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Overall survival and central nervous system activity of crizotinib in ROS1-rearranged lung cancer: final results of the EUCROSS trial

Background - In 2019, we reported the first efficacy and safety analysis of EUCROSS, a phase II trial investigating crizotinib in ROS1 fusion-positive lung cancer. At that time, overall survival (OS) was immature and the effect of crizotinib on intracranial disease control remained unclear. Here, we...

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Main Authors: Michels, Sebastian (Author) , Massutí, B. (Author) , Vasyliv, I. (Author) , Stratmann, J. (Author) , Frank, J. (Author) , Adams, A. (Author) , Felip, E. (Author) , Grohé, C. (Author) , Rodriguez-Abreu, D. (Author) , Bischoff, Helge (Author) , Carcereny i Costa, E. (Author) , Corral, J. (Author) , Pereira, E. (Author) , Fassunke, J. (Author) , Fischer, R. N. (Author) , Insa, A. (Author) , Koleczko, S. (Author) , Nogova, L. (Author) , Reck, M. (Author) , Reutter, T. (Author) , Riedel, R. (Author) , Schaufler, D. (Author) , Scheffler, M. (Author) , Weisthoff, M. (Author) , Provencio, M. (Author) , Merkelbach-Bruse, S. (Author) , Hellmich, M. (Author) , Sebastian, M. (Author) , Büttner, R. (Author) , Persigehl, T. (Author) , Rosell, R. (Author) , Wolf, J. (Author)
Format: Article (Journal)
Language:English
Published: February 2024
In: ESMO open
Year: 2024, Volume: 9, Issue: 2, Pages: 1-10
ISSN:2059-7029
DOI:10.1016/j.esmoop.2024.102237
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.esmoop.2024.102237
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S205970292400005X
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Author Notes:S. Michels, B. Massutí, I. Vasyliv, J. Stratmann, J. Frank, A. Adams, E. Felip, C. Grohé, D. Rodriguez-Abreu, H. Bischoff, E. Carcereny i Costa, J. Corral, E. Pereira, J. Fassunke, R.N. Fischer, A. Insa, S. Koleczko, L. Nogova, M. Reck, T. Reutter, R. Riedel, D. Schaufler, M. Scheffler, M. Weisthoff, M. Provencio, S. Merkelbach-Bruse, M. Hellmich, M. Sebastian, R. Büttner, T. Persigehl, R. Rosell & J. Wolf
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Summary:Background - In 2019, we reported the first efficacy and safety analysis of EUCROSS, a phase II trial investigating crizotinib in ROS1 fusion-positive lung cancer. At that time, overall survival (OS) was immature and the effect of crizotinib on intracranial disease control remained unclear. Here, we present the final analysis of OS, systemic and intracranial activity, and the impact of co-occurring aberrations. - Materials and methods - EUCROSS was a prospective, single-arm, phase II trial. The primary endpoint was best overall response rate (ORR) using RECIST 1.1. Secondary and exploratory endpoints were progression-free survival (PFS), OS, and efficacy in pre-defined subgroups. - Results - Median OS of the intention-to-treat population (N = 34) was 54.8 months [95% confidence interval (CI) 20.3 months-not reached (NR); median follow-up 81.4 months] and median all-cause PFS of the response-evaluable population (N = 30) was 19.4 months (95% CI 10.1-32.2 months). Time on treatment was significantly correlated with OS (R = 0.82; P < 0.0001). Patients with co-occurring TP53 aberrations (28%) had a significantly shorter OS [hazard ratio (HR) 11; 95% CI 2.0-56.0; P = 0.006] and all-cause PFS (HR 4.2; 95% CI 1.2-15; P = 0.025). Patients with central nervous system (CNS) involvement at baseline (N = 6; 20%) had a numerically shorter median OS and all-cause PFS. Median intracranial PFS was 32.2 months (95% CI 23.7 months-NR) and the rate of isolated CNS progression was 24%. - Conclusions - Our final analysis proves the efficacy of crizotinib in ROS1-positive lung cancer, but also highlights the devastating impact of TP53 mutations on survival and treatment efficacy. Additionally, our data show that CNS disease control is durable and the risk of CNS progression while on crizotinib treatment is low.
Item Description:Gesehen am 05.07.2024
Online verfügbar 12 February 2024, Version des Artikels 12 February 2024
Physical Description:Online Resource
ISSN:2059-7029
DOI:10.1016/j.esmoop.2024.102237

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