Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter Study

Area of Science:

• Oncology
• Molecular Diagnostics
• Pharmacology

Background:

• ROS1 rearrangement is a rare (1-2%) but targetable genetic alteration in non-small-cell lung cancer (NSCLC).
• Crizotinib is an approved tyrosine kinase inhibitor (TKI) for ROS1-positive NSCLC, but real-world data on its use are limited.
• Evaluating crizotinib's real-world effectiveness and safety is crucial for optimizing treatment strategies in this patient population.

Purpose of the Study:

• To assess the real-world safety and efficacy of crizotinib in patients with advanced or metastatic non-small-cell lung cancer (NSCLC) harboring ROS1 rearrangements.
• To compare real-world outcomes with findings from pivotal clinical trials.
• To identify prognostic factors influencing treatment response.

Main Methods:

• A multicenter, retrospective study involving 43 patients with advanced/metastatic ROS1-rearranged NSCLC treated with crizotinib.
• Data collection included efficacy endpoints (PFS, OS, ORR, DCR) and safety assessments (CTCAE v5.0).
• Patients received crizotinib in either the first- or second-line setting.

Main Results:

• The objective response rate (ORR) was 72.1% and disease control rate (DCR) was 79% with first-line crizotinib.
• Median progression-free survival (PFS) was 20.9 months, and median overall survival (OS) was 52.7 months.
• The most frequent adverse events were fatigue, elevated transaminases, and vision disorders, all of which were low-grade (1-2). ECOG performance status was a significant prognostic factor for ORR (p=0.02).

Conclusions:

• Crizotinib demonstrates significant efficacy and a favorable safety profile in real-world patients with ROS1-rearranged NSCLC.
• These findings support crizotinib's established role as a standard therapy for this molecularly defined subset of NSCLC.
• Further prospective research is recommended to investigate intracranial efficacy and long-term outcomes.