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Phase I study of FOLFIRI plus pimasertib as second-line treatment for KRAS -mutated metastatic colorectal cancer
Macarulla Mercadé, Teresa (Vall d'Hebron Institut d'Oncologia (VHIO))
Cervantes, A (Universidad de Valencia. Biomedical Research Institute (INCLIVA))
Tabernero Caturla, Josep (Vall d'Hebron Institut d'Oncologia (VHIO))
Roselló, S (Universidad de Valencia. Biomedical Research Institute (INCLIVA))
Van Cutsem, E (University Hospitals Gasthuisberg and KU Leuven)
Tejpar, S (University Hospitals Gasthuisberg and KU Leuven)
Prenen, H (University Hospitals Gasthuisberg and KU Leuven)
Martinelli, E (Second University of Naples. Department of Experimental and Clinical Medicine)
Troiani, T (Second University of Naples. Department of Experimental and Clinical Medicine)
Laffranchi, B (Merck Serono SA)
Jego, V (Merck Serono SA)
von Richter, O (Merck KGaA)
Ciardiello, F (Second University of Naples. Department of Experimental and Clinical Medicine)
Universitat Autònoma de Barcelona

Fecha: 2015
Resumen: The mitogen-activated protein kinase (MAPK) pathway has been implicated in the molecular pathogenesis of human cancers, including metastatic colorectal cancer (mCRC). This provides a rationale for the development of MAPK-targeted agents such as pimasertib. Patients with KRAS mutant mCRC were treated in the second-line setting with FOLFIRI (5-fluorouracil/folinic acid/irinotecan) plus pimasertib. The primary objective of the safety run-in phase was to determine the maximum-tolerated dose (MTD) and the recommended phase II dose of pimasertib combined with FOLFIRI. Sixteen patients were enrolled in the trial. Ten and six patients were treated daily with 45 and 60 mg of pimasertib plus FOLFIRI, respectively. The MTD was considered to be 45 mg per day. The most common treatment-emergent adverse events were diarrhoea, nausea, vomiting, asthenia and skin/rash event. Of the 15 patients in the efficacy analysis group, two patients had partial response, nine patients had stable disease, three patients had progressive disease as their best overall response and one patient could not be evaluated. Dose escalation of pimasertib in combination with FOLFIRI was limited by toxicity. At the MTD of 45 mg per day, pimasertib was adequately tolerated in patients with mCRC and no unexpected or new safety signals or concerns were identified.
Derechos: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials i que es distribueixin sota la mateixa llicència que regula l'obra original. Cal que es reconegui l'autoria de l'obra original. Creative Commons
Lengua: Anglès.
Documento: article ; recerca ; publishedVersion
Materia: Pimasertib ; MEK inhibitor ; FOLFIRI ; KRAS -mutated metastatic colorectal cancer ; Combination therapy ; Second-line treatment
Publicado en: British Journal of Cancer, Vol. 112 (June 2015) , p. 1874-1881, ISSN 1532-1827

DOI: 10.1038/bjc.2015.144
PMID: 25989270


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