TY  - JOUR
AU  - Nishio, M
AU  - Kim, D-W
AU  - Wu, Y-L
AU  - Nakagawa, K
AU  - Solomon, BJ
AU  - Shaw, AT
AU  - Hashigaki, S
AU  - Ohki, E
AU  - Usari, T
AU  - Paolini, J
AU  - Polli, A
AU  - Wilner, KD
AU  - Mok, T
Y2  - 2020/12/21
Y1  - 2018/07/01
SN  - 1598-2998
UR  - http://hdl.handle.net/11343/256499
AB  - 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.
LA  - English
PB  - KOREAN CANCER ASSOCIATION
T1  - Crizotinib versus Chemotherapy in Asian Patients with ALK-Positive Advanced Non-small Cell Lung Cancer
DO  - 10.4143/crt.2017.280
IS  - Cancer research and treatment : official journal of Korean Cancer Association
VL  - 50
IS  - 3
SP  - 691-700
L1  - /bitstream/handle/11343/256499/PMC6056984.pdf?sequence=1&isAllowed=y
ER  -