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    Final overall survival analysis from a study comparing first-line crizotinib versus chemotherapy in alk-mutation-positive non-small-cell lung cancer.

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    Authors
    Solomon, B
    Kim, D
    Wu, Y
    Nakagawa, K
    Mekhail, T
    Felip, E
    Cappuzzo, F
    Paolini, J
    Usari, T
    Tang, Y
    Wilner, K
    Blackhall, Fiona H
    Mok, T
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    Affiliation
    Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;
    Issue Date
    2018-05-16
    
    Metadata
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    Abstract
    Purpose The phase III PROFILE 1014 trial compared crizotinib with chemotherapy as first-line treatment in patients with anaplastic lymphoma kinase (ALK) -positive advanced nonsquamous non-small-cell lung cancer. Here, we report the final overall survival (OS) results. Patients and Methods Patients were randomly assigned to receive oral crizotinib 250 mg twice daily (n = 172) or intravenous pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin (area under the concentration-time curve of 5 to 6 mg·mL/min) every 3 weeks for a maximum of six cycles (n = 171). Crossover to crizotinib was permitted after disease progression. OS was analyzed using a stratified log-rank test and a prespecified rank-preserving structural failure time model to account for crossover. Results Median follow-up duration for OS was approximately 46 months for both arms. In the chemotherapy arm, 144 patients (84.2%) received crizotinib in subsequent lines. Hazard ratio for OS was 0.760 (95% CI, 0.548 to 1.053; two-sided P = .0978). Median OS was not reached (NR) with crizotinib (95% CI, 45.8 months to NR) and 47.5 months with chemotherapy (95% CI, 32.2 months to NR). Survival probability at 4 years was 56.6% (95% CI, 48.3% to 64.1%) with crizotinib and 49.1% (95% CI, 40.5% to 57.1%) with chemotherapy. After crossover adjustment, there was an improvement in OS that favored crizotinib (hazard ratio, 0.346; 95% bootstrap CI, 0.081 to 0.718). The longest OS was observed in crizotinib-treated patients who received a subsequent ALK tyrosine kinase inhibitor. No new safety signals were identified. Conclusion The final analysis of the PROFILE 1014 study provides a new benchmark for OS in patients with ALK-rearranged non-small-cell lung cancer and highlights the benefit of crizotinib for prolonging survival in this patient population.
    Citation
    Final overall survival analysis from a study comparing first-line crizotinib versus chemotherapy in alk-mutation-positive non-small-cell lung cancer. 2018, J Clin Oncol
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/621098
    DOI
    10.1200/JCO.2017.77.4794
    PubMed ID
    29768118
    Type
    Article
    Language
    en
    ISSN
    1527-7755
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.2017.77.4794
    Scopus Count
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