详情页 - 四川省肿瘤医院知识库

当前位置：首页 > 详情页

Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK-positive non-small-cell lung cancer

文献详情

资源类型：

作者：

机构： [1]Univ Manchester, Inst Canc Sci, Manchester, Lancs, England [2]Christie Hosp NHS Fdn Trust, Manchester, Lancs, England [3]Univ Colorado, Ctr Comprehens Canc, Div Oncol, Aurora, CO 80309 USA [4]Massachusetts Gen Hosp, Dept Hematol, Dept Oncol, Boston, MA USA [5]Inst Gustave Roussy, Dept Med Oncol, Paris, France [6]Peter MacCallum Canc Ctr, Dept Med Oncol, Melbourne, Vic, Australia [7]Hong Kong Canc Inst, State Key Lab South China, Shatin, Hong Kong, Peoples R China [8]Chinese Univ Hong Kong, Shatin, Hong Kong, Peoples R China [9]McGill Univ, Ctr Hlth, Div Med Oncol, Montreal, PQ, Canada [10]Harvard Med Sch, Lowe Ctr Thorac Oncol, Belfer Inst Appl Canc Sci, Dana Farber Canc Inst, Boston, MA USA [11]Chinese Acad Med Sci, Natl Canc Hosp, Natl Canc Ctr, Beijing Key Lab Clin Study Anticancer Mol Targete, Beijing, Peoples R China [12]Peking Union Med Coll, Beijing, Peoples R China [13]Natl Taiwan Univ Hosp, Dept Internal Med, Taipei, Taiwan [14]European Inst Oncol, Dept Oncol, Milan, Italy [15]Aichi Canc Ctr Cent Hosp, Dept Thorac Oncol, Nagoya, Aichi, Japan [16]Hosp Univ La Paz, Med Oncol Serv, Madrid, Spain [17]Pfizer Oncol, Milan, Italy [18]Pfizer Oncol, New York, NY USA [19]Pfizer Global Innovat Pharma Business, New York, NY USA [20]Pfizer Oncol, La Jolla, CA USA [21]Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea

出处：

DOI：

ISSN：

摘要：

Purpose Crizotinib is a potent, orally administered tyrosine kinase inhibitor approved for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC). We report final results from PROFILE 1005, the largest clinical trial to date for an ALK inhibitor in ALK-positive NSCLC. Patients and methods PROFILE 1005 (NCT00932451) was a multicenter, single-arm phase 2 trial of the efficacy, safety and tolerability of crizotinib (250 mg twice daily; 3 week continuous treatment cycles) in patients with ALK-positive NSCLC after failure of >= 1 lines of systemic treatment for locally advanced/ metastatic disease. Patients' tumour ALK status was initially determined by a central laboratory until a protocol amendment permitted enrolment of patients based on locally determined ALK status. Co-primary endpoints were objective response rate (ORR), evaluated using Response Evaluation Criteria in Solid Tumours V. 1.1 and adverse events (AEs). Cancerspecific patient-reported outcomes (PROs) were also assessed using the European Organisation for the Research and Treatment of Cancer QLQ-C30 and its lung cancer module QLQ-LC13. Results 1069 patients were enrolled; 1066 received crizotinib. The as-treated population comprised 908 and 158 patients, in whom tumour positive ALK-status was determined centrally (+/- locally) or locally only, respectively. At baseline, a majority of patients were < 65 years (84%), 66% were never smokers and 46% were Asian. Derived investigator-assessed ORR was 54% (95% CI 51 to 57) and 41% (95% CI 33 to 49) in the central-testing and local-testing subgroups, respectively. The most common treatment-related AEs in the overall population (any grade) were vision disorder (58%), nausea (51%), diarrhoea (47%) and vomiting (47%). PRO scores demonstrated clinically meaningful improvement in lung cancer symptoms and global quality of life. Conclusion The efficacy, safety and PRO profiles of crizotinib in this cohort of 1066 patients with ALK-positive NSCLC are consistent with previous reports.

基金：

语种：

被引次数：

WOS：

中科院(CAS)分区：

出版当年[2017]版：

无

最新[2023]版：

大类 | 2 区

医学

小类 | 2 区肿瘤学

第一作者：

第一作者机构： [1]Univ Manchester, Inst Canc Sci, Manchester, Lancs, England [2]Christie Hosp NHS Fdn Trust, Manchester, Lancs, England

通讯作者：

通讯机构： [21]Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea

推荐引用方式(GB/T 7714)：

APA：

MLA：