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
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Journal ArticleDOI
Targeted agents or immuno-oncology therapies as first-line therapy for BRAF-mutated metastatic melanoma: a real-world study.
Jason J. Luke,Sameer R. Ghate,Jonathan Kish,Choo Hyung Lee,Lindsay McAllister,Sonam Mehta,Briana Ndife,Bruce A. Feinberg +7 more
TL;DR: Despite higher risk patients, 1L TT resulted in higher response rate and longer treatment duration suggesting a preferred 1L sequence, compared to 1L IO, which had no survival difference.
Journal ArticleDOI
The safety and efficacy of dabrafenib and trametinib for the treatment of melanoma.
Sarah Knispel,Lisa Zimmer,Theodora Kanaki,Selma Ugurel,Dirk Schadendorf,Elisabeth Livingstone +5 more
TL;DR: There is a substantial need to prevent and treat also mild adverse events, as they play a central role for the quality of life of patients, due to an increased life expectancy.
Journal ArticleDOI
Paclitaxel-Loaded Nanosponges Inhibit Growth and Angiogenesis in Melanoma Cell Models.
Nausicaa Clemente,Monica Argenziano,Casimiro Luca Gigliotti,Benedetta Ferrara,Elena Boggio,Annalisa Chiocchetti,Fabrizio Caldera,Francesco Trotta,Elisa Benetti,Laura Annaratone,Simone Ribero,Stefania Pizzimenti,Giuseppina Barrera,Umberto Dianzani,Roberta Cavalli,Chiara Dianzani +15 more
TL;DR: The data demonstrated that the new PTX nanoformulation can respond to some important issues related to PTX treatment, lowering the anti-tumor effective doses and increasing the effectiveness in inhibiting melanoma growth in vivo.
Journal ArticleDOI
Comparative efficacy of combination immunotherapy and targeted therapy in the treatment of BRAF-mutant advanced melanoma: a matching-adjusted indirect comparison.
Michael B. Atkins,Ahmad A. Tarhini,Michael Rael,Komal Gupte-Singh,Elliott O'Brien,Corey Ritchings,Sumati Rao,David F. McDermott +7 more
TL;DR: Nivolumab + ipilimumab had significantly improved clinical outcomes versus BRAF +-MEK inhibitors, with benefits increasing after longer follow-up.
Journal ArticleDOI
Considering adjuvant therapy for stage II melanoma.
Andrew Poklepovic,Jason J. Luke +1 more
TL;DR: It has now been confirmed that these classes of agents have a benefit for patients with stage III melanoma after surgical resection, and anti‐PD1 and BRAF/MEK inhibitors are standards of care in this setting.
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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