Crizotinib versus Chemotherapy in Asian Patients with ALK-Positive Advanced Non-small Cell Lung Cancer
AuthorNishio, M; Kim, D-W; Wu, Y-L; Nakagawa, K; Solomon, BJ; Shaw, AT; Hashigaki, S; Ohki, E; Usari, T; Paolini, J; ...
Source TitleCancer research and treatment : official journal of Korean Cancer Association
PublisherKOREAN CANCER ASSOCIATION
University of Melbourne Author/sSolomon, Benjamin
AffiliationMedicine and Radiology
Document TypeJournal Article
CitationsNishio, M., Kim, D. -W., Wu, Y. -L., Nakagawa, K., Solomon, B. J., Shaw, A. T., Hashigaki, S., Ohki, E., Usari, T., Paolini, J., Polli, A., Wilner, K. D. & Mok, T. (2018). Crizotinib versus Chemotherapy in Asian Patients with ALK-Positive Advanced Non-small Cell Lung Cancer. CANCER RESEARCH AND TREATMENT, 50 (3), pp.691-700. https://doi.org/10.4143/crt.2017.280.
Access StatusOpen Access
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, openlabel 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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