Sorafenib for HCC in Child-Pugh B7 Patients: What s the Evidence?

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1 Sorafenib for HCC in Child-Pugh B7 Patients: What s the Evidence? Janine M. Davies MD BN MSc Clinical Assistant Professor University of British Columbia BC Cancer Agency- CSI 2013 WCGCCC Disclosures Investigator-Initiated Trials: Bayer (sorafenib) 1

2 Objectives To review the indications and evidence for sorafenib in the treatment of HCC. To review the data for sorafenib data in Child-Pugh B7. To convince you that CP-B7 patients should/should not be treated with sorafenib! Alec Guinness 2

3 Wilhelm et al. Nature Reviews Drug Discovery 5, (October 2006) doi: /nrd2130 Llovet, NEJM

4 SHARP Trial CP-A (up to A6) Llovet, NEJM 2008 SHARP Trial- Overall Survival mos 10.7 vs. 7.9 mo Llovet, NEJM

5 Llovet, NEJM 2008 FDA Label Health Canada Label For CP-A patients 5

6 BCLC Staging of HCC Llovet, JNCI 2008 A Refresher on Child-Pugh (CP) Scoring CP-B7? 6

7 What s the concern with CP class? AE of sorafenib: hepatitis AST/ALT liver failure, death less commonly- INR, bili SHARP trial was for CP-A patients chemo limitations based on underlying liver dysfunction patients with CP-B have a poorer prognosis that CP-A seems to worsen as score increases BUT WHAT OTHER OPTION(S) DO PATIENTS HAVE? Show me the evidence 7

8 8

9 47M HCV CP-C (12) BCLC D No extrahep disease >27mo sorafenib Gr 3 diarrhea x 1 Improved to CP-A (6) Pt refused ablative Rx Not candidate for xplant Ph II Trial of Sorafenib in HCC (that led to SHARP trial)- Retrospective Evaluation by CP Status CP-A (n=98) vs. CP-B (n=38) CP-B had more ECOG 1 No diff in PKs, drug discontinuation or dose reduction Median treatment duration 4 vs. 1.8mo CP-B had increased gr 3/4 AEs: bili (14% vs. 53%), encephalopathy (3 vs. 13%), ascites (3 vs. 5%) Abou-Alfa GI Ca Research

10 Ph II Trial of Sorafenib in HCC (that led to SHARP trial)- Retrospective Evaluation by CP Status mos 9.5mo vs. 3.2mo mpfs 4.4mo vs 2.5 mo Abou-Alfa GI Ca Research 2010 HCC outpatient clinic Consecutive patients with advanced HCC All started with sorafenib 400mg bid, regardless of liver function Worns, J Clin Gastroenterol

11 N=34 CP-B: 15 CP-C: 4 Median duration of Rx 2.2 mo Stopped for progression (11), death (6), AEs (3), noncompliance (1) Liver failure/dysfunction in 18pts: 18 had gr 1/2 2 had gr 3 6 had gr 4 Worns, J Clin Gastroenterol 2009 Worns, J Clin Gastroenterol

12 PR SD PD N/A mos Worns, J Clin Gastroenterol 2009 Conclusions for CP-B + CP-C CP-B- heterogeneous group RCT to evaluate CP-C- don t use sorafenib Toxicity profile similar between CP groups Worns, J Clin Gastroenterol

13 Miller, JCO 2009 Any mets disease, no other Rx options Miller, JCO

14 Recommended Starting Doses for Sorafenib by Liver Dysfunction (may consider dose escalation if well tolerated) 400mg BID 200mg BID <200mg q3d 200mg OD No difference in PKs by CP-A or CP-B; Many with hepatic dysfunction were not assessable (clinical deterioration) Miller, JCO 2009 Subanalysis of SHARP data based on liver function ALT/AST, AFP, bilirubin No hepatic or other toxicity with liver dysfunction mos ed with increasing dysfunction but mos better in all subgroups over placebo Raoul, J Hepatol

15 Sorafenib in Mild-Advanced Stage Liver Cirrhosis + HCC Retrospective use of sorafenib CP-A (n=26) vs. CP-B (n=23) vs. CP-C (n=10) ECOG 0 (53%), 1 (44%), 3 (3%) No trend to worse AEs by CP Status Pinter, Oncologist 2009 Response by CP Status Pinter, Oncologist

16 OS by CP Status mos 6.5mo CP-A >8.3mo CP-B 4.3mo CP-C 1.5mo Pinter, Oncologist 2009 GIDEON (Global Investigation of Therapeutic Decisions in HCC + of its Treatment with Sorafenib) Registry database N=3202 (CP-B: 666) CP-A vs CP-B- no differences in AEs (approx 85%) or gr 3/4 AEs (approx 32%) CP-B had more SAEs (36 vs. 60%) CP-B more likely to discontinue for AEs (29 vs. 40%) Median treatment duration 17.6 vs. 9.9 weeks Marrero, ASCO 2013 (abstr 4126) 16

17 GIDEON (Global Investigation of Therapeutic Decisions in HCC + of its Treatment with Sorafenib) mos: CP-A 13.6mo vs. CP-B 5.2mo. mos for by CP score: CP-B7 6.2mo CP-B8 4.8mo CP-B9 3.7mo. TTP approx 4.5mo in both Marrero, ASCO 2013 (abstr 4126) Proposed Clinical Trial Schema Abou-Alfa GI Ca Research

18 Conclusions CP-B7 patients haven t been looked at specifically, despite general understanding that CP-B7 biology seems to be more similar to CP-A than CP-B8+. Difficulty in conducting trials for CP-B patients (e.g. Competing COD with liver cirrhosis) will hamper interest in conducting such trials. Similar side effects from sorafenib as CP-A. Consistent (small) benefit across CP classes. Should CP-B7 patients be treated with Sorafenib? Highly selected CP-B7 patients may benefit. Lack of convincing data of harm Will need to identify biomarkers of response + resistance, understand tumour biology both blood and tumour 18

19 19

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