RT Journal Article
T1 Identification of ALK-positive patients with advanced NSCLC and real-world clinical experience with crizotinib in Spain (IDEALK study).
A1 Aguado de la Rosa, Carlos
A1 Cruz Castellanos, Patricia
A1 Lázaro-Quintela, Martín
A1 Dómine, Manuel
A1 Vázquez Estévez, Sergio
A1 López-Vivanco, Guillermo
A1 Fírvida Pérez, José Luis
A1 Alonso Romero, José Luis
A1 Ferrera Delgado, Lioba
A1 García Girón, Carlos
A1 Diz Taín, Pilar
A1 Álvarez Álvarez, Rosa
A1 Mut Sanchís, Pilar
A1 Fernández Cantón, Inmaculada
A1 Manrique Abós, Isabel
A1 Martínez Aguillo, Maite
A1 Gómez-Aldaraví Gutiérrez, Lorenzo
A1 Ortega Granados, Ana Laura
A1 Álvarez Cabellos, Ruth
A1 García Sebastián, Arancha
A1 García Sifuentes, Luis Fernando
A1 Reguart, Noemí
K1 ALK-positive non-small cell lung cancer (NSCLC)
K1 Anaplastic lymphoma kinase
K1 Crizotinib
K1 Incidence
K1 Real-world
K1 Tyrosine kinase inhibitors
AB 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. 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. 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. 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. gov: NCT02679170.
YR 2022
FD 2022-09-19
LK http://hdl.handle.net/10668/22355
UL http://hdl.handle.net/10668/22355
LA en
DS RISalud
RD May 10, 2025