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Safety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trial.

Publication ,  Journal Article
Michels, S; Massutí, B; Schildhaus, H-U; Franklin, J; Sebastian, M; Felip, E; Grohé, C; Rodriguez-Abreu, D; Abdulla, DSY; Bischoff, H; Insa, A ...
Published in: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
July 2019

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).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.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%).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.

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Published In

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

DOI

EISSN

1556-1380

ISSN

1556-0864

Publication Date

July 2019

Volume

14

Issue

7

Start / End Page

1266 / 1276

Related Subject Headings

  • Survival Rate
  • Response Evaluation Criteria in Solid Tumors
  • Proto-Oncogene Proteins
  • Protein-Tyrosine Kinases
  • Protein Kinase Inhibitors
  • Prospective Studies
  • Prognosis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
 

Citation

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Michels, S., Massutí, B., Schildhaus, H.-U., Franklin, J., Sebastian, M., Felip, E., … Wolf, J. (2019). Safety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trial. Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer, 14(7), 1266–1276. https://doi.org/10.1016/j.jtho.2019.03.020
Michels, Sebastian, Bartomeu Massutí, Hans-Ulrich Schildhaus, Jeremy Franklin, Martin Sebastian, Enriqueta Felip, Christian Grohé, et al. “Safety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trial.Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer 14, no. 7 (July 2019): 1266–76. https://doi.org/10.1016/j.jtho.2019.03.020.
Michels S, Massutí B, Schildhaus H-U, Franklin J, Sebastian M, Felip E, et al. Safety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trial. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2019 Jul;14(7):1266–76.
Michels, Sebastian, et al. “Safety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trial.Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer, vol. 14, no. 7, July 2019, pp. 1266–76. Epmc, doi:10.1016/j.jtho.2019.03.020.
Michels S, Massutí B, Schildhaus H-U, Franklin J, Sebastian M, Felip E, Grohé C, Rodriguez-Abreu D, Abdulla DSY, Bischoff H, Brandts C, Carcereny E, Corral J, Dingemans A-MC, Pereira E, Fassunke J, Fischer RN, Gardizi M, Heukamp L, Insa A, Kron A, Menon R, Persigehl T, Reck M, Riedel R, Rothschild SI, Scheel AH, Scheffler M, Schmalz P, Smit EF, Limburg M, Provencio M, Karachaliou N, Merkelbach-Bruse S, Hellmich M, Nogova L, Büttner R, Rosell R, Wolf J. Safety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trial. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2019 Jul;14(7):1266–1276.
Journal cover image

Published In

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

DOI

EISSN

1556-1380

ISSN

1556-0864

Publication Date

July 2019

Volume

14

Issue

7

Start / End Page

1266 / 1276

Related Subject Headings

  • Survival Rate
  • Response Evaluation Criteria in Solid Tumors
  • Proto-Oncogene Proteins
  • Protein-Tyrosine Kinases
  • Protein Kinase Inhibitors
  • Prospective Studies
  • Prognosis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male