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台 北 榮 總 肺 癌 診 療 共 識 V.1.1 2013

台 北 榮 總 肺 癌 診 療 共 識 V.1.1 2013. 台北榮總肺癌團隊 Revised on 2013/07/29. Multidisciplinary Team Taipei VGH Lung Cancer Panel Members TNM staging Taipei VGH supplement to TNM staging Table of stage grouping Evaluation and treatment Stage o (Tis)

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台 北 榮 總 肺 癌 診 療 共 識 V.1.1 2013

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  1. 台 北 榮 總 肺 癌 診 療 共 識V.1.1 2013 台北榮總肺癌團隊 Revised on 2013/07/29

  2. Multidisciplinary Team Taipei VGH Lung Cancer Panel Members TNM staging Taipei VGH supplement to TNM staging Table of stage grouping Evaluation and treatment Stage o (Tis) Stage I (T1ab-2a,N0) and Stage II (T1ab-2ab, N1; T2b, N0), and Stage IIB(T3, N0) Stage IIB (T3 invasion, N0) and stage IIIA (T3-4,N1) Stage IIIA (T1-3,N2) and Separate Pulmonary Nodules (stage IIB, IIIA, IV) Stage IIIB (T1-3, N3) Stage IIIB (T4 extension, N2-3) and Stage IV (M1a)(pleural or pericardial effusion) Stage IV (M1b: solitary site) Surveillance Therapy for Recurrence and Metastases Occult (Tx,N0,M0),Evaluation and Treatment Second Lung Primary, Evaluation, and Treatment Principles of Surgical Resection Principles ofPathology Principles of Radiation Therapy - Recommended Radiation Doses - Dose Volume Data for Radiation Pneumonitis Principles of CCRT Principles of Chemotherapy -Non-Small Cell Lung Cancer -Small Cell Lung Cancer Adjuvant Chemotherapy Neoadjuvant Chemotherapy Clinical Trials for Advanced/ Metastatic NSCLC Tracheal 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。 台 北 榮 總 肺 癌 診 療 共 識

  3. 癌委會 台北榮總肺癌委員會暨肺癌多專科團隊組織架構 肺癌委員會暨肺癌多專科團隊 召集人:蔡俊明、許文虎副召集人:賴信良、吳玉琮 個案管理師:宋易珍、洪秀瑩、 廖嘉苗 非核心成員 核心成員 胸內 胸外 放射 病理 放療 核醫 藥劑部 骨科 營養 社工

  4. 台北榮總肺癌多專科團隊核心人員 胸腔內科 李毓芹 蔡俊明 賴信良 陳育民 邱昭華 吳杰鴻 胸外 許文虎 吳玉琮 黃建勝 放射 許明輝 吳美翰 陳俊谷 病理 周德盈 葉奕成 放療 顏上惠 陳一瑋 藍耿立 核醫 王世楨 林可瀚 胡蓮欣

  5. NSCLC &SCLCTNM Staging * MX has been removed by a general rule from UICC/AJCC.

  6. Summary of Evaluation and Treatment • PFT: Necessary for all operable stages • PET (PET/CT) : recommend for all clinical stages, except • Non-operable stage IV • Mediastinoscopy: recommend for all clinical stages, except • Peripheral stage IA and non-operable stage IV p.s. N2 or N3 disease can be confirmed by methods including mediastinotomy, thoracoscopy, EBUS-FNA, EUS-FNA, CT-guided-FNA, supraclavicle LN biopsy • Brain MRI:recommend for all clinical stages, except • Stage I

  7. NSCL-1

  8. NSCL-2

  9. NSCL-3

  10. NSCL-4

  11. NSCL-5

  12. NSCL-6

  13. NSCL-7

  14. NSCL-8

  15. NSCL-9

  16. NSCL-10

  17. NSCL-11

  18. NSCL-12

  19. NSCL-13 Therapy for recurrent and advanced NON-SQUAMOUS CELL CARCINOMA Progression after EGFR-TKI EGFR-TKI regardless of PSb EGFR-TKI sensitive mutation (+)a Chemotherapy (category 1)PS= 0-1 or Bevacizumab + chemotherapy (if criteria met) PS= 2 Chemotherapy PS= 3-4 Best supportive care See NSCL-15 category 2B CR/PR/SD EGFR mutation testing EGFR-TKI sensitive mutation (-) PD See NSCL-16 EGFR mutation status unknown ALK mutation testing ALK mutation (+) ALK inhibitor (category 2B) a Tumors with EGFR gene deletion at exon 19, mutation at L858R, L861Q and G719X are those usually sensitive to EGFR-TKI. b EGFR-TKI is the preferred choice, but chemotherapy can be used if TKI is contraindicated or chemotherapy is the patient’s preference.

  20. NSCL-14 See NSCL-15

  21. NSCL-15 Maintenance Therapy First line Tx Maintenance Tx Pemetrexed or Erlotinib NON-SQUAMOUS CELL CARCINOMA CR/PR/SD or Regular follow-up Disease progression See NSCL-16 Erlotinib (category 2B) SQUAMOUS CELL CARCINOMA CR/PR/SD or Regular follow-up a Tumors with EGFR gene deletion at exon 19, mutation at L858R, L861Q and G719X are those usually sensitive to EGFR-TKI. b EGFR-TKI is the preferred choice, but chemotherapy can be used if TKI is contraindicated or chemotherapy is the patient’s preference.

  22. NSCL-16 Performancestatus 0-4 ALK mutation testing ALK mutation (+) ALK inhibitor

  23. 肺癌之手術治療原則 應當由通過專科認證並且以肺癌手術為主要執業項目的胸腔外科醫生來決定腫瘤可否以手術切除。 手術切除(包括楔形切除術)優於腫瘤消融術 (射頻消融、冷凍療法、立體定向放療)。每一位考慮行根治性局部治療的患者在接受評估時,都應諮詢胸腔腫瘤外科醫生的意見。手術切除高風險患者考慮以立體定位放射治療時,建議由包含放射腫瘤醫師之多專科團隊評估之。

  24. Local tumor ablation (Cryoablation/RFA/Microwave) Medically inoperable Node negative or node covered by radiotherapy Tumor Size < 4 cm ECOG <= 1

  25. 射頻腫瘤消融術(RFA) http://www.jaapa.com/rfa-is-an-effective-alternative-to-lobectomy-for-lung-cancer/article/123906/ 腫瘤內插入電極針,交流電被導入電極後經由人體流向貼在大腿的墊片再離開人體,射頻的能量在電極針非絕緣體部分釋放出來,導致腫瘤插針部位經由離子激化(ion agitation)產生熱量的形式,造成腫瘤局部組織的凝固性壞死(coagulation necrosis)。

  26. 肺癌之手術治療原則 在任何非緊急治療前,應完成完整治療計畫的制訂和必要的影像學檢查。 胸腔外科醫生應積極參加針對肺癌患者的多專科團隊討論和會議 (如多專科綜合治療門診和/或腫瘤委員會)。

  27. 肺癌之手術治療原則 • 對於大多數非小細胞肺癌患者,解剖性肺切除術為首選。 • 亞肺葉切除術(肺節切除和楔形切除)應當達到肺實質切緣大於等於2 公分或者大於等於結節的大小。 除非技術不可行性,術中在不顯著增加手術風險的情況下,應對Nl和N2淋巴結進行取樣活檢。肺節切除術(首選)或者楔形切除術基於下列原因可適用於部分特定患者: • 肺功能不佳(poor pulmonary reserve)或者因其他嚴重合併症而不能接受肺葉切除術 • 周圍型結節≤2 cm,並至少符合以下標準中的一項: • 組織學類型為純粹之原位型腺癌 (AIS) • CT檢查顯示結節≥50%表現為毛玻璃樣 • 影像學隨診檢查證實腫瘤倍增時間較長(≥400天)

  28. 肺癌之手術治療原則 如患者無解剖學和手術方面的禁忌症,只要不違反腫瘤治療標準和胸腔手術切除原則,電視輔助胸腔鏡外科手術(VATS)是一個可接受的合理選擇 在高個案量醫學中心(high volume centers)並具有相當的胸腔鏡外科手術經驗,選擇某些病人施行胸腔鏡肺葉切除可以改善短期結果(疼痛,住院天數,回復正常功能時間)而不會危及癌症預後 如解剖位置合適且能夠做到切緣(resection margin)陰性,保留肺組織的解剖性切除術(袖狀切除術)優於全肺切除術。

  29. 肺癌之手術治療原則 T3 (擴展) 及T4 局部侵犯腫瘤需要總括性(En-Bloc)切除所有腫瘤涉及之組織構造,以達到切緣陰性為目的。 如果外科醫師或醫學中心無法確定可否完整切除,可考慮取得其他高個案量醫學中心之外科第二意見 。 外科及病理的聯繫(Surgical pathologic correlation)對於評估顯然接近(apparent close)或陽性切緣非常重要 ,因為這些並不一定代表真正的切緣或代表真正會局部復發的區域(例如當隆凸下淋巴結分開廓清時,主支氣管或間支氣管的內面,或當沒有附著主動脈時鄰近主動脈的肋膜切緣) 。

  30. 肺癌之手術治療原則 N1和N2淋巴結切除並標明位置(最少對3個N2站的淋巴結進行取樣或行完全淋巴結清除術) IIIA期 (N2)患者在接受切除術時應行正規的同側縱隔淋巴結清除術 完整切除需求手術切緣陰性、系統性淋巴擴清或取樣、 無包膜外淋巴結腫瘤擴展( extracapsular nodal extension of tumor)、及最高位縱膈腔淋巴結為陰性。如果切緣陽性、包膜外淋巴結腫瘤擴展、無法移除的陽性淋巴結、或陽性肋膜或心包膜積液,則定義為非完整切除。完整切除歸類為R0 ,病理顯微鏡檢陽性為R1 ,肉眼可見殘餘腫瘤則為R2 。

  31. 肺癌之手術治療原則 術後病理分期為II期或以上的患者應當轉診至胸腔腫瘤內科進行評估。 IB期患者可考慮轉診至胸腔腫瘤內科,IIIA期患者可考慮轉診至放射腫瘤科。

  32. PRINCIPLES OF PATHOLOGICAL REVIEW 病理評估 病理評估的目的包括: 準確分類肺癌組織型態 依循AJCC建議確定所有分期參數,包括腫瘤大小、侵犯範圍(肋膜及支氣管)、手術切除邊緣適當性及淋巴結轉移評估 進一步確定腫瘤的特殊分子異常是預測使用tyrosine kinase inhibitors(TKI)治療的關鍵 手術病理報告應該有WHO肺癌組織分類。應於切除標本及小標本使用最新發表之肺腺癌分類,強烈建議不使用細支氣管肺泡癌(bronchioloalveolar carcinoma,BAC)這個診斷。 NSCLC這個診斷應盡量避免使用,除非是已經過廣泛病理診斷檢查後仍無法分辨特別分化之病例。 高度建議盡可能獲得新鮮冷凍之腫瘤組織來進行分子分析,特別是在末期疾病。福馬林固定石臘包埋之腫瘤亦可用於多數分析。 肺腺癌分類 Preinvasive lesions Atypical adenomatous hyperplasia Adenocarcinoma in situ (AIS; formerly BAC)- <3cm nodule, lepidic growth Minimally invasive adenocarcinoma (MIA)- <3cm nodule with <5mm invasion, predominantly lepidic growth Invasive adneocarcinoma- lepidic predominant growth with >5mm of invasion; acinar, papillary, micropapillary or solid with mucin production Invasive adenocarcinoma variants- mucinous adenocarcinomas, colloid, fetal and enteric morphologies

  33. PRINCIPLES OF PATHOLOGICAL REVIEW 免疫組織化學染色 免疫染色可幫助鑑別原發性肺癌分類或轉移肺腺癌,區別腺癌及惡性間皮細胞癌,決定腫瘤之神經內分泌分化。 原發性肺腺癌 TTF-1對區分原發或轉移肺腺癌很重要。大部分(70-100%)原發肺腺癌(nonmucinous)TTF-1為陽性,轉移腺癌(甲狀腺癌除外)為陰性反應。 Napsin A於>80%的肺腺癌表現,可用於輔助TTF-1。 Primary lung adenocarcinoma: TTF-1(+) / CK7(+) / CK20(-) / CDX-2 (-) Metastatic colorectal carcinoma: TTF-1(-) / CK7(-) / CK20(+) / CDX-2 (+) Mucicarmine, p63, CK5/6, CK34βE12可用於分辨肺腺癌及鱗狀細胞癌 TTF-1, Napsin A, p63及CK5/6可用於重新分類之前診斷為NSCLC的小標本。 神經內分泌分化 CD56, chromogranin及synaptophysin可用於辨識神經內分泌分化。 惡性間皮細胞癌vs.肺腺癌 建議使用兩個已知的間皮細胞癌免疫陽性抗體及兩個已知的腺癌免疫陽性抗體來做鑑別。 間皮細胞癌的免疫陽性抗體:WT-1, calretinin, D2-40, HMBE-1, cytokeratin 5/6 肺腺癌的免疫陽性抗體:CEA, B72.3, Ber-EP4, MOC31, CD15, TTF-1

  34. PRINCIPLES OF PATHOLOGICAL REVIEW 肺癌之分子診斷研究 • EGFR and KRAS • EGFR mutation之有無與TKI治療之反應相關;如TKI 對exon 21 mutation (L858R)與exon 19 deletion之腫瘤治療效果良好。 • EGFR與KRAS突變在肺癌病人中互不相存 • 腺癌EGFR突變的盛行率在西方人為10%,而在亞洲病人高達50%,且在非吸菸者、女性及非黏液腫瘤有較高EGFR突變頻率。最常見的突變位置在exon 21 (L858R)及exon 19 deletions。 • TKI治療抗藥性與KRAS突變及特殊後天的EGFR突變(如T790M)有關 • EML4-ALK • 多數EML4-ALK與EGFR突變互不相存。EML4-ALK轉位易發生在年輕病人、不吸菸以及較末期Adenocarcinoma。 • 最新分子診斷試驗利用fluorescence in situ hybridization (FISH)最近已被美國FDA認可用於診斷

  35. PRINCIPLES OF PATHOLOGICAL REVIEW 小細胞癌 • 小細胞癌(SCLC)是一種惡性上皮腫瘤,由極少細胞質、不清楚的細胞邊緣、細緻顆粒狀的核染色質及沒有或不明顯的核仁的小細胞所組成。這些細胞呈圓形、橢圓或梭狀,且核相嵌現象明顯。高達30%SCLC病人解剖時發現部分NSCLC分化,此現象較常於先前接受過治療的病人檢體上發現,暗示肺癌的形成來自能夠有不同分化的多潛能幹細胞。 • 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。 • 幾乎所有SCLCs免疫染色keratin、epithelial membrane antigen (EMA)及thyroid transcrption factor-1 (TTF-1)呈陽性。多數SCLC亦表現神經內分泌分化,CD56、synaptophysin、chromogranin A或neuron-specific enolase (NSE)呈陽性免疫染色。

  36. Volumetric Modulated Arc Therapy (RapidArc)

  37. 按2012年NCCN guideline的精神,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,來決定照射的角度、劑量和範圍,技術包括三度空間順形治療(3D conformal radiotherapy,3DCRT),強度調控放射治療(intensity-modulated radiotherapy,IMRT),動態式弧形放射治療 (Volumetric Modulated Arc Therapy,VMAT),影像導引斷層式治療(Tomotherapy) 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 。

  38. Recommended Radiation Doses for NSCLC(Modified doses for domestic patients)

  39. Recommended Dose/Volume Limit for Lung QUANTEC = Quantitative Analysis of Normal Tissue Effects in the Clinic V20 = % of whole lung receiving ≥ 20 Gy MLD = Mean Lung Dose • QUANTEC is recommended by NCCN guideline 2012 • For conventional fractionation, definitive RT: • V20 ≦ 30–35% and MLD ≦ 20–23 Gy to limit the risk of radiation pneumonitis to ≦ 20% • Limiting the dose to the central airways to ≦ 80 Gy to reduce the risk of bronchial stricture • Reference : Radiation dose-volume effects in the lung. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S70-6.

  40. Radiation Therapy for Small Cell Lung Cancer ◎Limited SCLC 1.年齡小於等於70歲,PS:0~1,接受CCRT DOSE:56~70 Gy/2Gy/day 排程:放療自開始持續做至 56~70 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PR/CR持續化學治療 2.年齡大於70歲,PS:0~1,採用接續性化放療(sequential chemoradiotherapy) DOSE:50~60 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PR/CR加做胸腔的放療及三個療程的化學治療 3.如有PD接受第二線化療。 ◎Prophylactic cranial irradiation (PCI) 1. Limited or extensive stage,CR 或 PR after initial treatment 且PS:0~1,可考慮加做PCI DOSE: 30Gy/ 2Gy/ day x15 fractionsor 25Gy/2.5Gy/day x10 fractions

  41. ◎NSCLC Dose: up to 60-66Gy/1.8-2Gy/day ◎Limited SCLC 1.年齡小於等於70歲,PS:0~1,接受CCRT DOSE:50~60 Gy/1.8Gy/day 排程:放療自開始持續做至50~60 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/ day x15 fractions(一天一次共十五次) 如有PR持續化學治療,但不做PCI 2.年齡大於70歲,PS:0~1,採用接續性化放療(sequential chemoradiotherapy) DOSE:50~60 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PCI 3.如有PD接受第二線化療。 同步化學併放射治療(CCRT)原則

  42. 同步化學併放射治療(CCRT)原則 • Principles of chemotherapy regimen • Chemotherapy at systemic doses results in superior outcome but at the cost of an increased toxicity. • Platinum-based regimen is preferred • Reference regimens with combination of platinum • Etoposide • Vinorelbine or Vinblastine • Alternative regimens with combination of platinum • Paclitaxel • Docetaxel • Pemetrexed • High-risk drugs for CCRT • Gemcitabine • EGFR-TKI (gefitinib, erlotinib) • Bevacizumab • Doxorubicin

  43. ◎第一線 - Gemcitabine (GC-G)G (1000-1250mg/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) + Cisplatin (60- 75 mg/m2), Q3W.2.Paclitaxel (60-80 mg/m2)-D1,8,15 + Cisplatin (60-75 mg/m2) -D1, Q4W. - Docetaxel (TC or TC-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. - Pemetrexed (AC)Pemetrexed (500mg/m2) + Cisplatin (60-75mg/m2), Q3W. -Gefitinib 250 mg, QD. (if Non-SQ ,EGFR sensitizing mutation(+) ) -Erlotinib 150 mg, QD. (if Non-SQ ,EGFR sensitizing mutation(+) ) ※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 chemotherapy 並用於第一線治療, 但限於non-squamous cell carcinoma, no hemoptysis, no untreated CNS mets 4. Pemetrexate/cisplatin用於第一線治療以及 pemetrexate用於第二線 治療都僅限於non-squamous cell carcinoma ◎第二線 - Docetaxel 1. Docetaxel (60 - 75mg/m2)-D1, Q3W. 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 - Erlotinib 150 mg, QD. (if NSCLC) 肺癌化學治療用藥準則 – 非小細胞肺癌 * 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

  44. 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)+ 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

  45. Chemotherapy Regimens for Adjuvant Therapy-platintinum based ( Indication: pathological stage II and IIIA ) Chemotherapy Regimens for Adjuvant Therapy-non platintinum based ( Indication: Adeno, pT2 and tumor size > 3 cm ) Chemotherapy Regimens for Adjuvant Therapy- Alternative Cisplatin 若改成 Carboplatin, 劑量為 (CCr+25) x AUC, AUC = 4-6 *Palitaxel+carboplatin regimen showed survival benefit in stage IB, > 4 cm

  46. Primary Tracheal Cancer Staging Proposed TNM classification and staging for primary tracheal carcinoma* *Ref: Paolo Macchiarini, Lancet Oncol 2006; 7: 83–91

  47. Primary Tracheal Cancer WORKUP CLINICAL STAGE ADDITIONAL EVALUATION (as clinically indicated) Medical fit for surgery, resectable See Primary Treatment (TRACH-1 ) a Medical unfit for surgery, or unresectable, or surgery not elected and patient medically able to tolerate chemotherapy • Multidisciplinary evaluation is encouraged • PET/CT scan • Consider 3D-CT reconstruction (multi-planar reconstruction, volume rendering technique, minimal intensity projector) b See Primary Treatment (TRACH-2 ) • H&P • CBC, platelet • Chemistry profile • Smoking cessation counseling • PFT • Chest CT scan • Bronchoscopy • Brain MRI Stage I-III, IVA Medical unfit for surgery and patient unable to tolerate chemotherapy See Primary Treatment (TRACH-2 ) Stage IVB Metastatic cancer See Primary Treatment (TRACH-3) a Medically able to tolerate major thoracic surgery b Unresctable tumor: greater than 50% of tracheal length involved by tumor, “frozen”mediastinum, poor general condition of patient, distant metastases in squamous cell carcinoma; Oncologist 1997;2;245-253

  48. Primary Tracheal Cancer PRIMARY TREATMENT ADJUNCTIVE/ADJUVANT TREATMENT Radiation c • Complete resection (R0): • 50Gy over tumor bed and adjacent mediastinum • Incomplete resection with residual margin • R1: • R2: • >60Gy over tumor bed and 50Gy over adjacent • mediastinum Medically fit for surgery, resectable c a Surgery 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

  49. Primary Tracheal Cancer PRIMARY TREATMENT Medical unfit for surgery, or unresectable, or surgery not elected and patient medically able to tolerate chemotherapy RT, 60Gy + concurrent chemotherapy (Cisplatin-based) (preferred) or Best supportive care b • Best Supportive Care • Obstruction: stent, laser, photodynamic therapy, RT (external 30-50Gy or brachytherapy) • Pain control: RT and/or medications • Nutrition Medical unfit for surgery and patient unable to tolerate chemotherapy RT 60-66Gy or Best supportive care b Unresctable tumor: greater than 50% of tracheal length involved by tumor, “frozen”mediastinum, poor general condition of patient, distant metastases in squamous cell carcinoma; Oncologist 1997;2;245-253 TRACH-2

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