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Crizotinib versus Chemotherapy in Advanced ALK-Positive Lung Cancer

Cited 2,193 time in Web of Science Cited 2,367 time in Scopus
Authors
Shaw, Alice T.; Kim, Dong-Wan; Nakagawa, Kazuhiko; Seto, Takashi; Crino, Lucio; Ahn, Myung-Ju; De Pas, Tommaso; Besse, Benjamin; Solomon, Benjamin J.; Blackhall, Fiona; Wu, Yi-Long; Thomas, Michael; O'Byrne, Kenneth J.; Moro-Sibilot, Denis; Camidge, D. Ross; Mok, Tony; Hirsh, Vera; Riely, Gregory J.; Iyer, Shrividya; Tassell, Vanessa; Polli, Anna; Wilner, Keith D.; Jaenne, Pasi A.
Issue Date
2013-06
Citation
New England Journal of Medicine, Vol.368 No.25, pp.2385-2394
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<0.001). The response rates were 65% (95% CI, 58 to 72) with crizotinib, as compared with 20% (95% CI, 14 to 26) with chemotherapy (P<0.001). An interim analysis of overall survival showed no significant improvement with crizotinib as compared with chemotherapy (hazard ratio for death in the crizotinib group, 1.02; 95% CI, 0.68 to 1.54; P = 0.54). Common adverse events associated with crizotinib were visual disorder, gastrointestinal side effects, and elevated liver aminotransferase levels, whereas common adverse events with chemotherapy were fatigue, alopecia, and dyspnea. Patients reported greater reductions in symptoms of lung cancer and greater improvement in global quality of life with crizotinib than with chemotherapy. Conclusions Crizotinib is superior to standard chemotherapy in patients with previously treated, advanced non-small-cell lung cancer with ALK rearrangement.
ISSN
0028-4793
URI
http://hdl.handle.net/10371/165470
DOI
https://doi.org/10.1056/NEJMoa1214886
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College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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