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1、乳腺癌的輔助治療乳腺癌的輔助治療從臨床指南走向臨床實(shí)際討論從臨床指南走向臨床實(shí)際討論安徽醫(yī)科大學(xué)第一附屬醫(yī)院 潘躍銀Treatment of Early-Stage Breast Cancer: ConsiderationsEnough?ADJUVANT BREAST CANCER DECISION= PUZZLE !Guidelines (NIH,NCCN, St-Gallen )Personal experience and local policyIndustry advertisingLiterature (individual studies, review)Reimbursemen

2、tconditions,insurance policyAdjuvant onlineWith so many parameters to consider, how do we approach treatment?Develop Clinical Practice GuidelinesDefined as “systematically developed statementsto assist practitioner and patient decisionsabout appropriate health care for specific clinical circumstance

3、sInstitute 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) Opin

4、ion of breast cancer experts is importantInter-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 d

5、iagnostic and treatment approach by country Different resources available Different uptake of the new approaches Different level of patient involvement in the decision making processPentheroudakis et al. Ann Oncol. 2021;19:2067-2078. Patient Examples: Key Points Local / national guidelines: Faster a

6、daptation 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 nodes G

7、rade 1 ER+, ,PR+. HER+ 輔輔助治助治療療方案方案?NCCN 2021ESMOST.GALLEN順應(yīng)癥 雌激素或孕激素受體陽(yáng)性的浸潤(rùn)性乳腺癌患者,不論年齡雌激素或孕激素受體陽(yáng)性的浸潤(rùn)性乳腺癌患者,不論年齡、淋巴結(jié)形狀或能否運(yùn)用了輔助化療,都應(yīng)思索輔助內(nèi)分、淋巴結(jié)形狀或能否運(yùn)用了輔助化療,都應(yīng)思索輔助內(nèi)分泌治療。泌治療。CASE 1 40 year old, premenopausal woman Infiltrating ductal carcinoma Tumor 0.5 cm 0/10 positive lymph nodes Grade 1 ER+, ,PR+. HE

8、R+ 輔輔助治助治療療方案方案? TAMCASE 2 Presentation for second opinion: 46 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風(fēng)險(xiǎn)評(píng)價(jià)與治療選擇風(fēng)險(xiǎn)評(píng)價(jià)與治療選擇CASE 2.

9、: Adjuvant! Online Results httpsadjuvantonlineCASE 2.: Adjuvant! Online Results 46 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%DFSOSProportional

10、Risk reduction (relapse)Proportional Risk reduction (mortality)Hormonal therapy 40%32%Chemotherapy50%44%Combined therapy60%62%Evolution of Chemotherapy in BCCMFMilanACB-15FEC50ICCG=CEFMA.5FACGEICAMTACBCIRG 001TCUS9735AC-PC9344B-28AC-TE1199AC-PwE1199AC2w-P2wC9741FEC100FASG05FEC-PwG9906FEC-TPACS01ESMO

11、 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 gallenST GALLENNCCNESMO化療方案化療方案Patient M.F.: Guideline Recommendations 46 y.o., pT2 (3cm), pN0, Grade 2, R0, ER/PR+, HER2-Risk CategoryTreatmentPreferred ChemotherapyESMOIntermediateET

12、 alone orCT ETACMF, CEF, ACT, TAC, FECT, FEC100, ATCMFSt. GallenIntermediateET (consider + CT)Specific regimens not listedNCCN-Consider 21-gene assay or ET CTTAC, TC, ACP, AC CT = chemotherapy; ET = endocrine therapyCASE 2Therapy recommendation:Recommendation: NNBC-3 trial ESMO: 3x FEC 3x Docetaxel;

13、 US: TAC; CHINA ? A-BASED Radiotherapy right breast Endocrine therapy (TAM)CASE 3 40 year 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? CT regimen?ESMO ST GALLENNCCNCASE 3 40 y., 2

14、.1cm, LN -ve, Grade 2, ER and PR -ve, HER2 +Risk CategoryTreatmentPreferred ChemotherapyTrastuzumabESMOMCT + HACMF, CEF, ACT, TAC, FECT, FEC100, ATCMF3-weekly x 1 ynot concurrent with anthraSt. GallenMCT + HNo specific regimenACPH, sequential HERA approach, TCHNCCN-CT + HTCH, ACPH, THFEC, ACTH CT =

15、chemotherapy; ET = endocrine therapy; H=trastuzumabCASE 3 40 year 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, TCHCASE 4 43 year old, premenopausal woman Infiltrating ductal

16、 carcinoma Tumor 3 cm 2/12 positive lymph nodes Grade 2 ER 9/12, PR 6/12 HER2 2+, TAM OR OTHER?ST GALLENESMONCCNASCOCASE 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歲 3CM,G1,

17、N- 5%浸潤(rùn)性導(dǎo)管癌,95%DCIS ER+,PR+. HER+ 輔助治療方案?輔助治療方案? TAM? CT? HECEPTIN?Endocrine-responsivenessCHEMOTHERAPYADJUVANT CHEMOTHERAPY REGIMENSIN 2021Standard efficacyStandard efficacy Superior efficacyCMF x 6FEC x 6AC x 4 P x 4 (or WP x 12)AC x 4 D x 4FEC x 3 D x 3 (PACS01)A x 3 D x 3 CMF x 3(BIG 02-98)A(E)C

18、 x 4 A(C) x 4 CMF x 3(TC x 4)TAC x 6 (BCIRG001)Dose-dense AC x 4 P x 4Regimens withdecreasedcardiac risk !D,T : docetaxelP : paclitaxelSELECTION OF ADJUVANT CHEMOTHERAPY REGIMENS : ACCORDING TO THE ENDOCRINE-RESPONSIVENESS AND THE RISK OF THE TUMOREndocrine-responsivenessAbsentUncertainHighlowInterm

19、ediateHighFECA(C) CMFACCMFEndocrine therapy Anthracyclines + taxane(e.g., FEC x 3 D x 3)FECA(C) CMFAnthracycline + taxaneRiskADD Endocrine therapyImportant 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?

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