1. Identification of ALK-positive patients with advanced NSCLC and real-world clinical experience with crizotinib in Spain (IDEALK study)
- Author
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Carlos Aguado de la Rosa, Patricia Cruz Castellanos, Martín Lázaro-Quintela, Manuel Dómine, Sergio Vázquez Estévez, Guillermo López-Vivanco, José Luis Fírvida Pérez, José Luis Alonso Romero, Lioba Ferrera Delgado, Carlos García Girón, Pilar Diz Taín, Rosa Álvarez Álvarez, Pilar Mut Sanchís, Inmaculada Fernández Cantón, Isabel Manrique Abós, Maite Martínez Aguillo, Lorenzo Gómez-Aldaraví Gutiérrez, Ana Laura Ortega Granados, Ruth Álvarez Cabellos, Arancha García Sebastián, Luis Fernando García Sifuentes, and Noemí Reguart
- Subjects
Tyrosine kinase inhibitors ,Male ,Pulmonary and Respiratory Medicine ,ALK-positive non-small cell lung cancer (NSCLC) ,Cancer Research ,Lung Neoplasms ,Incidence ,Anaplastic lymphoma kinase ,Real-world ,Crizotinib ,Oncology ,Spain ,Carcinoma, Non-Small-Cell Lung ,Quality of Life ,Humans ,Female ,Anaplastic Lymphoma Kinase ,Prospective Studies ,Protein Kinase Inhibitors ,Transaminases ,Retrospective Studies - Abstract
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.
- Published
- 2022