目录目录含法玛新FEC/CEF方案是NCCN指南和St Gallen共识推荐的早期乳腺癌辅助治疗的基础方案1，2FEC100相比FEC50显著提高10年无病生存率和总生存率3FEC100的迟发性心脏毒性和继发性恶性肿瘤发生率与FEC50无显著差异31. NCCN Clinical Practice Guidelines in Oncology；Breast Cancer ；3. Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. 2. A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 1133442007 St.Gallen 早期乳腺癌治疗专家共识早期乳腺癌治疗专家共识A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 1133442007St. Gallen共识重点：重申对早期乳腺癌患者根据内分泌治疗敏感性的评价来确定合适的系统治疗方案的重要性。A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 113344内分泌治疗高度敏感内分泌治疗敏感性不确定内分泌治疗不敏感2007St. Gallen共识共识对内分泌治疗的敏感性分类对内分泌治疗的敏感性分类A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 113344低度危险：淋巴结阴性并具备所有以下特征pT2cm病理分级为1级ER和/或PgR表达未侵犯肿瘤周边血管无HER2/neu基因过表达或扩增年龄35岁2007 St. Gallen共识：共识：早期乳腺癌早期乳腺癌危险度分级危险度分级A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 113344高度危险:淋巴结阳性(13个淋巴结受累)，ER和PgR缺失，或HER2/neu基因过表达或扩增淋巴结阳性（4个或4个以上淋巴结受累）2007 St. Gallen共识共识:乳腺癌危险度分级乳腺癌危险度分级A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 113344中度危险:淋巴结阴性并至少具备以下特征中的一项pT2cm病理分级为23级ER和PgR缺失有肿瘤周边血管侵犯HER2/neu基因过表达或扩增年龄35岁淋巴结阳性(1-3个淋巴结受累)， ER和PgR表达，且无HER2/neu基因过表达或扩增2007 St. Gallen共识：共识：早期乳腺癌危险度分级早期乳腺癌危险度分级A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 113344内分泌治疗高度敏感 内分泌治疗敏感性不确定内分泌治疗不敏感HER2阴性ET（根据患者危险度分级考虑加用化疗加用化疗）ET（根据患者危险度分级考虑加用化加用化疗疗）化疗化疗HER2阳性ET曲妥珠单抗化疗化疗ET曲妥珠单抗化疗化疗曲妥珠单抗化化疗疗ET: 内分泌治疗2007 St. Gallen共识早期乳腺癌共识早期乳腺癌治疗推荐治疗推荐: 化疗仍然是基础治疗化疗仍然是基础治疗A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 1133442007 St Gallen早期乳腺癌治疗：早期乳腺癌治疗：化疗化疗大部分专家支持对于所有的患者（除禁忌症）都可以使用含蒽环类的化疗方案联合环磷酰胺、5氟尿嘧啶和蒽环类抗生素治疗方案，如FEC/CEF等得到广泛的认同和支持“Most Panelists supported the use of anthracyclines for allpatients and an even greater majority supported anthracyclineuse for patients with HER2-positive diseaseCombinations of cyclophosphamide, 5-fluorouracil and an anthracycline(variously abbreviated as CAF, CEF, FEC, FAC 9396),commanded relatively wide support, as did the sequence ofanthracycline and cyclophosphamide followed by paclitaxel ordocetaxel”A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 113344法玛新法玛新用于辅助治疗提高淋巴结阳性，用于辅助治疗提高淋巴结阳性，预后差的早期乳腺癌患者的长期生存预后差的早期乳腺癌患者的长期生存（FASG-05 III 期、多中心随机研究10年随访结果）Bonneterre J, Roch H, Kerbrat P, et al. J Clin oncol. 2005 Apr 20;23(12): 2686-93.F 500 mg/m2 IVE 50 mg/m2 IV每每3周周 x 6疗程疗程*C 500 mg/m2 IVF 500 mg/m2 IV E 100 mg/m2 IV每每3周周 x 6疗程疗程*C 500 mg/m2 IV试验试验设计设计*禁止预防性使用集落刺激因子和抗生素研究人群研究人群 (n = 565)绝经前绝经前/后的妇女患者后的妇女患者早期乳腺癌术后早期乳腺癌术后腋窝淋巴结阳性腋窝淋巴结阳性随随随随机机机机化化化化3.Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. F:5-FU E:EPI C:CTX3.Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. 两组患者特征无统计学差异两组患者特征无统计学差异两组治疗情况相似两组治疗情况相似FEC100FEC100FEC50FEC50(n = 268)(n = 268)(n = 278)(n = 278)完成6个疗程治疗患者的百分比 94% 95.7%3.Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. 结果：结果：FEC100相比相比FEC50显著提高显著提高10年无病生存率年无病生存率3.Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. 随机后时间（月）0.51.00.30.40.200.10.60.70.80.924487296120144168无病生存率P=0.03650.7%45.3%FEC 100（n=266)FEC 50（n=271)结果：结果：FEC100相比相比FEC50显著提高显著提高10年总生存率年总生存率3.Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. 0.51.00.30.40.200.10.60.70.80.924487296120144168随机后时间（月）总生存率P=0.03854.8%50.0%FEC 100（n=266)FEC 50（n=271)FEC100 的迟发性心脏毒性和继发性恶性肿的迟发性心脏毒性和继发性恶性肿瘤的发生与瘤的发生与FEC50无显著差异无显著差异安全性 FEC50(n=271)No.(%) FEC100(n=266)No.(%) P 迟发性心脏毒性 4(1.5%) 3(1.1%) NS 继发性恶性肿瘤 27(10.0%) 22(8.3%) NS 3.Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. 结论结论FEC100相比FEC50显著提高10年无病生存率和总生存率FEC100的迟发性心脏毒性和继发性恶性肿瘤的发生与FEC50无显著差异3.Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. 总结总结含法玛新FEC/CEF方案是NCCN指南和St Gallen共识推荐的早期乳腺癌辅助治疗的基础方案1，2FEC100相比FEC50显著提高10年无病生存率和总生存率3FEC100的迟发性心脏毒性和继发性恶性肿瘤发生率与FEC50无显著差异31. NCCN Clinical Practice Guidelines in Oncology；Breast Cancer ；3. Jacques Bonneterre, Henri Roch, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93. 2. A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 113344法玛新处方资料信息法玛新处方资料信息(详细处方资料请参见产品说明书）