Insight into early-phase trials for lung cancer in the United States  

作　　者：Jin-Ji Yang Yi-Long Wu 

机构地区：[1]Guangdong Lung Cancer Institute(GLCI),Guangdong General Hospital (GGH),Guangdong Academy of Medical Sciences(GAMS)

出　　处：《Chinese Journal of Cancer》2015年第7期288-294,共7页

基　　金：supported by the Hengrui-US Chinese Anti-Cancer Association (USCACA) Scholarship program

摘　　要：Introduction:Few data have been published comparing early-phase trials for lung cancer between China and the United States(US).This study was to investigate the differences of phase 1 trials for lung cancer between these two countries.Methods:In 2014,a cross-sectional survey was conducted to compare phase 1 trials for lung cancer between the Guangdong Lung Cancer Institute(GLCI),the University of Wisconsin Carbone Cancer Center(UWCCC),and the University of Texas MD Anderson Cancer Center(MDACC).Results:We found that the GLCI had a lower percentage of phase 1 lung cancer trials than the MDACC in December2014(23.8%[5/21]vs.59.8%[28/47],P = 0.006) and the UWCCC in September 2014(16.7%[3/18]vs.34.8%[8/23],P = 0.345).Descriptive analyses were performed for early-phase trials conducted by the CancerTherapy Evaluation Program at the National Cancer Institute(CTEP/NCI),the MDACC,and the Chinese Thoracic Oncology Group(CTONG).There were 149 ongoing early-phase trials in the Department of Investigational Cancer Therapeutics(Phase 1 program) at the MDACC in October 2014.In contrast,no phase 1 trials had been initiated by the CTONG since its establishment in 2007.Conclusions:These data suggest that a significantly higher percentage of phase 1 trials for lung cancer were conducted in the US than in China.Early-phase oncology trials with robust preclinical data had a higher chance of being approved by the Investigational Drug Branch at the CTEP/NCI.Given the importance of early-phase oncology trials in developing innovative cancer medicines,such studies should be highly encouraged and strategically funded in China.Introduction：Few data have been published comparing early-phase trials for lung cancer between China and the United States（US）.This study was to investigate the differences of phase 1 trials for lung cancer between these two countries.Methods：In 2014,a cross-sectional survey was conducted to compare phase 1 trials for lung cancer between the Guangdong Lung Cancer Institute（GLCI）,the University of Wisconsin Carbone Cancer Center（UWCCC）,and the University of Texas MD Anderson Cancer Center（MDACC）.Results：We found that the GLCI had a lower percentage of phase 1 lung cancer trials than the MDACC in December2014（23.8%[5/21]vs.59.8%[28/47],P = 0.006） and the UWCCC in September 2014（16.7%[3/18]vs.34.8%[8/23],P = 0.345）.Descriptive analyses were performed for early-phase trials conducted by the CancerTherapy Evaluation Program at the National Cancer Institute（CTEP/NCI）,the MDACC,and the Chinese Thoracic Oncology Group（CTONG）.There were 149 ongoing early-phase trials in the Department of Investigational Cancer Therapeutics（Phase 1 program） at the MDACC in October 2014.In contrast,no phase 1 trials had been initiated by the CTONG since its establishment in 2007.Conclusions：These data suggest that a significantly higher percentage of phase 1 trials for lung cancer were conducted in the US than in China.Early-phase oncology trials with robust preclinical data had a higher chance of being approved by the Investigational Drug Branch at the CTEP/NCI.Given the importance of early-phase oncology trials in developing innovative cancer medicines,such studies should be highly encouraged and strategically funded in China.

关 键 词：阶段试验 早期 肺癌 美国 phase PROGRAM 临床试验 was 

分 类 号：R734.2[医药卫生—肿瘤]