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1、早期乳腺癌辅助治疗进展,复旦大学肿瘤医院 乳腺外科/乳腺癌研究所 陆劲松,乳腺癌辅助化疗的进展,19701985 CMF 方案口服/静脉给药 6 月/1年 +/- 强的松,198697 CEF 蒽环类方案 阿霉素/表阿霉素 低剂量/高剂量 +/- 5FU,1998 FEC-P紫杉类方案,2008-8-28,2,复旦大学肿瘤医院乳腺癌研究所,EBCTCG荟萃分析 2005-06 乳腺癌死亡率,10,0,0,0,50,0,40,30,20,死亡率 (%/年: 无复发妇女的总死亡率)和logrank分析,蒽环类 31.0%,紫杉类 25.9%,% + SE,10年获益 5.1% (SE 1.6) L
2、orank 2p 0.00001,15.3,12.8,年,10年获益 4.3% (SE 1.0) Lorank 2p 0.00003,10年获益4.3% (SE 1.0) Lorank 2p 蒽环类 CMF 无化疗,Peto R代表早期乳腺癌试验协作组(EBCTCG)于2007年12月13日在SABCS上发言,2008-8-28,3,复旦大学肿瘤医院乳腺癌研究所,MA.5：CEF较CMF显著提高10年无复发生存率,Levine MN, et al. J Clin Oncol 2005; 23:5166-5170.,MA.5：CEF较CMF显著提高10年总生存率,Levine MN, et al
3、. J Clin Oncol 2005; 23:5166-5170.,Poole CJ, et al. N Engl J Med, 2006; 355:1851-1862.,主要终点：RFS，OS 次要终点：安全性，剂量强度，生活质量,NEAT研究与BR9601研究：CMF+E vs. CMF,CMF方案联合法玛新的RFS显著长于CMF方案,Poole CJ, et al. N Engl J Med, 2006; 355:1851-1862.,100,75,50,25,0,0,1,2,3,4,5,手术后时间 (年),HR=0.69 95% CI=0.58-0.82 P0.001,法玛新+CMF
4、 (n=1189),CMF (n=1202),85,91,76,69,RFS (%),CMF方案联合法玛新的OS显著长于CMF方案,Poole CJ, et al. N Engl J Med, 2006; 355:1851-1862.,2005 EBCTCG荟萃分析：CMF vs. 含蒽环类方案,含蒽环类方案较CMF显著降低复发风险12% 含蒽环类方案较CMF显著降低乳腺癌死亡风险16%,EBCTCG. Lancet 2005; 365:1687-1717.,EBCTCG荟萃分析 2005-06 乳腺癌死亡率,10,0,0,0,50,0,40,30,20,死亡率 (%/年: 无复发妇女的总死亡
5、率)和logrank分析,蒽环类 31.0%,紫杉类 25.9%,% + SE,10年获益 5.1% (SE 1.6) Lorank 2p 0.00001,15.3,12.8,年,10年获益 4.3% (SE 1.0) Lorank 2p 0.00003,10年获益4.3% (SE 1.0) Lorank 2p 蒽环类 CMF 无化疗,Peto R代表早期乳腺癌试验协作组(EBCTCG)于2007年12月13日在SABCS上发言,2008-8-28,10,复旦大学肿瘤医院乳腺癌研究所,DFS meta 分析,OS meta,ER 分组,DFS 淋巴结分组meta,BCIRG001试验,Mart
6、in M, et al. SABCS 2010. Abstract S4-3.,BCRIG001 随访10年结果， 对于可切除淋巴结阳性乳腺癌妇女， TAC(多西他赛、多柔比星、环磷酰胺)辅助化疗 FAC(氟尿嘧啶、多柔比星、环磷酰胺),BCIRG 001研究终点和随访,研究目的 -主要：无病生存(ITT人群分析) -次要：总生存(ITT人群分析)、安全性、生活质量、肿瘤标志物 随访时间-前2年每3个月1次 -2-5年每6个月1次 -5-10年每年1次 每年检测1次LVEF，以评估长期心脏毒性,TAC: 76%,FAC: 69%,DFS at a Median 10-year Follow-u
7、p (ITT),Number at Risk,TAC,745,737,710,678,659,639,617,596,583,562,551,541,530,519,508,491,478,463,444,418,387,Disease-free survival probability,0.00,0.20,0.40,0.60,0.80,1.00,Disease-free survival time (months),0,6,12,18,24,30,36,42,48,54,60,66,72,78,84,90,96,102,108,114,120,HR=0.72 95%CI: 0.590.88
8、Log-rank P=0.001,HR=0.80 95%CI: 0.680.93 Log-rank P=0.0043,BCIRG 001 结果,OS at a Median 10-year Follow-up (ITT),429 deaths: 188 TAC; 241 FAC,Number at Risk,TAC,745,742,732,718,704,693,677,661,650,645,635,622,612,603,594,584,571,563,547,524,495,FAC,746,740,731,724,704,684,657,642,625,608,591,581,573,5
9、57,546,532,517,501,482,460,443,Overall survival probability,0.00,0.20,0.40,0.60,0.80,1.00,0,6,12,18,24,30,36,42,48,54,60,66,72,78,84,90,96,102,108,114,120,TAC: 87%,FAC: 81%,HR=0.70 95%CI: 0.530.91 Log-rank P=0.008,Survival time (months),BCIRG 001 结果,作为不良事件报告的心脏毒性事件患者数(%) 3级(轻度、对治疗反应良好)4级(严重、难治)CHF,*
10、Comparison of CHF rates not statistically significant: TAC 3.5% (95%CI: 2.35.1) vs FAC 2.3% (95%CI: 1.43.7); Chisquare P=0.18,BCIRG 001 心脏毒性,CHF的累积发生率,Number at Risk,TAC,744,713,679,647,620,591,566,540,515,484,437,FAC,736,716,672,621,588,554,522,490,466,429,392,Probability of CHF,0.00,0.01,0.03,0.04
11、,0.06,0.08,Time from randomization to CHF event (months),0,12,24,36,48,60,72,84,96,108,120,0.02,0.05,0.07,TAC,FAC,BCIRG 001 心脏毒性,BCIRG 001 心脏毒性,LVEF变化情况*,TAC组和FAC组CHF的发生率分别为3.5%和2.3% (P=0.17) 多数CHF为3级 TAC组和FAC组分别有2例和4例致死性CHF 两组LVEF显著降低率(20%)相似，(TAC组17%，FAC组15%) TAC组和FAC组分别有6例(0.8%) 和3例(0.4%) 患者出现血液恶
12、性肿瘤,GEICAM 9805,Adjuvant docetaxel improves disease-free survival (DFS) and overall survival (OS) in node-positive breast cancer patients. However, many patients at diagnosis are node-negative, and the role of docetaxel in such patients is not fully established. The GEICAM study began in 1998 and it
13、 showed that TAC is associated with a significant improvement in DFS compared with FAC, with manageable toxicity.,GEICAM 9805 试验设计,GEICAM 9805 主要入组标准,Age 1875 years Curative surgery for unilateral T1-T3 breast carcinoma No axillary lymph node involvement - At least 10 lymph nodes examined At least o
14、ne St Gallen 1998 high-risk criterion- Tumor grade 2 to 3- Tumors 2 cm- Age 35 years- Hormone-receptor negative,GEICAM 9805 病人特征,GEICAM 9805 具体化疗实施,GEICAM 9805 毒副反应,GEICAM 9805 安全性,GEICAM 9805 结果,GEICAM 9805 DFS,OS,GEICAM 9805 DFS,GEICAM 9805,GEICAM 9805,GEICAM 9805 结论,其他紫杉-蒽环联合方案,ECOG 试验 (E2197),对于
15、淋巴结阳性以及淋巴结阴性（65%）的高危乳腺癌辅助治疗的III期研究 AT (多柔比星/泰索帝) vs. AC (多柔比星/环磷酰胺) 研究设计:,E2197：AT的DFS与AC相似,Goldstein LJ, et al. J Clin Oncol 2008; 26:4092-4099.,E2197：无论淋巴结状态如何，AT都无优势,Goldstein LJ, et al. J Clin Oncol 2008; 26:4092-4099.,ECOG 试验 (E2197): 结果,E2197：AT的3/4级血液系统毒性明显高于AC,Goldstein LJ, et al. J Clin Oncol 2008; 26:4092-4099.,PACS 04：6FEC vs. 6ED75,化疗剂量单位均为mg/m2,Roche H, et al. SABCS 2009.,PACS 04：6ED75的DFS与6FEC100相似,Roche H, et al. SABCS 2009.,
