https://scholars.lib.ntu.edu.tw/handle/123456789/580094
標題: | mRECIST to predict survival in advanced hepatocellular carcinoma: Analysis of two randomised phase II trials comparing nintedanib vs sorafenib | 作者: | Meyer T. Palmer D.H. ANN-LII CHENG Hocke J. Loemb? A.-B. Yen C.-J. |
關鍵字: | angiogenesis; hepatocellular carcinoma; overall survival | 公開日期: | 2017 | 出版社: | Blackwell Publishing Ltd | 卷: | 37 | 期: | 7 | 起(迄)頁: | 1047-1055 | 來源出版物: | Liver International | 摘要: | Background & Aims: Response Evaluation Criteria in Solid Tumors (RECIST) has been shown to be a poor surrogate for survival benefit with targeted therapy in advanced hepatocellular carcinoma (HCC). Methods: We investigated whether response evaluated using modified RECIST (mRECIST) predicted overall survival (OS) using data from two Phase II clinical trials. Analyses were conducted on pooled data from 188 patients with advanced HCC treated with nintedanib or sorafenib, of whom 180 were evaluable for response. Cox regression and Kaplan-Meier survival analyses were used to explore differences in OS between the responders and non-responders according to RECIST 1.0 and mRECIST criteria. Multivariate Cox proportional hazards models, including factors known to influence survival, were used to compare survival according to RECIST and mRECIST response. Results: Discordance between RECIST and mRECIST evaluation was most common for assessment of partial response (12.2%) and stable disease (13.3%). OS was significantly longer in patients with response compared to patients without response—RECIST: hazard ratio (HR) 0.325 (95% confidence interval [CI] 0.130-0.815), P=.0122; mRECIST: HR 0.544 (95% CI 0.335-0.881), P=.0122. HRs from the multivariate models used to evaluate response by RECIST or by mRECIST as predictors of OS approached significance for RECIST (0.40 [95% CI 0.16–1.01]; P=.053) and for mRECIST (0.62 [95% CI 0.38–1.01]; P=.053). Conclusions: Response according to RECIST or mRECIST is associated with improved survival and should be considered as a valid endpoint for use in HCC clinical trials. ? 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85011708036&doi=10.1111%2fliv.13359&partnerID=40&md5=1a66d8f46d1e24dbce9f521a14e3a377 https://scholars.lib.ntu.edu.tw/handle/123456789/580094 |
ISSN: | 1478-3223 | DOI: | 10.1111/liv.13359 | SDG/關鍵字: | alpha fetoprotein; nintedanib; sorafenib; antineoplastic agent; carbanilamide derivative; indole derivative; nicotinamide; nintedanib; protein kinase inhibitor; sorafenib; adult; advanced cancer; Article; cancer chemotherapy; cancer radiotherapy; cancer staging; cancer survival; chemoembolization; Child Pugh score; controlled study; drug efficacy; drug safety; female; human; liver cell carcinoma; major clinical study; male; maximum tolerated dose; middle aged; multicenter study; overall survival; phase 1 clinical trial; phase 2 clinical trial; prediction; prospective study; radiofrequency ablation; randomized controlled trial; response evaluation criteria in solid tumors; systemic therapy; aged; analogs and derivatives; chi square distribution; clinical trial; comparative study; diagnostic imaging; Kaplan Meier method; liver cell carcinoma; liver tumor; mortality; multivariate analysis; nuclear magnetic resonance imaging; pathology; predictive value; proportional hazards model; risk factor; time factor; very elderly; x-ray computed tomography; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Hepatocellular; Chi-Square Distribution; Female; Humans; Indoles; Kaplan-Meier Estimate; Liver Neoplasms; Magnetic Resonance Imaging; Male; Middle Aged; Multivariate Analysis; Niacinamide; Phenylurea Compounds; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Protein Kinase Inhibitors; Response Evaluation Criteria in Solid Tumors; Risk Factors; Time Factors; Tomography, X-Ray Computed |
顯示於: | 醫學系 |
在 IR 系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。