total of 1528 women from 11 countries were randomly assigned to one of the two treatment regimens. Their median age was 57 years; 90% had epithelial ovarian cancer, 69% had a serous histologic type, 9% had high-risk early-stage disease, 30% were at high risk for progression, and 70% had stage IIIC or IV ovarian cancer. Progression-free survival (restricted mean) at 36 months was 20.3 months with standard therapy, as compared with 21.8 months with standard therapy plus bevacizumab (hazard ratio for progression or death with bevacizumab added, 0.81; 95% confidence interval, 0.70 to 0.94; P=0.004 by the log-rank test). Nonproportional hazards were detected (i.e., the treatment effect was not consistent over time on the hazard function scale) (P<0.001), with a maximum effect at 12 months, coinciding with the end of planned bevacizumab treatment and diminishing by 24 months. Bevacizumab was associated with more toxic effects (most often hypertension of grade 2 or higher) (18%, vs. 2% with chemotherapy alone). In the updated analyses, progression-free survival (restricted mean) at 42 months was 22.4 months without bevacizumab versus 24.1 months with bevacizumab (P=0.04 by log-rank test); in patients at high risk for progression, the benefit was greater with bevacizumab than without it, with progression-free survival (restricted mean) at 42 months of 14.5 months with standard therapy alone and 18.1 months with bevacizumab added, with respective median overall survival of 28.8 and 36.6 months. CONCLUSIONS: Bevacizumab improved progression-free survival in women with ovarian cancer. The benefits with respect to both progression-free and overall survival were greater among those at high risk for disease progression. (Funded by Roche and others; ICON7 Controlled-Trials.com number, ISRCTN91273375.). |
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Authors:
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Timothy J Perren; Ann Marie Swart; Jacobus Pfisterer; Jonathan A Ledermann; Eric Pujade-Lauraine; Gunnar Kristensen; Mark S Carey; Philip Beale; Andrés Cervantes; Christian Kurzeder; Andreas du Bois; Jalid Sehouli; Rainer Kimmig; Anne Stähle; Fiona Collinson; Sharadah Essapen; Charlie Gourley; Alain Lortholary; Frédéric Selle; Mansoor R Mirza; Arto Leminen; Marie Plante; Dan Stark; Wendi Qian; Mahesh K B Parmar; Amit M Oza; |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 365 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2011 Dec |
Date Detail:
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Created Date: 2011-12-29 Completed Date: 2012-01-05 Revised Date: 2012-03-29 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 2484-96 Citation Subset: AIM; IM |
Affiliation:
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St. James's Institute of Oncology, St. James's University Hospital, Leeds, United Kingdom. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ISRCTN/ISRCTN91273375 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Angiogenesis Inhibitors
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adverse effects,
therapeutic use* Antibodies, Monoclonal, Humanized / adverse effects, therapeutic use* Antineoplastic Combined Chemotherapy Protocols / adverse effects, therapeutic use* Carboplatin / administration & dosage Combined Modality Therapy Disease-Free Survival Double-Blind Method Female Humans Middle Aged Neoplasms, Glandular and Epithelial / drug therapy*, mortality, surgery Ovarian Neoplasms / drug therapy*, mortality, surgery Paclitaxel / administration & dosage Quality of Life Survival Analysis |
| Chemical | |
Reg. No./Substance:
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0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal, Humanized; 0/bevacizumab; 33069-62-4/Paclitaxel; 41575-94-4/Carboplatin |
| Investigator | |
Investigator/Affiliation:
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Jacobus Pfisterer / ; Anja Krüger / ; Gabriele Elser / ; Carina Paschold / ; Michaela Beha / ; Norbert Peters / ; Augustinus H Tulusan / ; Jalid Sehouli / ; Jochem Potenberg / ; Elke Keil / ; Peter Klare / ; Erich Weiss / ; Dirk Behringer / ; Martina Gropp / ; Martin Pölcher / ; Christian Kurbacher / ; Uwe-Jochen Göhring / ; Ralf Lorenz / ; Willibald Schröder / ; Christiane Frantzen / ; Petra Krabisch / ; Hermann Zoche / ; Sven Ackerman / ; Ronaldo Stuth / ; Inken Achtert / ; Georg Kunz / ; Ulrich Canzler / ; Steffen Dörfel / ; Cornelia Höss / ; Matthias W Beckmann / ; Pauline Wimberger / ; Stefan Niesert / ; Cornelia Kurz / ; Horst Ostertag / ; Lars Hanker / ; Volker Möbus / ; Hans Tesch / ; Annette Hasenburg / ; Norbert Marschner / ; Andreas Kuznik / ; Volker Hanf / ; Dietrich Mosch / ; Michael Hoedemaker / ; Karsten Münstedt / ; Thomas Dewitz / ; Günter Emons / ; Antje K Belau / ; Joachim Hulde / ; Tjoung-Won Park-Simon / ; Sven Mahner / ; Uwe Herwig / ; Peter Müller / ; Thomas Müller / ; Iris Schrader / ; Jörg Gade / ; Barbara Jahns / ; Christoph Uleer / ; Britta Seifert / ; Ingo Runnebaum / ; Anne Stähle / ; Hans-Ulrich Ulmer / ; Gerhard Deutsch / ; Hans Urbanczyk / ; Felix Hilpert / ; Joachim Schneider / ; Wolfgang Maurer / ; Daniel Pfisterer / ; Ursula Vehling-Kaiser / ; Harald Wolf / ; Peter Scheler / ; Brigitte Schuhmann / ; Marc Thill / ; Eric Boetel / ; Wolfgang Wiest / ; Joachim Bischoff / ; Erika Kettner / ; Marcus Schmidt / ; Marc Sütterlin / ; Klaus Baumann / ; Alexander Burges / ; Harald Sommer / ; Georg-Peter Breitbach / ; Katrin Borkowski / ; Hans-Georg Schnürch / ; Richard Berger / ; Jens Kosse / ; Dietmar Schwörer / ; Tobias Zeiser / ; Friedrich Dressler / ; Sven-Thomas Grasshoff / ; Barbara Richter / ; Gerhard Fischer / ; Peter Krieger / ; Bernd Gerber / ; Thomas Beck / ; Gerhard Bartzke / ; Wolfgang Dietz / ; Cornelia Jacob / ; Michael Weigel / ; Matthias Stamm / ; Volker Müller / ; Peter Krezdorn / ; Johannes Feltz-Süssenbach / ; Walter Aulitzky / ; Heinrich Stehle / ; Eike Simon / ; Helmut Forstbauer / ; Erich Solomayer / ; Rolf Kreienberg / ; Edina Sulea / ; Felix Bartzsch / ; Philipp Harter / ; Gerald Hoffmann / ; Thomas Hitschold / ; Karl Ulrich Petry / ; Werner Fett / ; Dietmar Kranzfelder / ; Philip Beale / ; Julie Martyn / ; Kim Gillies / ; Christopher Steer / ; Geraldine Goss / ; Danny Rischin / ; Tony Bonaventura / ; Michael Friedlander / ; Margaret Davy / ; Jeffrey Goh / ; Rob Mc Intosh / ; Sally Baron-Hay / ; Philip Beale / ; Michael Quinn / ; Martin Buck / ; Paul Vasey / ; Adam Boyce / ; Alison Davis / ; Gary Richardson / ; Bernie Fitzharris / ; David Perez / ; Anne O Donnell / ; Eric Pujade Lauraine / ; Frédéric Marmion / ; Benedicte Votan / ; Alain Lorholary / ; Anne Floquet / ; Florence Joly / ; Béatrice Weber / ; Eric Pujade-Lauraine / ; Anne-Claire Hardy-Bessard / ; François Goldwasser / ; Eric Levy / ; Rémy Delva / ; Jean-Claude Barats / ; Michel Fabro / ; Paul-Henri Couttu / ; Dominique Spaeth / ; Isabelle Ray-Coquard / ; Fawzia Mefti / ; Jean-Emmanuel Kurtz / ; Frédéric Selle / ; Gaëtan De Rauglaudre / ; Dominique Berton-Rigaud / ; Jean-François Geay / ; Cécile Guillemet / ; Hugues Bourgeois / ; Véronique Mari / ; Franck Priou / ; Laurence Gladieff / ; Xavier Durando / ; Jean-Louis Misset / ; Catherine Lhomme / ; Anne Lesoin / ; Anne Plantade / ; Jérôme Dauba / ; Mohammed Hebbar / ; Mehran Khatibi / ; Hervé Cure / ; Andrés Cervantes / ; Federico Nepote / ; Andrés Cervantes / ; Andrés Poveda / ; Ana Santaballa / ; Eva María Guerra / ; José María del Campo / ; Beatriz Pardo Burdalo / ; Belén Ojeda / ; Pere Gascón / ; Isabel Bover / ; Ana de Juan / ; Ana Herrero / ; Miguel Beltrán / ; Andrés Redondo / ; Timothy J Perren / ; Ann Marie Swart / ; Emma Hainsworth / ; Christina Howitt / ; Julie Bakobaki / ; Cybil Kwakye / ; Wendi Qian / ; Clare Griffin / ; Timothy J Perren / ; Jurjees Hasan / ; John Green / ; Dennis Yiannakis / ; Gordon Rustin / ; Raj Naik / ; Justin Waters / ; Yoodhivir Nagar / ; Jonathan Ledermann / ; Simon Pledge / ; Jeff Summers / ; Iain McNeish / ; Sajid Durrani / ; Sharadah Essapen / ; Marcia Hall / ; Bass Hassan / ; Penelope O Neill / ; Mojca Persic / ; Fiona Lofts / ; Graham Dark / ; Geoffrey Sparrow / ; Rozenn Allerton / ; Michelle Ferguson / ; Jamey Morgan / ; Steven Chan / ; Radi Counsell / ; Mojca Persic / ; Clive Irwin / ; Martin Gore / ; Saad Tahir / ; Sarah Blagden / ; Sath Gokul / ; Richard Osbourne / ; Mark Napier / ; Amanda Horne / ; Nigel Bailey / ; Radha Todd / ; Peter Harper / ; Barbara Crosse / ; Helena Earl / ; Ahmed El-Modir / ; Nick Reed / ; Paul Symonds / ; Malcolm Adams / ; Mary Quigley / ; Alan Lamont / ; Charlie Gourley / ; Gunnar Kristensen / ; Gerda Anderson / ; Bente Lund / ; Mansoor Mirza / ; Jørn Herrstedt / ; Jørn Herrstedt / ; Hanne Havsteen / ; Nina Keldsen / ; Svend Aage Engelholm / ; Ulla Puistola / ; Seija Grenman / ; Arto Leminen / ; Bengt Tholander / ; Per Rosenberg / ; Bengt Sorbe / ; Kjell Bergfeldt / ; Gunnar Kristensen / ; Harald Helland / ; Ingrid Baasland / ; Bent Fiane / ; Ralph Meyer / ; Monica Bacon / ; Brenda Evans / ; Mark Carey / ; Patti Power / ; Robert Grimshaw / ; Paul Bessette / ; Marie Plante / ; Walter Gotlieb / ; Diane Provencher / ; Asif Shaikh / ; Laurie Elit / ; Amit Oza / ; Leonard Kaizer / ; Monique Bertrand / ; Haji Chalchal / ; Robert Lotocki / ; Prafull Ghatage / ; Anna Tinker / ; Lee Ann Martin / ; Susan Ellard / ; Silvana Spadafora / ; Valerie Capstick / ; T Perren / ; A Oza / ; A M Swart / ; W Qian / ; C Griffin / ; M Parmar / ; L Farrelly / ; E Hainsworth / ; C Kwakye / ; N Thompson / ; C Irl / ; G Jayson / ; D Stark / ; M Sculpher / ; J Pfisterer / ; G Elser / ; A Kruger / ; P Beale / ; J Martyn / ; K Gillies / ; A Cervantes / ; F Nepote / ; E Pujade Lauraine / ; F Marmion / ; B Votan / ; M Carey / ; M Bacon / ; R Meyer / ; G Kristensen / ; G Andersen / ; E Hainsworth / ; C Kwakye / ; L Farrelly / ; A M Swart / ; W Qian / ; C Griffin / ; F Collinson / ; S Sim / ; F al-Terkait / ; W Qian / ; C Griffin / ; A M Swart / ; M Parmar / ; R Coleman / ; W Sauerbrei / ; U Menon / ; R Buckstein / ; C Parker / ; R Rudd / ; J Whelan / ; D Fink / ; M Mason / ; P Johnson / |
| Comments/Corrections | |
Comment In:
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Nat Rev Cancer. 2012 Feb;12(2):83
[PMID:
22270952
]
N Engl J Med. 2012 Mar 29;366(13):1256; author reply 1257-8 [PMID: 22455428 ] N Engl J Med. 2012 Mar 29;366(13):1257; author reply 1258 [PMID: 22455430 ] |
Erratum In:
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N Engl J Med. 2012 Jan 19;366(3):284 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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