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结直肠癌内科治疗课件

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直肠癌 内科 治疗 课件
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Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 结直肠癌内科治疗 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial n结直肠癌的辅助化疗 n转移性结直肠癌的联合化疗 n转移性结直肠癌的靶向治疗 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 结直肠癌是全球最常见的恶性肿瘤之一 在男性肿瘤发病率中居第3 3位 女性中居第2 2位 每年新发病例超过120120万万 死亡病例60 8760 87万万 发病率最高 澳大利亚 新西兰 欧洲和北美 最低 非洲和中南亚 男性发病比例远高于女性 Global Cancer Statistics CA CANCER J CLIN 2011 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 术后辅助治疗减低最初 年复发风险 HR of DFS by Arm HR of RFS by Arm Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 辅助化疗减低复发风险可转化为生存获益 ACCENT 8年的随访2009 最新结果 Sargent et al J Clin Oncol 2009 27 6 872 7 18个研究20898例结肠癌患者 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 辅助治疗可以使结肠癌患者获益 降低降低 复复发风险发风险发风险发风险 延延长长长长 生存期生存期 患者患者获获获获益益 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial MOSAIC 治疗方案 FOLFOX4 FOLFOX4 LV5FU2 奥沙利铂 85mg m D1 5FU静注 D2 5FU静注 LVLV5 FU 滴注 5 FU 滴注 OXA LV5FU2 LV5FU2 D1 5FU 静注 D2 5FU 静注 LVLV5 FU 滴注 5 FU 滴注 22462246例例 Baxter LV5 infusors 每每2 2周一次周一次 治疗治疗6 6个月个月 12 12周期周期 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 主要研究终点 3年DFS Data cut off June 2006Disease Free Survival months FOLFOX4 LV 5 FU2 Probability 1 0 0 8 0 6 0 4 0 2 0 0 9 0 7 0 5 0 3 0 1 06121824603036424854 Events FOLFOX4 304 1 123 27 1 LV 5 FU2 360 1 123 32 1 HR 0 80 95 CI 0 68 0 93 5 9 p 003 5 3 ITT intent to treat HR hazard ratio CI confidence interval de Gramont et al 2007 JCO 2009 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial DFS II vs III 期结肠癌 Data cut off June 2006 HR 95 CI p Value Stage II 0 84 0 62 1 14 258 Stage III 0 78 0 65 0 93 005 FOLFOX4 stage II LV 5 FU2 stage II FOLFOX4 stage III LV 5 FU2 stage III Time months Probability 1 0 0 8 0 6 0 4 0 2 0 0 9 0 7 0 5 0 3 0 1 061218246030364248546672 3 8 7 5 p 258 p 005 de Gramont et al 2007 JCO 2009 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 总生存 II III期 Data cut off January 2007 FOLFOX4 stage II LV 5 FU2 stage II FOLFOX4 stage III LV 5FU 2 stage III Overall Survival months Probability 1 0 0 8 0 6 0 4 0 2 0 0 9 0 7 0 5 0 3 0 1 06121824603036424854669672788490 HR 95 CI Stage II 1 00 0 71 1 42 Stage III 0 80 0 66 0 98 0 1 4 4 p 996 p 029 de Gramont et al 2007 Andr et al 2009 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial MOSAIC 毒性比较 NCI Gr 3 FOLFOX4 LV5FU2 n 1108 n 1111 血小板减少 1 6 0 4 中性粒细胞减少 41 0 Gr 4 12 2 4 7 粒缺性发热 0 7 0 1 腹泻 10 8 6 7 黏膜炎 2 7 2 2 呕吐 5 9 1 4 过敏 3 0 0 2 脱发 二度 5 0 5 0 治疗相关死亡 0 5 0 5 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial de Gramont et al 2007 MOSAIC研究结论 n在III期结肠癌患者中 加用奥沙利铂可以改善 nFOLFOX方案治疗患者DFS的获益可以维持在5年以上 nIII期患者可以有OS的显著获益 但是对于未经选择的II期 患者并无 高危 II期患者采用FOLFOX趋向有DFS的获益 nFOLFOX应用后4年以上 仍有3 5 的患者存在 2 3度的 12 1度 对于III期患者和II期高危患者 FOLFOX是标准的辅助治疗 方案 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 转移性结直肠癌联合化疗 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 三药 概念 OS mos 13 2 3 drugs x 0 1 R 2 85 Grothey Falcone et al 2007 Koopman et al 2007 0 10 20 30 40 50 60 70 80 伊立替康 滴注 5 FU LV 奥沙利铂 滴注 5 FU LV 伊立替康 推注 5 FU LV 伊立替康 奥沙利铂 推注 5 FU LV LV 5 FU2 FOLFOXIRI CAIRO 22 21 20 19 18 17 16 15 14 13 12 Median OS mos Patients With Three Drugs p 0001 一线治疗 多因素分析 对生存影响 p value 一线两药联合 69 所有的三药 005 2007 OS overall survival 5 FU2 bolus and infusional 5 FU 11 项III期临床试验 5 768 patients Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Tournigand研究 FOLFIRI方案一线治疗 mCRC疗效明确 FOLFIRI FOLFOX6 CPT 11 180mg m2 输注2h 奥沙利铂 100mg m2 输注2h LV 200或400 mg m2 输注2h LV 200或400 mg m2 输注2h 随后5 FU 400mg m2 推注和 随后5 FU 400mg m2 推注和 5 FU 2 4g 3 0g m2持续输注 46小时 5 FU 2 4g 3 0g m2持续输注46小时 均Q2w 均Q2w 随 机 N 109 FOLFIRI N 111 FOLFOX6 FOLFOX6 FOLFIRI 直到进展 直到进展 直到进展 直到进展 Tournigand et al J Clin Oncol J 2004 22 229 237 A组 B组 研究设计 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2 h 2 h L Folinic Acid 200 mg m2 5FU CIV 2 400 to 3 000 mg m2 Irinotecan 180 mg m2 2 h46 h Bolus 5FU 400 mg m2 FOLFIRIFOLFIRI FOLFOX6FOLFOX6 Bolus 5FU 400 mg m2 L Folinic Acid 200 mg m2 5FU CIV 2 400 to 3 000 mg m2 Oxaliplatin 100 mg m2 2 h46 h Tournigand et al J Clin Oncol 2004 22 Jan 15 V308研究用药方法 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 疗效结果 Tournigand et al J Clin Oncol 2004 22 229 237 A组 FOLFIRI FOLFOX n 109 n 81 B组 FOLFOX FOLFIRI n 111 n 69 中位第二无进展生存14 2月10 9月 中位一线无进展生存 8 5月8 0月 中位二线无进展生存 4 24 2月月 P P 0 003 0 003 2 5月 一线缓解率 二线缓解率 56 1515 P P 0 05 0 05 54 4 接受二线化疗的比例74 62 中位总生存21 5月20 6月 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial V308研究 生存曲线 Tournigand C et al J Clin Oncol 2004 22 229 237 至第二次进展时间总生存时间 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial A组 FOLFIRI FOLFOX B组 FOLFOX FOLFIRI 一线治疗后 PS 改善35 33 体重增加 5 35 P 0 05 23 二线治疗后 PS改善26 35 体重增加 5 9 6 体重及体力评分 PS 改善结果 Tournigand et al J Clin Oncol 2004 22 229 237 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial A组B组 FOLFIRIFOLFOXFOLFOXFOLFIRI 中位治疗周期数 13 1 43 8 2 23 12 1 38 6 1 33 总体3 4度不良反应 53 49 74 44 60天死亡率 4 4 3 3 由于不良反应导致 停药 6 12 11 1 FOLFIRI方案一线治疗晚期结直肠癌总体 不良反应更低 更易耐受 Tournigand et al J Clin Oncol 2004 22 229 237 P 0 001 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial V308研究结论 如果患者需要手指的 灵活性从事精细动作 时 或者寒冷地带从 事户外工作 选用 FOLFIRI方案 如果患者在意脱发或 腹泻 或者胆红素水 平升高或者Gilbert综 合征 则选用FOLFOX 方案 治疗活性 FOLFOX FOLFIRI 毒性层面 FOLFOX 神经毒性和 中性粒细胞降低 FOLFIRI 胃肠道毒 性和脱发 Tournigand C et al J Clin Oncol 2004 22 1 9 Tournigand et al J Clin Oncol 2004 22 229 237 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 联合奥沙利铂和伊利替康有何区别 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 氟尿嘧啶类药物是结直肠癌患者初始治疗的基石氟尿嘧啶类药物是结直肠癌患者初始治疗的基石 奥奥沙利铂与伊立替康在结直肠癌一线化疗中疗效沙利铂与伊立替康在结直肠癌一线化疗中疗效 相当 可互为一 二线治疗相当 可互为一 二线治疗 对于对于晚期患者 在能够耐受的情况下 首先考虑晚期患者 在能够耐受的情况下 首先考虑 选择联合化疗选择联合化疗方案方案 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 转移性结直肠癌靶向治疗转移性结直肠癌靶向治疗 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 目前应用于结直肠癌的靶向药物与靶点 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 化疗 贝伐珠单抗肠癌 期临床研究 AVF2107g 疾病进展后不应有贝伐珠单抗 疾病进展后可能应用贝伐珠单抗 疾病进展后可能应用贝伐珠单抗 IFL 推注 5 FU 500 mg m2 亚叶酸20 mg m2 伊立替康125 mg m2 每 4 6 wks 初治的转移性 CRC Bolus IFL 安慰剂 n 412 Bolus IFL BV n 403 5 FU LV BV n 110 5 FU LV 推注 5 FU 500 mg m2 亚叶酸 500 mg m2 每6 8 wks BV 5 mg kg q 2 wk Hurwitz H N Engl J Med 2004 350 2335 42 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 化疗 贝伐珠单抗肠癌 期临床研究 AVF2107g NRR PFS mo 生存 月 IFLIFL 41234 86 215 6 贝伐珠单抗贝伐珠单抗 IFL IFL 41044 8 10 6 20 3 p 0 05 Hurwitz H N Engl J Med 2004 350 2335 42 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial AVF2107g研究 OS 曲线 Hurwitz H N Engl J Med 2004 350 2335 42 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial BICC C研究 优化伊立替康联合用药 第1阶段 Celecoxib 400 mg bid 1st line mCRC N 430 Placebo Arm A FOLFIRI uIrinotecan 180 mg m2 D1 uLV 400 mg m2 over 2 h D1 u5 FU 400 mg m2 bolus D1 u5 FU 2400 mg m2 46 h infusion D1 uq2wks Arm B mIFL uIrinotecan 125 mg m2 D1 8 u5FU 500 mg m2 bolus D1 8 uLV 20 mg m2 D1 8 uq3wks Arm C CapeIRI uIrinotecan 250 mg m2 D1 uCapecitabine 1 000 mg m2 bid D1 14 uq3wks R R A A N N D D OO MM I I Z Z A A T T I I OO N N R R A A N N D D OO MM I I Z Z A A T T I I OO N N Dana Farber Fuchs CS et al J clin Oncol 2007 25 4779 86 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Arm A FOLFIRI u伊立替康 180 mg m2 D1 u亚叶酸 400 mg m2 over 2 hr D1 u5 FU 400 mg m2 bolus D1 u5 FU 2 400 mg m2 46 hr infusion D1 uq2wks Arm B mIFL u伊立替康 125 mg m2 D1 8 u5FU 500 mg m2 D1 8 u亚叶酸 20 mg m2 D1 8 uq3wks BICC C研究 优化伊立替康联合用药 第2阶段 未经治疗的晚期 结直肠癌N 117 5 mg kg 5 mg kg 贝伐珠单抗贝伐珠单抗 7 5 mg kg 7 5 mg kg 贝伐珠单抗贝伐珠单抗 R R A A N N D D OO MM I I Z Z A A T T I I OO N N Dana Farber Fuchs CS et al J clin Oncol 2007 25 4779 86 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 第1阶段 未联合BEV第2阶段 联合BEV 疗效 FOLFIRI N 144 mlFL N 141 Caplri N 145 FOLFIRI N 57 mlFL N 60 RR 4743395853 PFS mo 7 65 9 p 0 004 5 8 P 0 015 11 28 3 P NS OS mo 23 117 6 P NS 18 9 P NS 2819 2 P 0 037 Fuchs CS et al J clin Oncol 2007 25 4779 86 Fuchs CS et al J clin Oncol 2008 26 689 690 BICC C研究 疗效数据 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial BICC C 研究第2阶段 生存分析 Fuchs CS et al J clin Oncol 2008 26 689 690 生存期 月 生存患者的比例 19 2 28 0 中位随访34 4个月 FOLFIRI Bev组患者的总生存期显著优于mIFL Bev 组患者 28 0个月 vs 19 2个月 P 0 037 FOLFIRI Bev组和mIFL Bev组患者的1年生存率分别为87 和61 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial CRYSTAL 研究 分层因素 种族 ECOG PS 患者群 随即分组的患者 n 1217 安全性评价人群 n 1202 ITT 人群 n 1198 mFOLFIRI 西妥昔单抗 mFOLFIRI 随 机 EGFR 表达的 初治mCRC Eric V Cutsem et al N Engl J Med 2009 1408 1417 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial CRYSTAL 研究 KRAS 表达状态和疗效的相关性次要终点 缓解率 p 0 0025a FOLFIRI FOLFIRI Cetuximab aCochran Mantel Haenszel CMH test KRAS 野生型 n 348 仅仅有肝脏转脏转移的KRAS野生型 n 67 p 0 025a FOLFIRI FOLFIRI Cetuximab n 176 n 172 n 32 n 35 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial CRYSTAL 野生型KRAS患者PFS 0 0 2 0 4 0 6 0 8 1 0 04812 无进展生存 月 18 西妥昔单抗 FOLFIRI FOLFIRI 野生型 KRAS n 348 HR 0 68 P 017 261014 cetuximab FOLIFIRI中位PFS 9 9 mos FOLIFIRI中位PFS 8 7 mos 0 1 0 3 0 5 0 7 0 9 16 1 yr PFS rate 43 1 yr PFS rate 25 PFS Estimate Eric V Cutsem et al N Engl J Med 2009 1408 1417 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial CRYSTAL 研究 生存分析 Treatment arm FOLFIRI C 225 FOLFIRI Median OS mo 18 619 9 P value 0 31 HR 95 CI 0 93 0 81 1 07 Treatment arm FOLFIRI C 225 FOLFIRI Median OS mo 21 024 9 P value 0 22 HR 95 CI 0 84 0 64 1 11 Eric V Cutsem et al N Engl J Med 2009 1408 1417 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial CRYSTAL 2009 ESMO生存分析更新 Eric V Cutsem et al 2009 ESMO abstract 6077 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial CRYSTAL 2010 ESMO 肿瘤早期退缩 提示长期生存 KRAS野生型患者治疗疗后肿肿瘤早期退缩缩 8周评评价 早期肿瘤退缩 20 FOLFIRIFOLFIRI C 225 20 n 125 20 n 159 PFS 中位 月 95 CI 7 7 6 9 8 3 9 7 8 6 10 7 7 3 5 5 9 0 11 8 9 6 14 0 HR 95 CI p 值 0 689 0 495 0 957 0 0260 368 0 256 0 529 0 0001 OS 中位 月 95 CI 20 2 15 3 25 1 21 2 16 7 25 7 19 6 17 3 22 0 28 3 24 6 31 9 HR 95 CI p 值 0 814 0 626 1 059 0 1250 643 0 480 0 862 0 003 Piessevaux H et al 2010 ESMO abstract 596 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Ox based cetuximab FOLFIRI cetuximab Ox based bev Iri based bev AVF2107g 45 vs 35 P 0 004 BICC C 第2阶段58 vs 47 period 1 2 NO1696638 vs 38 P 0 99 IRC评价 CRYSTAL WT 59 vs 43 p 0025 OPUS WT 61 vs 37 P 011 FOLFOX only MRC COIN WT 64 vs 57 P 049 化疗联合靶向药物一线治疗mCRC研究结果 ORR Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Ox based cetuximab FOLFIRI cetuximab Ox based bev Iri based bev AVF2107g 10 6 m vs 6 2 m P 0 001 BICC C 第2阶段 11 2 m vs 7 6 m period 1 2 P NA NO 16966 9 4 m vs 8 0 P 0 0023 CRYSTAL WT 9 9 m vs 8 7m p 0 02 OPUS WT 7 7m vs 7 2 m P 0 016 FOLFOX only MRC COIN WT 8 6mo vs 8 6 mo P 0 60 化疗联合靶向药物一线治疗mCRC研究结果 PFS Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Ox based cetuximab FOLFIRI cetuximab Ox based bev Iri based bev AVF2107g 20 3 mo vs 15 6 mo P 0 001 BICC C 第2阶段 28 mo vs 23 1 mo period 1 2 P NA NO 16966 21 3 m vs 19 9 P 0 0769 CRYSTAL WT 23 5 m vs 20 0 p 0 0094 早期 退缩可达28 3个月 OPUS WT 22 8 m vs 18 5 P 0 38 FOLFOX only MRC COIN WT 17 9m vs 17 0 P 0 68 化疗联合靶向药物一线治疗mCRC研究结果 OS Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard b
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