Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study.
Georgina V. Long,Keith T. Flaherty,Daniil Stroyakovskiy,Helen Gogas,Evgeny Levchenko,F. de Braud,James Larkin,Claus Garbe,Thomas Jouary,Axel Hauschild,Vanna Chiarion-Sileni,Céleste Lebbé,Mario Mandalà,Michael Millward,Ana Arance,Igor Bondarenko,J.B.A.G. Haanen,Johan Hansson,Jochen Utikal,Virginia Ferraresi,Peter Mohr,V. Probachai,Dirk Schadendorf,Paul Nathan,Caroline Robert,Antoni Ribas,Michael A. Davies,Stephen R. Lane,Jeffrey J. Legos,Bijoyesh Mookerjee,J.-J. Grob +30 more
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TLDR
It is demonstrated that durable (≥3 years) survival is achievable with dabrafenib plus trametinib in patients with BRAF V600-mutant metastatic melanoma and support long-term first-line use of the combination in this setting.About:
This article is published in Annals of Oncology.The article was published on 2017-07-01 and is currently open access. It has received 483 citations till now. The article focuses on the topics: Dabrafenib & Trametinib.read more
Citations
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Journal ArticleDOI
Dabrafenib and Trametinib Treatment in Patients With Locally Advanced or Metastatic BRAF V600-Mutant Anaplastic Thyroid Cancer
Vivek Subbiah,Robert J. Kreitman,Zev A. Wainberg,Jae Yong Cho,Jan H.M. Schellens,Jan H.M. Schellens,Jean-Charles Soria,Patrick Y. Wen,Christoph C. Zielinski,Maria E. Cabanillas,Gladys Urbanowitz,Bijoyesh Mookerjee,Dazhe Wang,Fatima Rangwala,Bhumsuk Keam +14 more
TL;DR: Dabrafenib plus trametinib is the first regimen demonstrated to have robust clinical activity in BRAF V600E-mutated anaplastic thyroid cancer and was well tolerated, representing a meaningful therapeutic advance for this orphan disease.
Journal ArticleDOI
Dabrafenib plus trametinib in patients with BRAFV600-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial
Michael A. Davies,Philippe Saiag,Caroline Robert,Jean-Jacques Grob,Keith T. Flaherty,Ana Arance,Vanna Chiarion-Sileni,Luc Thomas,Thierry Lesimple,Laurent Mortier,Stergios J. Moschos,David Hogg,Ivan Marquez-Rodas,Michele Del Vecchio,Céleste Lebbé,Nicolas Meyer,Ying Zhang,Yingjie Huang,Bijoyesh Mookerjee,Georgina V. Long +19 more
TL;DR: Results from the phase 2 COMBI-MB trial provide evidence of clinical benefit with dabrafenib plus trametinib and support the need for additional research to further improve outcomes in patients with melanoma brain metastases.
Journal ArticleDOI
Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial
Reinhard Dummer,Paolo A. Ascierto,Helen Gogas,Ana Arance,Mario Mandalà,Gabriella Liszkay,Claus Garbe,Dirk Schadendorf,Ivana Krajsová,Ralf Gutzmer,Vanna Chiarion Sileni,Caroline Dutriaux,Jan Willem de Groot,Naoya Yamazaki,Carmen Loquai,Laure Moutouh-de Parseval,Michael D Pickard,Victor Sandor,Caroline Robert,Keith T. Flaherty +19 more
TL;DR: The prespecified interim overall survival analysis of the COLUMBUS trial improved progression-free survival compared with vemurafenib in patients with BRAFV600-mutant melanoma and provided clinically meaningful efficacy as shown by overall survival.
Journal ArticleDOI
Cutaneous melanoma, version 2.2019
Daniel G. Coit,John A. Thompson,Mark R. Albertini,Christopher A. Barker,William E. Carson,Carlo M. Contreras,Gregory A. Daniels,Dominick J. DiMaio,Ryan C. Fields,Martin D. Fleming,Morganna Freeman,Anjela Galan,Brian R. Gastman,Valerie Guild,Douglas B. Johnson,Richard W. Joseph,Julie R. Lange,Sameer K. Nath,Anthony J. Olszanski,Patrick A. Ott,Aparna Priyanath Gupta,Merrick I. Ross,April K.S. Salama,Joseph J. Skitzki,Jeffrey A. Sosman,Susan M. Swetter,Kenneth K. Tanabe,Evan Wuthrick,Nicole R. McMillian,Anita M. Engh +29 more
TL;DR: The data and rationale supporting extensive changes to the recommendations for systemic therapy as adjuvant treatment of resected disease and as treatment of unresectable or distant metastatic disease are summarized.
Journal ArticleDOI
Molecular testing for BRAF mutations to inform melanoma treatment decisions: a move toward precision medicine.
TL;DR: A literature search was performed using MEDLINE/PubMed and scientific congress databases using the terms ‘BRAF,’ ‘mutation, and ‘cancer/tumor.’ These results were filtered to include diagnostic tests for determining BRAF mutation status as mentioned in this paper.
References
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Journal ArticleDOI
Combined BRAF and MEK Inhibition in Melanoma with BRAF V600 Mutations
Keith T. Flaherty,J. R. Infante,Adil Daud,Rene Gonzalez,Richard F. Kefford,Jeffrey A. Sosman,Omid Hamid,Lynn M. Schuchter,Jonathan Cebon,Nageatte Ibrahim,Ragini Kudchadkar,Howard A. Burris,Gerald S. Falchook,Alain Algazi,Karl D. Lewis,Georgina V. Long,Igor Puzanov,Peter F. Lebowitz,Ajay Singh,Shonda M Little,Peng Sun,Alicia Allred,Daniele Ouellet,Kevin B. Kim,Kiran Patel,Jeffrey S. Weber +25 more
TL;DR: Dabrafenib and trametinib were safely combined at full monotherapy doses, and the rate of pyrexia was increased with combination therapy, whereas the rates of proliferative skin lesions was nonsignificantly reduced.
Journal ArticleDOI
Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial.
Jeffrey S. Weber,Sandra P. D'Angelo,David R. Minor,F. Stephen Hodi,Ralf Gutzmer,Bart Neyns,Christoph Hoeller,Nikhil I. Khushalani,Wilson H. Miller,Christopher D. Lao,Gerald P. Linette,Luc Thomas,Paul Lorigan,Kenneth F. Grossmann,Jessica C. Hassel,Michele Maio,Mario Sznol,Paolo A. Ascierto,Peter Mohr,Bartosz Chmielowski,Alan H. Bryce,Inge Marie Svane,Jean-Jacques Grob,Angela M. Krackhardt,Christine Horak,Alexandre Lambert,Arvin Yang,James Larkin +27 more
TL;DR: Nivolumab led to a greater proportion of patients achieving an objective response and fewer toxic effects than with alternative available chemotherapy regimens for patients with advanced melanoma that has progressed after ipilimumab or ipilicumab and a BRAF inhibitor.
Journal ArticleDOI
Improved Overall Survival in Melanoma with Combined Dabrafenib and Trametinib
Caroline Robert,Boguslawa Karaszewska,Jacob Schachter,Piotr Rutkowski,Andrzej Mackiewicz,Daniil Stroiakovski,Michael Lichinitser,Reinhard Dummer,Florent Grange,Laurent Mortier,Vanna Chiarion-Sileni,Kamil Drucis,Ivana Krajsová,Axel Hauschild,Paul Lorigan,Pascal Wolter,Georgina V. Long,Keith T. Flaherty,Paul Nathan,Antoni Ribas,Antoni Ribas,Anne-Marie Martin,Peng Sun,Wendy A. Crist,Jeff Legos,Stephen D. Rubin,Shonda M Little,Dirk Schadendorf +27 more
TL;DR: Dabrafenib plus trametinib, as compared with vemurafenib monotherapy, significantly improved overall survival in previously untreated patients with metastatic melanoma with BRAF V600E or V600K mutations, without increased overall toxicity.
Journal ArticleDOI
Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma
Dirk Schadendorf,F. Stephen Hodi,Caroline Robert,Jeffrey S. Weber,Kim Margolin,Omid Hamid,Debra A. Patt,Tai-Tsang Chen,David Berman,Jedd D. Wolchok +9 more
TL;DR: A plateau in the survival curve was observed, beginning at approximately 3 years, which was independent of prior therapy or ipilimumab dose, and added to the evidence supporting the durability of long-term survival in ipILimumab-treated patients with advanced melanoma.
Journal ArticleDOI
Combined BRAF and MEK Inhibition versus BRAF Inhibition Alone in Melanoma
Georgina V. Long,Daniil Stroyakovskiy,Helen Gogas,Evgeny Levchenko,F. de Braud,James Larkin,Claus Garbe,T. Jouary,Axel Hauschild,Jean-Jacques Grob,V. Chiarion Sileni,Céleste Lebbé,Mario Mandalà,Michael Millward,Ana Arance,Igor Bondarenko,John B. A. G. Haanen,Johan Hansson,Jochen Utikal,Virginia Ferraresi,Nadezhda Kovalenko,Peter Mohr,V. Probachai,Dirk Schadendorf,Paul Nathan,Caroline Robert,Antoni Ribas,Douglas J. DeMarini,Jhangir G. Irani,Michelle Casey,Daniele Ouellet,Anne-Marie Martin,Ngocdiep T. Le,Kiran Patel,Keith T. Flaherty +34 more
TL;DR: A combination of dabraenib and trametinib, as compared with dabrafenib alone, improved the rate of progression-free survival in previously untreated patients who had metastatic melanoma with BRAF V600E or V600K mutations.
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