乳腺癌辅助治疗规范的解读(肿瘤医院内科)
1,乳腺癌辅助治疗规范的解读,肿瘤医院内科,2,Treatment Guidelines are useful,Guidelines provide a benchmark and integrate new findings into clinical practice They are dynamic documents, which need periodic update They are developed to reduce under-treatment, over-treatment and wrong treatment Compliance with guidelines has been shown to improve patient outcome,3,Adjuvant Therapy for Breast Cancer Treatment Guidelines,78,83,88,92,95,98,01,03,05,80,85,90,2000,Guidelines,St. Gallen,NIH,NCCN,96,yearly,07,如何掌握、使用？,4,讨论内容,辅助治疗对哪些人有益？ 如何选择哪种辅助治疗方法？ 化疗方案的选择 分子靶向治疗作用 内分泌治疗方法的选择,5,Adapted from Bonadonna G. Cancer Res. 1992.,All Patients,1 3 5 7 9 11 13 15 years,LOG-RANK : P = 0.002 WILCOXON : P = 0.0001,100 50 0,% Relapse-free survival,CMF Surgery,36% 26%,1 3 5 7 9 11 13 15 years,LOG-RANK : P = 0.02 WILCOXON : P = 0.02,100 50 0,% Overall survival,CMF Surgery,51% 35%,Breast Cancer: Adjuvant CMF (12 months) or Surgery Alone,Premenopausal,6,30 years follow up of randomised studies of adjuvant CMF in Operable breast cancer : cohort study,Relapse free survival,Overall survival,Bonadonna BMJ 330:217, 2005,复发相对危险降低 34% HR 0.71 ( P = 0.005 ),各种死亡降低 22% HR 0.79 ( P = 0.04 ),7,30 years follow up of randomised studies of adjuvant CMF in Operable breast cancer : cohort study,Overall survival,Bonadonna BMJ 330:217, 2005,8,Comparative Efficacy of Adjuvant Chemotherapy: EBCTCG Meta-Analyses,Therapy,Reduction in Annual Odds, %,Recurrence,Death,Polychemotherapy vs 23.5 15 no chemotherapy (1995) (P .00001) (P .00001) Anthracyclines vs 12 11 CMF (1995) (P = .006) (P = .02) Anthracyclines vs 10.8 15.7 CMF (2000) (P = .0005) (P .00001),9,2000 Oxford Overview Analysis A/E+ vs CMF: All Deaths,0.5,1.5,2.0,15.7% (SE 3.) reduction 2p 0.00001,Deaths/Women Allocated Adjusted A/E+ CMF*,A/E+ Deaths Logrank Variance OE of OE,Year Code and Study Name,Months & Treatment,76A4 SECSG 2,6FAC v 6CMF,93/260,89/268,-2.9,41.6,78L2 ONCOFRANCE,12FACV v 12CMF,52/138,58/113,-10.9,25.0,80C1 SE Sweden BCG A,8AC v 7CMF (+R),8/21,13/22,-2.2,5.0,80M INT Milan,8CMF+4A v 12CMF,-/211,-/212,(no data),83A NSABC Israel Br0283,2CMF+4AVbCMF v 6CMF,23/55,21/50,-1.3,10.1,84B NSABP B-15*,4AC±3CMF v 6CMF (+R),716/1562,2(374/776),-14.8,224.7,84K1 GUN-3 Naples,3CMFEV v 6CMF,45/105,58/115,-5.2,23.7,84L ICCG Charing Cross,8/6FEC v 6CMF,20/256,32/259,-5.5,11.8,84Q2 Austrian BCSG 3,6CMFVA v 6CMF,67/121,75/124,-3.1,30.8,85Y1 PRONACAM85 N+/Pre,FECM v CMF,(no data),86G2 NHG Japan,10FAC c 10CMF (± Tam),(no data),87D4+5+6 GABG 3 Germany,6FEC v 6CMF (± Tam),52/142,60/146,-7.5,23.6,87Q1 PRONACAM 87,4/5CMFEP v 6CMF,(no data),88R Brussels Belgium*,8EC v 6CMF,138/537,2(69/267),2.1,44.1,88V H San Carlos, Madrid,6FAC v 6CMF,(no data),89B2 SWOG 8897,6FAC v 6CMF (+R±Tam),173/1461,223/1470,-25.9,97.1,89R NCI-C MA.5,6FEC v 6CMF,118/356,135/360,-10.1,59.1,89W123456c Denmark-Sweden*,9FEC V9CMF (+Pmd),150/601,0.8(290/781),-31.8,91.0,91H NSABP B-23 ER-,AC v CMF (+Tam),91/1003,100/1005,-5.5,46.8,91Q GUN MAM1 Naples,ZolTaM+(A;CMF v CMF),34/232,43/234,-3.8,18.2,94J1+2+3 GOIRC SANG 2B Italy,6CMFEV v 6CMF (+Tam),(no data),Scottish,4E;4CMF v 8CMF,(no data),1780/ 6850 (26.0%),-128.4,2019/ 6906 (29.2%),752.5,Total §*,99% or 95% CI,A/E+ better,CMF better,Treatment effect 2p 0.00001,§ 1 trial with no data does not contribute to total (allocated A/E+: 211; allocated CMF: 212) * For balance, control patients in 3-way trial strata count half or twice in subtotal(s) and in final total of events/women.,1.0,0,(? Patients),(100 Patients),(322 Patients),(158 Patients),( 480 Patients),(? Patients),Ratio of annual death rates A/E+ : CMF,10,11,12,HER2 predicts benefit from adjuvant paclitaxel after AC in node-positive breast cancer: CALGB 9344,D.F.Hayes ASCO 2006 Abs510,ER+,13,BCIRG 001 Study Design,Docetaxel 75 mg/m2 Doxorubicin 50 mg/m2 Cyclophosphamide 500 mg/m2,5-FU 500 mg/m2 Doxorubicin 50 mg/m2 Cyclophosphamide 500 mg/m2,R,Dexamethasone premedication, 8 mg bid, 3 days Prophylactic Cipro 500 mg bid, day 5-14,Every 3 weeks x 6 cycles,Stratification: Nodes: 1-3 4+ Center,14,TAC,FAC,0,6,12,18,24,30,36,42,48,Months,Number at Risk,TAC,FAC,745,736,710,678,654,373,152,23,1,746,729,699,656,605,334,150,31,0,50,60,70,80,90,100,% Alive and Disease Free,Disease Free Survival (ITT),BCIRG 001,Median follow-up: 33 months,15,Number at Risk,TAC,FAC,745,741,732,718,700,393,171,24,1,746,738,728,713,678,375,171,33,1,Overall Survival (ITT),BCIRG 001,TAC,FAC,0,6,12,18,24,30,36,42,48,Months,50,60,70,80,90,100,% Alive,Median follow-up: 33 months,16,Disease Free Survival by Hormonal Status,TAC,FAC,0,12,24,36,48,Months,N at Risk,TAC,FAC,231,217,188,47,0,228,202,158,34,0,50,60,70,80,90,100,% Alive and Disease Free,TAC,FAC,0,12,24,36,48,Months,N at Risk,TAC,FAC,514,493,466,105,1,518,497,447,116,0,50,60,70,80,90,100,Negative,Positive,RR = 0.62 p = 0.005
