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Prostate Cancer - Hormone-Refractory Patients Still Waiting for Treatment Breakthroughs

Posted on: Wednesday, 9 January 2008, 06:00 CST

Reportlinker.com announces that a new market research report related to the Pharmaceutical industry industry is available in its catalogue.

Stakeholder Insight: Prostate Cancer - Hormone-refractory patients still waiting for treatment breakthroughs

To order that report:

www.reportlinker.com/p073694/Stakeholder-Insight-Prostate -Cancer---Hormone-refractory-patients -still-waiting-for-treatment-breakthroughs.html

For more information, contact Nicolas by email nbo@reportlinker.com , by phone +33 4 37 65 17 03.

As a result of market dominance by agents such as leuprolide, and AstraZeneca's Zoladex (goserelin) and Casodex (bicalutamide), there is little space in the antihormonal therapies market for new competition unless significant clinical superiority or a unique selling point is demonstrated.

While Taxotere-based chemotherapy is the established first-line standard for hormone-refractory prostate cancer, many patients are still precluded from treatment due to toxicity concerns. This, coupled with a lack of second-line standard therapy, indicates a major gap in the market that could be potentially lucrative for drug developers.

Enthusiasm has been shown by key opinion leaders regarding certain late-phase pipeline products, however, during the time of writing, publication of negative clinical trial data has meant a dampening of this optimism. It will therefore be some time before the high unmet needs in the hormone-refractory prostate cancer market are satisfied.

Identify key factors that influence prescribing patterns for systemic therapy of prostate cancerExamine the significant unmet needs in the prostate cancer market and identify opportunities for new product developmentEnhance commercial positioning by increasing understanding of current dynamics within the prostate cancer market

CHAPTER 1 EXECUTIVE SUMMARY 3

Scope of the analysis 3

Datamonitor insight into the prostate cancer market 3

Contributing experts 5

Related reports 5

Upcoming reports 5

CHAPTER 2 INTRODUCTION AND SCOPE 8

Introduction 8

Coverage of the Stakeholder Insight Survey 8

Disease definition and epidemiology 8

Patient segmentation 8

Drug therapy for prostate cancer 8

Recurrent prostate cancer 9

Hormone-refractory prostate cancer 9

Pipeline products for hormone-refractory prostate cancer 9

CHAPTER 3 COUNTRY TREATMENT TREES 11

Introduction 11

Country treatment trees 12

US 12

Japan 16

France 20

Germany 24

Italy 28

Spain 32

UK 36

CHAPTER 4 DISEASE DEFINITION AND EPIDEMIOLOGY 40

Definition of prostate cancer 40

Prostate cancer 40

The most common cancer type and second leading cause of cancer-related death in males 40

Histology 40

The majority of prostate tumors are adenocarcinomas 40

Risk factors 41

Older age 41

Race 41

Family history 42

Hormones 42

Dietary factors 42

Symptoms 43

Symptoms frequently occur only at an advanced stage of prostate cancer 43

Screening and diagnosis 43

Measurement of PSA has proved fairly useful in the detection of prostate cancer, however, several issues need to be resolved 43

A widespread screening program exists in the US... 44

...however, in Europe, results from the ERSPC trial are necessary before screening programs can be considered 44

Though PSA screening has been shown useful in Japan, the practice is not widespread 44

Staging 45

Prostate cancer is staged using the TNM system and a histologically-based Gleason score 45

Epidemiology of prostate cancer 46

Incidence of prostate cancer 46

Prostate cancer is a tumor associated with older men, therefore incidence is rising in line with the ageing population 46

Mortality from prostate cancer 47

Potentially asymptomatic disease and a high rate of fatality from co-morbidities mean mortality from prostate cancer is not especially high 47

Prevalence of prostate cancer 49

Prevalence is high given the tendency for early diagnosis and low mortality 49

CHAPTER 5 PATIENT SEGMENTATION 51

Introduction 51

Staging of prostate cancer 51

Staging at diagnosis 51

Around half of all prostate cancer cases are diagnosed at a localized stage 51

Staging at the time of survey 53

A greater proportion have advanced-stage prostate cancer if patients at the time of survey are examined 53

One-quarter of all prostate cancer patients have hormone-refractory disease 55

Differences in staging 55

Urologists encounter more early-stage patients, while medical oncologists typically treat advanced disease... 55

...however, the difference is minimal in Japan due to its structure of medical practice 59

CHAPTER 6 INITIAL DRUG THERAPY FOR PROSTATE CANCER 60

Introduction 60

Overview of initial therapy for prostate cancer 60

Localized prostate cancer patients can undergo watchful waiting or radical prostatectomy 60

Initial treatment of locally advanced and metastatic prostate cancer constitutes androgen deprivation therapy 61

Initial treatment of prostate cancer 62

Initial use of drug therapy 62

As expected, use of initial drug therapy increases with an advancing stage of prostate cancer 64

However, a higher than expected proportion of localized stage patients appear to receive drug therapy 64

A lower proportion than average of locally advanced and metastatic prostate cancer patients receive initial drug therapy in the US 65

Specific initial drug therapy of prostate cancer 66

Across all stages of prostate cancer 66

LHRH agonist monotherapy and total androgen blockade are the favored drug regimens used in the initial treatment of prostate cancer 66

Localized prostate cancer 68

LHRH agonist monotherapy is generally sufficient given that an aggressive approach is not needed while the tumor is localized... 69

...however, in Spain and Japan, total androgen blockade is the favored initial treatment approach for localized prostate cancer 69

Anti-androgen monotherapy is the third most frequently used drug regimen for localized tumors due to its lower efficacy than medical castration 70

Use of cytotoxics with or without antihormonal therapy is very low in the initial treatment of localized prostate cancer 70

Locally advanced prostate cancer 72

On average, similar trends are seen in the initial treatment of locally advanced prostate cancer as for localized 73

More locally advanced patients receive TAB than localized patients, at the expense of use of anti-androgen monotherapy 74

Use of cytotoxics with or without antihormonal therapy is still low 74

Advanced prostate cancer 74

On average, the majority of advanced prostate cancer patients appear to receive the more aggressive total androgen blockade regimen as initial treatment, although this observation is deceptive 75

More advanced disease which may require more aggressive treatment means the combination of cytotoxics and antihormonal therapy is the third preferred initial regimen 76

Use of cytotoxics in the initial treatment of prostate cancer is relatively high across all stages in Germany 78

LHRH agonist monotherapy 78

Use of anti-androgens to counter testosterone flare 78

Use of anti-androgens to prevent testosterone flare from LHRH agonists increases with a more advanced stage of prostate cancer 78

Use of temporary anti-androgen therapy is, surprisingly, lowest in the US and Germany, and highest in the UK 80

Use of specific LHRH agonists as monotherapy 83

Leuprolide is the favored LHRH agonist for use as monotherapy across all stages of prostate cancer due to its availability in a variety of depot formulations 83

Goserelin is the second preferred LHRH agonist monotherapy across all stages of prostate cancer 85

Use of the various LHRH agonists varies greatly between countries, with use of leuprolide highest in the US and use of goserelin highest in the UK 85

Anti-androgen monotherapy 89

Use of specific anti-androgens as monotherapy 89

Bicalutamide, in varying dosing formulations, is the leading anti-androgen for use as monotherapy across all stage of prostate cancer 89

Despite being the only branded product in a heavily genericized market, Casodex (bicalutamide) remains the leader due to a number of advantages over its competition 91

Casodex is by far the preferred anti-androgen for use as monotherapy in each of the seven major pharmaceutical markets 91

Casodex 150mg has had a tumultuous regulatory pathway to date 94

The EPC trial showed that 150mg Casodex daily is suitable for treatment of locally advanced prostate cancer, but not localized disease 94

Casodex 150mg is still used in localized prostate cancer, according to surveyed physicians 95

In Japan, only 80mg Casodex is available, while in the US, only 50mg Casodex is available 95

In the EU, use of Casodex is more fragmented between the 50mg and 150mg formulations 95

Use of flutamide is highest in the US 96

Use of cyproterone and nilutamide are highest in the EU 96

Total androgen blockade 97

Use of specific total androgen blockade regimens 97

A combination of leuprolide and bicalutamide is the top TAB regimen across all stages of prostate cancer 97

No specific recommendations for TAB regimen are made, therefore the choice of agents is most likely due to physician preference or cost 98

In the US and Japan, the top three TAB regimens do not vary by stage, with the leading combination constituting leuprolide and bicalutamide 99

More variation is seen in the top three TAB regimens used in each of the five European countries, although leuprolide or goserelin with bicalutamide still emerge as the first or second preferred regimen in all markets 101

Use of specific formulations of LHRH agonists 107

Use of specific formulations as monotherapy or as part of combination regimens 107

On average across the seven major markets, the three-month depot version of leuprolide is the leading formulation of LHRH agonist 107

Three-month goserelin emerges as the second preferred formulation of LHRH agonist 108

Three-month formulations of LHRH agonist are deemed to offer the most convenience and flexibility to patients 109

In the US, use of alternative leuprolide formulations is favored 110

Triptorelin and buserelin formulations appear in the top three preferred LHRH agonist formulations only in four of the EU countries 110

CHAPTER 7 RECURRENT PROSTATE CANCER 111

Introduction 111

Overview of therapy for recurrent prostate cancer 111

Treatment of recurrent prostate cancer typically involves further lines of antihormonal therapy 111

Remission rates 112

Remission rates by stage of disease 112

Remission rates are surprisingly high in the more advanced stages of prostate cancer, indicating that systemic therapy may offer sufficient disease control 112

High use of TAB to treat localized disease in Japan may result in a significantly higher remission rate in these patients 114

Duration of remission 114

Duration of remission is longest in localized prostate cancer patients and shortest in advanced patients 114

A high proportion of localized patients are initially treated with drug therapy in Spain, thereby resulting in a higher duration of remission 116

Relapse rates 116

Patients who relapse following remission 116

As expected, relapse rates are highest among advanced prostate cancer patients and lowest in localized disease 116

Highest relapse rates in Spain, albeit for no apparent reason 117

Stage of disease present at relapse 118

Due to enhanced detection of rising PSA levels, relapsed disease can be identified while still at a localized stage 118

Hormone-refractory disease at relapse 120

Patients with more advanced disease may have more aggressive tumors, potentially placing them at a higher risk of developing hormone-refractory disease more quickly at relapse 120

Drug therapy for recurrent prostate cancer 122

Use of drug therapy for relapse 122

The majority of prostate cancer patients who relapse go on to receive further antihormonal and/or cytotoxic therapy 122

Surprisingly, drug therapy for relapsed disease is highest in the Japan and lowest in the US 123

Specific drug regimens used to treat recurrent prostate cancer 124

Drug therapy following LHRH agonist monotherapy 124

In accordance with treatment guidelines, the majority of patients receive TAB for relapsed disease after undergoing LHRH agonist monotherapy as initial therapy 124

Cytotoxic-based regimens are the second preference after LHRH agonist monotherapy, most likely for those patients with HRPC at relapse 125

Third choice varies between anti-androgen monotherapy or LHRH agonist monotherapy depending on the country 126

Drug therapy following anti-androgen monotherapy 126

TAB appears the favored regimen to follow initial anti-androgen monotherapy 126

On average, LHRH agonist monotherapy appears the second preferred treatment approach following initial anti-androgen monotherapy, although in some countries use is equivalent to that of cytotoxic-based regimens 128

The seven-market average dictates that cytotoxic-based regimens are the third preferred treatment option following initial anti-androgen monotherapy 129

Anti-androgen monotherapy in both the initial and second-line treatment settings has been clinically proven to offer few benefits 129

Drug therapy following total androgen blockade 130

Cytotoxic-based regimens are administered to the majority of patients who receive initial therapy with TAB 130

Continued TAB appears to be the second most popular approach following initial TAB therapy, possibly as part of an intermittent dosing regimen 131

On average, the third favored approach following initial TAB is LHRH agonist monotherapy, although significant differences occur between individual countries 132

Drug therapy following cytotoxic-based regimens with or without antihormonal therapy 133

Cytotoxic-based regimens are not typically used as initial therapy, therefore second-line treatment is highly fragmented between countries 133

CHAPTER 8 HORMONE-REFRACTORY PROSTATE CANCER 135

Introduction 135

Overview of therapy for hormone-refractory prostate cancer 135

Taxotere-based chemotherapy forms the first-line standard of care for HRPC patients 135

Bisphosphonates can be used to prevent the formation of bone metastases and to alleviate bone pain 136

Optimal second-line therapy for HRPC is yet to be defined 136

Progression to hormone-refractory prostate cancer 137

Patients who progress to hormone-refractory prostate cancer 137

Patients diagnosed with advanced prostate cancer are more likely to progress to HRPC than earlier-stage patients 137

Duration of antihormonal therapy prior to progression to HRPC 138

Localized patients undergo a longer duration of hormonal therapy prior to development of HRPC, while advanced patients progress more quickly 138

Drug therapy for hormone-refractory prostate cancer 140

Use of drug therapy for HRPC 140

Given the aggressive nature of HRPC, approximately three-quarters of patients receive drug therapy as treatment 140

Highest use of initial drug therapy for HRPC seen in Japan, lowest use seen in the US 142

First-line drug therapy 142

First-line drug regimens used to treat HRPC 142

Taxotere-based chemotherapy regimens are used heavily across all seven major pharmaceutical markets in the first-line treatment of HRPC 142

The leading seven-market first-line regimen is Taxotere and prednisone, which is expected given that this combination has regulatory approval for treatment of HRPC in the US and EU 144

Single-agent estramustine and single-agent Taxotere see equal use in the first-line treatment of HRPC when the seven-market average is examined despite a lack of robust supporting clinical data 145

Greater evidence exists supporting the first-line use of a Taxotere and estramustine combination in comparison to either agent as monotherapy 146

Use of secondary hormonal therapy as first-line treatment for HRPC may still be appropriate in those cases where androgen receptors are still active 147

Second-line drug therapy 147

Progression from first-line to second-line therapy 147

The majority of HRPC patients progress to second-line therapy, although variation is shown across the seven major markets 147

Second-line drug regimens used to treat HRPC 149

Use of Taxotere-based regimens is still high in the second-line treatment of HRPC, although mitoxantrone is also used frequently at this stage 149

The leading seven-market second-line regimens are single-agent mitoxantrone and a combination of Taxotere and prednisone, both administered to equal proportions of HRPC patients 151

Single-agent Taxotere is the third leading second-line regimen for the treatment of HRPC, most likely due to a lack of other approved agents 152

Use of single-agent estramustine is still high in the second-line treatment of HRPC in Japan, as well as in France, Italy and Spain 152

Continued use of a combination of Taxotere and estramustine is seen in the second-line treatment of HRPC in Japan 152

In Germany, a combination of vinorelbine and estramustine appears in the top three second-line regimens, most likely due to vinorelbine's milder toxicities 153

Secondary hormonal therapy is used in the second-line treatment of HRPC in Italy and the UK, which is somewhat surprising at this late stage 153

Key prescribing influences 153

Key prescribing influences for drug therapy of HRPC 153

The ability to improve overall survival, symptoms and quality of life are the leading two influences on prescribing for treatment of HRPC 153

The third leading prescribing influence concerns side-effect profiles, which is obviously of significance following improvements to survival and quality of life 156

The importance of remaining key prescribing influences vary depending on country-specific issues, with cost issues, method and frequency of administration and physician product familiarity more or less of similar weight 156

Relatively high importance of cost issues is expected in the more cost-conservative UK, but not in the US 156

Method of administration, frequency of dosing and physician product familiarity are all of similar relevance in each of the seven markets 156

Pharmaceutical company marketing and services appears to be the least important key prescribing influence across the seven major markets 157

CHAPTER 9 PIPELINE PRODUCTS FOR HORMONE-REFRACTORY PROSTATE CANCER 158

Introduction 158

Prostate cancer pipeline overview 158

Key pipeline product profiles 164

Abbott's Xinlay (atrasentan) 165

Spectrum Pharmaceuticals/GPC Biotech's Orplatna (satraplatin) 166

Dendreon's Provenge (sipuleucel-T) 167

Cell Genesys's GVAX 169

Novacea/Schering-Plough's Asentar (calcitriol, DN-101) 170

Northwest Biotherapeutics' DCVax-Prostate 172

Genentech/Roche's Avastin (bevacizumab) 172

Key attributes 174

Key attributes for HRPC pipeline products 174

As expected, the top desired attributes in a pipeline drug for HRPC is to prolong overall survival duration and improve quality of life 174

Superiority over the current first-line standard 176

Clinical improvements required for a pipeline drug to be used ahead of the current first-line standard, Taxotere plus prednisone 176

In order for a pipeline drug to be used in combination with Taxotere over the current first-line standard, relatively large improvements in clinical benefits would need to be shown 176

Acceptable price increase for a pipeline drug to be used in advance of the current first-line standard, Taxotere plus prednisone 177

Physicians speculate that payers are prepared to pay nearly 20% more for a pipeline drug if survival is increased, even at the expense of increased toxicity 177

Predicted performance of late-phase pipeline products 178

Pipeline drugs are predicted to have some advantages over the current standard 178

Taxotere-based regimens are ranked highest in terms of overall survival and symptom/quality of life improvements, which is expected given the solid clinical evidence available 180

In terms of side-effect profile, method of administration and frequency of dosing, pipeline products are all ranked ahead of the standard Taxotere-based regimen, which is ranked the lowest for each 181

Provenge is ranked highest in terms of side-effect profile 181

Xinlay is ranked highest in terms of method of administration and frequency of dosing 181

No difference is shown between pipeline products in terms of cost issues 182

Taxotere and Avastin are ranked higher in terms of pharmaceutical company services, most likely owing to the large and well-established nature of their manufacturers 182

Taxotere-based regimens and Avastin were ranked highest in terms of physician product/class familiarity, which is not surprising, given these two agents are formally approved for treatment of cancer 183

Brand mapping 183

Interpreting a brand map 183

The brand map confirms the observations made with respect to predicted performance of pipeline products for HRPC 185

APPENDIX A 186

Physician research methodology 186

Physician sample breakdown 186

US 186

Japan 187

France 187

Germany 188

Italy 188

Spain 189

UK 189

Supplementary data 190

Brand map interpretation 195

Key opinion leader interview transcripts 197

APPENDIX B 198

The survey questionnaire 198

1. Patient segmentation 198

2. Drug therapy for prostate cancer 199

3. Recurrent prostate cancer 209

4. Hormone-refractory prostate cancer 214

5. Pipeline drugs 218

APPENDIX C 221

Bibliography 221

List of tables 230

List of figures 231

List of abbreviations 231

About Datamonitor 233

About Datamonitor Healthcare 233

About the Oncology analysis team 234

Disclaimer 235

To order that report:

www.reportlinker.com/p073694/Stakeholder-Insight-Prostate -Cancer---Hormone-refractory-patients- still-waiting-for-treatment-breakthroughs.html

For more information, contact Nicolas by email nbo@reportlinker.com , or by phone +33 4 37 65 17 03.

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