Please use this identifier to cite or link to this item: http://hdl.handle.net/10553/69918
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dc.contributor.authorMichels, Sebastianen_US
dc.contributor.authorMassutí, Bartomeuen_US
dc.contributor.authorSchildhaus, Hans Ulrichen_US
dc.contributor.authorFranklin, Jeremyen_US
dc.contributor.authorSebastian, Martinen_US
dc.contributor.authorFelip, Enriquetaen_US
dc.contributor.authorGrohé, Christianen_US
dc.contributor.authorRodriguez-Abreu, Delvysen_US
dc.contributor.authorAbdulla, Diana S.Y.en_US
dc.contributor.authorBischoff, Helgeen_US
dc.contributor.authorBrandts, Christianen_US
dc.contributor.authorCarcereny, Enricen_US
dc.contributor.authorCorral, Jesúsen_US
dc.contributor.authorDingemans, Anne Marie C.en_US
dc.contributor.authorPereira, Evaen_US
dc.contributor.authorFassunke, Janaen_US
dc.contributor.authorFischer, Rieke N.en_US
dc.contributor.authorGardizi, Masyaren_US
dc.contributor.authorHeukamp, Lukasen_US
dc.contributor.authorInsa, Ameliaen_US
dc.contributor.authorKron, Annaen_US
dc.contributor.authorMenon, Roopikaen_US
dc.contributor.authorPersigehl, Thorstenen_US
dc.contributor.authorReck, Martinen_US
dc.contributor.authorRiedel, Richarden_US
dc.contributor.authorRothschild, Sacha I.en_US
dc.contributor.authorScheel, Andreas H.en_US
dc.contributor.authorScheffler, Matthiasen_US
dc.contributor.authorSchmalz, Petraen_US
dc.contributor.authorSmit, Egbert F.en_US
dc.contributor.authorLimburg, Meikeen_US
dc.contributor.authorProvencio, Marianoen_US
dc.contributor.authorKarachaliou, Nikien_US
dc.contributor.authorMerkelbach-Bruse, Sabineen_US
dc.contributor.authorHellmich, Martinen_US
dc.contributor.authorNogova, Luciaen_US
dc.contributor.authorBüttner, Reinharden_US
dc.contributor.authorRosell, Rafaelen_US
dc.contributor.authorWolf, Jürgenen_US
dc.date.accessioned2020-02-05T12:51:17Z-
dc.date.accessioned2020-06-08T13:55:07Z-
dc.date.available2020-02-05T12:51:17Z-
dc.date.available2020-06-08T13:55:07Z-
dc.date.issued2019en_US
dc.identifier.issn1556-0864en_US
dc.identifier.otherScopus-
dc.identifier.urihttp://hdl.handle.net/10553/69918-
dc.description.abstractIntroduction: ROS1 rearrangements are found in 1% of lung cancer patients. Therapeutic efficacy of crizotinib in this subset has been shown in early phase trials in the United States and East Asia. Here we present data on efficacy and safety of a prospective phase II trial evaluating crizotinib in European ROS1-positive patients (EUCROSS). Patients and Methods: The trial was a multicenter, single-arm phase II trial (Clinicaltrial.gov identifier: NCT02183870). Key eligibility criteria included patients who were 18 years of age or older with advanced/metastatic lung cancer and centrally confirmed ROS1-rearranged lung cancer (fluorescence-in situ hybridization). Treatment included 250 mg crizotinib twice daily. The primary endpoint was investigator-assessed objective response rate (ORR) (Response Evaluation Criteria in Solid Tumors, version 1.1). Key secondary endpoints were progression-free survival (PFS), overall survival, efficacy by independent radiologic review, safety, health-related quality of life, and molecular characterization of tumor tissue. Results: Thirty-four patients received treatment. Four patients were excluded from efficacy analysis. Investigator ORR was 70% (95% confidence interval [CI]: 51–85; 21 of 30 patients) and median PFS was 20.0 months (95% CI: 10.1–not reached). Two patients with ROS1 wild-type sequences assessed by DNA sequencing had progression as best response. CD74-ROS1-positive patients had a trend towards a higher ORR and longer median PFS. TP53-co-mutant patients had a significantly shorter median PFS than wild-type patients (7.0 months, 95% CI: 1.7–20.0 versus 24.1 months, 95% CI: 10.1–not reached; p = 0.022). Treatment-related adverse events were documented in 33 of 34 patients (97%). Conclusions: Crizotinib is highly effective and safe in patients with ROS1-rearranged lung cancer. ROS1-/TP53-co-aberrant patients had a significantly worse outcome compared to TP53 wild-type patients.en_US
dc.languageengen_US
dc.relation.ispartofJournal of Thoracic Oncologyen_US
dc.sourceJournal of Thoracic Oncology [ISSN 1556-0864],v. 14 (7), p. 1266-1276en_US
dc.subject320101 Oncologíaen_US
dc.subject.otherCrizotiniben_US
dc.subject.otherLung Canceren_US
dc.subject.otherRos1en_US
dc.subject.otherTargeted Treatmenten_US
dc.subject.otherTp53en_US
dc.titleSafety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trialen_US
dc.typeinfo:eu-repo/semantics/Articleen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.jtho.2019.03.020en_US
dc.identifier.scopus85066096118-
dc.identifier.isi000472506000025-
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dc.description.lastpage1276en_US
dc.identifier.issue7-
dc.description.firstpage1266en_US
dc.relation.volume14en_US
dc.investigacionCiencias de la Saluden_US
dc.type2Artículoen_US
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dc.utils.revisionen_US
dc.contributor.wosstandardWOS:Michels, S-
dc.contributor.wosstandardWOS:Massuti, B-
dc.contributor.wosstandardWOS:Schildhaus, HU-
dc.contributor.wosstandardWOS:Franklin, J-
dc.contributor.wosstandardWOS:Sebastian, M-
dc.contributor.wosstandardWOS:Felip, E-
dc.contributor.wosstandardWOS:Grohe, C-
dc.contributor.wosstandardWOS:Rodriguez-Abreu, D-
dc.contributor.wosstandardWOS:Abdulla, DSY-
dc.contributor.wosstandardWOS:Bischoff, H-
dc.contributor.wosstandardWOS:Brandts, C-
dc.contributor.wosstandardWOS:Carcereny, E-
dc.contributor.wosstandardWOS:Corral, J-
dc.contributor.wosstandardWOS:Dingemans, AMC-
dc.contributor.wosstandardWOS:Pereira, E-
dc.contributor.wosstandardWOS:Fassunke, J-
dc.contributor.wosstandardWOS:Fischer, RN-
dc.contributor.wosstandardWOS:Gardizi, M-
dc.contributor.wosstandardWOS:Heukamp, L-
dc.contributor.wosstandardWOS:Insa, A-
dc.contributor.wosstandardWOS:Kron, A-
dc.contributor.wosstandardWOS:Menon, R-
dc.contributor.wosstandardWOS:Persigehl, T-
dc.contributor.wosstandardWOS:Reck, M-
dc.contributor.wosstandardWOS:Riedel, R-
dc.contributor.wosstandardWOS:Rothschild, SI-
dc.contributor.wosstandardWOS:Scheel, AH-
dc.contributor.wosstandardWOS:Scheffler, M-
dc.contributor.wosstandardWOS:Schmalz, P-
dc.contributor.wosstandardWOS:Smit, EF-
dc.contributor.wosstandardWOS:Limburg, M-
dc.contributor.wosstandardWOS:Provencio, M-
dc.contributor.wosstandardWOS:Karachaliou, N-
dc.contributor.wosstandardWOS:Merkelbach-Bruse, S-
dc.contributor.wosstandardWOS:Hellmich, M-
dc.contributor.wosstandardWOS:Nogova, L-
dc.contributor.wosstandardWOS:Buttner, R-
dc.contributor.wosstandardWOS:Rosell, R-
dc.contributor.wosstandardWOS:Wolf, J-
dc.date.coverdateJulio 2019en_US
dc.identifier.ulpgces
dc.description.sjr3,218
dc.description.jcr13,357
dc.description.sjrqQ1
dc.description.jcrqQ1
dc.description.scieSCIE
item.fulltextCon texto completo-
item.grantfulltextopen-
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