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Identification of ALK-positive patients with advanced NSCLC and real-world clinical experience with crizotinib in Spain (IDEALK study)

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dc.contributor.authorAguado de la Rosa, Carlos
dc.contributor.authorCruz Castellanos, Patricia
dc.contributor.authorLázaro Quintela, Martín
dc.contributor.authorDómine, Manuel
dc.contributor.authorVázquez Estévez, Sergio
dc.contributor.authorLópez Vivanco, Guillermo
dc.contributor.authorFírvida Pérez, José Luis
dc.contributor.authorAlonso Romero, José Luis
dc.contributor.authorFerrera Delgado, Lioba
dc.contributor.authorGarcía Girón, Carlos
dc.contributor.authorDiz Taín, Pilar
dc.contributor.authorÁlvarez Álvarez, Rosa
dc.contributor.authorMut Sanchís, Pilar
dc.contributor.authorFernández Cantón, Inmaculada
dc.contributor.authorManrique Abós, Isabel
dc.contributor.authorMartínez Aguillo, Maite
dc.contributor.authorGómez-Aldaraví Gutiérrez, Lorenzo
dc.contributor.authorOrtega Granados, Ana Laura
dc.contributor.authorÁlvarez Cabellos, Ruth
dc.contributor.authorGarcía Sebastián, Arancha
dc.contributor.authorGarcía Sifuentes, Luis Fernando
dc.contributor.authorReguart, Noemí
dc.contributor.departmentMedicina
dc.date.accessioned2024-11-05T11:41:36Z
dc.date.available2024-11-05T11:41:36Z
dc.date.issued2022-11
dc.description© 2022 The Authors. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/ This document is the Published version of a Published Work that appeared in final form in Lung Cancer. To access the final edited and published work see https://doi.org/10.1016/j.lungcan.2022.09.010
dc.description.abstractObjectives To determine the incidence of ALK translocations in patients with advanced/metastatic NSCLC in Spain, to describe the clinical characteristics of these patients, and to evaluate the effectiveness and safety of treatment with crizotinib in a real-world setting. Methods This is an observational prospective and retrospective cohort study to determine the incidence of ALK translocations and to analyze the effectiveness and safety of crizotinib in a real-world setting. Patient characteristics, treatment patterns, time to best overall response, duration of treatment, objective response rates (ORR), rates of adverse events (AE), progression free survival (PFS) and overall survival (OS) were evaluated in the ALK study cohort of patients treated with crizotinib (prospective and retrospective). ALK incidence and quality of life (QoL) questionnaires were measured from patients included in the prospective cohort. Results The incidence of ALK translocations was 5.5 % (31 of 559 patients). Compared with ALK-negative patients, ALK-positive patients were significantly younger, predominantly female, and non-smokers. In the crizotinib effectiveness and safety study, 91 patients (42 prospective, 49 retrospective) with ALK-positive NSCLC (43.9 % in first-line, 56.1 % in second or more lines) were included. The ORR was 59.3 % and the median duration of response was 13.5 months (IQR, 5.3–26.2). The median PFS was 15.8 months (95 % CI, 11.8–22.3) and the median OS was 46.5 months, with 53 patients (58.2 %) still alive at data cut-off date. Frequently reported AEs included elevated transaminases, gastrointestinal disorders, and asthenia. Most patients (76.5 %) reported improved or stable scores for global QoL during treatment. Conclusions The observed incidence of ALK translocations in NSCLC patients is aligned with published reports. This analysis of the real-world clinical experience in Spain confirms the therapeutic benefit and safety of crizotinib in advanced/metastatic ALK-positive NSCLC.es
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dc.format.extent11es
dc.identifier.citationLung Cancer, 2022, Vol. 173, pp. 83-93
dc.identifier.doihttps://doi.org/10.1016/j.lungcan.2022.09.010
dc.identifier.issnPrint: 0169-5002
dc.identifier.issnElectronic: 1872-8332
dc.identifier.urihttp://hdl.handle.net/10201/145990
dc.languageenges
dc.publisherElsevier
dc.relationThis research was sponsored by Pfizeres
dc.relation.publisherversionhttps://www.sciencedirect.com/science/article/pii/S0169500222006365?via%3Dihub
dc.rightsinfo:eu-repo/semantics/openAccesses
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectAnaplastic lymphoma kinasees
dc.subjectALK positive non small cell lung canceres
dc.subjectCrizotinibes
dc.subjectReal worldes
dc.subjectIncidencees
dc.subjectTyrosine kinase inhibitorses
dc.titleIdentification of ALK-positive patients with advanced NSCLC and real-world clinical experience with crizotinib in Spain (IDEALK study)es
dc.typeinfo:eu-repo/semantics/articlees
dspace.entity.typePublicationes
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