Crizotinib versus chemotherapy in advanced ALK-positive lung cancer

Alice T. Shaw, Dong Wan Kim, Kazuhiko Nakagawa, Takashi Seto, Lucio Crinó, Myung Ju Ahn, Tommaso De Pas, Benjamin Besse, Benjamin J. Solomon, Fiona Blackhall, Yi Long Wu, Michael Thomas, Kenneth J. O'Byrne, Denis Moro-Sibilot, D. Ross Camidge, Tony Mok, Vera Hirsh, Gregory J. Riely, Shrividya Iyer, Vanessa TassellAnna Polli, Keith D. Wilner, Pasi A. Jänne

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: In single-group studies, chromosomal rearrangements of the anaplastic lymphoma kinase gene (ALK ) have been associated with marked clinical responses to crizotinib, an oral tyrosine kinase inhibitor targeting ALK. Whether crizotinib is superior to standard chemotherapy with respect to efficacy is unknown. METHODS: We conducted a phase 3, open-label trial comparing crizotinib with chemotherapy in 347 patients with locally advanced or metastatic ALK-positive lung cancer who had received one prior platinum-based regimen. Patients were randomly assigned to receive oral treatment with crizotinib (250 mg) twice daily or intravenous chemotherapy with either pemetrexed (500 mg per square meter of body-surface area) or docetaxel (75 mg per square meter) every 3 weeks. Patients in the chemotherapy group who had disease progression were permitted to cross over to crizotinib as part of a separate study. The primary end point was progression-free survival. RESULTS: The median progression-free survival was 7.7 months in the crizotinib group and 3.0 months in the chemotherapy group (hazard ratio for progression or death with crizotinib, 0.49; 95% confidence interval [CI], 0.37 to 0.64; P

Original languageEnglish
Pages (from-to)2385-2394
Number of pages10
JournalNew England Journal of Medicine
Volume368
Issue number25
DOIs
Publication statusPublished - 2013

ASJC Scopus subject areas

  • Medicine(all)

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