Exposure–response analyses of BRAF- and MEK-inhibitors dabrafenib plus trametinib in melanoma patients

Davies H, Bignell GR, Cox C, Stephens P, Edkins S, Clegg S et al (2002) Mutations of the BRAF gene in human cancer. Nature 417:949–954

Article  CAS  PubMed  Google Scholar 

The Cancer Genome Atlas Network (2015) Genomic classification of cutaneous melanoma. Cell 161:1681–1696

Article  PubMed Central  Google Scholar 

Rozeman EA, Dekker TJA, Haanen JBAG, Blank CU (2018) Advanced melanoma: current treatment options, biomarkers, and future perspectives. Am J Clin Dermatol 19:303–317

Article  PubMed  Google Scholar 

Ouellet D, Gibiansky E, Leonowens C, O’Hagan A, Haney P, Switzky J et al (2014) Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol 54:696–706

Article  CAS  PubMed  Google Scholar 

Ouellet D, Kassir N, Chiu J, Mouksassi MS, Leonowens C, Cox D et al (2016) Population pharmacokinetics and exposure-response of trametinib, a MEK inhibitor, in patients with BRAF V600 mutation-positive melanoma. Cancer Chemother Pharmacol 77:807–817

Article  CAS  PubMed  Google Scholar 

Verheijen RB, Yu H, Schellens JHM, Beijnen JH, Steeghs N, Huitema ADR (2017) Practical recommendations for therapeutic drug monitoring of kinase inhibitors in oncology. Clin Pharmacol Ther 102:765–776

Article  PubMed  PubMed Central  Google Scholar 

Menzies AM, Ashworth MT, Swann S, Kefford RF, Flaherty K, Weber J et al (2015) Characteristics of pyrexia in BRAFV600E/K metastatic melanoma patients treated with combined dabrafenib and trametinib in a phase I/II clinical trial. Ann Oncol 26:415–421

Article  CAS  PubMed  Google Scholar 

Balakirouchenane D, Guegan S, Csajka C, Jouinot A, Heidelberger V, Puszkiel A et al (2020) Population pharmacokinetics/pharmacodynamics of dabrafenib plus trametinib in patients with BRAF-mutated metastatic melanoma. Cancers (Basel) 58:1–19

Google Scholar 

Rousset M, Dutriaux C, Bosco-Lévy P, Prey S, Pham-Ledard A, Dousset L et al (2017) Trough dabrafenib plasma concentrations can predict occurrence of adverse events requiring dose reduction in metastatic melanoma. Clin Chim Acta 472:26–29

Article  CAS  PubMed  Google Scholar 

Kim HY, Duong JK, Gonzalez M, Long GV, Menzies AM, Rizos H et al (2019) Pharmacokinetic and cytokine profiles of melanoma patients with dabrafenib and trametinib-induced pyrexia. Cancer Chemother Pharmacol 83:693–704

Article  CAS  PubMed  Google Scholar 

Herbrink M, De Vries N, Rosing H, Huitema ADR, Nuijen B, Schellens JHM et al (2018) Development and validation of a liquid chromatography–tandem mass spectrometry analytical method for the therapeutic drug monitoring of eight novel anticancer drugs. Biomed Chromatogr 32:1–9

Article  Google Scholar 

Wang Y, Chia Y, Nedelman J, Schran H, Mahon F, Molimard M (2009) A therapeutic drug monitoring algorithm for refining the imatinib trough level obtained at different sampling times. Ther Drug Monit 31:579–584

Article  CAS  PubMed  Google Scholar 

Janssen JM, Dorlo TPC, Beijnen JH, Huitema ADR (2020) Evaluation of extrapolation methods to predict trough concentrations to guide therapeutic drug monitoring of oral anticancer drugs. Ther Drug Monit 42:532 (ePub ahead of print 5 May 2020)

Infante JR, Fecher LA, Falchook GS, Nallapareddy S, Gordon MS, Becerra C et al (2012) Safety, pharmacokinetic, pharmacodynamic, and efficacy data for the oral MEK inhibitor trametinib: a phase 1 dose-escalation trial. Lancet 13:773–781

Article  CAS  Google Scholar 

Summary of product characteristics dabrafenib. https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-productinformation_en.pdf

Schemper M, Smith TL (1996) A note on quantifying follow-up in studies of failure time. Control Clin Trials 17:343–346

Article  CAS  PubMed  Google Scholar 

R Core Development Team (2016) A language and environment for statistical computing. R Found Statistical Computing, Vienna. https://www.r-project.org/

Falchook GS, Lewis KD, Infante JR, Gordon MS, Vogelzang NJ, DeMarini DJ et al (2012) Activity of the oral MEK inhibitor trametinib in patients with advanced melanoma: a phase 1 dose-escalation trial. Lancet Oncol 13:782–789

Article  CAS  PubMed  PubMed Central  Google Scholar 

Committee for Medicinal Products for Human Use (CHMP). European medicines. Trametinib European Public Assessment Report. 2014. https://www.ema.europa.eu/en/documents/assessment-report/mekinist-epar-public-assessment-report_en.pdf

Gilmartin AG, Bleam MR, Groy A, Moss KG, Minthorn EA, Kulkarni SG et al (2011) GSK1120212 (JTP-74057) is an inhibitor of MEK activity and activation with favorable pharmacokinetic properties for sustained in vivo pathway inhibition. Clin Cancer Res 17:989–1000

Article  CAS  PubMed  Google Scholar 

Corcoran RB, Settleman J, Engelman JA (2011) Potential therapeutic strategies to overcome acquired resistance to BRAF or MEK inhibitors in BRAF mutant cancers. Oncotarget 2:336–346

Article  PubMed  PubMed Central  Google Scholar 

Hatzivassiliou G, Song K, Yen I, Brandhuber BJ, Anderson DJ, Alvarado R et al (2010) RAF inhibitors prime wild-type RAF to activate the MAPK pathway and enhance growth. Nature 464:431–435

Article  CAS  PubMed  Google Scholar 

Heidorn SJ, Milagre C, Whittaker S, Nourry A, Niculescu-Duvas I, Dhomen N et al (2010) Kinase-dead BRAF and oncogenic RAS cooperate to drive tumor progression through CRAF. Cell 140:209–221

Article  CAS  PubMed  PubMed Central  Google Scholar 

Poulikakos PI, Zhang C, Bollag G, Shokat KM, Rosen N (2010) RAF inhibitors transactivate RAF dimers and ERK signalling in cells with wild-type BRAF. Nature 464:427–430

Article  CAS  PubMed  PubMed Central  Google Scholar 

Committee for Medicinal Products for Human Use. European Medicines Agency. European Public Assessment Report Dabrafenib. 2013. https://www.ema.europa.eu/en/documents/assessment-report/tafinlar-epar-public-assessment-report_en.pdf

Falchook GS, Long GV, Kurzrock R, Kim KB, Arkenau HT, Brown MP et al (2014) Dose selection, pharmacokinetics, and pharmacodynamics of BRAF inhibitor dabrafenib (GSK2118436). Clin Cancer Res 20:4449–4458

Article  CAS  PubMed  Google Scholar 

Wollenberg L, Marchand M, Merdjan H, Litwiler K (2018) Development of a population pharmacokinetic model for binimetinib with subsequent exposure-response analyses in NRAS mutant melanoma. Am Conf Pharmacometr:T-051

Committee for Medicinal Products for Human Use. European Medicines Agency. European Public Assessment Report Binimetinib. 2018. https://www.ema.europa.eu/en/documents/assessment-report/mektovi-epar-public-assessment-report_en.pdf. Accessed 28 Dec 2022

Schadendorf D, Long GV, Stroiakovski D, Karaszewska B, Hauschild A, Levchenko E et al (2017) Three-year pooled analysis of factors associated with clinical outcomes across dabrafenib and trametinib combination therapy phase 3 randomised trials. Eur J Cancer 82:45–55

Article  CAS  PubMed  Google Scholar 

留言 (0)

沒有登入
gif