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Dabrafenib

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https://www.readbyqxmd.com/read/28919011/dabrafenib-plus-trametinib-in-patients-with-previously-untreated-braf-v600e-mutant-metastatic-non-small-cell-lung-cancer-an-open-label-phase-2-trial
#1
David Planchard, Egbert F Smit, Harry J M Groen, Julien Mazieres, Benjamin Besse, Åslaug Helland, Vanessa Giannone, Anthony M D'Amelio, Pingkuan Zhang, Bijoyesh Mookerjee, Bruce E Johnson
BACKGROUND: BRAF(V600E) mutation occurs in 1-2% of lung adenocarcinomas and acts as an oncogenic driver. Dabrafenib, alone or combined with trametinib, has shown substantial antitumour activity in patients with previously treated BRAF(V600E)-mutant metastatic non-small-cell lung cancer (NSCLC). We aimed to assess the activity and safety of dabrafenib plus trametinib treatment in previously untreated patients with BRAF(V600E)-mutant metastatic NSCLC. METHODS: In this phase 2, sequentially enrolled, multicohort, multicentre, non-randomised, open-label study, adults (≥18 years of age) with previously untreated metastatic BRAF(V600E)-mutant NSCLC were enrolled into cohort C from 19 centres in eight countries within North America, Europe, and Asia...
September 8, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28918496/recurrent-papillary-craniopharyngioma-with-brafv600e-mutation-treated-with-neoadjuvant-targeted-therapy
#2
Elham Rostami, Petra Witt Nyström, Sylwia Libard, Johan Wikström, Olivera Casar-Borota, Olafur Gudjonsson
Craniopharyngiomas are histologically benign but locally aggressive tumors in the sellar region that may cause devastating neurological and endocrine deficits. They tend to recur following surgery with high morbidity; hence, postoperative radiotherapy is recommended following sub-total resection. BRAFV600E mutation is the principal oncogenic driver in the papillary variant of craniopharyngiomas. Recently, a dramatic tumor reduction has been reported in a patient with BRAFV600E mutated, multiply recurrent papillary craniopharyngioma using a combination therapy of BRAF inhibitor dabrafenib and MEK inhibitor trametinib...
September 16, 2017: Acta Neurochirurgica
https://www.readbyqxmd.com/read/28893027/unusual-skin-carcinomas-induced-by-braf-inhibitor-for-metastatic-melanoma-a-case-report
#3
Stefano Cavalieri, Lorenza Di Guardo, Mara Cossa, Carolina Cimminiello, Michele Del Vecchio
The most frequently reported skin tumours during treatment with targeted therapies for BRAF (B type Rapidly Accelerated Fibrosarcoma kinase) mutated metastatic melanoma are squamous cell carcinomas (SCCs). Basal cell carcinomas (BCCs) have been described in such setting, but no cases of multiple and recurring tumours have been reported so far. A patient with a history of chronic sun exposure and more than 10 BCCs removed since 1998 started treatment with vemurafenib for BRAF mutated metastatic melanoma. Therapy was complicated by sporadic episodes of atrial fibrillation and by the development of recurrent, multiple and diffuse BCCs...
July 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28891408/adjuvant-dabrafenib-plus-trametinib-in-stage-iii-braf-mutated-melanoma
#4
Georgina V Long, Axel Hauschild, Mario Santinami, Victoria Atkinson, Mario Mandalà, Vanna Chiarion-Sileni, James Larkin, Marta Nyakas, Caroline Dutriaux, Andrew Haydon, Caroline Robert, Laurent Mortier, Jacob Schachter, Dirk Schadendorf, Thierry Lesimple, Ruth Plummer, Ran Ji, Pingkuan Zhang, Bijoyesh Mookerjee, Jeff Legos, Richard Kefford, Reinhard Dummer, John M Kirkwood
Background Combination therapy with the BRAF inhibitor dabrafenib plus the MEK inhibitor trametinib improved survival in patients with advanced melanoma with BRAF V600 mutations. We sought to determine whether adjuvant dabrafenib plus trametinib would improve outcomes in patients with resected, stage III melanoma with BRAF V600 mutations. Methods In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 870 patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations to receive oral dabrafenib at a dose of 150 mg twice daily plus trametinib at a dose of 2 mg once daily (combination therapy, 438 patients) or two matched placebo tablets (432 patients) for 12 months...
September 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28879519/safety-tolerability-and-pharmacokinetic-profile-of-dabrafenib-in-japanese-patients-with-braf-v600-mutation-positive-solid-tumors-a-phase-1-study
#5
Yutaka Fujiwara, Naoya Yamazaki, Yoshio Kiyohara, Shusuke Yoshikawa, Noboru Yamamoto, Arata Tsutsumida, Hiroshi Nokihara, Kenjiro Namikawa, Akihira Mukaiyama, Fanghong Zhang, Tomohide Tamura
Background Dabrafenib is a BRAF inhibitor that has demonstrated clinical activity with a good tolerability profile in patients with BRAF (V600E) mutated metastatic melanoma. This study evaluated the safety and tolerability, pharmacokinetics and preliminary efficacy of dabrafenib in Japanese patients. Methods This phase I, open-label, dose escalation study was conducted in 12 Japanese patients with BRAF (V600) mutation positive solid tumours. Primary endpoint was safety, assessed by monitoring and recording of all adverse events (AEs), serious AEs, drug-related AEs; secondary endpoints were pharmacokinetic profiles and efficacy measured by tumour response...
September 7, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28861837/cardiovascular-effects-of-the-mek-inhibitor-trametinib-a-case-report-literature-review-and-consideration-of-mechanism
#6
REVIEW
Mary Banks, Karen Crowell, Amber Proctor, Brian C Jensen
The MEK inhibitor trametinib was approved in 2013 for the treatment of unresectable or metastatic melanoma with a BRAF V600E mutation, the most common pathogenic mutation in melanoma. Trametinib blocks activation of ERK1/2, inhibiting cell proliferation in melanoma. ERK1/2 also protects against multiple types of cardiac insult in mouse models. Trametinib improves survival in melanoma patients, but evidence of unanticipated cardiotoxicity is emerging. Here we describe the case of a patient with metastatic melanoma who developed acute systolic heart failure after trametinib treatment and present the results of the literature review prompted by this case...
August 31, 2017: Cardiovascular Toxicology
https://www.readbyqxmd.com/read/28857272/acanthoma-planoepitheliale-hyperkeratoticum-lesions-associated-with-braf-inhibitor-in-metastatic-melanoma
#7
M Sokołowska-Wojdyło, B Olszewska, M Sobjanek, M Sławińska, K Sosińska-Mielcarek, W Biernat, R Nowicki
A 68-year-old woman was diagnosed with BRAF V600 mutation positive melanoma of unknown primary (MUP) with metastasis to the lung, liver and brain. According to local standards dabrafenib monotherapy was started in July 2016. Control CT performed after two months revealed disease stabilization. The tolerance of therapy was good, but after 2 months of treatment with dabrafenib the patient developed disseminated skin lesions with extended seborrheic keratosis G2 (according to international common toxicity criteria CTC)...
August 30, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28838438/donor-derived-metastatic-melanoma-and-checkpoint-inhibition
#8
S M Boyle, N Ali, A J Olszanski, D J Park, G Xiao, S Guy, A M Doyle
Donor-derived malignancy, particularly melanoma, is a rare but known complication of organ transplantation. Here we describe a case of metastatic melanoma in a deceased-donor kidney transplant recipient. After diagnosis, the patient was successfully treated with cessation of immunosuppression, explantation of the renal allograft, and novel melanoma therapies, including the mutation-targeted agents dabrafenib and trametinib and the immune checkpoint inhibitor nivolumab. These 2 new classes of melanoma therapy have revolutionized the course of metastatic melanoma, altering it from one of nearly certain mortality to one of potential cure...
September 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28827234/multiple-treatment-comparison-of-seven-new-drugs-for-patients-with-advanced-malignant-melanoma-a-systematic-review-and-health-economic-decision-model-in-a-norwegian-setting
#9
Eva Pike, Vida Hamidi, Ingvil Saeterdal, Jan Odgaard-Jensen, Marianne Klemp
OBJECTIVE: To assess the relative effectiveness and cost-effectiveness of seven new drugs (cobimetinib, dabrafenib, ipilimumab, nivolumab, pembrolizumab, trametinib and vemurafenib) used for treatment of patients with advanced malignant melanoma in the Norwegian setting. DESIGN: A multiple technology assessment. PATIENTS: Patients with advanced malignant melanoma aged 18 or older. DATA SOURCES: A systematic search for randomised controlled trials in relevant bibliographic databases...
August 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28818062/ocular-toxicity-due-to-trametinib-and-dabrafenib
#10
Stephanie Sarny, Michael Neumayer, Julian Kofler, Yosuf El-Shabrawi
BACKGROUND: To report a case of uveitis and neuroretinal detachment in a patient treated with Trametinib and Dabrafenib due to metastatic cutaneous melanoma stage IV. CASE PRESENTATION: We evaluated slit lamp examination, fundoscopy, optical coherence tomography, fluorescein and indocyanine green angiography in a 66 years old man suffering visual loss. Fundoscopy showed serous neuroretinal detachment of the fovea accompanied with white spots surrounding the fovea in both eyes...
August 17, 2017: BMC Ophthalmology
https://www.readbyqxmd.com/read/28805135/intermittent-dosing-of-dabrafenib-and-trametinib-in-metastatic-braf-v600e-mutated-papillary-thyroid-cancer-two-case-reports
#11
Paul S White, Anita Pudusseri, Stephanie L Lee, Omar Eton
BACKGROUND: A multi-institutional, randomized phase II trial of continuous dosing of dabrafenib with or without trametinib is ongoing in metastatic thyroid cancer. Preclinical evidence and emerging clinical experience in other cancers support evaluating intermittent dosing of these two agents to achieve more durable response, while being better tolerated and more cost effective. PATIENTS: Two consecutive patients with symptomatic, metastatic radioactive iodine-resistant BRAF(V600E) mutated papillary thyroid cancer and poor performance status were treated initially with dabrafenib 150 mg twice daily plus trametinib 2 mg once daily, first in continuous daily dosing, then in a five-week-on and three-week-off schedule...
September 2017: Thyroid: Official Journal of the American Thyroid Association
https://www.readbyqxmd.com/read/28777388/choroidal-neovascularization-in-multifocal-choroiditis-after-dabrafenib-and-trametinib
#12
Giorgia C Albertini, Eleonora Corbelli, Maurizio Battaglia Parodi, Francesco Bandello
PURPOSE: To describe a case of bilateral choroidal neovascularization (CNV) in multifocal choroiditis (MFC) associated with dabrafenib and trametinib chemotherapy for metastatic melanoma. CASE: We present a case of a 57-year-old man with MFC who underwent combination therapy with dabrafenib plus trametinib for metastatic melanoma. The patient presented to our ophthalmology department complaining of bilateral vision loss of 2 days' duration. He underwent multimodal imaging showing a MFC reactivation complicated by bilateral CNV...
August 2, 2017: European Journal of Ophthalmology
https://www.readbyqxmd.com/read/28723725/meningeal-melanomatosis-following-discontinuation-of-dabrafenib-implications-for-the-maintenance-of-long-term-complete-remission
#13
Victoria Grätz, Nadine Lüttmann, Ozan Haase, Ewan A Langan, André Kemmling, Detlef Zillikens, Patrick Terheyden
A subset of 10-20% of patients under continuous BRAF inhibitor monotherapy achieve long-term progression-free and overall survival. Definitive criteria for the safe cessation of BRAF inhibitor monotherapy in treatment-responsive melanoma patients are lacking. We report a patient who remained in complete remission (CR) for 5 years under dabrafenib. The treatment was withdrawn because of concerns about cardiac toxicity. Four months thereafter the patient developed neurological symptoms, including diplopia and bilateral visual loss...
July 18, 2017: Melanoma Research
https://www.readbyqxmd.com/read/28716527/identification-of-a-synergistic-combination-of-smac-mimetic-and-bortezomib-to-trigger-cell-death-in-b-cell-non-hodgkin-lymphoma-cells
#14
Irfan Ahmed Bhatti, Behnaz Ahangarian Abhari, Simone Fulda
Recently, copy number gains and increased expression levels of cIAP1 and cIAP2 have been reported in B-cell non-Hodgkin lymphomas (NHL). Therefore, we investigated the therapeutic potential of the Smac mimetic BV6 that antagonizes cIAP1/2 and XIAP. Here, we discover that subtoxic concentrations of BV6 prime B-cell NHL cells to proteasome inhibitor Bortezomib-induced cell death. Synergistic induction of cell death by BV6 and Bortezomib is confirmed by calculation of combination index in different cell lines, emphasizing the broader relevance of this combination...
October 1, 2017: Cancer Letters
https://www.readbyqxmd.com/read/28711086/the-new-paradigm-of-systemic-therapies-for-metastatic-melanoma
#15
REVIEW
Virginia O Volpe, Daniel M Klufas, Upendra Hegde, Jane M Grant-Kels
New treatments for metastatic melanoma work through distinct mechanisms: enhancing the immune response and blocking cellular proliferation. Agents that enhance the immune response include ipilimumab, pembrolizumb, and nivolumab; agents that block cellular proliferation include vemurafenib, dabrafenib, trametinib, cobimetinib, binimetinib, and selumetinib. The translational impact of laboratory discoveries has revolutionized management of metastatic melanoma and enhanced the prognosis of affected patients.
August 2017: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/28709799/trough-dabrafenib-plasma-concentrations-can-predict-occurrence-of-adverse-events-requiring-dose-reduction-in-metastatic-melanoma
#16
Marine Rousset, Caroline Dutriaux, Pauline Bosco-Lévy, Sorilla Prey, Anne Pham-Ledard, Léa Dousset, Emilie Gérard, Stephane Bouchet, Mireille Canal-Raffin, Karine Titier, Mathieu Molimard
INTRODUCTION: Dabrafenib and trametinib bitherapy provides significant benefits in BRAFV600(mut) metastatic melanoma patients; however, adverse events (AE) occur, leading to dose reduction in 33% of patients. We aimed to investigate a relation between plasma dabrafenib and trametinib concentrations and occurrence of AE. METHODS: Plasma samples from metastatic BRAFV600(mut) melanoma patients treated with dabrafenib±trametinib were prospectively collected at trough concentration before any dose reduction...
July 12, 2017: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/28707403/melanocytic-lesion-evolution-patterns-with-targeted-therapies-and-immunotherapies-for-advanced-metastatic-melanoma-an-observational-study
#17
Cathy Yunjia Zhao, Shelley Ji Eun Hwang, Deepal Wakade, Giuliana Carlos, Rachael Anforth, Pablo Fernández-Peñas
BACKGROUND/OBJECTIVES: Various cutaneous side-effects have been reported with anti-melanoma systemic therapies. This study investigated the changes in melanocytic lesion pigmentation in patients on four different therapies. METHODS: We analysed the serial dermatoscopic photographs of atypical melanocytic lesions taken from patients with advanced metastatic melanoma on four different systemic therapies (selective BRAF-inhibitor monotherapy, dabrafenib combined with trametinib [D&T], anti-programmed cell death protein 1 [anti-PD1] therapies, and anti-PD1 combined with ipilimumab) seen from February 2013 to May 2016...
July 14, 2017: Australasian Journal of Dermatology
https://www.readbyqxmd.com/read/28695986/acute-heart-failure-as-a-result-of-granulomatous-myocarditis-case-report-on-a-patient-with-metastatic-melanoma-treated-with-dabrafenib-and-trametinib
#18
J K Winkler, K Buder-Bakhaya, E Ellert, E Herpel, U M Martens, A Enk, J C Hassel
Treatment options for metastatic melanoma have changed substantially in recent years. Targeting immune checkpoints has improved prognosis of melanoma patients. For melanomas harboring BRAF mutations, inhibition of the mitogen-activated protein kinase pathway is a promising therapeutic option. Combined BRAF and MEK inhibition improves progression-free and overall survival. This article is protected by copyright. All rights reserved.
July 11, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28684402/braf-v600-inhibition-alters-the-microrna-cargo-in-the-vesicular-secretome-of-malignant-melanoma-cells
#19
Taral R Lunavat, Lesley Cheng, Berglind O Einarsdottir, Roger Olofsson Bagge, Somsundar Veppil Muralidharan, Robyn A Sharples, Cecilia Lässer, Yong Song Gho, Andrew F Hill, Jonas A Nilsson, Jan Lötvall
The BRAF inhibitors vemurafenib and dabrafenib can be used to treat patients with metastatic melanomas harboring BRAF(V600) mutations. Initial antitumoral responses are often seen, but drug-resistant clones with reactivation of the MEK-ERK pathway soon appear. Recently, the secretome of tumor-derived extracellular vesicles (EVs) has been ascribed important functions in cancers. To elucidate the possible functions of EVs in BRAF-mutant melanoma, we determined the RNA content of the EVs, including apoptotic bodies, microvesicles, and exosomes, released from such cancer cells after vemurafenib treatment...
July 18, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28652244/targeting-adenosine-in-braf-mutant-melanoma-reduces-tumor-growth-and-metastasis
#20
Arabella Young, Shin Foong Ngiow, Jason Madore, Julia Reinhardt, Jennifer Landsberg, Arash Chitsazan, Jai Rautela, Tobias Bald, Deborah S Barkauskas, Elizabeth Ahern, Nicholas D Huntington, Dirk Schadendorf, Georgina V Long, Glen M Boyle, Michael Hölzel, Richard A Scolyer, Mark J Smyth
Increasing evidence exists for the role of immunosuppressive adenosine in promoting tumor growth and spread in a number of cancer types, resulting in poor clinical outcomes. In this study, we assessed whether the CD73-adenosinergic pathway is active in melanoma patients and whether adenosine restricts the efficacy of clinically approved targeted therapies for commonly mutated BRAF(V600E) melanoma. In AJCC stage III melanoma patients, CD73 expression (the enzyme that generates adenosine) correlated significantly with patients presenting nodal metastatic melanoma, suggesting that targeting this pathway may be effective in advanced stage disease...
June 26, 2017: Cancer Research
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