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《淋巴瘤》课件

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Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. Highlights of Lymphoma ASCO 2012 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 惰性淋巴瘤和套细胞淋巴瘤 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 惰性B细胞和套细胞淋巴瘤的挑战  美国每年有大约25,000例新增病例 – 中位OS 5~10年 高患病率 – 明显的临床和生物学异质性  尚无可根治的标准治疗  大多数患者存在慢性复发病程  序贯治疗  累积毒性限制了下一步的治疗  需要更有效,耐受性更好的治疗方法 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. Bendamustine plus Rituximab versus CHOP plus Rituximab as First-Line Treatment in patients with Indolent and Mantle Cell Lymphomas: Update Results from the StiL NHL1 study on behalf the StiL (Study Group indolent Lymphomas, Germany) Mathias, et al. 2012 ASCO abstr No. 3 Oral Presentation Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 背景:苯达莫司汀 适应症  FDA:2008 – CLL – 利妥西单抗难治的 惰性B-NHL  E.U.:2010 – 惰性NHL – CLL – MM Mathias, et al. 2012 ASCO abstr No. 3 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. StiL NHL 1-2003试验设计 CD20阳性的 滤泡型淋巴瘤/ 华氏巨球蛋白血症/ 边缘区淋巴瘤/ 小细胞型淋巴瘤/ 套细胞型淋巴瘤(老年); III期/IV期; WHO 0-2; 未经化疗,干扰素或利妥 西单抗治疗; 符合治疗适应症 * (MCL除外) R B-R B: 苯达莫司汀 90mg/m2 d1+2, R: 利妥西单抗 375mg/m2 d1 CHOP-R CHOP: 环磷酰胺 750 mg/m2 d1, 多柔比星 50mg/m2 d1, 长春新碱 1.4mg/m2 d1, 泼尼松 100mg/m2 d1-5, R: 利妥西单抗 375mg/m2 d1 主要终点 证明B-R 非劣效CHOP 即B-R组3年后PFS的减少小于10% 次要终点 – 缓解率RR,至下次治疗 时间,无事件生存,OS – 急性和迟发毒性,感染 性并发症 – 年轻患者的干细胞动员 能力 *治疗适应症定义: B症状; 造血功能衰竭(Hb5cm或1个区域7.5cm); 进展迅速(6个月内肿瘤增大50%); 疾病相关并发症(疼痛,脾梗死,高粘滞血症等) Mathias, et al. 2012 ASCO abstr No. 3 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 入组情况 B-RCHOP-R 年龄 (中位) Totaln26125364 滤泡54%13914060 套细胞18%454870 边缘区13%373066 华氏8%221964 SLL4%101168 无法分类2%7569 •德国81个中心,2003.9-2008.8,共入组549例 •2009 ASH 报告了早期数据 •更新的数据截至2011.10.31 ; 中位随访45月 •随机入组549例,514例可评估疗效及毒性 Mathias, et al. 2012 ASCO abstr No. 3 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 血液学检测结果:最差的CTCAE级别 Mathias, et al. 2012 ASCO abstr No. 3 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 毒性(所有CTC级别) B-R(n=261) (n) CHOP-R(n=253 ) (n) P值 脱发 -+++2年 vs 4 年R维持 – MCL,WM,MZL: BR- R 维持 vs 观察 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. A subgroup analysis of small lymphocytic and marginal zone lymphomas in the Eastern Cooperative Oncology Group protocol E4402 (RESORT): A randomized phase III study comparing two different rituximab dosing strategies for low tumor burden indolent non-Hodgkin lymphoma Michael E. Williams,et al. 2012 ASCO abstr NO. 8007 Oral Presentation Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. E4402:研究设计 无痛非霍奇金淋巴瘤 III-IV期 未接受过化疗或放疗 PS 0-1 可测量病灶 按GELF标准定义低肿瘤 负荷: 肿块大小≤7cm;少于3 个结节肿块>3cm;无 各系统症状或B症状; CT检查无脾肿大> 16cm;无临近器官受压 ;无血细胞减少症 R 利妥昔 单抗诱 导治疗 ( 375mg /m2, q4wks )直至 PR或 CR Michael E. Williams,et al. 2012 ASCO abstr NO. 8007 利妥昔单 抗维持治 疗(MR) 375mg/m2 q3 mos 利妥昔单 抗进展时 再治疗 (RR) 375mg/m2 q4wks 首要终点 :TTTF 次要终点 :TTCT 毒性 QOL TTTF: time to treatment failure 指距离最后一次R给药6个月内出现进展,或对RR无反应 , 或更换治疗,或无法完成试验方案的治疗 TTCT: time to first cytotoxic therapy Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. E4402 :患者特征 Michael E. Williams,et al. 2012 ASCO abstr NO. 8007  入组患者:2003.11 ~ 2008.9  384例滤泡型淋巴瘤  129例非滤泡型淋巴瘤 -55例小淋巴细胞型(SLL) -71例边缘型(MZL) -3例其他  50例利妥昔单抗诱导后的非滤泡型淋巴瘤 -21例入组到RR -29例入组到MR Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. E4402 :TTTF Michael E. Williams,et al. 2012 ASCO abstr NO. 8007 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. E4402 :TTCT 为以后研究提供基准 ; 毒性; 免疫学相关(FcR 多 态性, NK / T细胞, 血浆细胞因子) R 治疗方案: §雷那度胺组(L) -d1-21, q28d ×12周期; -1st 周期 15mg, 之后如果耐受增至20mg和25mg (ANC=1000, Plts=50k, 其他毒性1级) -出现3/4级粒细胞减少或=1级血小板减少,下个周期降低剂量5mg §雷那度胺+利妥西单抗组(L+R) (L)+R 375mg/m2 d8,15,22,29 , 1st 周期 §主要支持治疗 -ASA或抗凝(DVT或动脉血栓的高危患者 (显著FH,PS=2,应用COP,应用ESA, DM H或CAD) John P. Leonard et al. 2012 ASCO abstr No. 8000 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 患者情况 L (N=45) L+R (N=44) 中位年龄63 (34-85 ) 62 (36-89 ) FLIPI 低 中 高 31.4% 42.9% 25.7% 48.5% 30.3% 21.2% TTP 自最近R给药 1.6年1.3年 分期 I/II III/IV 20.0% 80.0% 30.2% 69.8% LDHNL16.3%2.4% %L (N=45) L+R (N=44) 完成治疗35.661.4 试验终止 进展/NR 24.44.6 试验终止 不良反应 22.218.2 退出/其他17.711.5 剂量调整64.467.4 剂量密度80.985.5 患者特征 治疗情况(%) John P. Leonard et al. 2012 ASCO abstr No. 8000 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 不良事件 血栓  共9例患者发生血栓 – 7例(L)-16% • 1例未预防,5例接受ASA, 1例丢失 – 2例(L+R)-4% • 1例未预防,1例接受ASA+ 其他抗血小板药物 – 两组无显著差异(p=0.158)  无患者接受ESAs L (N=45) L+R (N=44) 血液 Hgb ANC Plt 0/0 16/0 0/0 0/0% 14/5% 5/5% 疲乏9/012/2% 皮疹2/2 5/3% 感染4/00/0% 血栓9/72/2% 3/4级不良事件(%) John P. Leonard et al. 2012 ASCO abstr No. 8000 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 结果:缓解率和无事件生存 中位F/U 1.7年(0.1-4.1) 未调整的EFS HR (L vs L+R) =2.1 (P=0.010) 调整(for FLIPI) EFS HR (L vs L+R) =1.9 (P=0.061) %L (N=45) L+R (N=44) ORR51.1% 95%CI(35.8-66.3) 72.7% (52.2-85.0)% CR13.3%36.4% PR37.8%36.4% 中位EFS1.2年2.0年 2年EFS27%44% John P. Leonard et al. 2012 ASCO abstr No. 8000 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 结果:EFS John P. Leonard et al. 2012 ASCO abstr No. 8000 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 结果:OS John P. Leonard et al. 2012 ASCO abstr No. 8000 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 结论:  雷那度胺治疗复发FL有显著活性 – 单药 (ORR 51.1% ;EFS 1.2年) – 联合利妥西单抗 (ORR 72.7% ;EFS 2年)  雷那度胺联合组疗效更好,毒性相似  免疫学和其他相关研究在进行 John P. Leonard et al. 2012 ASCO abstr No. 8000 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 结论:  剂量调整较为普遍,两组剂量密度约为计划的80%  3/4度毒性主要为血液学,疲乏和血栓  雷那度胺单药组的血栓发生率更高,但无显著差异 – 并不受危险因素或抗血小板、抗凝治疗的影响 – 考虑可能与联合组更强的抗肿瘤效应相关 雷那度胺联合利妥西单抗(L+R)方案需要在复发和一线 FL中作进一步研究,且应作为以后非细胞毒性药物联合方 案的基石! John P. Leonard et al. 2012 ASCO abstr No. 8000 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 讨论:  雷那度胺(L)单药或联合利妥西单抗(R)在经R治疗后 复发的FL患者中表现出活性 – 在不同风险亚组(FLIPI,FLIPI2, β2M+LDH)结果是否一致? – 联合治疗的预测性生物学标记物?  雷那度胺的最佳应用模式,是复发还是一线?单药还是联 合?或是作为维持治疗的一部分? Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. 正在进行和计划中的研究  CALGB 50803(已经完成入组) – II期研究 L+R在II-IV期FL的一线治疗  Alliance A0501202 (进行中) – I 期研究 PI3K抑制剂CAL-101(GS-1101)联合L+R治疗复发FL  Alliance A0501103(进行中) – I/II期研究 Btk抑制剂PCI-32765(Ibrutinib)联合L+R一线治疗FL Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. R-CVP versus R-CHOP versus R-FM as first-line therapy for advanced-stage follicular lymphoma: Final results of FOLL05 trial from the Fondazione Italiana Linfomi (FIL) M. Federico, et al. 2012 ASCO abstr NO. 8006 Oral Presentation Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. FOLL05:研究设计 晚期活跃性滤泡型淋巴 瘤 I-IIIa级 II-IV期 未接受过化疗或放疗 18-75岁 N=534 * R 利妥昔单抗( 375mg/m2) CVP 8周期 (n=178) 利妥昔单抗 (375mg/m2) CHOP 6周期 (n=178) 利妥昔单抗 (375mg/m2) FM 6周期(n=178) (氟达拉滨: 25 mg/m2, d1,3 米拖蒽醌:10mg/m2 d1) 首要研究 终点: 至治 疗失 败时 间 (TTF) M. Federico, et al. 2012 ASCO abstr NO. 8006 *入组患者:2006.3~2010.9,30例患者因 不符合入组标准而排除 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. FOLL05 :患者基线特征 R-CVP, n=168 R-CHOP, n=165 R-FM, n=171 总计 N=504 中位年龄,(范 围) 56 (31-75)56 (33-75)54(30-75)56(30-75) 性别 (男 )52505552 分期(III-IV期)92909392 LDH(>UNL)18212120 BM(+)50545954 B2M(>UNL)42444744 LoDLIN (> 6cm) 26242927 组织学(3级)12161214 FLIPI 0-1/2/3-5 26/36/3821/43/3618/44/3821/24/37 FLIPI 2 0/1-2/3-5 18/60/2219/53/2714/55/3117/56/27 M. Federico, et al. 2012 ASCO abstr NO. 8006 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. FOLL05 :3/4度毒性反应 M. Federico, et al. 2012 ASCO abstr NO. 8006 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. FOLL05 :3/4度中性粒细胞减少 M. Federico, et al. 2012 ASCO abstr NO. 8006 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. FOLL05 : R-CVP, n=168 ITT,N(%) R-CHOP, n=165 ITT,N(% ) R-FM, n=171 ITT,N(% ) 总计 N=504 N(%) CR*113 (67)119(72)123(72)355(70) PR35(21)35(21)33(19)103(20) ORR*148(88)154(93)156(91)458(91) SD/PD/EW19(11)10(6)14(8)43(8) 治疗前缺失1(1)1(1)1(1)3(1) M. Federico, et al. 2012 ASCO abstr NO. 8006 *卡方检验CR:P=0.543; ORR:P=0.247 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. FOLL05 :OS 28:4184)  减低强度预处理和异基因移植 – 难治性患者的PFS: 12% (Thomson et al. JCO 2009;22:426) 复发/难治侵袭性B细胞淋巴瘤无满意的疗效! 研究目的 1. 本研究应用异基因干细胞移植前淋巴瘤导向的(lymphoma-directed )清髓性预处理 2. 允许GvHD 以诱导移植物抗淋巴瘤效应 Bertram Glass, et al. 2012 ASCO abstr No. 8004 Through this publicity campaign, further improve the sense of business integrity of tourism enterprises to help tourism consumers and operators to safeguard the legitimate rights and interests, to ensure that our City's tourism sustainable, healthy and coordinated Development. Allo SCT在侵袭性淋巴瘤:试验设计 假设及主要终点: –1y OS40% –应用利妥西单抗后,1度急性GVHD至
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