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Crizotinib versus Chemotherapy in Asian Patients with ALK-Positive Advanced Non-small Cell Lung Cancer

Cancer Research and Treatment
2018년 50권 3호 p.691 ~ p.700
 ( Nishio Makoto ) - Cancer Institute Hospital of JFCR Thoracic Oncology Center

김동완 ( Kim Dong-Wan ) - Seoul National University Hospital Department of Internal Medicine
 ( Wu Yi-Long ) - Guangdong Lung Cancer Institute
 ( Nakagawa Kazuhiko ) - Kindai University
 ( Solomon Benjamin J. ) - Peter MacCallum Cancer Centre
 ( Shaw Alice T. ) - Massachusetts General Hospital
 ( Hashigaki Satoshi ) - Pfizer Oncology
 ( Ohki Emiko ) - Pfizer Oncology
 ( Usari Tiziana ) - Pfizer Oncology
 ( Paolini Jolanda ) - Pfizer Oncology
 ( Polli Anna ) - Pfizer Oncology
 ( Wilner Keith D. ) - Pfizer Oncology
 ( Mok Tony ) - University of Hong Kong Hong Kong Cancer Institute State Key Laboratory of South China

Abstract

Purpose: Crizotinib has demonstrated superior progression-free survival (PFS) and objective response rates (ORRs) versus chemotherapy in previously treated and untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). We report the safety and efficacy of crizotinib in Asian subpopulations of two global phase III trials.

Materials and Methods: This analysis evaluated previously treated and untreated patients in two randomized, open-label phase III trials of crizotinib versus chemotherapy in ALK-positive advanced NSCLC in second-line (PROFILE 1007) and first-line settings (PROFILE 1014). Efficacy and safety were analyzed by race in the intention-to-treat and “as-treated” populations for efficacy and safety endpoints, respectively.

Results: In previously treated (n=157) and untreated (n=157) Asian patients, PFS was statistically significantly longer with crizotinib versus chemotherapy (hazard ratio for PFS, 0.526; 95% confidence interval, 0.363 to 0.762; p < 0.001 and hazard ratio, 0.442; 95% confidence interval, 0.302 to 0.648; p < 0.001, respectively). Similar antitumor activity was seen in the non-Asian and overall populations. ORRs were statistically significantly higher with crizotinib versus chemotherapy in both Asian and non-Asian previously treated and untreated patients (p < 0.05). The most common treatment-emergent adverse events (any grade)with crizotinib were vision disorder, diarrhea, and nausea, which were observed at a comparable incidence across Asian and non-Asian populations, irrespective of previous treatment status. Most adverse events were mild to moderate in severity.

Conclusion: These data, currently the only analysis showing Asian and non-Asian populations in the same study, support the efficacy and safety of crizotinib in Asian patients with previously treated or untreated ALK-positive advanced NSCLC.

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SCI(E) MEDLINE 학술진흥재단(KCI) KoreaMed 대한의학회 회원 
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