Minds に何を求めるのか？ ～作る立場から～

1 Minds NCCN ASCO NCCN ASCO Systematically developed statementsto assist practitioner and patient decisionsabout appropriate health care for specific clinical circumstancesInstitute of Medicine, 1990 NCI Clinical Alert Strengthof evidence Casereport Case series( Case controlstudy( Cohortstudy RCT NCCN ASCO 1978:1. ABC conference Wildhaus/SG 79 delegates 1984 conference St. Gallen225 delegates 1988 conference St.))

2 Gallen540 delegates 1992 conference St. Gallen820 delegates 1995 conference St. Gallen1250 delegates 1998 conference St. Gallen1800 delegates 2001 conference St. Gallen2500 delegates 2003 conference St. Gallen3100 delegates 2005 conference St. Gallen>3800 delegates 2007 conference St. Gallen>4000 delegates 2009 conference St. Gallen>4500 delegates13 USA 8 Switzerland 3 USA 13 Switzerland 4 Japan 1 Russia 1 The Netherlands 1 Austria 1 Belgium 1 Denmark 1 Poland 1 Canada 1 AUS 2 Germany 2 UK 2 France 3 Sweden 3 Italy 2 20052007 Austria 1 Belgium 1 Denmark 1 Poland 1 Spain 1 AUS 2 Canada 2 France 2 Germany 2 Sweden 2 UK 2 Italy 2 50 69 , ER : TAM TAM (11333 : 73% )EBCTCG Lancet 365:1687-1717, 2005 50 , ER : TAM TAM (2254 : 34% )EBCTCG Lancet 365.

3 1687-1717, 2005 012345679108 2 35 years or older, Grade 1 After menopauseBefore +ER-ER+ER-ER+ > 2 Low RiskIntermediate RiskHigh RiskTumor size (cm) 21 PROLIFERATIONKi-67 STK15 SurvivinCyclin B1 MYBL2 ESTROGENERPRBcl2 SCUBE2 INVASIONS tromelysin 3 Cathepsin L2 HER2 GRB7 HER2 BAG1 GSTM1 REFERENCEBeta-actinGAPDHRPLPOGUSTFRCCD68 16 Cancer and 5 Reference Genes From 3 StudiesCategoryRS (0 -100)Low riskRS <18 Int riskRS 18 -30 High riskRS 31 Paik et al. N Engl J ;351 =+ x HER2 Group Score x ER Group Score + x Proliferation Group Score+ x Invasion Group Score + x x x BAG1 OncotypeDX 21-Gene Recurrence Score (RS) Risk Patients (RS < 18)Tam + ChemoTamp = Events218 11135 5 96%95% Risk (RS 18 -30)Tam + ChemoTamp = Events89 945 889%90%Int Risk (RS 18-30) Risk Patients (RS ?)

4 31)Tam + ChemoTamp = Events117 1347 1860%88%High Risk (RS 30)Low Risk (RS 18 )Paik S, et al. Breast Cancer Res Treat 88 (S1):A24, 2004 Recurrence score and benefit from CMF adjuvant therapyB20 results (ER+, N-, TAM vs TAM/CMF) NCCN Consensusbased on evidence Expert opinion in areas where no data exists Formal consensus process: Iteration and Feedback Bias must be managedEBM Continuum of disease and patient careHigh-level evidence existsGaps in evidence filled with expert consensusEvidence-based guidelineEvidence-based consensus guideline -HER2 b Composition of panels: Large: Representation from each NCCN institution Diverse Multidisciplinary Geographically Philosophically Process of external review:Iteration and feedbackNCCN Robert Carlson (chair)Harold BursteinJohn ErbanSharon GiordanoLori GoldsteinWilliam GradisharDaniel HayesClifford HudisMohammad JahanzebP.

5 Kelly MarcomIngrid MayerLisle NabellElizabeth Reed Mary Lou SmithGeorge SomloJohn WardEric WinerAntonio Wolf Benjamin AndersonW. Bradford CarterStephen EdgeWilliam Farrar Beryl McCormickLori Pierce D. Craig AllredBritt-Marie Ljung Neal Topham 1 2A 2B 3 2A NCCN 2007 A B C D 2010 A B C1 C2 D Is axillary dissection based on the sentinel node biopsy result acceptable after preoperative chemotherapy?

6 C Recommended Grade C No evidence is available that supports omission of dissection based on the sentinel node biopsy result after preoperative chemotherapy. NCCN 2A NCCN Categories of Consensus 2A SNB NCCN SNB There are limited data on the accuracy of SNB performed either before or after preoperative chemotherapy. NCCN guidelines recommend that sentinel node biopsy be performed before preoperative chemotherapy18 Advanced/recurrent breast cancer NCCN * 7/199754,82018 NCCN18 7/20004,3447 9/20055,4198 1/20072,5288 1/20045586* Number of patients abstracted as of October 29, : LabelSubgroupRecommended TreatmentNCCN PatientsConcordant PatientsAll PatientsCenter RangesBluesPatientsBlues Concordant% BluesNn%(low -high %)Nn%Stage I and II Chemo / Hormone Therapy 5 Stage I/II, T > 1 cm, Node Negative or pN1mic, HR-Adjuvant Chemotherapy52349494%( 90 -100 ) 24722892%NCCN ASCO St Gallen - - ( )( - )

7 1 2 1 NCCN Clinical Practice Guidelines in Oncology NCCN ASCO / 3 1 2 1 1 2 3 1 2 2 WEB WEB WEB WEB Minds WEB WEB 2011 6 2 2 CQ WEB nd WEB CQ 3rd 4th 5th i-PAD i-Phone,Android NCCN ASCO RCT DRG/PPS EBM Variance RCT