Unresectable or boarderline resectable disease

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1 ESMO Preceptorship Colorectal Cancer Nov 2016 Barcelona Unresectable or boarderline resectable disease Claus-Henning Köhne Klinik für Onkologie und Hämatologie North West German Cancer Center (NWTZ)

2 Learning objectives All patients with liver limited or oligometastatic disease have a potential chance for cure A multidisciplinary aproach is essential The clinical presentation may be considered as Resectable, boarderline resectable, potentially resectable after chemotherapy In resectable disease surgery alone or following chemotherapy are options In boarderline and unresectable disease the most effective and still tolerable chemotherapy according to the molecular profile should be used within a multidisciplinary context Even if surgery might not be curative it extends overall survival and can be considered as a further line of chemotherapy or a form of maintenance chemotherapy

3 Guidelines CRC mut mut

4 ESMO Guidelines for resectable (liver) metastases

5 Liver limited disease: Patient groups Clearly resectable Borderline resectable Definitely NOT resectable

6 Resectable LLD but high risk of recurrence Fong Score Primary tumor N + DFI < 12 Monate > 1 Metastasis > 5 cm CEA > 200 ng/ml >12cm Age 51y Rectal Adeno-Ca: ct3, N+ Synchroneous LLD, ø 12 cm CEA 568 ng/ml High Fong Score Estimated 5y < 10%

7 Group 0 Resectable metastases Primary tumor N + DFI < 12 Monate > 1 Metastasis > 5 cm CEA > 200 ng/ml Fong score > 2 Disease specific survival (DSS)

8 Adjuvant systemic chemotherapy of CLM: Overall survival Combined analysis FFCD / EORTC trial 5-FU/FA Overall survival FOLFIRI 1.00 Treatment HR=0.89: 95%CI [ ] Probability year DFS: 63% vs. 77% 2-year DFS: 46% vs. 51% Months Number at risk LV5FUs LV5FUs+IRI LV5FUs adjusted Logrank p=0.43 LV5FUs+IRI Mitri et al. JCO 2008 Ychou et al. ASCO 2008

9 Resectable Colorectal Liver Metastases Presented By Jeanne Tie at 2016 ASCO Annual Meeting

10 Neoadjuvant (perioperative) Chemotherapy in resectable CRC Liver metastases EORTC (EPOC) RFS OS R FOLFOX -> OP -> FOLFOX OP Nordlinger et al. Lancet Oncol 2013

11 Progression-free survival in eligible patients MOST LIKELY BENEFIT Borderline resectable pts? High proliferative tumors? MOST LIKELY NO BENEFIT Easily resectable? Fong score 0-2? (years) O N Number of patients at risk : Nordlinger et al. Lancet 2008

12 New EPOC study Neoadjuvant FOLFOX +/- Cetuximab in LLD R FOLFOX -> OP -> FOLFOX FOLFOX + Cetuximab -> OP -> FOLFOX + Cetuximab Primrose et al. Lancet Oncol 2014

13 Neoadjuvant (perioperative) Chemotherapy in resectable CRC Liver metastases EORTC (EPOC) and new EPOC RFS Nordlinger et al. Lancet Oncol 2013 OS RFS Primrose et al. Lancet Oncol 2014 OS

14 Liver limited diesase: Patient selection EPOC New EPOC Surgery Chemo Chemo Inclusion Definitely resectable Definitely and suboptimal resectable N Lesions Maximum 4 unlimited unresectable 10% 4% 12-19% Köhne JCO 2015

15 Potential disadvantage of effective neoadjuvant chemotherapy inresectable liver metastases CT/MRI prior chemo CT/MRI after chemo prior surgery Non - visible on CT/MRI, potentially visible during operation Visible on CT/MRI Köhne JCO 2015

16 Conclusions resectable & boarderline resectable disease Resectable : Perioperative Chemotherapy questionable Boarderline : no restrictions in Chemo regimens including use of EGFR

17 Guidelines CRC unresectable (LLD) mut mut

18 Case: Male 44 y, sigmoid adenocarcinoma well until 4 months ago, PS 2 weight loss ~ 5 Kg within last 3 months grossly enlarged palpable liver abdominal US: difuse hypodensic liver leasons CT scans: Synchroneous diffuse liver metastases LDH elevated, WBC /dl Bilirubin normal, LFT < 4x ULN

19 Case: Male 44 y, 05/06 Base line 05/06-11/06 FOLFIRI + Cetux 11/06-03/07 FOLFOX + Cetux PS 2 PS 0 liver mets operable primary tumor pcr + 5 kg mets not operable Patient died 02/15

20 Response and resection rates within trials Trials with neoadjuvant focus Trials with palliative focus CRC Give the most active(rr) regimen still tolerable by the patient Folprecht G.Köhne CH et al. Ann Oncol 2005; Jones R et al. Eur J Cancer, 2014

21 100% 50% 0% 50% 100% CELIM: Blindedsurgicalreview Baseline Follow-up % % 0% 50% Patient 100% Patient resectable non - resectable resectable non - resectable 32% 60%, p<0.01 Folprecht G.Köhne CH et al. Lancet Oncol 2010

22 ESMO acknowledges response parameters like early tumor shrinkage (ETS) or depth of response (DpR) for conversion therapy Fire-3 data Lethal tumor load OS Tumor load at Baseline ETS Tumor nadir PFS Time since start of treatment Morbidity No CT =<5 cycles 6-9 cycles =>10 cycles Karoui Nordlinger et al, Ann.Surg Steatohepatitis Sinusoidal distention Vauthey et al. JCO 2006

23 FOLFIRI vs. FOFOXIRI Regimen N RR Author FOLFIRI % Falcone FOLFOXIRI % JCO 2007 FOLFIRI+Bev % Falcone FOLFOXIRI+Bev % NEJM 2015 FOLFOXIRI more effective than FOLFIRI Unproven role of bevacizumab

24 Randomised trials of EGFR antibodies 1 st line k-ras exon 2 wt only European & Asian experience Trial Therapy ORR CRYSTAL (n=666) FOLFIRI +/- Cetux 40% vs. 57% Chinese * (n=138) FOLFIRI or FOLFOX+/- Cetux 40% vs. 57% Infusional 5FU PRIME (n=656) OPUS (n=197) FOLFOX +/- Pani FOLFOX +/- Cetux 48% vs. 57% 34% vs. 57% Bolus 5FU Cape Tailor (n=380) COIN (n=729) NORDIC (n=194) FOLFOX +/- Cetux 34% vs. 56% XELOX/FOLFOX +/- Cetux 57% vs. 64% FLOX +/- Cetxu 47 vs. 46% sig. diff; (clinically relevant not statist. Sig); no sig. diff * LLD only

25 Chinese randomized trial in patients with non resectable k-ras exon 2 wt CRC LLD Chemotherapy +/- Cetuximab Ye et al. JCO 2013

26 CELIM: R0 Resection as a surgical maintenance therapy in the continuum of care Progression free survival Overall survival R0 resected: %CI: Not R0 res.: %CI: HR 2.10 [ ] p<0.001 R0 resected: %CI: Not R0 res.: %CI: HR 2.25 [ ], p= y-OS: 45.8% few patients without relaps Update CELIM 12/2012, ASCO 2013

27 Randomized trials in patients with non resectable k-ras exon 2 wt CRC LLD Chemotherapy +/- Cetuximab METHEP Chinese study CELIM OLIVIA FOLFIRI/F OLFOX ~30 FOLFOXIRI N=30 FOLFIRI/FOL FOX N=68 CT + Cet N=70 FOLFIRI/F OLFOX + Cet N=67 FOLFOX + Bev N=39 FOLFOXIRI + Bev N=41 RR ~60 73% 40% 57% 70% 62% 81% R0 resection ~23 30% 7% 26% 33% 31% 54% OS all pts (mo) OS resected pts (mo) ~ NR Ychou Ann Surg Oncol 2013; Ye et al. JCO 2013; Folprecht...Köhne Lancet Oncol 2010; Gruenberger Ann Oncol 2015

28 Response and resection rates within trials Trials with palliative focus CRC Jones, Folprecht Eur J Cancer 2014

29 FIRE3: Blinded review for resectability Neumann et al, ESMO 2016

30 FIRE3: Blinded review for resectability Neumann et al, ESMO 2016

31 FIRE3: Blinded review for resectability Neumann et al, ESMO 2016

32 Patients treated with palliative chemo at a regional oncology centre Jones et al, BJS 2012

33 Overall response rate left & right JY Douillard & JP Pignon ESMO 2016

34 Duration of response 1st line: in most arms duration of response appears to be longer in left-sided disease Left, n Right, n Median DoR (95% CI), months Responder Responder Actual treatment s Progressed s Progressed Left Right PRIME Pmab + FOLFOX ( ) 9.7 ( ) (1st line) FOLFOX alone ( ) 7.6 ( ) PEAK Pmab + FOLFOX ( ) 8.7 ( ) (1st line) Beva + FOLFOX ( ) 9.2 ( ) 181 (2nd line) 2nd line: not enough responses in right-sided disease to calculate duration of response Left, n Right, n Median DoR (95% CI), months Actual treatment Responders Progressed Responders Progressed Left Right Pmab + FOLFIRI ( ) NE (9.5 NE) FOLFIRI alone ( ) NE (NE NE) Beva, bevacizumab; CI, confidence interval; DoR, duration of response; NE, not evaluable; Pmab, panitumumab

35 Clearly resectable Borderline resectable Liver limited / dominant diesase S U R G E R Y Chemotherapy? adjuvant to surgery Definitely NOT resectable C H E M O Surgery! Adjuvant to chemotherapy Maintenance or an additional line of chemotherapy to chemotherapy

36 Learning objectives All patients with liver limited or oligometastatic disease have a curative chance A multidisciplinary aproach is essential Clinical presentation may be considered as Resectable, boarderline resectable, potentially resectable after chemotherapy In resectable disease surgery alone or following chemotherapy are options In boarderline and unresectable disease the most effective and still tolerable chemotherapy according to the molecular profile should be used within a multidisciplinary context Even if surgery is not curative it extends overall survival and can be considered as a line of chemotherapy or a form of maintenance chemotherapy

37 Thank you for your attention!

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