Abstract
The use, safety and effectiveness of crizotinib as part of the management of ROS1-rearranged NSCLC patients in a real-world Canadian clinical cohort was the focus of this retrospective review. Twenty-one ROS1-rearranged patients with advanced/metastatic disease receiving crizotinib between 2014–2020 were identified; crizotinib demonstrated tolerability and effectiveness in this population where outcomes were similar to those described in other crizotinib-treated real-world cohorts, but lower than those of the PROFILE 1001 clinical trial population. Systemic anti-cancer therapy prior to crizotinib initiation occurred in half of the study cohort, with platin-pemetrexed and immune checkpoint inhibitors being most common. Platin-pemetrexed showed good effectiveness in this cohort, but despite high prevalence of upregulated PD-L1 expression, immune checkpoint inhibitors showed poor effectiveness in his cohort. Among all systemic therapies received, crizotinib showed the most effective disease control, although longer intervals between diagnosis and crizotinib initiation were more common among those showing a lack of clinical response to crizotinib, and patients with brain metastases at the time of crizotinib initiation also showed increased diagnosis to crizotinib initiation intervals and decreased clinical response to crizotinib. This study reveals crizotinib has clinical benefit, but timely identification of ROS1-rearrangements and initiation targeted therapies appears important to maximize outcome in this population.
Highlights
The accepted survival gain associated with crizotinib treatment in ROS1-rearranged non-small cell lung cancer (NSCLC) patients is derived mainly from non-randomized phase II clinical trials (Appendix A, Table A1), some of which require three years to accrue as few as 50 patients [5]
It is recognized that patients seen in routine clinical practice are more diverse than those accrued to clinical trials
Real-world data which accurately captures the inherent variation in patients and clinical scenarios found in everyday clinical practice is uncommon
Summary
The accepted survival gain associated with crizotinib treatment in ROS1-rearranged NSCLC patients is derived mainly from non-randomized phase II clinical trials (Appendix A, Table A1), some of which require three years to accrue as few as 50 patients [5]. A tendency to defer ROS1-fusion testing until onset of late stage advanced or metastatic disease, often on an ad hoc basis after ruling out other oncogenic drivers such as EGFR and ALK, adds another layer of clinical heterogeneity [6]. Recognition of these issues has led to an increased interest in real world evidence to confirm the impact of these new therapies in the general population. Real-world data which accurately captures the inherent variation in patients and clinical scenarios found in everyday clinical practice is uncommon
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