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1、台 北 榮 總 肺 癌 診 療 共 識V.1.0 2009,台北榮總肺癌團隊Revised on 2009/04/13Released on 2009/05/04,台 北 榮 總 肺 癌 診 療 共 識,Multidisciplinary TeamTaipei VGH Lung Cancer Panel MembersTNM stagingTaipei VGH supplement to TNM stagingTable of stage groupingEvaluation and treatment Stage o(Tis)Stage I(T1-2,N0)and Stage II(T1-2
2、,N1)Stage IIB(T3,N0)and stage IIIA(T3,N1)Stage IIIA(T1-3,N3)and stage IIIB(T4,N0-1)Stage IIIB(T1-3,N3)Stage IIIB(T4,N2-3)(T4:pleural effusion or pericardial effusion)Stage IV(M1:solitary site or disseminated)SurveillanceTherapy for Recurrence and MetastasesOccult(Tx,N0,M0),Evaluation and TreatmentSe
3、cond Lung Primary,Evaluation,and Treatment,Principles of Surgical ResectionPrinciples of PathologyPrinciples of Radiation Therapy-Recommended Radiation Doses-Dose Volume Data for Radiation PneumonitisPrinciples of CCRTPrinciples of Chemotherapy-Non-Small Cell Lung Cancer-Small Cell Lung CancerAdjuva
4、nt ChemotherapyNeoadjuvant ChemotherapyClinical Trials for Advanced/Metastatic NSCLCTracheal cancer References關於此臨床指引：肺癌的診療仍在發展階段，本指引主要在呈現目前肺癌診療的進展與共識，醫師應鼓勵病患參與臨床試驗，使其有機會得到最好的治療。在本指引中的化療用藥建議是基於現有的臨床證據，和目前的衛生署或健保局規定無關。,癌委會,胸內,核心成員,召集人：蔡俊明、許文虎副召集人：賴信良、吳玉琮,肺癌委員會暨肺癌多專科團隊,非核心成員,胸外,放射,病理,骨科,核醫,社工,營養,放療,台北
5、榮總肺癌委員會暨肺癌多專科團隊組織架構,藥劑部,個案管理師：宋易珍,台北榮總肺癌多專科團隊核心人員,胸腔內科,陳育民,賴信良,李毓芹,蔡俊明,胸外,吳玉琮,許文虎,放射,吳美翰,許明輝,病理,林可瀚,周德盈,放療,陳一瑋,顏上惠,邱昭華,陳俊谷,核醫,王世楨,NSCLC TNM Staging,Lababede,O.et al.Chest 1999;115:233-235,Clifton F.Mountain,CHEST1997,Regional Lymph Node Classification for Lung Cancer Staging,-Extended mediastinoscop
6、y-Mediastinotomy-VATS,-EUS-FNA-VATS,-EBUS-TBNA-VATS(limited to 10 and 11),-Mediastinoscopy EUS-FNA EBUS-TBNAVATS,-Mediastinoscopy;EUS-FNA,EBUS-TBNA,N1=Ipisilateral hilar nodesN2=Subcarinal,ipisilateral mediastinal nodesN3=Contralateral hilar/mediastinal,or supraclavicular or scalene nodes,How to App
7、roach,EUS:Endoscopic Ultrasound;EBUS:Endobronchoscopic ultrasound;FNA:Fine Needle Aspiration;TBNA:Transbronchoscopic Needle Aspiration;VATS:Video Assisted Thoracoscopic Surgery,Summary of Evaluation and Treatment,PFT:Necessary for all operable stagesPET(PET/CT):recommend for all clinical stages,exce
8、pt Wet IIIB or stage IV with disseminate M1Mediastinoscopy:recommend for all clinical stages,exceptPeripheral T1N0 Wet IIIB or stage IV with disseminate M1p.s.N2 or N3 disease can be confirmed by other methods including mediastinotomy,thoracoscopy,EBUS-FNA,EUS-FNA,CT-guided-FNA,supraclavicle LN biop
9、sy Brain MRI:recommend for all clinical stages,exceptStage I Wet IIIB or stage IV with disseminate M1,正子掃描（PET/CT SCAN）：肺癌clinical stage 的pre-treament workup，至於安排時間點是在胸腔電腦斷層（chest-CT）後。除非Chest CT或PET SCAN都無縱膈腔異常發現且主要病灶在週邊(peripheral IA lesion)可以不做縱膈腔鏡外，否則縱膈腔鏡仍是評估縱膈腔淋巴結的gold standardBrain MRI取代brain
10、CT建議在clinical stage II及stage III以上的病人安排。術中病理檢查若有R1(microscopic residual tumor)或R2(macroscopic residual tumor)，應視實際情形考慮reresection/（+chemotherapy）或是chemoradiation/（+chemotherapy）。,NSCL-1,From NCCN guideline,V.2.2009,NSCL-2,From NCCN guideline,V.2.2009,NSCL-3,From NCCN guideline,V.2.2009,NSCL-4,From N
11、CCN guideline,V.2.2009,NSCL-5,From NCCN guideline,V.2.2009,NSCL-6,From NCCN guideline,V.2.2009,NSCL-7,From NCCN guideline,V.2.2009,NSCL-8,From NCCN guideline,V.2.2009,NSCL-9,From NCCN guideline,V.2.2009,NSCL-10,From NCCN guideline,V.2.2009,NSCL-11,From NCCN guideline,V.2.2009,NSCL-12,From NCCN guide
12、line,V.2.2009,NSCL-13,Gefitinib or Erlotinib(if criteria met)z(2B),Gefitinib or Erlotinib(if criteria met)z(2B),(2B),(2B),Z Criteria for treatment with gefitinib(IPASS trial):Adenocarcinoma,non-smoker or light ex-smoker(quit 15yrs and 10 pack-years or fewer)No pre-existing idiopathic pulmonary fibro
13、sisby evidence on chest CT,From NCCN guideline,V.2.2009,NSCL-14,From NCCN guideline,V.2.2009,NSCL-15,OrGefitinib,OrGefitinib,Gefitinib and Erlotinib in 2nd-line therapy:adenocarcinomaGefitnib in 3rd-line therapy:adenocarcinoma;Erlotinib in 3rd-line therapy:NSCLC,From NCCN guideline,V.2.2009,PRINCIPL
14、ES OF SURGICAL RESECTION,非緊急狀況下，術前所需影像學檢查應完備。是否可切除(resectablility)之決定建議應由有經驗之胸腔外科醫師來決定。如生理狀況許可(physiologically feasible)，應採取lobectomy或pneumonectomy。如生理狀況受限制(physiologically compromised)，應採局部切除(Limited resection-segmentectomy or wedge resection)。在不違背標準腫瘤手術原則下，可採用VATS(Video-assisted thoracic surgery)。
15、,PRINCIPLES OF SURGICAL RESECTION,N1&N2 node resection and mapping(minimum of three N2 stations sampled or complete lymph node dissection)如內科狀況無法開刀(medically inoperable)，clinical stage I&II病人應接受potential curative radiotherapy。假如解剖位置適當與邊緣可切除乾淨(anatomically appropriate and margin-negative resection)，採
16、取肺葉保存術式比全肺切除好(lung sparing anatomic resection-sleeve lobectomy preferred over pneumonectomy)。,PRINCIPLES OF PATHOLOGICAL REVIEW,病理評估的目的包括:classify the lung cancer;determine the extent of invasion;establish the status of cancer involvement of surgical margins;determine the molecular abnormalities to
17、predict for response to EGFR-TKI。手術病理報告應該有WHO肺癌組織分類。Pure bronchioloalveolar carcinoma(BAC)應無stroma、pleura與lymphatic spaces之侵犯。免疫染色:Non-mucinous BAC=TTF-1(+)/CK7(+)/CK20(-);Mucinous BAC=TTF-1(-)/CK7(+)/CK20(+)。免疫染色可幫助鑑別原發或轉移肺腺癌，區別腺癌及惡性間皮細胞癌，決定腫瘤之神經內分泌分化。EGFR:Epidermal Growth Factor ReceptorTKI:Tyrosi
18、ne Kinase InhibitorTTF-1:Thyroid transcription factor-1,PRINCIPLES OF PATHOLOGICAL REVIEW,TTF-1對區分原發或轉移肺腺癌很重要。大部分原發肺腺癌TTF-1為陽性，轉移腺癌(甲狀腺癌除外)為陰性反應。Primary lung adenocarcinoma:TTF-1(+)/CK7(+)/CK20(-)/CDX-2(-)Metastatic colorectal carcinoma:TTF-1(-)/CK7(-)/CK20(+)/CDX-2(+)EGFR mutation之有無與TKI治療之反應相關；如TK
19、I 對exon19 deletion之腫瘤治療效果良好。K-ras與吸煙相關；K-ras與EGFR mutation為mutually exclusive；有K-ras mutation對TKI治療效果不佳。小細胞癌多數(95%)原發自肺，少數則來自肺外器官，二者有類似之臨床和生物特性，極易廣泛轉移。小細胞癌細胞通常Keratin 及至少一種之neuroendocrine differentiation markers(CD56,synaptophysin或 chromogranin A)呈陽性免疫染色。,3D conformal technique,按2009年NCCN guideline的
20、精神，其所建議的放射治療已非傳統二次元定位的方式，而是因應放射治療技術的進步，以電腦斷層評估腫瘤的位置、體積和淋巴結引流的三次元定位方式，來決定照射的角度、劑量和範圍。美國NCCN所建議的放射照射劑量並不完全適用於國人，本共識以依國內病人狀況要做適度的調整。,Recommended Radiation Doses for NSCLC(Modified doses for domestic patients),Dose Volume Data for Radiation Pneumonitis(Modified for domestic patients),MLD-Mean Lung Dose,
21、LP:percentage of lung that received radiation(Gy),同步化學併放射治療(CCRT)原則,NSCLC Dose:up to 60-66Gy/1.8-2Gy/day Limited SCLC1.年齡小於等於70歲，PS：01，接受CCRT DOSE：5060 Gy/1.8Gy/day 排程：放療自開始持續做至5060 Gy，而化學治療自開始先做三個療程後休 息，須重新評估病患治療反應，之後再依實際情形安排接續的治療。如有CR 加做预防性全腦放射治療(prophylactic cranial irradiation,PCI)DOSE：30Gy/2Gy/
22、day x15 fractions(一天一次共十五次）如有PR 持續化學治療，但不做PCI2.年齡大於70歲，PS：01，採用接續性化放療(sequential chemoradiotherapy)DOSE：5060 Gy/1.8Gy/day 排程：連續的三個療程的化學治療後休息，在二週內重新評估 如有CR 加做PCI,DOSE：30Gy/2Gy/day x15 fractions(一天一次共十五次）如有PR 加做胸腔的放療及三個療程的化學治療，但不做PCI3.如有PD 接受第二線化療。,肺癌化學治療用藥準則 非小細胞肺癌,第一線-Gemcitabine(GC-G)G(1000-1250mg/
23、m2)+Cisplatin(60-75mg/m2),Q3-4W.-Vinorelbine(NC-N)Vinorelbine(25-30 mg/m2 i.v.or 60-80 mg/m2 p.o.)+Cisplatin(60-75 mg/m2),Q3-4W.-Paclitaxel(TaC or TaC-Ta-Ta)1.Paclitaxel(160-175 mg/m2)-D1+Cisplatin(60-75 mg/m2)-D1,Q3W.2.Paclitaxel(60-80 mg/m2)-D1,8,15+Cisplatin(60-75 mg/m2)-D1,Q4W.-Docetaxel(TC or T
24、C-T)1.Docetaxel(60-75 mg/m2)-D1+Cisplatin(60-75 mg/m2)-D1,Q3W.2.Docetaxel(30-35 mg/m2)-D1,8+Cisplatin(60-75 mg/m2)-D1,Q3W.備註:1.Elderly or poor performance status：cisplatin omited 2.Cisplatin 若改成 Carboplatin,劑量為(CCr+25)x AUC,AUC=4-6 3.Bevacizumab 7.5 mg/kg 可與 Gemcitabine/cisplatin或 paclitaxel/carbopl
25、atin可並用於第一線化學治療(2B)4.Gefitinib可用於第一線治療,if adenocarcinoma,non-smoker or light ex-smoker(quit 15yrs and 10 pack-years or fewer)and no pre-existing idiopathic pulmonary fibrosisby evidence on chest CT(2B)5.Pemetrexate/cisplatin可用於第一線化學治療 in non-squamous(2B),第二線-Docetaxel 1.Docetaxel(60-75mg/m2)-D1,Q3W.
26、2.Docetaxel(30-35mg/m2)-D1,8,Q3W.-Pemetrexed(500mg/m2)-D1,Q3W.-Gefitinib 250 mg,QD.(if Adeno)-Erlotinib 150 mg,QD.(if Adeno)第三線-Gefitinib 250 mg,QD.(if Adeno)-Erlotinib 150 mg,QD(if NSCLC),*病患若參加本院 IRB 同意之臨床試驗，則依該臨床試驗之治療計畫進行,肺癌化學治療用藥準則 小細胞肺癌（臨床試驗病例除外）,Standard regimens(PVP):1.Cisplatin(60-75 mg/m2)+
27、VP-16(60-80 mg/m2)D1,2,3/Q3W 2.Carboplatin(AUC=5)D1+VP-16(60-80 mg/m2)D1,2,3/Q3W Relapsed regimens:1.Ifosfamide 1000 mg/m2 D1-3+oral VP16 50 mg D1-10/Q3W 2.Topotecan 1.5 mg/m2 D1-3+epirubicin 30 mg/m2 D1/Q3W,Chemotherapy Regimens for Adjuvant Therapy-Cisplatin base,Chemotherapy Regimens for Adjuvant
28、 Therapy-Alternative,Cisplatin 若改成 Carboplatin,劑量為(CCr+25)x AUC,AUC=4-6,*Palitaxel+carboplatin regimen showed no survival benefit in stage IB patients,Staging,Proposed TNM classification and staging for primary tracheal carcinoma*,Primary Tracheal Cancer,*Ref:Paolo Macchiarini,Lancet Oncol 2006;7:83
29、91,H&PCBC,plateletChemistry profileSmoking cessation counselingPFTChest CT scanBronchoscopy Brain MRI,Stage I-III,IVA,Stage IVBMetastatic cancer,Multidisciplinary evaluation is encouragedPET/CT scanConsider 3D-CT reconstruction(multi-planar reconstruction,volume rendering technique,minimal intensity
30、 projector),Medical fit for surgery,resectable,Medical unfit for surgery,or unresectable,or surgery not elected and patient medically able to tolerate chemotherapy,Medical unfit for surgery and patient unable to tolerate chemotherapy,See Primary Treatment(TRACH-1),See Primary Treatment(TRACH-2),See
31、Primary Treatment(TRACH-2),See Primary Treatment(TRACH-3),WORKUP,CLINICAL STAGE,ADDITIONAL EVALUATION(as clinically indicated),Primary Tracheal Cancer,a,a Medically able to tolerate major thoracic surgery b Unresctable tumor:greater than 50%of tracheal length involved by tumor,“frozen”mediastinum,po
32、or general condition of patient,distant metastases in squamous cell carcinoma;Oncologist 1997;2;245-253,b,Primary Tracheal Cancer,Medically fit for surgery,resectable,PRIMARY TREATMENT,Surgery,ADJUNCTIVE/ADJUVANT TREATMENT,Radiation,Complete resection(R0):50Gy over tumor bed and adjacent mediastinum
33、 Incomplete resection with residual margin R1:R2:60Gy over tumor bed and 50Gy over adjacent mediastinum,a,a Medically able to tolerate major thoracic surgery c R0=No cancer at resection margins,R1=Microscopic residual cancer,R2=Macroscopic residual cancer,TRACH-1,c,c,Primary Tracheal Cancer,Medical
34、unfit for surgery,or unresectable,or surgery not elected and patient medically able to tolerate chemotherapy,Medical unfit for surgery and patient unable to tolerate chemotherapy,RT,60Gy+concurrent chemotherapy(Cisplatin-based)(preferred)or Best supportive care,RT 60-66Gy or Best supportive care,PRI
35、MARY TREATMENT,Best Supportive CareObstruction:stent,laser,photodynamic therapy,RT(external 30-50Gy or brachytherapy)Pain control:RT and/or medicationsNutrition,b Unresctable tumor:greater than 50%of tracheal length involved by tumor,“frozen”mediastinum,poor general condition of patient,distant meta
36、stases in squamous cell carcinoma;Oncologist 1997;2;245-253,TRACH-2,b,Primary Tracheal Cancer,Stage IVBMetastatic cancer,Karnofsky performance score 60 or ECOG performance score2,Karnofsky performance score 60 or ECOG performance score3,SALVAGE THERPAY,RT,60Gy+concurrent chemotherapy(Cisplatin-based)(preferred)or Chemotherapy or Best supportive care,Best supportive care,Best Supportive CareObstruction:stent,laser,photodynamic therapy,RT(external 30-50Gy or brachytherapy)Pain control:RT and/or medicationsNutrition,TRACH-3,台 北 榮 總 肺 癌 診 療 共 識 主要依據-NCCN v2 2009,本治療指引將每六個月檢討修訂一次預定下次修訂日期:2009年10月,
