Table of Contents
ABOUT DATAMONITOR HEALTHCARE
- About the Oncology pharmaceutical analysis team
- Andrew Paramore - Oncology Lead Analyst & Head of Product Development
Chapter 1 EXECUTIVE SUMMARY
- Scope of analysis
- Datamonitor insight into the hepatocellular carcinoma market
Chapter 2 HCC OVERVIEW
- Liver function
- The damaged liver and its implications
- Hepatocellular carcinoma
- Epidemiology
- Increasing incidence in the West
- Poor prognosis but improving
- Risk factors
- Increasing hepatitis infection attributed to rising HCC incidence
- Hepatitis B infection
- Hepatitis C infection
- Liver cirrhosis is a major risk factor for HCC
- Aflatoxin exposure increases HCC risk
- Diagnosis and screening
- Diagnostic criteria
- Diagnostic procedures
- Biopsy
- Ultrasound
- Computerized tomography
- Magnetic resonance imaging
- Angiography
- Alpha-fetoprotein
- Staging
- AJCC TNM staging system
- Child-Pugh classification
- Okuda staging system
- The Cancer of the Liver Italian Program (CLIP)
- BCLC classification
Chapter 3 CURRENT TREATMENT OPTIONS
- Introduction
- Treatment modalities
- Surgical resection remains the mainstay of treatment for HCC
- Liver transplantation is an option for patients with localized disease
- Radiofrequency ablation may be as effective as surgery in selected
patient cohorts
- Opportunity for immunotherapy?
- Use of percutaneous ethanol injection remains marginal
- High complication rate of cryosurgery may limit its applicability
- Transcatheter arterial chemoembolization (TACE) offers a survival
improvement
- Randomized study will be required to fully define role of hepatic
arterial pumps
Chapter 4 CHEMOTHERAPY REGIMENS IN UNRESECTABLE HCC
- Introduction
- Compromised liver function may restrict use of chemotherapy
- Single agents used in the management of HCC offer limited benefit
- Doxorubicin
- Doxil/Caelyx/Myocet (pegylated liposomal doxorubicin - Ortho
Biotech/Schering-Plough/Cephalon/Sopherion)
- Cisplatin
- Gemzar (gemcitabine - Eli Lilly)
- Xeloda (capecitabine - Roche)
- Epirubicin
- Tamoxifen
- Intron A/Roferon A (interferon-alpha - Schering-Plough/Roche)
- Combination regimens fail to demonstrate any significant efficacy
advantage
- Cisplatin and doxorubicin
- Cisplatin, interferon-alpha, doxorubicin and 5-FU (PIAF)
- Cisplatin, doxorubicin and Xeloda
- Cisplatin and Gemzar
- Cisplatin, epirubicin, UFT and leucovorin
- Cisplatin, mitoxantrone and 5-FU
- Gemzar and oxaliplatin
- Liposomal doxorubicin plus Gemzar
- Liposomal doxorubicin plus Xeloda or Gemzar
- Interferon combinations
Chapter 5 UNMET NEEDS
- Unmet needs
- Curbing the increasing incidence of HCC
- Lack of effective treatment
- Poor clinical trial designs
- Relatively modest R&D interest
Chapter 6 HCC PIPELINE ANALYSIS
- Pipeline drugs for HCC
- Pipeline drugs by phase
- Pipeline drugs by drug class
- Pipeline drugs by phase and drug class
- Pipeline drugs in Phase III development
- Talaporfin (LS11) - Light Sciences Oncology
- Minimal toxicity is the key for talaporfin
- Nexavar (sorafenib) - Onyx Pharmaceuticals /Bayer Schering
- Phase III trial results indicate a 44% overall survival benefit
associated with Nexavar
- Phase II trial suggests Nexavar' s potential to significantly improve
median survival offered by doxorubicin
- Ongoing Phase II combination trial will give better indication of
Nexavar' s worth
- Nexavar does not have overlapping toxicities with doxorubicin
- First-to-market status and collaboration will ensure Nexavar is the
leading multi-kinase inhibitor in HCC
- Thado (thalidomide) - TTY BioPharm
- Phase II trial results do not support the use of thalidomide in HCC
- Additional Phase II trial does not support use of thalidomide in HCC
- Response in some patients may be due to etiology
- Thalidomide unlikely to make its mark on the HCC market
- AMT-2003 - Auron Healthcare
- Dearth of data for AMT-2003
- Key pipeline drugs in Phase II development
- Avastin (bevacizumab) - Genentech/Roche/Chugai
- Erbitux (cetuximab) - ImClone/Bristol-Myers Squibb/Merck Serono
- Tarceva (erlotinib) - OSI Pharmaceuticals/Genentech/Roche/Chugai
- Iressa (gefitinib) - AstraZeneca
- Recentin (AZD2171/cediranib) - AstraZeneca
- Velcade (bortezomib) - Millennium Pharmaceuticals/Ortho Biotech
- Tykerb/Tycerb (lapatinib) - GlaxoSmithKline
- Sutent (sunitinib) - Pfizer
APPENDIX
- Contributing experts
- UN Population Data
- Bibliography
- List of tables
- List of figures
- About Datamonitor
- About Datamonitor Healthcare
- About the Oncology analysis team
- Disclaimer
List of Tables
- Table 1: Incidence of HCC in the seven major markets, 2007-2016
- Table 2: Prevalence of HBV in various areas worldwide
- Table 3: AJCC TNM staging for liver tumors (including intrahepatic bile
ducts)
- Table 4: Child-Pugh classification
- Table 5: Okuda staging system
- Table 6: CLIP scoring for HCC
- Table 7: Barcelona Clinic Liver Cancer classification
- Table 8: Reported outcomes of surgical resection for HCC
- Table 9: Improvement in five-year survival rates in HCC patients
undergoing liver transplantation
- Table 10: Comparison of RFA and surgical resection in terms of recurrence
rates and overall survival
- Table 11: Comparison of RFA in HCC patients with Child-Pugh class A and
class B
- Table 12: Arterial embolization or chemoembolization compared to systemic
treatment for HCC
- Table 13: Summary results of commonly used cytotoxic monotherapy in
first-line unresectable HCC
- Table 14: Summary results of commonly used cytotoxic combinations in
first-line unresectable HCC
- Table 15: Combining doxorubicin with cisplatin does not increase response
rate
- Table 16: Drugs in clinical development for HCC, 2007
- Table 17: Ongoing clinical trials of Avastin in HCC
- Table 18: Results of Phase II studies for unresectable HCC, 2007
- Table 19: UN Population Data, 2002-2016
List of Figures
- Figure 1: Liver anatomy
- Figure 2: Incidence of HCC in the seven major markets, 2007-2016
- Figure 3: Five-year survival rates for liver and intrahepatic bile duct
cancer, 1975-1998
- Figure 4: Association between HBV/HCV prevalence and HCC incidence
- Figure 5: HCV disease progression leading to HCC
- Figure 6: Treatment algorithm for HCC
- Figure 7: Summary results of commonly used cytotoxic monotherapy in
first-line unresectable HCC
- Figure 8: Summary results of commonly used cytotoxic combinations in
first-line unresectable HCC
- Figure 9: Pipeline drugs for HCC by phase, 2007
- Figure 10: Pipeline drugs for HCC by class, 2007
- Figure 11: Pipeline drugs for HCC by phase and class, 2007
- Figure 12: Results of Phase II studies for unresectable HCC, 2007
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