表柔比星法玛新乳腺癌治疗课件

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1，2 FEC100相比FEC50显著提高10年无病生存率和 总生存率3 FEC100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3 1. NCCN Clinical Practice Guidelines in Oncology；Breast Cancer ；V.2.2007 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 2007 St.Gallen 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: 113344 2007St. 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 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： 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 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: 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： 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 ） ET（根据患者危险 度分级考虑加用化 疗） 化疗 HER2阳性ET曲妥珠单抗 化疗 ET曲妥珠单抗 化疗 曲妥珠单抗化 疗 ET: 内分泌治疗 2007 St. Gallen共识早期乳腺癌治疗推荐: 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: 113344 2007 St Gallen早期乳腺癌治疗： 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 all patients and an even greater majority supported anthracycline use 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 of anthracycline and cyclophosphamide followed by paclitaxel or docetaxel” 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 （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 IV E 50 mg/m2 IV每3周 x 6疗程* C 500 mg/m2 IV F 500 mg/m2 IV E 100 mg/m2 IV每3周 x 6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 (n = 565) 绝经前/后的妇女患者 早期乳腺癌术后 腋窝淋巴结阳性 随随 机机 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:CTX 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. 两组患者特征无统计学差异 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FEC50 显著提高10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） 0.5 1.0 0.3 0.4 0.2 0 0.1 0.6 0.7 0.8 0.9 24 487296120144168 无病生存率 P=0.036 50.7% 45.3% FEC 100 （n=266) FEC 50 （n=271) 结果：结果：FEC100相比FEC50 显著提高10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. 0.5 1.0 0.3 0.4 0.2 0 0.1 0.6 0.7 0.8 0.9 24 487296120 144168 随机后时间（月） 总生存率 P=0.038 54.8% 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 瘤的发生与FEC50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 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):2686-9