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Radiological evaluation aasld 2011

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mbouattour

This study evaluated 60 patients with advanced hepatocellular carcinoma treated with sorafenib using RECIST, modified RECIST (mRECIST), and Choi criteria to assess tumor response. mRECIST and Choi criteria identified more patients with objective responses compared to RECIST, including some considered non-responders by RECIST. Objective responses by mRECIST and Choi correlated with longer survival, suggesting they better capture treatment benefit compared to RECIST. The study concludes mRECIST and Choi criteria can reclassify some RECIST non-responders as true partial responders with significant survival benefit from sorafenib.

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AASLD 2011 BLINDED INDEPENDENT CENTRAL RESPONSE ASSESSMENT USING RECIST, MODIFIED RECIST, AND CHOI CRITERIA IN PATIENTS TREATED WITH SORAFENIB FOR ADVANCED HEPATOCELLULAR CARCINOMA Mohamed Bouattour, Johanna Wassermann, Onorina Bruno, B¨¦atrice Larroque, Laurent Castera, Chantal Dreyer, Val¨¦rie Vilgrain, Jacques Belghiti, Eric Raymond, Sandrine Faivre Beaujon University Hospital Clichy, France
AASLD 2011 No disclosure to declare
RECIST do Not Capture the True Benefit of Sorafenib in HCC ? Sorafenib improves survival but yields low objective response rate by RECIST (< 5%)1,2 ? Sustained survival despite NO response by RECIST suggest that RECIST are inappropriate to capture the true benefit of sorafenib3 ? Modified RECIST (mRECIST)4 are used to assess vascular effects of TACE5 and CHOI criteria were proposed to evaluate necrosis induced by targeted agents in HCC6 1 LlovetJM ; N Engl J Med 2008 4 Lencioni R ; Semin Liver Dis. 2010 2 Cheng AL ; Lancet Oncol 2009 5 Gillmore R, J Hepatol 2011 3 Edeline J, Cancer 2011 6 Faivre S, Clin Cancer Res 2011 AASLD 2011
Objectives ? At the first tumor evaluation, are mRECIST and CHOI criteria predicting overall survival in patients with HCC treated with sorafenib? ? Can mRECIST and CHOI criteria reallocate to the objective response group, patients who were inappropriately considered non-responders by RECIST? AASLD 2011
Study Method/Radiological Evaluation ? Retrospective single center cohort analysis ? January 2007- December 2009 ? Beaujon Hospital ? Baseline evaluation within 6 weeks prior to sorafenib ? First tumor evaluation by CT-scan 2-3 months after sorafenib initiation AASLD 2011
Radiological Evaluation ? Quality control criteria ¨C Multiphasic CT-scan fully available for central review ¨C Central Review of data by a radiologist highly experienced in liver cancers, blinded to clinical data ¨C Evaluation of tumor response by RECIST, mRECIST, and CHOI criteria RECIST mRECIST CHOI criteria HU AASLD 2011
Results: Study Population Selection Patients with BCLC B-C, Child-Pugh A-B, advanced hepatocellular carcinoma treated with sorafenib from 2007 to 2009 (n=82) Non-evaluable patients (n=22) ¨C Non-evaluable CT scan (n=9) ¨C Target lesions in pretreated area (n=9) ¨C No target lesion (n=3) ¨C Missing data (n=4) ? Lost of follow up ? Early death Patients evaluated in this study (n=60) AASLD 2011
Patient Characteristics Median age, years 61 (37-77) Sex M/F 52/8 Etiology, % (number of patients) Viral 48 (29) Alcohol 23 (14) Child Pugh Score, % (number of patients) A 80 (48) B 20 (12) BCLC stage , % (number of patients) B 33 (20) C 67 (40) Pathological diagnosis, % (number of patients) 88 (53) Extrahepatic Spread , % (number of patients) 35 (21) Prior treatments, % (number of patients) None 32 (19) Surgery 27 (16) Radio Frequency Ablation 5 (3) Trans-Arterial Chemo-Embolization 36 (22) Median duration of sorafenib, months 5.7 Median time for the first evaluation, months 2.1 AASLD 2011
mRECIST and CHOI Criteria Identify More Responder Patients Than RECIST Venn diagram of tumor response according to three criteria 15 10 2 RECIST n=2 mRECIST n=12 CHOI criteria n=27 AASLD 2011
Response Rates by RECIST, mRECIST, and CHOI Criteria 70 Objective response % of response rates by each criteria 60 Stable Disease 62 Progressive Disease 50 40 48 45 30 35 32 30 20 23 21 10 3 0 RECIST mRECIST CHOI N=60 N=56* AASLD 2011 N=60 *4 pts non evaluable
At the first tumor evaluation, are mRECIST and CHOI criteria predicting overall survival in patients with HCC treated with sorafenib? AASLD 2011
Responses by RECIST Criteria Correlate with Survival 1 0,9 0,8 RECIST Probability of survival 0,7 0,6 Objective response (PR/CR) 0,5 Stable Disease Progressive Disease 0,4 0,3 0,2 0,1 p=0.0012 0 0 5 10 15 20 25 30 35 40 45 Duration of survival, months
Radiological evaluation aasld 2011
Can mRECIST and CHOI criteria reallocate to the objective response group, patients who were inappropriately considered non- responders by RECIST? AASLD 2011
Examples of discrepancies Between methods of evaluation RECIST mRECIST CHOI criteria Baseline ? Stable ? Response ? Response ¨K HU Baseline ? Progression ? Response ? Response ¨K HU AASLD 2011
Many Stable and Some Progressive Diseases by RECIST Are Objective Responses by mRECIST and CHOI Criteria Objective responses according to each criteria 45% Number of patients with objective response 30 3 25 Response by RECIST Progressive Disease 20 21.4% 15 22 Stable Disease 1 Objective response 10 3.3% 9 5 2 2 2 0 Responders Responders Responders RECIST (n=2) AASLD 2011 (n=27) mRECIST (n=12) CHOI
Conclusion ? Response rate using mRECIST and CHOI criteria correlates with survival in advanced HCC patients treated with sorafenib ? mRECIST and CHOI criteria identify patients with true benefit (partial responders with higher survival) among ¡°RECIST-stable¡± and ¡°RECIST-progressive¡± patients ? mRECIST and CHOI criteria compared to RECIST increase the number of partial responders who also are patients with a median overall survival >14 months AASLD 2011

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Radiological evaluation aasld 2011

  • 1. AASLD 2011 BLINDED INDEPENDENT CENTRAL RESPONSE ASSESSMENT USING RECIST, MODIFIED RECIST, AND CHOI CRITERIA IN PATIENTS TREATED WITH SORAFENIB FOR ADVANCED HEPATOCELLULAR CARCINOMA Mohamed Bouattour, Johanna Wassermann, Onorina Bruno, B¨¦atrice Larroque, Laurent Castera, Chantal Dreyer, Val¨¦rie Vilgrain, Jacques Belghiti, Eric Raymond, Sandrine Faivre Beaujon University Hospital Clichy, France
  • 3. RECIST do Not Capture the True Benefit of Sorafenib in HCC ? Sorafenib improves survival but yields low objective response rate by RECIST (< 5%)1,2 ? Sustained survival despite NO response by RECIST suggest that RECIST are inappropriate to capture the true benefit of sorafenib3 ? Modified RECIST (mRECIST)4 are used to assess vascular effects of TACE5 and CHOI criteria were proposed to evaluate necrosis induced by targeted agents in HCC6 1 LlovetJM ; N Engl J Med 2008 4 Lencioni R ; Semin Liver Dis. 2010 2 Cheng AL ; Lancet Oncol 2009 5 Gillmore R, J Hepatol 2011 3 Edeline J, Cancer 2011 6 Faivre S, Clin Cancer Res 2011 AASLD 2011
  • 4. Objectives ? At the first tumor evaluation, are mRECIST and CHOI criteria predicting overall survival in patients with HCC treated with sorafenib? ? Can mRECIST and CHOI criteria reallocate to the objective response group, patients who were inappropriately considered non-responders by RECIST? AASLD 2011
  • 5. Study Method/Radiological Evaluation ? Retrospective single center cohort analysis ? January 2007- December 2009 ? Beaujon Hospital ? Baseline evaluation within 6 weeks prior to sorafenib ? First tumor evaluation by CT-scan 2-3 months after sorafenib initiation AASLD 2011
  • 6. Radiological Evaluation ? Quality control criteria ¨C Multiphasic CT-scan fully available for central review ¨C Central Review of data by a radiologist highly experienced in liver cancers, blinded to clinical data ¨C Evaluation of tumor response by RECIST, mRECIST, and CHOI criteria RECIST mRECIST CHOI criteria HU AASLD 2011
  • 7. Results: Study Population Selection Patients with BCLC B-C, Child-Pugh A-B, advanced hepatocellular carcinoma treated with sorafenib from 2007 to 2009 (n=82) Non-evaluable patients (n=22) ¨C Non-evaluable CT scan (n=9) ¨C Target lesions in pretreated area (n=9) ¨C No target lesion (n=3) ¨C Missing data (n=4) ? Lost of follow up ? Early death Patients evaluated in this study (n=60) AASLD 2011
  • 8. Patient Characteristics Median age, years 61 (37-77) Sex M/F 52/8 Etiology, % (number of patients) Viral 48 (29) Alcohol 23 (14) Child Pugh Score, % (number of patients) A 80 (48) B 20 (12) BCLC stage , % (number of patients) B 33 (20) C 67 (40) Pathological diagnosis, % (number of patients) 88 (53) Extrahepatic Spread , % (number of patients) 35 (21) Prior treatments, % (number of patients) None 32 (19) Surgery 27 (16) Radio Frequency Ablation 5 (3) Trans-Arterial Chemo-Embolization 36 (22) Median duration of sorafenib, months 5.7 Median time for the first evaluation, months 2.1 AASLD 2011
  • 9. mRECIST and CHOI Criteria Identify More Responder Patients Than RECIST Venn diagram of tumor response according to three criteria 15 10 2 RECIST n=2 mRECIST n=12 CHOI criteria n=27 AASLD 2011
  • 10. Response Rates by RECIST, mRECIST, and CHOI Criteria 70 Objective response % of response rates by each criteria 60 Stable Disease 62 Progressive Disease 50 40 48 45 30 35 32 30 20 23 21 10 3 0 RECIST mRECIST CHOI N=60 N=56* AASLD 2011 N=60 *4 pts non evaluable
  • 11. At the first tumor evaluation, are mRECIST and CHOI criteria predicting overall survival in patients with HCC treated with sorafenib? AASLD 2011
  • 12. Responses by RECIST Criteria Correlate with Survival 1 0,9 0,8 RECIST Probability of survival 0,7 0,6 Objective response (PR/CR) 0,5 Stable Disease Progressive Disease 0,4 0,3 0,2 0,1 p=0.0012 0 0 5 10 15 20 25 30 35 40 45 Duration of survival, months
  • 14. Can mRECIST and CHOI criteria reallocate to the objective response group, patients who were inappropriately considered non- responders by RECIST? AASLD 2011
  • 15. Examples of discrepancies Between methods of evaluation RECIST mRECIST CHOI criteria Baseline ? Stable ? Response ? Response ¨K HU Baseline ? Progression ? Response ? Response ¨K HU AASLD 2011
  • 16. Many Stable and Some Progressive Diseases by RECIST Are Objective Responses by mRECIST and CHOI Criteria Objective responses according to each criteria 45% Number of patients with objective response 30 3 25 Response by RECIST Progressive Disease 20 21.4% 15 22 Stable Disease 1 Objective response 10 3.3% 9 5 2 2 2 0 Responders Responders Responders RECIST (n=2) AASLD 2011 (n=27) mRECIST (n=12) CHOI
  • 17. Conclusion ? Response rate using mRECIST and CHOI criteria correlates with survival in advanced HCC patients treated with sorafenib ? mRECIST and CHOI criteria identify patients with true benefit (partial responders with higher survival) among ¡°RECIST-stable¡± and ¡°RECIST-progressive¡± patients ? mRECIST and CHOI criteria compared to RECIST increase the number of partial responders who also are patients with a median overall survival >14 months AASLD 2011