Exonabhängige Subgruppenanalyse der nicht-interventionellen REASON-Studie: PFS und OS beim EGFR-mutierten NSCLC mit Behandlung von Gefitinib versus Chemotherapie

Zusammenfassung

Ziel der Studie: Untersuchung des Einflusses der Lokalisation von Mutationen im Gen des epidermalen Wachstumsfaktorrezeptors (EGFR) auf das progressionsfreie (PFS) und Gesamtüberleben (OS) bei Patienten (Pt) mit nicht-kleinzelligem Lungenkarzinom (NSCLC), die unter Routinebedingungen in der REASON-Studie mit Gefitinib (Gef) bzw. Chemotherapie (CT) behandelt wurden.

Methodik: Die ermittelten Subgruppen von Pt mit Exon 19- (n = 141), 18/20- (n = 43) und 21- (n = 104) Mutationen wurden in Abhängigkeit von Gef oder CT hinsichtlich PFS und OS ausgewertet und mittels log-rank-Test verglichen.

Ergebnisse: Pt mit Mutationen in den Exonen 19 und 18/20 mit Gef wiesen ein längeres PFS bzw. OS auf als Patienten mit CT. Der PFS-Unterschied war für Pt mit Exon 19-Mutation mit first-line Gef vs. CT mit 11,3 vs. 6,5 Monaten statistisch signifikant, für Exon 21-Mutationen lag ein vergleichbares PFS mit 9,1 vs. 9,3 Monaten vor. Das OS mit Gef vs. kein TKI während der Behandlung war bei Exon 19-Pt mit 21,8 vs. 10,6 Monaten signifikant verlängert, bei Exon 21-Pt mit 14,1 vs. 13,9 Monaten gleich.

Schlussfolgerung: Die unterschiedlichen EGFR Mutationen beeinflussen unter Routinebedingungen PFS und OS einer Therapie mit Gef und sollten deshalb detailliert ermittelt und beurteilt werden.

Abstract

Purpose: To analyze the influence of the localization of mutations in the epidermal growth factor receptor (EGFR) gene on progression-free (PFS) and overall survival (OS) in patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with gefitinib (gef) or chemotherapy (CT) under real world conditions within the REASON study.

Methods: Subgroups of pts with mutations in exon 19 (n = 141), 18/20 (n = 43), and 21 (n = 104) were analyzed for PFS and OS according to gef or CT treatment and compared using the log-rank test.

Results: Pts with mutations in exon 19 and 18/20 treated with gef as first line therapy showed increased PFS and OS compared to CT. This increase was statistically significant in pts with exon 19 mutation (11.3 vs. 6.5 months), but was not found in pts with exon 21 mutation (9.1 vs. 9.3 months). Also, OS was significantly increased in patients with mutation in exon 19 treated with gef ever over all treatment lines compared to CT (21.8 vs. 10.6 months), whereas this was not found in pts with mutation in exon 21 (14.1 vs. 13.9 months).

Conclusion: Localization and nature of EGFR mutations influences gefitinib treatment outcomes under routine conditions and should therefore be analyzed in detail.

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