Stakeholder Opinions: Esophageal Cancer Treatment paradigms need revolution not evolution

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Publication Date: 2007-03-06

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Globally, esophageal cancer is the ninth most common tumor type and seventh leading cause of cancer-related death, however, its incidence fluctuates widely depending on geographical area. While relatively uncommon in Western countries, 50% of patients still present with locally advanced unresectable or distant metastatic disease, where treatment is complicated and chances of a cure are reduced.

Scope

Current diagnosis and treatment of esophageal cancer, including treatment regimens by stage and ongoing controversies

Issues, unmet needs, and geographical variations in screening and treatment strategies

Examination of pipeline activity and potential future opportunities for drug developers

Stakeholder opinions and interview transcripts based on qualitative interviews with key opinion leaders from the US and Europe

Report Highlights
As the incidence of esophageal cancer subtypes shift due to a changing prevalence of risk factors including an increasing incidence of obesity and gastroesophageal reflux disease, preventative strategies may take on a more prominent role and existing treatment paradigms will need to evolve in order to yield improved patient outcomes.

Given that the majority of esophageal cancer patients present with locally advanced unresectable or distant metastatic disease, as reflected by poor overall survival rates and disease prognosis, increased rates of earlier diagnosis and greater research into more effective systemic therapies is crucial.

Due to a relatively low incidence in the West, esophageal cancer has not been the most commercially attractive indication for US and EU drug developers, as evidenced by the lack of approved agents for its treatment. However, there are numerous targeted therapies in Phase II trials, which show potential to transform existing treatment paradigms.

Reasons to Purchase

Identify the limitations of current therapy available to esophageal cancer patients and the potential of future therapy

Understand current epidemiological trends in esophageal cancer and ongoing treatment controversies

Assess the opportunities for innovative targeted therapies in esophageal cancer, particularly in metastatic disease

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Oncology pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of analysis - page 3
- Datamonitor insight into the esophageal cancer market - page 4
  - As the incidence of esophageal cancer subtypes shift due to a changing prevalence of risk factors, preventative strategies may take on a more prominent role and existing treatment paradigms will need to evolve in order to yield improved patient outcomes - page 4
  - Conflicting opinions regarding the use of neoadjuvant chemoradiotherapy for locally advanced disease requires clarification, potentially via the future use of genetic profiling - page 6
  - Given that the majority of patients present with advanced disease, reflected by poor overall survival rates and disease prognosis, increased rates of earlier diagnosis and greater research into more effective systemic therapies is crucial - page 7
  - Due to its relatively low incidence in the West, esophageal cancer has not been the most commercially attractive indication for US and European drug developers, as evidenced by the lack of approved agents for its treatment. However, there are numerous targeted therapies in Phase II trials, which have the potential to transform existing treatment paradigms - page 9
CHAPTER 2 DISEASE OVERVIEW - page 15
- Introduction - page 15
  - Disease overview - page 15
    - Esophageal cancer: a major source of cancer-related death - page 15
  - Anatomy of the esophagus - page 15
- Esophageal cancer - page 18
  - Definition - page 18
    - Increasing number of distal esophageal tumors - page 18
  - Pathology - page 19
    - Predominance of histolological subtypes varies by geographical region - page 19
  - Epidemiology - page 20
    - Increasing rates of adenocarcinoma in the West drive an increasing incidence of esophageal cancer across the seven major markets - page 20
    - Mortality from esophageal cancer is high in comparison to its incidence due to a typically advanced stage at diagnosis - page 23
  - Risk factors - page 25
    - Risk factors are better defined for squamous cell carcinoma than for adenocarcinoma - page 25
    - Genetic and environmental factors - page 26
    - Precursor conditions - page 30
  - Symptoms - page 33
    - A lack of initial symptoms mean half of patients present with advanced disease - page 33
  - Screening - page 35
    - Regular surveillance of patients with Barrett's esophagus is recommended - page 35
  - Diagnosis - page 38
    - Endoscopy is used most frequently in the West to diagnose esophageal cancer - page 38
  - Staging - page 39
    - Esophageal cancer has been pathologically staged since 2002 - page 39
  - Survival - page 42
    - The high rate of advanced-stage diagnoses is reflected by relatively poor survival rates - page 42
  - Prognosis - page 43
    - Stage of disease is the main prognostic indicator for esophageal cancer - page 43
  - Prevention - page 44
    - For Barrett's esophagus, a variety of preventative measures exist to halt progression to malignancy - page 44
    - Weight reduction may form a viable preventative strategy for GERD, and ultimately, esophageal cancer - page 45
    - Chemoprevention of esophageal cancer may be possible using NSAIDs or aspirin - page 46
CHAPTER 3 CURRENT TREATMENT OPTIONS AND CONTROVERSIES - page 47
- Introduction - page 47
- Treatment guidelines - page 47
  - US treatment guidelines - page 47
    - US treatment guidelines for esophageal cancer focus on the use of chemoradiotherapy for most patients - page 47
  - European treatment guidelines - page 48
    - European treatment guidelines focus on the use of chemoradiotherapy when surgery is not a viable option - page 48
  - Treatment of esophageal cancer in Japan - page 49
    - Greater emphasis is placed on surgery in Japan for the treatment of esophageal cancer - page 49
- Treatment of early-stage and locally advanced esophageal cancer - page 50
  - Surgery - page 50
    - Resection has the greatest utility in the treatment of early-stage esophageal cancer patients - page 50
  - Primary chemoradiotherapy for locally advanced disease - page 51
    - Primary chemoradiotherapy may provide a cure for locally advanced esophageal cancer patients - page 51
  - Neoadjuvant therapy - page 56
    - Neoadjuvant radiotherapy has been shown of little use in improving either resectability or survival - page 56
    - Neoadjuvant chemotherapy has demonstrated a survival advantage without increasing postoperative complications - page 57
    - Neoadjuvant chemoradiotherapy confers a high level of treatment-related mortality - page 59
    - Several Phase III studies are ongoing to further investigate the utility of neoadjuvant therapy - page 63
  - Adjuvant therapy - page 65
    - Adjuvant radiotherapy may result in decreased survival in comparison with surgery alone - page 66
    - Adjuvant chemotherapy: some regimens have conferred a survival benefit, however, this treatment modality has not been widely investigated - page 67
    - Adjuvant chemoradiotherapy is not associated with survival benefits and has not been widely investigated - page 68
    - Clinical trial activity investigating adjuvant therapy in esophageal cancer is somewhat limited - page 69
  - Surgery versus systemic therapy or combined modality treatment for locally advanced disease - page 70
    - Genetic testing may eventually resolve the issue of what constitutes ideal treatment for individual esophageal cancer patients - page 70
- Treatment of advanced-stage and metastatic esophageal cancer - page 72
  - Radiotherapy - page 72
    - Primary radiotherapy is reserved for palliative purposes or for those patients medically unfit to undergo chemotherapy - page 72
  - Chemotherapy for advanced disease - page 73
    - No standard chemotherapy regimen exists for advanced disease due to a lack of large-scale, randomized clinical trial data - page 73
    - Cisplatin forms the basis of chemotherapy for esophageal cancer, given that its single-agent activity is higher than any other cytotoxic tested to date - page 73
    - Phase II studies have shown combination chemotherapy to confer increased survival, albeit at the expense of increased toxicity and morbidity - page 74
    - The NCCN recommends 5-fluorouracil or cisplatin-based chemotherapy for metastatic esophageal cancer, since no Phase III studies have been completed for 15 years - page 75
    - The ECF (epirubicin, cisplatin and 5-fluorouracil) regimen is used as standard chemotherapy for metastatic disease in the UK - page 76
    - Despite an urgent need for more definitive data, no Phase III clinical trials are currently ongoing - page 79
  - Photodynamic therapy - page 80
    - Photodynamic therapy forms an alternative palliative treatment option in advanced esophageal cancer - page 80
    - Axcan Pharma's Photofrin is approved for the palliation of advanced esophageal cancer - page 81
- Estimated treatment of esophageal cancer in the five major European markets - page 83
  - Estimated use of surgery - page 83
    - Heavier reliance on potentially curative surgery at the earlier stages of esophageal cancer - page 83
  - Estimated use of chemotherapy - page 84
    - Not surprisingly, a heavy reliance is placed upon a combination of cisplatin and 5-fluorouracil in the first-line treatment of esophageal cancer in the EU - page 84
CHAPTER 4 UNMET NEEDS - page 89
- Introduction - page 89
- Unmet needs - page 89
  - Improving prognosis of esophageal cancer - page 89
    - 50% of patients present with advanced disease, therefore better or facilitated techniques to increase earlier diagnosis are needed - page 89
    - Improving patient lifestyle factors could prevent or delay the onset of esophageal cancer - page 90
  - Enhanced treatment options required across all stages of disease - page 91
    - New and more effective systemic therapies for advanced disease are required - page 91
    - More effective neoadjuvant or adjuvant therapy for patients who undergo surgery, to reduce relapse rates - page 93
    - Adequate palliative treatment options for metastatic esophageal cancer patients are still necessary - page 94
  - Future treatment of esophageal cancer - page 94
    - More large-scale, randomized clinical trials are necessary to define optimal treatment strategies at all stages of esophageal cancer - page 94
    - Espohageal cancer fails to generate significant commercial interest - page 95
- Summary of unmet needs - page 97
CHAPTER 5 PIPELINE ANALYSIS - page 98
- The esophageal cancer pipeline - page 98
  - Phase III pipeline - page 98
    - Pfizer's Camptosar (irinotecan) - current off-label use may mean that formal approval may not be sought - page 99
    - Sanofi-Aventis's Eloxatin (oxaliplatin) - results from the REAL-2 trial and recent genericization in Europe may increase uptake - page 102
    - Roche's Xeloda (capecitabine) - pharmacoeconomic issues may hinder uptake - page 104
  - Phase I/II pipeline - page 106
    - Already proven a popular target in colorectal cancer, EGFR inhibitors have shown some antitumor activity to date in early-phase trials for esophageal cancer - page 109
    - Inhibition of angiogenesis appears a successful strategy in gastroesophageal junction cancer, however, ongoing trials need to focus only on esopahgeal cancer patients - page 112
    - Definitive conclusions regarding the full potential of targeted therapies in esophageal cancer cannot be made yet. - page 114
CHAPTER 6 KEY OPINION LEADER INTERVIEW TRANSCRIPTS - page 115
- Contributing experts - page 115
- Key opinion leader interview transcripts - page 115
APPENDIX - page 116
- Bibliography - page 116
- List of tables - page 127
- List of figures - page 130
- About Datamonitor - page 131
  - About Datamonitor Healthcare - page 131
  - About the Oncology analysis team - page 132
- Disclaimer - page 133

List of Tables
Table 1: Crude incidence rates of esophageal cancer by gender per 100,000 in the seven major pharmaceutical markets, 2002 - page 20
Table 2: Estimated incidence of esophageal cancer in the seven major pharmaceutical markets, 2001-15 - page 21
Table 3: Crude mortality rates of esophageal cancer by gender per 100,000 in the seven major pharmaceutical markets, 2002 - page 23
Table 4: Incidence and mortality from esophageal cancer in 2001 and 2015 across the seven major pharmaceutical markets - page 24
Table 5: Comparison of mortality to incidence ratios for selected tumor types in the US, 2001 - page 25
Table 6: Risk factors for the development of esophageal cancer - page 26
Table 7: Common presenting symptoms of esophageal cancer - page 34
Table 8: Surveillance guidelines for patients with Barrett's esophagus - page 37
Table 9: TNM classification system for esophageal cancer - page 40
Table 10: TNM staging system for esophageal cancer - page 41
Table 11: Stage distribution and five-year survival rates for esophageal cancer in the US - page 43
Table 12: Five-year survival by stage of esophageal cancer - page 43
Table 13: Esophageal cancer treatment guidelines in the US - page 48
Table 14: Esophageal cancer treatment guidelines for recurrent disease in the US - page 48
Table 15: Esophageal cancer treatment guidelines in Europe - page 49
Table 16: Extent of resection of esophageal cancer - page 51
Table 17: Results from the RTOG 85-01 study - page 52
Table 18: Results from the INT-0123/RTOG 94-05 study - page 53
Table 19: Results from randomized clinical trials comparing neoadjuvant radiotherapy with surgery alone in potentially resectable esophageal cancer - page 56
Table 20: Results from the INT-0113 study comparing neoadjuvant chemotherapy with surgery alone - page 58
Table 21: Results from the MRC study comparing neoadjuvant chemotherapy with surgery alone - page 58
Table 22: Results from a meta-analysis of 11 studies investigating neoadjuvant therapy for esophageal cancer - page 60
Table 23: Results from randomized clinical trials comparing neoadjuvant chemoradiotherapy with surgery alone - page 61
Table 24: Results from a randomized clinical trial comparing neoadjuvant chemoradiotherapy with or without surgery - page 62
Table 25: Results from a randomized clinical trial comparing adjuvant radiotherapy with surgery alone - page 67
Table 26: Results from the JCOG-9204 trial comparing adjuvant chemotherapy with surgery alone - page 68
Table 27: Results from a randomized clinical trial investigating adjuvant chemoradiotherapy - page 69
Table 28: Single-agent activity of cytotoxics in advanced esophageal cancer - page 74
Table 29: Results from Phase II studies investigating combination chemotherapy regimens for advanced esophageal cancer - page 75
Table 30: Results from a randomized trial comparing ECF with FAMTX in advanced esophagogastric cancer - page 76
Table 31: Results from a randomized trial comparing ECF with MCF in advanced esophagogastric cancer - page 77
Table 32: Survival results from the REAL-2 study - page 78
Table 33: Toxicity from the REAL-2 study - page 79
Table 34: Proportion of patients at each stage of esophageal cancer who undergo surgery across the five EU markets, 2006 - page 83
Table 35: Proportion of patients at each stage of esophageal cancer who receive chemotherapy across the five EU markets, 2006 - page 84
Table 36: Proportion of stage III/IV esophageal cancer patients who receive multiple lines of chemotherapy across the five EU markets, 2006 - page 85
Table 37: Use of first-line chemotherapy regimens in esophageal cancer across the five EU markets, 2006 - page 85
Table 38: Use of second-line chemotherapy regimens in esophageal cancer across the five EU markets, 2006 - page 86
Table 39: Use of third-line chemotherapy regimens in esophageal cancer across the five EU markets, 2006 - page 86
Table 40: Phase III esophageal cancer pipeline, 2007 - page 98
Table 41: Ongoing clinical trials investigating Camptosar for resectable esophageal cancer, 2007 - page 100
Table 42: Ongoing clinical trials investigating Camptosar for metastatic or unresectable esophageal cancer, 2007 - page 101
Table 43: Ongoing clinical trials investigating Eloxatin for esophageal cancer, 2007 - page 103
Table 44: Ongoing clinical trials investigating Xeloda for esophageal cancer, 2007 - page 105
Table 45: Phase II esophageal cancer pipeline (cytotoxics), 2007 - page 106
Table 46: Phase II esophageal cancer pipeline (targeted therapies and miscellaneous), 2007 - page 107
Table 47: Phase I esophageal cancer pipeline, 2007 - page 108

List of Figures
Figure 1: Anatomy of the esophagus - page 16
Figure 2: Cross section of the esophagus - page 17
Figure 3: Esophageal cancer belt - page 19
Figure 4: Estimated incidence of esophageal cancer in the seven major pharmaceutical markets, 2001-15 - page 21
Figure 5: Incidence and mortality from esophageal cancer in 2001 and 2015 across the seven major markets - page 24
Figure 6: Use of chemotherapy regimens in the treatment of esophageal cancer across the five EU markets, 2006 - page 87
Figure 7: Summary of unmet needs in the esophageal cancer market, 2007 - page 97

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Stakeholder Opinions: Esophageal Cancer Treatment paradigms need revolution not evolution

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