Michels, S. 
ORCID: 0000-0003-3164-870X, Massutí, B., Vasyliv, I., Stratmann, J., Frank, J., Adams, A. ORCID: 0000-0003-3286-1131, Felip, E., Grohé, C., Rodriguez-Abreu, D. ORCID: 0000-0003-0506-1366, Bischoff, H., Carcereny i Costa, E., Corral, J., Pereira, E., Fassunke, J. ORCID: 0000-0002-8391-5577, Fischer, R.N. ORCID: 0009-0001-5271-2160, Insa, A., Koleczko, S., Nogova, L. ORCID: 0000-0002-4502-1812, Reck, M. ORCID: 0000-0002-5348-4462, Reutter, T. ORCID: 0009-0001-5153-7049, Riedel, R. ORCID: 0000-0002-8883-1188, Schaufler, D., Scheffler, M. ORCID: 0000-0002-9031-1368, Weisthoff, M. ORCID: 0000-0001-6536-3898, Provencio, M., Merkelbach-Bruse, S. ORCID: 0000-0002-0312-5760, Hellmich, M. ORCID: 0000-0001-5174-928X, Sebastian, M. ORCID: 0000-0002-0404-7741, Büttner, R. ORCID: 0000-0001-8806-4786, Persigehl, T. ORCID: 0000-0001-5928-4405, Rosell, R. ORCID: 0000-0003-0817-3400 and Wolf, J. ORCID: 0000-0001-7577-464X
(2024).
Overall survival and central nervous system activity of crizotinib in ROS1-rearranged lung cancer—final results of the EUCROSS trial.
ESMO Open, 9 (2).
pp. 1-10.
Elsevier.
ISSN 2059-7029
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Abstract
[Artikel-Nr.: 102237] 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 ¼ 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 ¼ 30) was 19.4 months (95% CI 10.1-32.2 months). Time on treatment was significantly correlated with OS (R ¼ 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 ¼ 0.006] and all-cause PFS (HR 4.2; 95% CI 1.2-15; P ¼ 0.025). Patients with central nervous system (CNS) involvement at baseline (N ¼ 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. Key words: lung cancer, ROS1, crizotinib, overall survival, EUCROSS
| Item Type: | Article |
| Creators: | Creators Email ORCID ORCID Put Code Massutí, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vasyliv, I. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stratmann, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Frank, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Felip, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Grohé, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bischoff, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Carcereny i Costa, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Corral, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pereira, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Insa, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Koleczko, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schaufler, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Provencio, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED |
| URN: | urn:nbn:de:hbz:38-813988 |
| Identification Number: | 10.1016/j.esmoop.2024.102237 |
| Journal or Publication Title: | ESMO Open |
| Volume: | 9 |
| Number: | 2 |
| Page Range: | pp. 1-10 |
| Number of Pages: | 10 |
| Date: | February 2024 |
| Publisher: | Elsevier |
| ISSN: | 2059-7029 |
| Language: | English |
| Faculty: | Faculty of Medicine |
| Divisions: | Faculty of Medicine > Innere Medizin > Klinik I für Innere Medizin - Hämatologie und Onkologie Faculty of Medicine > Medizinische Statistik und Bioinformatik > Institut für Medizinische Statistik und Bioinformatik � IMSB Faculty of Medicine > Pathologie und Neuropathologie > Institut für Pathologie Faculty of Medicine > Radiologische Diagnostik > Institut und Poliklinik für Radiologische Diagnostik Faculty of Medicine > Weitere > Centrum für integrierte Onkologie (CIO) |
| Subjects: | General statistics Life sciences Medical sciences Medicine |
| Uncontrolled Keywords: | Keywords Language lung cancer ; ROS1 ; crizotinib ; overall survival ; EUCROSS English |
| ['eprint_fieldname_oa_funders' not defined]: | Publikationsfonds UzK |
| Refereed: | Yes |
| URI: | http://kups.ub.uni-koeln.de/id/eprint/81398 |
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