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1、乳腺癌的辅助治疗 从临床指南走向临床实践讨论,安徽医科大学第一附属医院 潘跃银,Treatment of Early-Stage Breast Cancer: Considerations,Enough?,ADJUVANT BREAST CANCER DECISION = PUZZLE !,Guidelines (NIH, NCCN, St-Gallen ),Personal experience and local policy,Industry advertising,Literature (individual studies, review),Reimbursement conditi
2、ons，insurance policy,Adjuvant online,With so many parameters to consider, how do we approach treatment?,Develop Clinical Practice Guidelines,Defined as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances”
3、,Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines, 1990.,TREATMENT GUIDELINES FOR ADJUVANT THERAPY OF BREAST CANCER,Aim : to enhance individual clinical decision-making Evidence : from clinical trials / metaanalysis (= Average treatment effects) Opi
4、nion of breast cancer experts is important,Inter-Guideline Comparison,As expected, significant agreement in scientific content Eg, in 9 guidelines on NSCLC included in the analysis, the concordance was 80% (80-98%) Heterogeneity reflects Different development groups and intended focus Differences in
5、 diagnostic and treatment approach by country Different resources available Different uptake of the new approaches Different level of patient involvement in the decision making process,Pentheroudakis et al. Ann Oncol. 2008;19:2067-2078.,Patient Examples: Key Points,Local / national guidelines: Faste
6、r adaptation of clinical trial data Similar recommendations of evidence-based regimens More practical International guidelines: More general Slower/longer process of integrating newer regimens,CASE 1,40 year old, premenopausal woman Infiltrating ductal carcinoma Tumor 0.5 cm 0/10 positive lymph node
7、s Grade 1 ER+，PR+. HER+ 辅助治疗方案?,NCCN 2010,ESMO,ST.GALLEN,适应症,雌激素或孕激素受体阳性的浸润性乳腺癌患者，不论年龄、淋巴结状态或是否应用了辅助化疗，都应考虑辅助内分泌治疗。,CASE 1,40 year old, premenopausal woman Infiltrating ductal carcinoma Tumor 0.5 cm 0/10 positive lymph nodes Grade 1 ER+，PR+. HER+ 辅助治疗方案? TAM,CASE 2,Presentation for second opinion: 4
8、6 years Large regional breast center: tumor excision + sentinel node biopsy right side + breast reduction both sides Invasive ductal breast cancer: pT2 (3 cm), pN0 (sn) Grade 2 ，R0 ER +, PR+, HER2 0 Premenopausal,风险评价与治疗选择,CASE 2.: Adjuvant! Online Results https:/,CASE 2.: Adjuvant! Online Results,4
9、6 y.o., pT2 (3cm), pN0, Grade 2, R0, ER/PR+, HER2- 2nd generation regimen + tamoxifen Risk of relapse at 10 yrs with no additional therapy = 37% Risk of death at 10 yrs with no additional therapy = 17%,Evolution of Chemotherapy in BC,CMF Milan,AC B-15,FEC50 ICCG,=,=,CEF MA.5,FAC GEICAM,TAC BCIRG 001
10、,TC US9735,AC-P C9344 B-28,AC-T E1199,AC-Pw E1199,AC2w-P2w C9741,FEC100 FASG05,FEC-Pw G9906,FEC-T PACS01,ESMO,46 y.o., pT2 (3cm), pN0, Grade 2, R0, ER/PR+, HER2-,ST GALLEN,46 y.o., pT2 (3cm), pN0, Grade 2, R0, ER/PR+, HER2-,St gallen,ST GALLEN,NCCN,ESMO,化疗方案,Patient M.F.: Guideline Recommendations,4
11、6 y.o., pT2 (3cm), pN0, Grade 2, R0, ER/PR+, HER2-,CT = chemotherapy; ET = endocrine therapy,CASE 2,Therapy recommendation: Recommendation: NNBC-3 trial ESMO: 3x FEC 3x Docetaxel; US: TAC; CHINA ? A-BASED Radiotherapy right breast Endocrine therapy (TAM),CASE 3,40 year old, premenopausal woman Infil
12、trating ductal carcinoma Tumor 2.1 cm 0/10 positive lymph nodes Grade 2 ER and PgR-negative HER2 2+, FISH positive LVEF = 52% HECEPTIN? CT regimen？,ESMO,ST GALLEN,NCCN,CASE 3,40 y., 2.1cm, LN -ve, Grade 2, ER and PR -ve, HER2 +,CT = chemotherapy; ET = endocrine therapy; H=trastuzumab,CASE 3,40 year
13、old, premenopausal woman Infiltrating ductal carcinoma Tumor 2.1 cm 0/10 positive lymph nodes Grade 2 ER and PgR-negative HER2 2+, FISH positive LVEF = 52% HECEPTIN. ACPH, TCH,CASE 4,43 year old, premenopausal woman Infiltrating ductal carcinoma Tumor 3 cm 2/12 positive lymph nodes Grade 2 ER 9/12,
14、PR 6/12 HER2 2+, TAM OR OTHER?,ST GALLEN,ESMO,NCCN,ASCO,CASE 4,43 year old, premenopausal woman Infiltrating ductal carcinoma Tumor 3 cm 2/12 positive lymph nodes Grade 2 ER 9/12, PR 6/12 HER2 2+, TAM OR TAM + OS( ? YEARS),CASE 5,40岁 3CM,G1,N- 5%浸润性导管癌，95%DCIS ER+，PR+. HER+ 辅助治疗方案?,辅助治疗方案?,TAM? CT?
15、HECEPTIN?,SELECTION OF ADJUVANT ENDOCRINE THERAPY JULES BORDET VIEW,R I S K,AI Upfront,TAM alone,Switch TAMAI,AI upfront,ADD CHEMOTHERAPY,C H E M O T H E R A P Y,ADJUVANT CHEMOTHERAPY REGIMENS IN 2010,Regimens with decreased cardiac risk !,D,T : docetaxel P : paclitaxel,SELECTION OF ADJUVANT CHEMOTH
16、ERAPY REGIMENS : ACCORDING TO THE ENDOCRINE-RESPONSIVENESS AND THE RISK OF THE TUMOR,Endocrine-responsiveness,Absent,Uncertain,High,low,Intermediate,High,FEC A(C) CMF,AC CMF,Endocrine therapy,Anthracyclines + taxane (e.g., FEC x 3 D x 3),FEC A(C) CMF,Anthracycline + taxane,Risk,ADD Endocrine therapy
17、,Important Questions That Remain,Do guidelines work and to what extent should they reflect multidisciplinary collaboration? Do clinicians follow the published guidelines? Is this country-specific? Are we reducing physician freedom of choice? General guidelines vs “specific, one question answering” g
18、uidelines/recommendations? How does reimbursement fit it? Best treatment vs best available treatment Impact of todays guidelines on future development Should we design trials in areas where level of evidence is low?,Conclusions,Guidelines using an evidence-based approach have great value for standardizing treatment decision making Limitation continues to be lack of flexibility and lack of information about impact on practice Envision the future to include the integration of increasingly more complex patient- and treatment-specific characteristics for a more individualized approach,谢谢！,