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Subgroup Analysis Confirms Efficacy, Safety of Sorafenib in Patients With Late-Stage Liver Cancer: Presented at EASL
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By Cameron Johnston
http://www.docguide.com
COPENHAGEN, Denmark -- April 24, 2009 -- Sorafenib is effective and safe in patients with intermediate and advanced hepatocellular carcinoma (HCC), according to a subgroup analysis of a large multicentre trial presented here at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL).
The study also showed that while patients with the more advanced disease did not live as long as those with less advanced disease, the drug more or less slowed disease progression and improved overall survival at the same rate in both groups when compared with placebo.
The subgroup analysis, presented by Jordi Bruix MD, Centre for Biomedical Investigation of Diseases of the Liver and Digestion, University of Barcelona, Barcelona, Spain, comprised patients who were in the Sorafenib HCC Assessment Randomized Protocol (SHARP) study. The oral presentation was made on April 24.
The initial study demonstrated the efficacy of sorafenib in treating HCC. The subgroup analysis was undertaken to determine whether this effect was seen among patients with cancers that were classified as either Barcelona Clinic Liver Cancer Stage B (BCLC-B) or BCLC Stage C.
A positive finding would suggest that the drug did not lose its efficacy for patients with more severe disease, or that it was only successful in treating patients with a lower stage of the disease.
The analysis included 54 patients with stage B disease and 245 with stage C disease, who received sorafenib 400 mg/day. They were compared against 51 patients with stage B disease and 252 with stage C disease who were treated with a placebo.
Endpoints in the analysis included overall survival, time to disease progression, and disease control rate, which was defined as partial or complete response lasting for more than 28 days, as well as safety.
Overall survival rates were a median of 14.5 months and 9.7 months for patients with stage B and C disease who were treated with sorafenib. These compare with 11.4 months and 7.0 months for patients who received the placebo. Hazard ratios were 0.72 and 0.70 for the 2 groups, respectively.
Time to progression (TTP) also favoured patients who received sorafenib, with median times of 6.9 months and 4.9 months for those with stage B and stage C disease, respectively. TTP for patients receiving placebo was 4.4 months and 2.8 months, and hazard ratios were 0.47 and 0.59.
Half of the patients (50.0%) with stage B disease who received sorafenib had controlled disease compared with 43.1% of those in the placebo arm. As for patients with stage C disease, 42.0% of those in the treatment arm and 29.4% of the placebo arm had controlled disease.
According to Dr. Bruix, the fact that both subsets of patients had largely similar hazard ratios shows that there is "the same biological impact, in both categories of patients." The results of the study confirm the safety and efficacy of sorafenib, and importantly, "supports the use of sorafenib in a broad range of patients and at different stages of the disease."
[Presentation title: Efficacy and Safety of Sorafenib in Patients With Hepatocellular Carcinoma (HCC): Subanalysis of Sharp Trial Based on Barcelona Clinic Liver Cancer (BCLC) Stage.]
EASL POSTERS
1. THE COMBINATION EVEROLIMUS (RAD001) PLUS SORAFENIB IS SUPERIOR TO SORAFENIBMONOTHERAPY IN THE TREATMENT OF HEPATOCELLULAR CARCINOMA
2. SORAFENIB DECREASES PORTAL PRESSURE, PORTOSYSTEMIC COLLATERAL BLOOD FLOW AND SPLANCHNIC BLOOD FLOW IN RATS WITH PREHEPATIC PORTAL HYPERTENSION
3. SORAFENIB PLUS OCTREOTIDE IN ADVANCED HEPATOCELLULAR CARCINOMA: UPDATED RESULTS OF A MULTICENTER STUDY
4. EFFICACY, SAFETY AND IMPACT ON QUALITY OF LIFE OF SORAFENIB IN ELDERLY PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA. PRELIMINARY RESULTS OF A PHASE II STUDY
5. EVALUATION OF TOLERANCE AND OUTCOME OF PATIENTS WITH HEPATOCELLULAR CARCINOMA TREATED BY SORAFENIB (AFTER THE SHARP STUDY)
6. IMPACT OF LUNG AND LYMPH NODE METASTASIS ON EFFICACY AND SAFETY FOLLOWING TREATMENT WITH SORAFENIB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA FROM THE ASIA-PACIFIC REGION
7. EVALUATION OF TUMOR PERFUSION AT COMPUTED TOMOGRAPHY AS A TOOL TO DETECT THE EFFECT OF SORAFENIB TREATMENT IN PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC)
8. SORAFENIB FOR THE TREATMENT OF ADVANCED HEPATOCELLULAR CARCINOMA. FEASIBILITY AND SAFETY OUTSIDE RESEARCH TRIALS
9. IMPACT OF PRIOR TACE/TAE ON THE EFFICACY AND SAFETY OF SORAFENIB IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCNIOMA (HCC) FROM THE ASIA-PACIFIC REGION
10. SKIN TOXICITY AS A PREDICTIVE FACTOR FOR TUMOR CONTROL IN ADVANCED HCC PATIENTS TREATED WITH SORAFENIB
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