Colon Cancer Liver Metastases: Liver-Directed Therapy

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1 Colon Cancer Liver Metastases: Liver-Directed Therapy Shishir K. Maithel, MD FACS Assistant Professor of Surgery Division of Surgical Oncology Winship Cancer Institute Emory University August 10, 2014

2 Outline Non-resection Liver-Directed Therapy Rationale for Surgery Risk stratification Patient selection Preoperative Chemotherapy Rationale Morbidity Duration of therapy Disappearing lesions EORTC trial Clinical Strategy Metachronous Synchronous

3 Non-Resection Liver-Directed Therapy 1. Ablation 2. Trans-arterial Chemoembolization (TACE) 3. Hepatic arterial infusion therapy 4. Yttrium-90 Radioembolization 5. SBRT

4 Resection vs Ablation Study design 418 patients ( ) 190 (45%) resection only 101 (24%) resection + RFA 57 (14%) RFA only 70 (17%) chemotherapy or no treatment No difference Tumor sizes Tumor numbers Patient characteristics Primary tumor characteristics Abdalla EK et al. Ann Surg 2004

5 Increased Recurrence with RFA Abdalla EK et al. Ann Surg 2004

6 Improved Survival with Resection Abdalla EK et al. Ann Surg 2004

7 55 patients Median 2 treatments of DEBIRI Failed prior systemic therapy Liver predominant disease Martin RCG et al. Ann Surg Onc 2011

8 Hepatic Arterial Infusion Pump

9 CALGB 9481 Randomized Trial HAIP-FUDR vs SYS-FU/LV Survival (months) Response (CR/PR) HAIP n=68 SYS n=67 p-value % 24% Kemeny N, et al. JCO. 24(9): 2006

10 HAI FUDR and Dex plus Systemic Oxaliplatin/CPT-11 Previous Sys. chemo No prior therapy (n=26) (n=21) Complete Response 2 2 Partial Response Stable Disease 1 Response Rate 23/26 (88%) 21/21 (100%) Median Survival 35 months 50 months Patients resected 10 (45%) 12 (57%) Kemeny N et al. JCO 21(20) 2009

11 HAIP and SIR-Spheres Randomized trial N=70 Liver +/- portal LN disease Unresectable CRCLM 34 patients: HAIP only 36 patients: HAIP + Y-90 (infused through port) Gray B et al. Ann Oncol 12: 2001

12 HAIP / Y-90 Improves Tumor Response Gray B et al. Ann Oncol 12: 2001

13 HAIP / Y-90 and Survival Improved Hepatic PFS Similar OS Similar grade 3-4 toxicity profile Gray B et al. Ann Oncol 12: 2001

14 Place HAIP first BEFORE doing SIRT Therapy Need GDA

15 RESECTABLE DISEASE

16 Rationale for surgery Natural history of unresected hepatic metastases Wagner, et al (Mayo 1983) Extent of liver mets 3 yr survival 5 yr survival Solitary (n=39) 21% 3% Multiple, one lobe (n=31) 6% 0% Widespread (n=182) 6% 2% Wood, et al (Glasgow 1976) Extent of liver mets 1 yr survival 3 yr survival Solitary (n=15) 60% 13% Multiple, one lobe (n=11) 27% 10% Widespread (n=87) 6% 0%

17 5 yr Survival: 0% Colucci et al. JCO 2005

18 Hepatic Resection for Colorectal Metastases Study N Mortality% 5-yr Surv Hughes, NS 33 Scheele, Rosen, Scheele, Nordlinger, Jamison, Fong, Abdalla, NS 58 Adam,

19 Factors to Consider Number of tumors Size of tumors Unilobar versus bilobar disease Stage of primary cancer Nodal status Response to chemotherapy Presence of extra-hepatic disease Disease-free interval

20 10-year survival (n=612) What precludes long term survival? <2yr 2-5yr 5-10yr >10yr Survival Survival Survival Survival Synchronous Dz (%) 13% 11% 5% 7% Node positive primary % 63% 56% 52% 50% Preop CEA > % 11% 8% 7% DFI < 12mos 51% 46% 36% 36% # of hepatic mets >1 59% 51% 32% 39% Size of hepatic met>5cm 53% 41% 41% 35% Margin Positive 20% 10% 9% 0% Resection: Lobectomy 63% 63% 62% 68% 4 metastases 23% 16% 11% 5% Tomlinson et al. J Clin Onc 2007

21 Partial Hepatectomy is Potentially Curative Proportion surviving <2yr 2-5yr 5-10 yr n = 612 with 10 yr FU Median Survival 44mos >10 yr CURE n= Years Tomlinson et al. JCO 2007

22 Shift in Perspective Surgery is not an adjunct to Chemotherapy Chemotherapy is an adjunct to Surgery

23 CHEMOTHERAPY

24 Preoperative Chemotherapy Rationale Eradicate microscopic disease prior to resection Allows determination of effectiveness of chosen regimen Time delay to surgery allows declaration of occult disease (biologic selection) Identify patients who progress Patients will not tolerate chemo after surgery Considerations Toxicity (patient and hepatic) Duration of therapy Disappearing lesions

25 Adam R et al. Ann Surg 2010

26 No Difference in Survival Preop Chemo No Preop Chemo Postop Chemo did NOT influence OS or DFS in patients with tumors < 5 cm in size Adam R et al. Ann Surg 2010

27 Identical Recurrence Pattern Adam R et al. Ann Surg 2010

28 Adam R et al. Ann Surg 2004

29 Blazer DG, Vauthey JN et al. JCO 2008

30 Gallagher DJ, Kemeny N et al. Ann Surg Onc 2009

31 Carpizo DR, D Angelica M et al. Ann Surg Onc 2009

32 Carpizo DR, D Angelica M et al. Ann Surg Onc 2009

33 CHEMOTHERAPY TOXICITY

34 Oxaliplatin Toxicity Sinusoidal Obstruction Portal Hypertension Splenomegaly Thrombocytopenia Overman MJ et al. JCO 2010

35 Rubbia-Brandt L et al. Ann of Oncology 2004

36 No Preop Chemo Preop Oxaliplatin Postop Complication 18.3% 26.5% Major Complication 9.5% 15.1% Vauthey JN et al. JCO 2006

37 No Steatohepatitis Steatohepatitis 90-Day Mortality 1.6% 14.7% Death from postop liver failure 0.8% 5.8% Vauthey JN et al. JCO 2006

38 Neoadjuvant Chemotherapy Study design 67 patients Major liver resection for colorectal metastases ( 3 segments) 45 (67%) had neoadjuvant chemotherapy 22 (33%) no preoperative therapy Chemotherapeutic agents FOLFOX FOLFIRI Karoui M et al. Ann Surg 2006; 243(1): 1-7

39 Neoadjuvant Chemotherapy Results Increased morbidity in chemotherapy group Karoui M et al. Ann Surg 2006; 243(1): 1-7

40 Neoadjuvant Chemotherapy Duration Minimal change in tumor response in the 4 6 month interval White, Kemeny et al. J. Surg Onc 2008

41 Complete Response (CR) after Chemotherapy: Does it mean cure? 586 patients treated 38 patients with CR of at least 1 lesion 66 sites disappeared on imaging Surgery 4 weeks after imaging Benoist S et al. JCO 24(24) 2006

42 Radiologic Response Does NOT Equal Pathologic Response 66 Sites with CR 20 sites seen at surgery 46 sites no lesion found 15 sites resected 31 sites left in place 12 (80%) viable tumor cells In situ recurrence in 23 (74%) 55/66 (83%) not cured Benoist S et al. JCO 24(24) 2006

43 mcrc with Liver only Metastases (up to 4 lesions) (N=364) R A N D O M I Z A T I O N Chemo Surg Chemo (n=182) Surgery (n=182) Endpoint 3-yr PFS Chemotherapy = FOLFOX4 X 6 cycles before and after surgery Nordlinger et al. Lancet 2008

44 Progression Free Survival Chemo + Surgery Surgery alone Nordlinger et al. Lancet 2008

45 Details of the EORTC Trial Not a trial of preoperative vs postoperative chemotherapy Only 7% progressed on preoperative chemotherapy 36 patients not given postoperative chemotherapy 6 patients: toxic effects from preop chemo 8 patients: perioperative complications Nordlinger et al. Lancet 2008

46 Details of the EORTC Trial Postop Complications Preop Chemo Surgery 25% 16% Preop Chemo Surgery 3-yr PFS 35.4% 28.1% 7.3% improvement in 3-yr PFS 6% difference in unresectability rate (4% vs 10%) 1 patient not resected due to liver damage from chemotherapy Survival curves remain parallel after time point of resection No difference in OS at 8-year follow up Nordlinger et al. Lancet 2008

47 CLINICAL STRATEGY METACHRONOUS

48 Resectable Disease Low CRS ( 2) High CRS (> 2) Resection Preoperative Chemotherapy (limited duration of 2 months) Postoperative Chemotherapy Resection Postoperative Chemotherapy

49 CLINICAL STRATEGY SYNCHRONOUS

50 Asymptomatic Primary Lesion Poultsides et al. JCO 2009

51 Simultaneous Resection Study design 240 patients with synchronous metastases Retrospective review Sep 1984 Nov 2001 Results Group I: 134 patients with simultaneous resection Small and fewer liver metastases Less extensive liver resection Group II: 106 patients with staged resection Blumgart L et al. JACS 2003

52 Results Simultaneous Resection Postoperative outcomes Fewer complications in Group I 49% versus 67% Decreased hospital stay (10 versus 18 days) No difference in perioperative mortality (< 3%) Conclusions Simultaneous resection is safe and efficient in selected patients Blumgart L et al. JACS 2003

53 Resectable Disease Symptomatic Resection (Primary ± Liver) Chemotherapy (limited duration of 2 months) Liver Resection Asymptomatic Preoperative Chemotherapy (limited duration of 2 months) Resection (Simultaneous or Staged) Postoperative Chemotherapy Postoperative Chemotherapy

54 Conclusions Patient selection is key Complete resection is the goal Perioperative chemotherapy is individualized

55 Colon Cancer Liver Metastases: Liver-Directed Therapy Shishir K. Maithel, MD FACS Assistant Professor of Surgery Division of Surgical Oncology Winship Cancer Institute Emory University August 10, 2014

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