Journal ArticleDOI
Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial
Georgina V. Long,Georgina V. Long,Daniil Stroyakovskiy,Helen Gogas,Evgeny Levchenko,Filippo de Braud,James Larkin,Claus Garbe,Thomas Jouary,Axel Hauschild,Jean-Jacques Grob,Vanna Chiarion-Sileni,Céleste Lebbé,Mario Mandalà,Michael Millward,Ana Arance,Igor Bondarenko,John B. A. G. Haanen,Johan Hansson,Jochen Utikal,Jochen Utikal,Virginia Ferraresi,Nadezhda Kovalenko,Peter Mohr,Volodymr Probachai,Dirk Schadendorf,Paul Nathan,Caroline Robert,Caroline Robert,Antoni Ribas,Douglas J Demarini,Jhangir G. Irani,Suzanne Swann,Jeffrey J. Legos,Fan Jin,Bijoyesh Mookerjee,Keith T. Flaherty +36 more
TLDR
The improvement in overall survival establishes the combination of dabrafenib and trametinib as the standard targeted treatment for BRAF Val600 mutation-positive melanoma.About:
This article is published in The Lancet.The article was published on 2015-08-01. It has received 1099 citations till now. The article focuses on the topics: Dabrafenib & Trametinib.read more
Citations
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Journal ArticleDOI
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
TL;DR: 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.
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
Emerging Concepts for Immune Checkpoint Blockade-Based Combination Therapies
TL;DR: It is proposed that reducing tumor burden and increasing tumor immunogenicity are key factors to improve immunotherapy.
Journal ArticleDOI
Combined BRAF, EGFR, and MEK Inhibition in Patients with BRAFV600E-Mutant Colorectal Cancer
Ryan B. Corcoran,Thierry André,Chloe E. Atreya,Jan H.M. Schellens,Takayuki Yoshino,Johanna C. Bendell,Antoine Hollebecque,Autumn J. McRee,Salvatore Siena,Gary Middleton,Kei Muro,Michael S. Gordon,Josep Tabernero,Rona Yaeger,Peter J. O'Dwyer,Yves Humblet,Filip de Vos,A. Scott Jung,Jan C. Brase,Savina Jaeger,Severine Bettinger,Bijoyesh Mookerjee,Fatima Rangwala,Eric Van Cutsem +23 more
TL;DR: This trial demonstrates that combined BRAF + EGFR + MEK inhibition is tolerable, with promising activity in patients with BRAFV600E colorectal cancer, and highlights the MAPK pathway as a critical target in BRAFv600Ecolorectals and the need to optimize strategies inhibiting this pathway to overcome both primary and acquired resistance.
Journal ArticleDOI
Cutaneous melanoma: From pathogenesis to therapy (Review)
Giulia Costanza Leonardi,Luca Falzone,Rossella Salemi,Antonino Zanghì,Demetrios A. Spandidos,James A. McCubrey,Saverio Candido,Massimo Libra +7 more
TL;DR: The epidemiological features of cutaneous melanoma along with the biological mechanisms involved in its development and progression are summarized and the current state-of-the-art of advanced stage melanoma treatment strategies and the currently available evidence of the use of predictive and prognostic biomarkers are discussed.
References
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New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
Elizabeth Eisenhauer,P. Therasse,Jan Bogaerts,Lawrence H. Schwartz,Daniel J. Sargent,Robert Ford,Janet Dancey,S. Arbuck,S. Gwyther,Margaret M. Mooney,Larry Rubinstein,Lalitha K. Shankar,Lori E. Dodd,Robert M. Kaplan,Denis Lacombe,Jaap Verweij +15 more
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Improved Survival with Ipilimumab in Patients with Metastatic Melanoma.
F. Stephen Hodi,Steven J. O'Day,David F. McDermott,R. W. Weber,Jeffrey A. Sosman,John B. A. G. Haanen,Rene Gonzalez,Caroline Robert,Dirk Schadendorf,Jessica C. Hassel,Wallace Akerley,Alfons J.M. van den Eertwegh,Jose Lutzky,Paul Lorigan,Julia Vaubel,Gerald P. Linette,David W. Hogg,Christian H. Ottensmeier,Céleste Lebbé,Christian Peschel,Ian Quirt,Joseph I. Clark,Jedd D. Wolchok,Jeffrey S. Weber,Jason Tian,Michael Yellin,Geoffrey M. Nichol,Axel Hoos,Walter J. Urba +28 more
TL;DR: Ipilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma.
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Pembrolizumab versus Ipilimumab in Advanced Melanoma
Caroline Robert,Caroline Robert,Caroline Robert,Jacob Schachter,Georgina V. Long,Ana Arance,Jean-Jacques Grob,Laurent Mortier,Laurent Mortier,Adil Daud,Matteo S. Carlino,Catriona M. McNeil,Michal Lotem,James Larkin,Paul Lorigan,Bart Neyns,Christian U. Blank,Omid Hamid,Christine Mateus,Christine Mateus,Ronnie Shapira-Frommer,Ronnie Shapira-Frommer,Michele Kosh,Honghong Zhou,Nageatte Ibrahim,Scot Ebbinghaus,Antoni Ribas +26 more
TL;DR: The anti-PD-1 antibody pembrolizumab prolonged progression-free survival and overall survival and had less high-grade toxicity than did ipilimumab in patients with advanced melanoma.
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Nivolumab in previously untreated melanoma without BRAF mutation.
Caroline Robert,Georgina V. Long,Benjamin Brady,Caroline Dutriaux,Michele Maio,Laurent Mortier,Jessica C. Hassel,Piotr Rutkowski,Catriona M. McNeil,Ewa Kalinka-Warzocha,Kerry J. Savage,Micaela Hernberg,Céleste Lebbé,Julie Charles,Catalin Mihalcioiu,Vanna Chiarion-Sileni,Cornelia Mauch,Francesco Cognetti,Ana Arance,Henrik Schmidt,Dirk Schadendorf,Helen Gogas,Lotta Lundgren-Eriksson,Christine Horak,Brian Sharkey,Ian M. Waxman,Victoria Atkinson,Paolo A. Ascierto,Abstr Act +28 more
TL;DR: Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation.
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A multiple testing procedure for clinical trials.
TL;DR: The overall size of the procedure is shown to be controlled with virtually the same accuracy as the single sample chi-square test based on N(m1 + m2) observations and the power is found to bevirtually the same.
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