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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2018.1
- 수록면
- 691 - 700 (10page)
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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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참고문헌 (12)
참고문헌 신청
Grande E / 2011 / Targeting oncogenic ALK: a promising strategy for cancer treatment / Mol Cancer Ther 10:569~579
Gridelli C / 2014 / ALK inhibitors in the treatment of advanced NSCLC / Cancer Treat Rev 40:300~306
Shaw AT / 2009 / Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK / J Clin Oncol 27:4247~4253
Shaw AT / 2013 / ALK in lung cancer: past, present, and future / J Clin Oncol 31:1105~1111
Camidge DR / 2012 / Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study / Lancet Oncol 13:1011~1019
Gridelli C / 2014 / ALK inhibitors in the treatment of advanced NSCLC / Cancer Treat Rev 40:300~306
Shaw AT / 2009 / Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK / J Clin Oncol 27:4247~4253
Shaw AT / 2013 / ALK in lung cancer: past, present, and future / J Clin Oncol 31:1105~1111
Camidge DR / 2012 / Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study / Lancet Oncol 13:1011~1019
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