Reference Detail

Ref Type

Journal Article

PMID

(36162227)

Authors

Aguado de la Rosa C, Cruz Castellanos P, Lázaro-Quintela M, Dómine M, Vázquez Estévez S, López-Vivanco G, Fírvida Pérez JL, Alonso Romero JL, Ferrera Delgado L, García Girón C, Diz Taín P, Álvarez Álvarez R, Mut Sanchís P, Fernández Cantón I, Manrique Abós I, Martínez Aguillo M, Gómez-Aldaraví Gutiérrez L, Ortega Granados AL, Álvarez Cabellos R, García Sebastián A, García Sifuentes LF, Reguart N

Title

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

Journal	Vol	Issue	Date	Pages	Journal Short Title
Lung cancer (Amsterdam, Netherlands)	173		2022 Nov	83-93	Lung Cancer

URL

Abstract Text

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.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
ALK rearrange	lung non-small cell carcinoma	sensitive	Crizotinib	Clinical Study	Actionable	In a clinical study, Xalkori (crizotinib) treatment resulted in an objective response rate of 59.3% (48/81, 8 complete responses), clinical benefit rate of 86.4% (70/81), median duration of response of 13.5 months, median progression-free survival of 15.8 months, and median overall survival of 46.5 months in patients with non-small cell lung cancer harboring an ALK rearrangement (PMID: 36162227; NCT02679170).	36162227