表柔比星法瑪新乳腺癌治療

1、目錄,含法瑪新®FEC/CEF方案是NCCN指南和St Gallen共識推薦的早期乳腺癌輔助治療的基礎方案1，2FEC100相比FEC50顯著提高10年無病生存率和總生存率3FEC100的遲發(fā)性心臟毒性和繼發(fā)性惡性腫瘤發(fā)生率與FEC50無顯著差異3,1. NCCN Clinical Practice Guidelines in Oncology?；Breast Cancer ；V.2.2007,3. Jacques B

2、onneterre, Henri Roché, 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 S

3、tudy 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.

4、 Annals of Oncology 2007；18: 1133–44,,,2007 St.Gallen 早期乳腺癌治療專家共識,A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of

5、Oncology 2007；18: 1133–44,2007St. Gallen共識重點：重申對早期乳腺癌患者根據(jù)內(nèi)分泌治療敏感性的評價來確定合適的系統(tǒng)治療方案的重要性。,A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast can

6、cer 2007. Annals of Oncology 2007；18: 1133–44,內(nèi)分泌治療高度敏感內(nèi)分泌治療敏感性不確定內(nèi)分泌治療不敏感,2007St. Gallen共識對內(nèi)分泌治療的敏感性分類,A. Goldhirsch et al. Progress and promise: highlights of the international expert consensus on the primary therap

7、y of early breast cancer 2007. Annals of Oncology 2007；18: 1133–44,低度危險：淋巴結(jié)陰性并具備所有以下特征pT≤2cm病理分級為1級ER和/或PgR表達未侵犯腫瘤周邊血管無HER2/neu基因過表達或擴增年齡≥35歲,2007 St. Gallen共識：早期乳腺癌危險度分級,A. Goldhirsch et al. Progress and promise

8、: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 1133–44,高度危險:淋巴結(jié)陽性(1－3個淋巴結(jié)受累)，ER和PgR缺失，或HER2/neu基因過表達或擴增淋巴結(jié)陽性（4個或4個以上淋巴結(jié)受累）,2007 St. Ga

9、llen共識:乳腺癌危險度分級,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: 1133–44,中度危險:淋巴結(jié)陰性并至少具備以下特征中的一

10、項pT＞2cm病理分級為2－3級ER和PgR缺失有腫瘤周邊血管侵犯HER2/neu基因過表達或擴增年齡＜35歲淋巴結(jié)陽性(1-3個淋巴結(jié)受累)， ER和PgR表達，且無HER2/neu基因過表達或擴增,2007 St. Gallen共識：早期乳腺癌危險度分級,A. Goldhirsch et al. Progress and promise: highlights of the international expert

11、consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 1133–44,ET: 內(nèi)分泌治療,2007 St. Gallen共識早期乳腺癌治療推薦: 化療仍然是基礎治療,A. Goldhirsch et al. Progress and promise: highlights of the internationa

12、l expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 1133–44,2007 St Gallen早期乳腺癌治療：化療,大部分專家支持對于所有的患者（除禁忌癥）都可以使用含蒽環(huán)類的化療方案聯(lián)合環(huán)磷酰胺、5－氟尿嘧啶和蒽環(huán)類抗生素治療方案，如FEC/CEF等得到廣泛的認同和支持,“……Most

13、 Panelists supported the use of anthracyclines for allpatients and an even greater majority supported anthracyclineuse for patients with HER2-positive disease……Combinations of cyclophosphamide, 5-fluorouracil and an an

14、thracycline(variously abbreviated as CAF, CEF, FEC, FAC [93–96]),commanded relatively wide support, as did the sequence ofanthracycline and cyclophosphamide followed by paclitaxel ordocetaxel……”,A. Goldhirsch et al.

15、Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Annals of Oncology 2007；18: 1133–44,法瑪新®用于輔助治療提高淋巴結(jié)陽性，預后差的早期乳腺癌患者的長期生存,,（FASG-05 III 期、多中心隨

16、機研究10年隨訪結(jié)果）,,,Bonneterre J, Roché H, Kerbrat P, et al. J Clin oncol. 2005 Apr 20;23(12): 2686-93.,F500 mg/m2 IVE 50 mg/m2 IV每3周 x 6療程*C 500 mg/m2 IV,F 500 mg/m2 IV E 100 mg/m2 IV每3周 x 6療程*C 500 mg/m2 I

17、V,試驗設計,*禁止預防性使用集落刺激因子和抗生素,,,研究人群 (n = 565)絕經(jīng)前/后的婦女患者早期乳腺癌術后腋窩淋巴結(jié)陽性,,,隨機化,,,,,3.Jacques Bonneterre, Henri Roché, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Pro

18、gnosis, 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 Roc

19、hé, 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 Random

20、ized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93.,兩組患者特征無統(tǒng)計學差異,兩組治療情況相似,FEC100FEC50(n = 268)(n = 278)完成6個療程治療患者的百分比 94% 　　　95.7%,,,,3.Jacques Bonneterre, Henri Roché, et al. Epirubicin Increas

21、es 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

22、 20;23(12):2686-93.,結(jié)果：FEC100相比FEC50顯著提高10年無病生存率,3.Jacques Bonneterre, Henri Roché, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Brea

23、st 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.,結(jié)果：FEC100相比FEC50顯著提高10年總生存率,3.Jacques Bonneterre, Henri Roché, et al. Epirubici

24、n 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.

25、 2005 Apr 20;23(12):2686-93.,FEC100 的遲發(fā)性心臟毒性和繼發(fā)性惡性腫瘤的發(fā)生與FEC50無顯著差異,,,3.Jacques Bonneterre, Henri Roché, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-P

26、ositive, 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.,結(jié)論,FEC100相比FEC50顯著提高10年無病生存率和總生存率FEC100的遲發(fā)性心臟毒性和繼發(fā)性惡性腫瘤的發(fā)生與FEC50無

27、顯著差異,3.Jacques Bonneterre, Henri Roché, 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 F

28、rench Adjuvant Study Group 05 Randomized Trial. J Clin Oncol. 2005 Apr 20;23(12):2686-93.,總結(jié),含法瑪新®FEC/CEF方案是NCCN指南和St Gallen共識推薦的早期乳腺癌輔助治療的基礎方案1，2FEC100相比FEC50顯著提高10年無病生存率和總生存率3FEC100的遲發(fā)性心臟毒性和繼發(fā)性惡性腫瘤發(fā)生率與FEC50無顯著

29、差異3,1. NCCN Clinical Practice Guidelines in Oncology?；Breast Cancer ；V.2.2007,3. Jacques Bonneterre, Henri Roché, et al. Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognos

30、is, 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