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Prostate Cancer - A Prostrate Market Waiting For Innovations


Description: Introduction

The prostate cancer market is reaching maturity, and major players sales have been eroded by the launch of various LHRH agonist depot formulations. Safety concerns with AstraZenecas Casodex (bicalutamide) have also seen a significant proportion of physicians switching to alternatives. Establishing the optimal timing of antihormonal therapy will provide the key to market growth.

Scope

- Current treatment practices for hormone-sensitive and hormone-refractory prostate cancer based on 180 physician interviews in the seven major markets

- Changes in prescribing habits for prostate cancer between 2003 and 2005
Physician awareness and ratings of late-stage pipeline drugs for prostate cancer, including Abbotts Xinlay and Dendreons Provenge

- Potential drug regimens for prostate cancer in 2010 based on physicians opinion

Highlights

The use of bicalutamide has significantly decreased in localized stage between 2003 and 2005 since the EPC trial demonstrated increased mortality with bicalutamide 150mg. This has not only undermined physicians confidence in the drug in localized stage but it has also affected the uptake of the drug in locally advanced and advanced stage disease.

TAB has failed to conclusively establish survival benefit in clinical trials and remains used in a minority of patients in advanced stage. Cost is also a problem for TAB, even in the US. However, oral drugs are expected to be reimbursable under Medicare from 2006 and that should increase the uptake of anti-androgens as well as that of TAB regimens.

Although physicians are hopeful of molecular-targeted agents for HRPC, primary research suggests that its use will remain relatively low in 2010 and they are not expected to be used in a level similar to that seen in other tumors. However, opinion leaders have identified angiogenesis inhibitors to be the most promising for prostate cancer.

Reasons to Purchase

- Quantify the size and scope of the antihormonals market for prostate cancer by examining the uptake of LHRH agonists and anti-androgens

- Examine the potential of late-stage pipeline drugs for prostate cancer through physician awareness and ratings.

- Develop commercial strategies by analyzing physicians opinion on the potential drug regimens for prostate cancer in 2010


Contents: bout the Oncology pharmaceutical analysis team 2

CHAPTER 1 3.


CHAPTER 2 INTRODUCTION 13.

Scope 13
The prostate 14
Prostate cancer 14
Histology 15
Etiology 15
Age and race 16
Family history 16
Hormones 17
Dietary fat 17

CHAPTER 3 TREATMENT TREES 19.

US 20
Japan 23
France 26
Germany 29
Italy 32
Spain 35
UK 38

CHAPTER 4 ANTIHORMONAL THERAPIES 41.

Stages of diagnosis 41
Mis-staging may be common in some markets 43
Antihormonal therapy 44
Localized stage 45
Locally advanced stage 49
Advanced stage 50

CHAPTER 5 ANTIHORMONAL DRUGS 54.

Localized stage 54
LHRH agonist monotherapy is the standard of care in localized stage 55
Bicalutamide is the leading anti-androgen 63
The lack of clinical evidence for TAB in localized stage 67
Locally advanced stage 75
More aggressive therapy in locally advanced stage 77
Bicalutamide remains dominant 81
TAB has yet to gain a wider uptake 85
Advanced stage 89
LHRH agonist monotherapy remains the standard therapy in advanced stage 94
Bicalutamide remains in the driving seat 97
The use of TAB is surprisingly low 100

CHAPTER 6 THE USE OF ANTIHORMONALS BETWEEN 2003 AND 2005 103.

Changes in the use of drug classes 103
Significant increase in the use of LHRH agonist monotherapy at the expense of TAB 104
Decline in the use of anti-androgen in localized stage 106
Market differences 107
Percentage of patients treated with LHRH agonists between 2003 and 2005 109
Market differences 112
Percentage of patients receiving anti-androgens between 2003 and 2005 114
Market differences 117
Percentage of patients treated with TAB between 2003 and 2005 120
Market differences 122

CHAPTER 7 DURATION OF TREATMENT 125.

Treatment duration 125
LHRH agonists 125
Anti-androgens 127
Total androgen blockade 129
Overall average treatment duration 132
Intermittent hormonal therapy 133
IHT is used most commonly in localized stage 135
Reduced usage of IHT in more advanced stages 136
The use of IHT between 2003 and 2005 136

CHAPTER 8 RECURRENT PROSTATE CANCER 140.

Remission rate 140
The chronic nature of prostate cancer 141
Aggressive TAB therapy benefiting localized patients in Japan 141
Recurrence rate 142
Poor disease control in France? 143
Treatment of recurrent prostate cancer 144
Leuprolide remains the dominant LHRH agonist 146
Increase in the use of bicalutamide 150
Leuprolide- and bicalutamide-based regimens are the mainstay of TAB regimens 152

CHAPTER 9 HORMONE-REFRACTORY PROSTATE CANCER 155.

Progression to HRPC 155
High progression rate in localized stage in France, Germany and Spain 156
Discrepancy in advanced stages across the markets 157
Time to HRPC progression 157
Long time to progression in the UK in localized stage 158
Asymptomatic versus symptomatic HRPC 159
Nearly equal split 160
Active treatment of HRPC 161
Higher proportion of symptomatic patients are actively treated 162
Drug regimens for asymptomatic HRPC 162
Top three drug regimens for asymptomatic HRPC 164
Drug regimens for symptomatic HRPC 174
Top three drug regimens for symptomatic HRPC 176
Drug regimens for HRPC in 2003 and 2005 185
Estramustine monotherapy increases in use between 2003 and 2005 187
Increase in taxane-based regimens 187
No increase for vinorelbine 187
Decreasing use of ‘older’ drugs 188

CHAPTER 10 DRUGS IN DEVELOPMENT FOR PROSTATE CANCER 189.

Xinlay (atrasentan) [Abbott] 190
Physician awareness of Xinlay 190
Physician rating of Xinlay 192
Satraplatin [GPC Biotech] 194
Physician awareness of satraplatin 194
Physician rating of satraplatin 195
Provenge [Dendreon] 197
Physician awareness of Provenge 198
Physician rating of Provenge 200
DN-101 (calcitriol) [Novacea] 202
Physician awareness of DN-101 202
Physician rating of DN-101 203
Thalomid (thalidomide) [Celgene] 205
Physician awareness of Thalomid 206
Physician rating of Thalomid 207
GVAX [Cell Genesys] 208
Physician awareness of GVAX 208
Physician rating of GVAX 210
Comparative awareness and physician ratings of pipeline drugs for prostate cancer 212

CHAPTER 11 FUTURE PRESCRIBING 214.

Drug regimens for hormone-sensitive prostate cancer in 2010 214
LHRH agonist monotherapy will still be the standard of care especially in France, Italy and the UK 215
Physicians will remain skeptical of TAB 216
Chemotherapy plus antihormonals will gain support 216
Molecular-targeted agents will be minimally used 217
Trends in prescribing for hormone-sensitive prostate cancer 219
Drug regimens for HRPC in 2010 222
Taxane-based regimens will be the most commonly used drug therapies for HRPC 223
Novel agents are not expected to make a significant impact 224
Trends in prescribing for HRPC 225

CHAPTER 12 APPENDIX 227.

Supplementary data 227
Respondent breakdown 241
Opinion leader interview transcripts 242
Dr Judd W Moul, Professor and Chief, Division of Urologic Surgery, Duke University Medical Center, NC, US 242
Dr Daniel Petrylak, Director of Genitourinary Oncology Program, Columbia Presbyterian Medical Center, NY, US 250
Dr Alessandro Sciarra, Department of Urology, University La Sapienza, Rome, Italy 258
Dr Marcos Lujan, Urology Department, Hospital Universitario de Getafe, Madrid, Spain 264
Study questionnaire 270
References 290
LIST OF TABLES 298
LIST OF FIGURES 304








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