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1、1中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTERAb 7003, 7004, 7005 点评点评1Ab 7003MIC x 2 / 3 wkMIC x 2 / 3 wkMitomycin: 6 mg/m/d1Ifosfamide: 1.5 g/m/d1-3Cisplatin: 30 mg/m/d1-3 Surgery Surgery If OR: +2 MIC pT3, pN2: RT 60 Gy RandomizationDepierre et al, J Clin Oncol 2001; 20:247-532 23中山大学
2、肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER34中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER“将一大组异质性病人的平均规律用于指导将一大组异质性病人的平均规律用于指导具体个例的治疗,可能造成危险的误导具体个例的治疗,可能造成危险的误导” Indeed, concentration exclusively on overall average effects produced by pooling biologically different disease ent
3、ities can result in dangerously misleading advice for individual patients.2003 ST Gallen Breast Cancer Guide Lines45中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER56中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER寻找耐药基因寻找耐药基因67中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CEN
4、TER 含顺铂类术后化疗含顺铂类术后化疗Meta-分析分析(LACE)JCO 2008; Vol 26:3552-3559HR = 0.89 (95% CI, 0.82-0.96; P=0 .005)78中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTERIALT 研究研究 2006 UpdateNEJM 2006 ERCC1 ERCC1 +89中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTERERCC1和和RRM1与早期肺癌预后与早期肺癌预后NEJM 2007;356
5、:800-8Stage I (187例例)9NSCLCNSCLCpT1(xpT1(x 2cm)2cm)pT2N0M0pT2N0M0R0 R0 resectionresectionPS 0-1PS 0-1N98N98AssignmentAssignmentCisplatin-Cisplatin-Gemcitabine Gemcitabine x 4x 4vsvsObservationObservationSurgerySpecimen CollectionERCC1 & RRM1ERCC1 & RRM1Testing (AQUA)Testing (AQUA)EnrollmentS0720: Pr
6、oof of Concept Study:S0720: Proof of Concept Study:Biomarker-directed Adjuvant Therapy Biomarker-directed Adjuvant Therapy of Stage I NSCLCof Stage I NSCLCPI: BeplerRRMI RRMI 40.5 40.5ANDANDERCC1 66.0ERCC1 66.0Active MonitoringActive Monitoring All Others All Others (RRM1 40.5 (RRM1 40.5 OROR ERCC1
7、66.0 )ERCC1 75% of patients assigned)12中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER寻找更准确的分期寻找更准确的分期1213中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTERJCO 2007; Vol 25:5506-5518 辅助化疗的获益辅助化疗的获益 1314中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER肺癌的分子分期肺癌的分子分期 -3基因组基因组
8、J Clin Oncol 2007;Vol 25:5562-5569I 期期II 期期III 期期1415中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER肺癌的分子分期肺癌的分子分期 -蛋白表达蛋白表达 J Clin Oncol 2009中山大学附属肿瘤医院研究结果中山大学附属肿瘤医院研究结果1516中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER 肺癌新辅助肺癌新辅助/ /辅助化疗的未来辅助化疗的未来 所有病人均所有病人均接受经过大接受经过大型随机临床型随机临床
9、研究的结果研究的结果证实的最好证实的最好治疗治疗(EBM)每个病人根每个病人根据个体的分据个体的分子生物学差子生物学差异决定接受异决定接受某一种治疗某一种治疗: 对个体的生物学差对个体的生物学差异理解不够异理解不够Genetic的个体化分析的个体化分析16Daniel Karp, MDUT M. D. Anderson Cancer CenterE5597: Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer
10、Daniel D. Karp, Sandra Lee, Gail Shaw Wright, David Johnson, Michael Johnston, Gary Goodman, Gerald Clayman, Gordon Okawara, Randolph Marks, Jack RuckdeschelEastern Cooperative Oncology GroupTogether withCancer and Acute Leukemia Group BNCI Canada Treatment Group North Central Cancer Treatment Group
11、Radiation Therapy Oncology GroupSouthwest Oncology GroupEnrollment from Oct. 2000 Nov. 2009Ab 7004Daniel Karp, MDUT M. D. Anderson Cancer CenterResults 4. E5597 Selenium Prevention Study: SPTs and Recurrence Worst for Active Smokers* stratified log rank (p=0.016) corrects for treatmentOverall Lung C
12、ancer Risk at 5 yearsActive smokers30%Former smokers24%Never smokers20%50%50%19中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER19Ab 7005Pts with completely Pts with completely resected stage resected stage IB,II, and IIIA IB,II, and IIIA NSCLCNSCLCStratified byStratified by - - stage stage
13、- histology - histology - post-op RT - - post-op RT - sex - sex - adjuvant adjuvant chemotherapy*chemotherapy*GefitinibGefitinib250 mg po250 mg podaily x 2 yrsdaily x 2 yrsPlaceboPlacebo0 mg po 0 mg po daily x 2 yrsdaily x 2 yrs Randomized 1:1*Protocol amended January 2003 to allow adjuvant chemotherapy which became a stratification factor21中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER靶向治疗在早期靶向治疗在早期NSCLC治疗的作用治疗的作用2122中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER2223中山大学肿瘤防治中心中山大学肿瘤防治中心 SUN YAT-SEN UNIVERSITY CANCER CENTER 谢 谢!23