前瞻性临床实验肝癌病患肿瘤切除後由肝门脉辅助性化学药物灌注课件

Hepatic Resection for BCLC Stage B and C HCC 周嘉揚 台北榮總 一般外科 Gar-Yang Chau, MD Professor of Surgery Department of Surgery Taipei Veterans General Hospital Outline Hepatic resection for BCLC stage B and C 1) 目前的 正反意見(pros and cons) 2) 現在主要的爭議點在那裡 3) 提出update evidences 4) 如何design 研究解決unsolved issue Barcelona Clinic Liver Cancer (BCLC) Staging Performance status Tumor charactersLiver function Very early stage 0Single tumor 50% Operative mortality 5 cm, to put patients either into BCLC A or B? Recently, the BCLC team stresses that a single HCC above 5 cm should be classified as BCLC A - Forner A, et al. Nat Rev Clin Oncol 2014;11:525 - Bruix J, et al. Ann Surg 2015;262:e30 Chang et al. Surgery 2012;152:809 n5-year survival BCLC B31846% BCLC C16029% Operative mortality 132.7% In this study, patients with single HCC 5 cm were included in stage B. Recently the BCLC team emphasized that all single HCCs of any size with no satellites and/or vascular invasion should be classified as BCLC-A stage. Stage reassignment is necessary (a single HCC above 5 cm was classified as BCLC A and not B). Stage Reassignment of BCLC Stage A and B Patients BCLC A (n=533) BCLC B (n=347) BCLC C (n=194) BCLC A (n=659) BCLC B(n=221) BCLC C (n=194) Single HCC 5 cm as BCLC ASingle HCC 5 cm as BCLC B 47%41% BCLC B total (n=221) Disease-free (n=32) (14.5%) 1074 HCC patient undergoing hepatic resection, Taipei VGH, from 1991-2005 Patients with long-term ( 10 years) disease-free survival, still alive at the time of this analysis BCLC C total (n=194) Disease-free (n=26) (13.4%) Recent Strategies in the Treatment of BCLC B and C HCC: In favor of Hepatic Resection as the First-line of Treatment NCNN guidelines The APASL recommendation 台灣肝癌醫學會2014肝癌診療共識 3232 Beyond the AASLD Guidelines NCCN Guidelines for the Treatment of HCC (version 1.2016) Tumor size is not a determinant of hepatic resection Resection can be considered in patients with Limited and resectable multifocal disease In HCC with major vascular invasion National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. 2016 Contents Agree (6 voters) If agree, please give score of E and R 2. 多發性肝癌若侷限於單一肝葉，仍可 有機會給予治癒性切除。若多發性肝 癌發生於兩側肝葉， 3顆病灶，且位 於肝深部或肝門侵犯，則不適合切除 。(E-2, R-B) 6/6 (100%) E-2 : 6 (100%) R-B: 5 (83%) A: 1 (17%) 台灣肝癌醫學會2014肝癌診療共識: Surgery (2) Ref(1) Ho MC, et al. Ann Surg Oncol 2009;16:848 (2) Ishizawa T, et al. Gastroenterology 2008;134:1908 (3) Yau T, et al. Gastroenterology 2014;146:1691 Contents Agree (6 voters) If agree, please give score of E and R 3. 肝癌單側門脈侵襲，仍可有機會給予 治癒性切除。若發生門脈主幹侵襲或 對側分支侵襲，則不適合切除。(E-2, R-B) 6/6 (100%) E-2 : 6 (100%) R-B: 5 (83%) C: 1 (17%) 台灣肝癌醫學會2014肝癌診療共識: Surgery (3)Surgery (3) Ref(1) Liu PH, et al. Ann Surg Oncol 2014;21:1825 (2) Wu CC, et al. Arch Surg 2000;135:1273 (3) Chen XP, et al. Ann Surg Oncol 2006; 13:940 (4) Pawlik TM, et al. Surgery 2005; 137: 403 Contents Agree (6 voters) If agree, please give score of E and R 4. 肝癌發生單枝肝靜脈侵襲，仍可有機 會給予治癒性切除。若發生下腔靜脈 或右心室侵襲，則不適合切除。(E-2, R-B) 6/6 (100%) E-2 : 5 (83%) 3: 1 (17%) R-B: 5 (83%) C: 1 (17%) 台灣肝癌醫學會2014肝癌診療共識: Surgery (4) Ref (1) Wu CC, et al. Surgery 2012;151:223 (2) Kokudo T, et al. J Hepatology 2014;61:583 Contents Agree (6 voters) If agree, please give score of E and R 5. 肝癌發生單一器官肝外轉移，仍可有 機會給予治癒性切除。若發生多處轉 移或肝癌肝內病灶進展中，則不適合 切除。(E-3, R-B) 6/6 (100%) E-2 : 3 (50%) 3: 3 (50%) R-B: 4 (67%) C: 2 (33%) 台灣肝癌醫學會2014肝癌診療共識: Surgery (5) Surgery (5) Ref(1) Chan KM, et al. World J Gastroenterol 2009;15:5481 (2) Jung SM, et al. 2012;27:684 (3) Lin CC, et al. J Gastroenterol Hepatol 2009;24:815 Resection TACESorafenib Simplicity- + Safety+ + Oncological efficacy Curability+ - To prolong survival + Treatment priority B1 23 C132 3838 Treatment Option for BCLC B/C HCC Treatment strategy for BCLC stage B and C HCC Torzilli G, et al. Ann Surg 2015;262:e31 Hepatic Resection for BCLC B/C HCC Practical and Ethical Consideration AscitesT.Bil 2 (mg/dL) Alb3 (g/dL) Technical curability Remnant 40% (LC+) Severe co- morbidities Patient reluctant Resection +No +No +No -No +No +No +No 4040 We need properly designed randomized controlled trials with adequate sample size comparing hepatic resection with state of the art TACE procedures in BCLC B and C patients Potential confounding factors Tumor staging Liver function Tumor location Surgical margin Need of extensive liver resection Co-morbidities Some issues Very poor outcome for TACE Ill-defined inclusion criteria Patients in the TACE group had slightly larger tumors and slightly poorer liver function than those in the surgical cohort No report on performance status Only 7% of the patients screened met the inclusion criteria for being randomized J Hepatol 2014;61:82 Roayaie S. J Hepatol 2014;61:3 Metussin A, et al. J Heptal 2015;62:739 Pang Q, et al. J Hepatol 2015;62:748 Questions Remain Unanswered To differentiate patients who are more likely to benefit from hepatic resection from those who are unlikely to benefit in such a heterogeneous BCLC stage B and C HCC population To know which proportion these patients represent among the whole population of patients at BCLC stage B or C We have to recognize that most patients with HCC in the world are treated at less specialized centers, and whether a more conservative approach might be reasonable “You ask, what is our aim? I can answer in one word: Victory. Victory at all costs Victory, however long and hard the road may be, for without victory there is no survival.” 4444 Sir Winston Churchill, (1874 1965) ) In the fighting against HCC 4545 “You ask, what is our aim? I can answer in one word: Survi