io_deb tace io journal club primer final.pdf
Post on 11-Jan-2016
277 Views
Preview:
TRANSCRIPT
Open-‐Label Single-‐Arm Phase II Trial of Sorafenib Therapy with Drug-‐elu=ng Bead Transarterial Chemoemboliza=on in Pa=ents with Unresectable Hepatocellular Carcinoma: Clinical Results SIR-‐RFS Journal Club
BOTTOM LINE • Based on a prospective study on 50 patients, combined continuous sorafenib therapy and on-‐
demand drug-‐eluting (DEB) transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC) provided successful disease control and may have a survival beneJit in patients with advanced HCC
MAJOR POINTS • The 6-‐month disease control rate (complete response plus partial response plus stable disease) was
94% • Median time to progression (TTP) was 13.0 months • Overall survival (OS) was 20.4 months
CRITICISM
• Confounding of overall survival when considered for other standards of care once patients were removed from study having already undergone therapeutic interventions
• Patients with macrovascular invasion and asymptomatic extrahepatic disease and ECOG score of 1 were included in order to reJlect the patient population of US tertiary care centers
• No other criticisms mentioned
Quick Summary
SINGLE CENTER SINGLE-‐ARM, OPEN-‐LABEL PHASE II TRIAL • 50 patients with unresectable HCC treated with DEB TACE from March 2009-‐
January 2012, treated in six-‐week cycles INCLUSION CRITERIA • Age greater than 18 • Diagnosis of unresectable HCC on the basis of histologic conJirmation, a
hypervascular lesion within a cirrhotic liver at cross-‐sectional imaging or an alpha-‐fetoprotein level of 200ng/mL or greater
• ECOG performance status of 0-‐1, Child-‐Pugh liver function class of A-‐B7, life expectancy greater than 12 weeks
• Total bilirubin less than 3mg/dL and serum albumin level greater than 2.0mg/dL
• Adequate cardiac, bone marrow and renal function EXCLUSION CRITERIA • Symptomatic extrahepatic disease, hepatic tumor burden greater than 70% of
the total liver volume, complete occlusion of the portal venous system, uncontrolled hypertension, evidence of bleeding diathesis or coagulopathy and active second primary malignancy
Study design
To determine the ef-icacy of combined continuous sorafenib therapy and drug-‐eluting bead (DEB) transarterial chemoembolization (TACE) in patients with unresectable HCC
Purpose
All subjects had unresectable HCC Tumor Evaluation:
» Baseline recorded as : Liver mass > 1cm on CT or MR
§ Tumor Response on follow up triphasic CT / MR, clinical examination and serum biochemistry 1 month following treatment and at subsequent 3-‐month intervals for Jirst year and then biannually with coinciding clinical exam and imaging
DEB TACE: » Treatment consisted of 6 week cycles, one with continuous sorafenib therapy (400mg twice daily oral dosing one week
prior to DEB TACE) and DEB TACE performed during week 2 of each cycle
» DEB TACE consisted of 100mg doxorubicin per procedure loaded onto 100-‐300 micron LC beads
» Total dose delivered determined by vascularity of tumor on hepatic angiography
» End point was either complete delivery of DEB TACE or reduced Jlow of the feeding artery
» Maximum of four procedures over six months
Analysis: » Primary end point was safety, secondary end points were assessment of response, TTP and survival
» Complete responses was deJined as 100% tumor necrosis, partial response >50% tumor necrosis, progressive disease was deJined as an increase in tumor enhancement by more than 25%, stable disease present if other criteria not met
» Disease control rate was deJined as complete response plus partial response plus stable disease
» TTP deJined as interval from start of therapy to progression of lesions targeted by DEB TACE
» OS assessed with Kaplan-‐Meier estimates of survival, and Mantel-‐Cox log-‐rank test used to determine differences in survival
» All patients who received at least one dose of sorafenib were included in the analysis
» Analyses carried out with STATA version 12.0 and two sided P value of <0.05 used
Interven7on: DEB + TACE 50 pa7ents
Overall survival was 20.4 months. Median survival was 45.6 months for BCLC stage A disease and 29.7 months for BCLC stage B disease and 8.0 months for BCLC stage C disease. For those who
underwent greater than 6 months sorafenib therapy, survival was 21 months compared to those who
underwent therapy for less than 6 months at 6.8 months.
Outcome
Median TTP in all subjects was 13.9 months. When BCLC
strati-ied, median TTP was 9.5 months for patients with stage C disease, 24.7 months for patients with stage B disease and 27.6
months for patients with stage A disease.
Credits
SUMMARY BY: Alyson Kil M.D., PGY2 Department of Radiology Walter Reed National Military Medical Center/National Capital Consortium FULL CITATION: Cosgrove, David P., Reyes, Diane K., Pawlik, Timothy M., Feng, Allen L., Kamel, Ihab R., Jean-‐Francois, H. Geschwind.. “Comparison of Combination Therapies in the Management of Hepatocellular Carcinoma" Journal of Vascular and Interventional Radiology. 26.3 (2015): 330-‐341.
Society of Interven7onal Radiology 3975 Fair Ridge Drive | Suite 400 North Fairfax, VA 22033 (703) 460-‐5583
sirweb.org
top related