Lung Cancer For non-small cell lung cancer

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1 胰臟癌癌症中心胰臟癌醫療團隊擬定為參考國家衛生研究院出版之胰臟癌臨床指引及其他參考文獻, 於由胰臟癌團隊相關人員陳以書康朞翔蔡忠育江佳陵陳海雄張國桢李懷寶葉昶宏等人討論後共同修訂注意事項 : 這個診療準則主要作為醫師和其他保健專家診療癌症病人參考之用假如你是一個癌症病人, 直接引用這個研究資訊及診療準則並不恰當只有你的醫師才能決定給你最恰當的治療 1

15 由胰臟癌團隊相關人員陳以書康朞翔蔡忠育江佳陵陳海雄張國桢李懷寶葉昶宏等人討論後共同修

2 會議討論日期上次會議 : , 本共識與上一版的差異增加癌症藥物停藥準則 2

3 評估診斷治療追蹤病史, 理學檢查營養及日常體能狀態胸部 X 光血液常規電解質及肝腎功能腫瘤指標 (CEA, Ca19-9) 腹部超音波腹部電腦斷層攝影核磁共振檢查內視鏡超音波 +FNA 經內視鏡逆行性膽胰管攝影術 (ERCP) 必要時評估腹腔鏡 Resectable 膽道阻塞 Resectable 剖腹手術或腹腔鏡手術切除術中發現不可切除切片 R0,LN(-) R0,LN(+) R1 Unresectable 可考慮繞道手術 ± Adjuvant C/T Adjuvant C/T Adjuvant C/T 或 CCRT+C/T ( 比照局部晚期 ) Adjuvant C/T 或 CCRT +C/T 或 IA ( 比照局部晚期 ) GOT/GPT, ALP, Alb, CBC, CEA, CA199 Every 3 months for 2 years Every 6 months for 3-5years then annually CXR Every 3 months for 5 years then annually Abdominal CT or MRI Annually for 3 years then as clinically indicated 術前膽管炎暫時性支架體外引流術前膽管炎繞道手術 (Biliary ± GI bypass) 術前黃疸但無膽管炎不需引流永久性支架流體外引流 3

部晚期 ) Adjuvant C/T 或 CCRT +C/T 或 IA ( 比照局部晚期 ) GOT/GPT, ALP, Alb, CBC, CEA, CA199 Every 3 months for 2 years Every 6 months for 3-5years then annually CXR Every 3 months for 5 years then

4 評估診斷治療追蹤病史, 理學檢查營養及日常體能狀態胸部 X 光血液常規電解質及肝腎功能腫瘤指標 (CEA, Ca19-9) 腹部超音波腹部電腦斷層攝影核磁共振檢查內視鏡超音波 +FNA 經內視鏡逆行性膽胰管攝影術 (ERCP) 必要時評估腹腔鏡 Borderline Resectable 剖腹手術或腹腔鏡手術 Neoadjuvant C/T 或 IA ( 比照局部晚期 ) 可 R0 切除不可 R0 切除評估手術可能性手術切除切片 ± 繞道手術 (Biliary ± GI bypass) 可 R0 切除不可 R0 切除手術切除切片 ± 繞道手術 (Biliary ± GI bypass) Adjuvant C/T Adjuvant C/T 或 CCRT+C/T 或 IA ( 比照局部晚期 ) 可考慮 C/T C/T 或 CCRT+ C/T 或 IA ( 比照局部晚期 ) GOT/GPT, ALP, Alb, CBC, CEA, CA199 Every 3 months for 2 years Every 6 months for 3-5years then annually CXR Every 3 months for 5 years then annually Abdominal CT or MRI Annually for 3 years then as clinically indicated 4

除不可 R0 切除手術切除切片 ± 繞道手術 (Biliary ± GI bypass) Adjuvant C/T Adjuvant C/T 或 CCRT+C/T 或 IA ( 比照局部晚期 ) 可考慮 C/T C/T 或 CCRT+ C/T 或 IA ( 比照局部晚期 ) GOT/GPT, ALP, Alb, CBC,

5 評估診斷治療追蹤病史, 理學檢查營養及日常體能狀態胸部 X 光血液常規電解質及肝腎功能腫瘤指標 (CEA, Ca19-9) 腹部超音波腹部電腦斷層攝影核磁共振檢查內視鏡超音波 +FNA 經內視鏡逆行性膽胰管攝影術 (ERCP) Unresectable 局部晚期遠處轉移切片 ( 體外或 EUS+FNA) 切片 ( 可針對轉移病灶 ) 日常體能狀態 (ECOG) Grade 0-2 Grade >2 分 C/T 或 CCRT +C/T 支持性治療或 C/T GOT/GPT, ALP, Alb, CBC, CEA, CA199 Every 3 months for 2 years Every 6 months for 3-5years then annually CXR Every 3 months for 5 years then annually Abdominal CT or MRI Annually for 3 years then as clinically indicated 必要時評估腹腔鏡 5

0-2 Grade >2 分 C/T 或 CCRT +C/T 支持性治療或 C/T GOT/GPT, ALP, Alb, CBC, CEA, CA199 Every 3 months for 2 years Every 6 months for 3-5years then

6 * 可手術切除 (MD-CT or MRI): 1 無遠處轉移 2 上腸繫膜靜脈 (SMV) 或肝門靜脈 (PV) 完好 3 腹腔動脈幹 (celiac trunk) 肝動脈 (HA) 上腸繫膜動脈 (SMA) 完好 *Borderline 可切除 : 1 無遠處轉移 2 上腸繫膜靜脈 (SMV) 或肝門靜脈 (PV) 可能被侵犯, 但可手術切除部份血管並清除腫瘤 3 胃十二指腸動脈 (GDA) 或肝動脈 (HA) 被侵犯, 但可手術切除部份血管並清除腫瘤 4 上腸繫膜動脈 (SMA) 完好, 但未超過 180 * 不可切除 : 胰臟頭部腫瘤 1 有遠處轉移 2 上腸繫膜動脈 (SMA) 被侵犯 >180, 或 celiac trunk 被侵犯 3 上腸繫膜靜脈 (SMV) 或肝門靜脈 (PV) 不可切除 ( 無法重建血管 ) 4 主動脈或下腔靜脈被侵犯胰臟體部腫瘤 1 有遠處轉移 2 上腸繫膜動脈 (SMA) 被侵犯 >180 3 上腸繫膜靜脈 (SMV) 或肝門靜脈 (PV) 不可切除 ( 無法重建血管 ) 4 主動脈被侵犯胰臟尾部腫瘤 1 有遠處轉移 2 上腸繫膜動脈 (SMA) 被侵犯 >180 3 淋巴結轉移至切除範圍外

: 胰臟頭部腫瘤 1 有遠處轉移 2 上腸繫膜動脈 (SMA) 被侵犯 >180, 或 celiac trunk 被侵犯 3 上腸繫膜靜脈 (SMV) 或肝門靜脈 (PV) 不可切除 ( 無法重建血管 ) 4 主動脈或下腔靜脈被侵犯胰臟體部腫瘤 1 有遠處轉

7 化學治療處方建議表 Adjuvant chemotherapy(r0 切除 ) TS mg/day (po 4 weeks on, 2 weeks off/ or po 2 weeks on, 1 weeks off) BSA 1.5m 2 : 120mg /day, 1.25m 2_ 1.5m 2 : 100mg/day, <1.25m 2 : 80mg/day Schedule Q42 d /cycle x 4 Reference (No)/ strength of Evidence NO.04/Level IB Gemcitabine 1000 mg/m 2, IV,D1,D8,D15 Q28 d /cycle x 6 NO.05/Level IB NO.06 /Level IB 5-FU/LV Leucovorin 20mg/m 2, IV bolus, and then 5-FU 425mg/m 2, IV bolus, total 5 days Q28 d/cycle x 6 NO.07/Level IB 健保用藥 9.4.1:Gemcitabine 限用於晚期或無法手術切除之非小細胞肺癌及胰臟癌病患健保用藥 9.46:TS-1 治療局部晚期無法手術切除或轉移性胰臟癌病人 a. 若淋巴結陽性, 符合晚期可以開立健保給付之 Gemcitabine 與 TS-1 b. 若淋巴結陰性, 不符合晚期 Gemcitabine 與 TS-1 需用自費開立 ; 或使用 5-FU/LV 則無給付之疑慮, 但證據強度較 Gemcitabine 低 7

06 /Level IB 5-FU/LV Leucovorin 20mg/m 2, IV bolus, and then 5-FU 425mg/m 2, IV bolus, total 5 days Q28 d/cycle x 6 NO.07/Level IB 健保用藥 9.4.1:Gemcitabine 限用於晚期或無法手術切除之非小細胞肺癌及胰臟癌病患健保用藥 9.

8 化學治療處方建議表 Chemotherapy for unresectable (ECOG grade 0-2) Schedule Reference (No)/ strength of Evidence FOLFIRINOX Oxaliplatin 85 mg/m 2,IV,2hrs Leukovorin 400 mg/m 2,IV,2hrs Irinotecan 180 mg/m 2,IV,90mins 5-FU 400 mg/m 2,IV bolus 5-FU 2400 mg/m 2,IV,46hrs Q2W NO.08/Level IB Gemcitabine 1000 mg/m 2, IV,D1,D8,D15 Q28 d NO.09/Level IA Gemcitabine 1000 mg/m 2, IV,D1,D8 TS mg/day BSA 1.5m 2 : 100mg /day, 1.25m 2_ 1.5m 2 : 80mg/day, <1.25m 2 : 60mg/day,PO,D1-14 TS mg/day (po 4 weeks on, 2 weeks off/ or po 2 weeks on, 1 weeks off) BSA 1.5m 2 : 120mg /day, 1.25m 2_ 1.5m 2 : 100mg/day, <1.25m 2 : 80mg/day Q21 d Q42 d /cycle NO.10 /Level IB NO.10 /Level IB 8

09/Level IA Gemcitabine 1000 mg/m 2, IV,D1,D8 TS-1 60-100mg/day BSA 1.5m 2 : 100mg /day, 1.25m 2_ 1.5m 2 : 80mg/day, <1.

9 化學治療處方建議表 Chemotherapy for unresectable(ecog grade > 2) Schedule Reference (No)/ strength of Evidence Gemcitabine 1000 mg/m 2, IV,D1,D8,D15 Q28 d NO.09/Level IA TS mg/day (po 4 weeks on, 2 weeks off/ or po 2 weeks on, 1 weeks off) BSA 1.5m 2 : 120mg /day, 1.25m 2_ 1.5m 2 : 100mg/day, <1.25m 2 : 80mg/day 支持性治療 Q42 d /cycle NO.10 /Level IB 9

09/Level IA TS-1 80-120mg/day (po 4 weeks on, 2 weeks off/ or po 2 weeks on, 1 weeks off)

10 動脈內化學放射治療處方建議表 Indications: 1.Borderline resectable, 術中發現不可切除 2.Unresectable, locally advanced, with or without regional lymph nodes 3.Unresectable, liver only metastases, with or without regional lymph nodes Intra-arterial Chemoradiotherapy for unresectable ( 局部晚期或肝轉移,ECOG grade 0-2) IA Chemotherapy regimen (IA port implantation) Gemcitabine 100 mg/m 2 /d; 5-FU 200 mg/m 2 /d; cisplatin 10 mg/m 2 /d; MMC 2 mg/m 2 /d, leucoverin 15mg/m 2 /d, d1-5 Radiation therapy 2 Gy/d for 5 days, 4wks, total Gy Schedule d1-d5, IA CCRT d8-d12, R/T d15-d19, R/T d21-d25, R/T Followed by IA C/T on d1-d5/28-d cycle until disease progression Reference (No)/ strength of Evidence NO.11/Level IA, NO.12/Level IB NO.13/Level IIB 10

port implantation) Gemcitabine 100 mg/m 2 /d; 5-FU 200 mg/m 2 /d; cisplatin 10 mg/m 2 /d; MMC 2 mg/m 2 /d, leucoverin 15mg/m 2 /d, d1-5 Radiation therapy 2 Gy/d for 5 days, 4wks, total

11 放射治療處方建議表 Indication: (1)Adjuvant CCRT for R1 resection and R2 resection (2)For medically fit patients but unresectable cancer without distant metastasis (3)For medically unfit patients without distant metastasis (4)Following CCRT, additional maintenance chemotherapy is suggested Reference (No)/ strength of Evidence N0.14/Level CCRT: (1)Radiation therapy: Target volume: tumor bed, adjacent LN and surgical anastomosis (for post OP adjuvant CCRT) Dose: Gy (1.8-2 Gy/day) (2)Chemotherapy regimen: Gemcitabine (600 mg/m2 ) beginning the first day of RT (before RT), then weekly thereafter during RT 11

12 癌症藥物停藥準則影像學檢查, 腫瘤有變大或轉移變多, 應停止或改變治療方式 12

13 Reference 1.NCCN guideline Version Pancreatic Adenocarcinoma 2.NHRI/TCOG Cancer Practice Guideline Pancreatic Cancer 3.Seufferlein T, Bachet JB, Van Cutsem E, Rougier P; ESMO Guidelines Working Group: Pancreatic adenocarcinoma: ESMO-ESDO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol Oct;23 Suppl 7:vii Akira Fukutomi et al. JASPAC 01 trial (ASCO 2013) 5. Helmut Oettle et al. Adjuvant Chemotherapy With Gemcitabine vs Observation in Patients Undergoing Curative-Intent Resection of Pancreatic Cancer. (JAMA. 2007; 297: ). 6. H Ueno et al. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer.(British Journal of Cancer 2009, 101, ). 7. John P. Neoptolemos et al. Adjuvant Chemotherapy With Fluorouracil Plus Folinic Acid vs Gemcitabine Following Pancreatic Cancer Resection (JAMA. 2010: ). 8. Thierry Conroy et al. FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer. (N Engl J Med 2011;364: ). 9. H A Burris 3 rd et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. (J Clin Oncol Jun;15(6): ) 10. Hideki Ueno et al. Randomized Phase III Study of Gemcitabine Plus S-1, S-1 Alone, or Gemcitabine Alone in Patients With Locally Advanced and Metastatic Pancreatic Cancer in Japan and Taiwan: GEST Study(J Clin Oncol 31: ). 11.Liu F, Tang Y, Sun J, Yuan Z, Li S, Sheng J, Ren H, Hao J. Regional Intra-Arterial vs. systemic Chemotherapy for Advanced Pancreatic Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS ONE 2012;7(7):e

2012 Oct;23 Suppl 7:vii33-40. 4. Akira Fukutomi et al. JASPAC 01 trial (ASCO 2013) 5. Helmut Oettle et al.

14 Reference 12.Tanaka T, Sakaguchi H, Anai H, Yamamoto K, Morimoto K, Tamamoto T, Kichikawa K. Arterial Infusion of 5- Fluorouracil Combined with Concurrent Radiotherapy for Unresectable Pancreatic Cancer: Results from a Pilot Study. AJR 2007; 189: Tanaka T, Sho M, Nishiofuku H, Sakaguchi H, Inaba Y, Nakajima Y, Kichikawa K. Unresectable Pancreatic Cancer: Arterial Embolization to Achieve a Single Blood Supply for Intraarterial Infusion of 5-Fluorouracil and Full-Dose IV Gemcitabine. AJR 2012; 198: Gemcitabine Alone Versus Gemcitabine Plus Radiotherapy in Patients With Locally Advanced Pancreatic Cancer: AN Eastern Cooperative Oncology Group Trial. J Clin Oncol 2011 Nov 1;29(31):

Tanaka T, Sho M, Nishiofuku H, Sakaguchi H, Inaba Y, Nakajima Y, Kichikawa K.

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<A7DCC0F9C3C4AAABAA76C0F8A6DBA7DAB7D3C555A4E2A5552DA4BAA4E52E706466> 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 您的長期治療及追蹤計畫一覽表日期手術治療治療計畫追蹤計畫化學放射電腦超音波 X 光抽血骨髓內視鏡全身骨治療治療斷層檢查檢查檢查檢查檢查骼掃瞄人工血