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Efficacy and safety of crizotinib in the treatment of advanced non-small cell lung cancer with ROS1 gene fusion: a systematic literature review and meta-analysis of real-world evidence.
Nadal, Ernest; Rifi, Nada; Kane, Sarah; Mbacke, Sokhna; Starkman, Lindsey; Suero, Beatrice; Le, Hannah; Samjoo, Imtiaz A.
Afiliación
  • Nadal E; Department of Medical Oncology, Catalan Institute of Oncology (ICO), Avda Gran via, 199-203. L'Hospitalet, 08908, Barcelona, Spain; Preclinical and Experimental Research in Thoracic Tumors (PReTT) Group, OncoBell Program, IDIBELL, L'Hospitalet, Barcelona, Spain. Electronic address: esnadal@iconcolog
  • Rifi N; Pfizer, Inc., New York, New York, USA.
  • Kane S; EVERSANA™, Burlington, Ontario, Canada.
  • Mbacke S; EVERSANA™, Burlington, Ontario, Canada.
  • Starkman L; EVERSANA™, Burlington, Ontario, Canada.
  • Suero B; EVERSANA™, Burlington, Ontario, Canada.
  • Le H; Pfizer, Inc., New York, New York, USA.
  • Samjoo IA; EVERSANA™, Burlington, Ontario, Canada. Electronic address: imtiaz.samjoo@eversana.com.
Lung Cancer ; 192: 107816, 2024 06.
Article en En | MEDLINE | ID: mdl-38749072
ABSTRACT

BACKGROUND:

Crizotinib was approved to treat patients with advanced non-small cell lung cancer (aNSCLC) with ROS proto-oncogene 1 (ROS1) gene fusion in 2016. We conducted a systematic literature review to identify real-world evidence (RWE) studies and estimated the efficacy and safety of crizotinib using meta-analyses (MA) for objective response rate (ORR), real-world progression-free survival (PFS), and overall survival (OS).

METHODS:

We searched MEDLINE®, Embase, and Cochrane CENTRAL from January 2016 to March 2023 using Ovid® for published single-arm or comparative RWE studies evaluating patients (N ≥ 20) receiving crizotinib monotherapy for aNSCLC with ROS1 gene fusion. Pooled estimates for ORR and grade 3/4 adverse events (AEs) were derived using the metafor package in R while pooled estimates for median real-world PFS (rwPFS) and OS were derived using reconstructed individual patient data from published Kaplan-Meier curves. The primary analysis included all studies regardless of crizotinib line of therapy; a subgroup analysis (SA) was conducted using studies evaluating patients receiving first-line crizotinib.

RESULTS:

Fourteen studies met the eligibility criteria and were considered feasible for MA. For the primary analysis, the pooled ORR (N = 9 studies) was 70.6 % (95 % confidence interval [CI] 57.0, 81.3), median rwPFS was 14.5 months (N = 11 studies), and OS was 40.2 months (N = 9 studies). In the SA, the pooled ORR (N = 4 studies) was 81.1 % (95 % CI 76.1, 85.2) and the median rwPFS (N = 4 studies) and OS (N = 2 studies) were 18.1 and 60 months, respectively. All MAs were associated with significant heterogeneity (I2 > 25 %). Grade 3/4 AEs occurred in 18.7 % of patients (pooled estimate).

CONCLUSION:

The results from this study are consistent with clinical trial data and, taken collectively, supports crizotinib as a safe and effective treatment across different lines of therapy in patients with ROS1 aNSCLC in the real-world setting.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas Tirosina Quinasas / Proteínas Proto-Oncogénicas / Carcinoma de Pulmón de Células no Pequeñas / Inhibidores de Proteínas Quinasas / Crizotinib / Proto-Oncogenes Mas / Neoplasias Pulmonares Límite: Humans Idioma: En Revista: Lung Cancer Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article Pais de publicación: Irlanda

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas Tirosina Quinasas / Proteínas Proto-Oncogénicas / Carcinoma de Pulmón de Células no Pequeñas / Inhibidores de Proteínas Quinasas / Crizotinib / Proto-Oncogenes Mas / Neoplasias Pulmonares Límite: Humans Idioma: En Revista: Lung Cancer Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article Pais de publicación: Irlanda