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This slide deck is being provided in response to an
unsolicited request and is intended only for
members of the media. Do not copy, print,
distribute, or otherwise disseminate this slide deck.

NEW PERSPECTIVES:
A Multidisciplinary Approach
To Managing Advanced Prostate
Cancer
PRESS BRIEFING
Sunday, March 20, 2011
09:00 – 11:00AM

COM.CAB.11.03.03 03/2011

Disclosures unsolicited request and is intended only for

• This press briefing is sponsored by sanofi-aventis, a
premier sponsor of the EAU Congress Vienna.

• Cabazitaxel has been filed with the EMA, but no
marketing authorization has yet been granted. Cabazitaxel
is currently approved in the United States, Brazil, Curaçao,
and Israel and is marketed under the trade name
JEVTANA®.

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COM.CAB.11.03.03 03/2011

Press Briefing Agenda unsolicited request and is intended only for

• 9:00 – 9:05 AM – Welcome/Introduction of Panel

• 9:05 – 9:25 AM – The MDT Approach to Improving Survival in Prostate Cancer

• 9:25 – 9:40 AM – Highlights of TROPIC Study

• 9:40 – 9:55 AM – Assessing Patient Eligibility for Cabazitaxel

• 9:55 – 10:00 AM – Final Points

• 10:00 – 10:15 AM – Questions from the Media

• 10:15 – 10:20 AM – Closing Remarks

• 10:20 – 11:00 AM – Interviews with Panelists

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Panelist Introductions unsolicited request and is intended only for

• Bernard Peyrical, Head of Region Europe Communications, sanofi-
aventis

• Amit Bahl, Consultant Oncologist, Head of Research, Head of
Radiotherapy, Bristol Haematology and Oncology Centre, University
Hospitals Bristol, UK

• Stéphane Oudard, M.D., Ph.D., Professor of Oncology and Chief of
the Oncology Translational Research Unit at the Georges Pompidou
Hospital, Paris, France

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The MDT Approach to Improving Survival in
Prostate Cancer

Dr. Amit Bahl
Dr. Stéphane Oudard

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Prostate Cancer Overview unsolicited request and is intended only for

• Prostate cancer is the second-most common cancer in men (worldwide) and
the third leading cause of cancer death (in developed countries)1,2

• Established risk factors include3:
• Age: the median age at diagnosis is 68 years

• Race: African American men have the highest incidence rates

• Family history

• 10% to 20% of patients present with metastatic disease at diagnosis6

1. Nelen V. Recent Results Cancer Res. 2007;175:1-8.
2. American Cancer Society. Global Cancer Facts & Figures 2007. Atlanta: American Cancer Society; 2007.
3. American Cancer Society. Cancer Facts & Figures 2010. Atlanta: American Cancer Society; 2010.
4. Ferlay J, Parkin DM, Steliarova-Foucher E. Eur J Cancer. 2010;46(4):765-781.
5. International Agency for Research on Cancer. GLOBOCAN 2002 Database. http://www-dep.iarc.fr/.Accessed March 10, 2010.
6. Tannock IF, de Wit R, Berry WR, et al. N Engl J Med. 2004;351(15):1502-1512.

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Treatment Options for Prostate Cancer unsolicited request and is intended only for

Rising Metastatic Metastatic
No Localised PSA hormone hormone
cancer disease after local sensitive resistant
therapy

Active surveillance

Curative °Radical prostatectomy or external beam radiation
therapy° therapy or brachytherapy

Hormonal treatment

Chemotherapy

Clinical trials

COM.CAB.11.03.03 03/2011

Treatment of Advanced Prostate Cancer unsolicited request and is intended only for

• The cornerstone treatment for advanced prostate cancer
is androgen deprivation therapy (ADT)
– Objective response > 80% of patients but with time
the cancer will become resistant to hormone therapy (Hormone
Refractory Prostate cancer - HRPC)
• Once a patient with metastatic prostate cancer fails
androgen deprivation therapy, chemotherapy with
docetaxel has become a standard1-4
– To delay disease progression
– To prolong survival
– To improve QOL

Heidenreich A, et al. (2010 update) www.uroweb.org 2Mohler J, et al. (2009 update) www.nccn.org
1

Basch EM, et al. J Clin Oncol 2007;25:5313–18 4Horwich A, et al. Ann Oncol 2009;20(Suppl 4):76–8
3

COM.CAB.11.03.03 03/2011

Prostate Cancer: Management unsolicited request and is intended only for

• Earlier diagnosis means more “curable” disease
• 80% of ‘high risk’ prostate cancer will develop
biochemical relapse or clinical failure within 10 years1
• High risk and advanced or metastatic disease require:
– Multiple systemic therapies
– Ideally within the multi-disciplinary team approach

D’Amico. JCO 2003, 21, 2163
1

.

COM.CAB.11.03.03 03/2011

Multidisciplinary Teams in Prostate Cancer:

Patient-Centric Management members of the media. Do not copy, print,

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COM.CAB.11.03.03 03/2011

The Extended Team Supports the Patient unsolicited request and is intended only for

Treating physicians Diagnostic Supporting physicians
Urologist management Pain management
Medical oncologist Radiologist Neurosurgeon
Radiation oncologist Pathologist Psychiatrist
Onco-geriatrician Primary care physician

Clinical and
Patient
fundamental
research teams
Support staff
Specialist nurse
Dietician
Physiotherapist
Palliative care specialist

COM.CAB.11.03.03 03/2011

Increased Collaboration Between This slide deck is being provided in response to an
Urologists and Oncologists distribute, or otherwise disseminate this slide deck.

• As the role of chemotherapy for the treatment of HRPC evolves, the
need for strong partnerships between urologists and oncologists
increases1

• Optimal patient management should involve close coordination
between urologists and oncologists to ensure that all appropriate,
and potentially beneficial, treatment options are explored1

• Only about 30% of patients with mHRPC are referred for
chemotherapy by their urologist2

1. Kibel AS. Urology 2005; 65 (Suppl): 13–18.
2. Crawford ED. Rev Urol 2003; 5 (Suppl 2): S48–52.

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COM.CAB.11.03.03 03/2011

Patient Benefits of MDT Approach in Prostate This slide deck is being provided in response to an

Cancer Care members of the media. Do not copy, print,

• Mutual alignment of expectations and treatment goals among
urologists, oncologists, and patients can improve patient care.1

• “Patients managed by teams which function effectively are more likely
to be offered appropriate information and guidance, to receive continuity
of care through all stages of their disease, and to be treated in
accordance with locally agreed protocols and clinical guidelines”2

1. Gomella LG, Lin J, Hoffman-Censits J, et al. Enhancing prostate cancer care through the multidisciplinary clinic
approach: a 15-year experience. J Clin Pract. 2010;6(6):e5-e10.
2. NICE. The Manual. 2002

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Patient Benefits of MDT Approach in Prostate This slide deck is being provided in response to an

Cancer Care members of the media. Do not copy, print,

• Core team members provide expert multidimensional approach to
identifying disease progression and moving patients towards more
effective therapies as soon as possible.1

• MDTs encourage men to receive supportive care, rehabilitation and
emotional support, all of which are important in the treatment of
advanced prostate cancer.1

1. Valdagni R, Albers P, Bangma C, et al. “The Requirements of a specialist Prostate Cancer Unit: a discussion
paper from the European School of Oncology. Eur J Cancer. 2011 Jan;47(1):1-7.

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MDT Approach Influences Diagnostic and This slide deck is being provided in response to an

Treatment Decisions members of the media. Do not copy, print,

• 296 patients presented MDT with an outside diagnosis
of a urologic malignancy
N/A 17.1%
38% change in
Other 10.4%
diagnostic
decision or
Change in Dx and Tx 8.9% treatment

Change in Dx/no change in Tx 5.6%

No change Dx/change Tx 23.4%

No change in Dx or Tx 34.6%

0.0% 10.0% 20.0% 30.0% 40.0%
Dx = diagnostic decision. Tx = treatment decision
Kurpad R, et al. Urol Oncol 2009 [Epub ahead]of print]

COM.CAB.11.03.03 03/2011

Multidisciplinary Teams in Prostate Cancer: This slide deck is being provided in response to an
NICE Guidance: improving outcomes distribute, or otherwise disseminate this slide deck.

• All patients with urological cancer – both newly diagnosed and
existing – should be managed by appropriate MDTs1

• The MDT can comprise of: lead clinician; urologist; specialist nurse;
radiologist; pathologist; oncologist; and palliative care specialist1

1. NICE. The Manual. 2002

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COM.CAB.11.03.03 03/2011


7 OUT OF 10 unsolicited request and is intended only for

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COM.CAB.11.03.03 03/2011


Practical example:
European Hospital Georges Pompidou

‘Prendre Soin’
(Taking Care)

Stephane Oudard

COM.CAB.11.03.03 03/2011


Supportive Care in Cancer unsolicited request and is intended only for

Supportive care is the prevention and management of
Supportive care is the prevention and management of
the adverse effects of cancer and its treatment across
the adverse effects of cancer and its treatment across
the entire continuum of a patient’s illness — including
the entire continuum of a patient’s illness — including
the enhancement of rehabilitation and survivorship
the enhancement of rehabilitation and survivorship

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COM.CAB.11.03.03 03/2011

What’s Up at HEGP in Supportive This slide deck is being provided in response to an
Care? distribute, or otherwise disseminate this slide deck.

• RCP:Réunion de concertation pluridisciplinaire, (Staff) in Supportive care

• Second degree formation in supportive care (1st in France)

• Many clinical trials

• Relationship with association in SCC
– National (AFSOS)
– International (MASCC)
• Outpatient care development

• Inpatient care development

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COM.CAB.11.03.03 03/2011

Supportive Care Unit in HEGP unsolicited request and is intended only for

Specific dedicated medical hospitalisation structure

• 6 beds (1 pain, 1 interventional, 4 standards)

• Coordination (pain, psycho-oncology, palliative care, supportive care
team)

• Anticipated situations to avoid emergencies hospitalisation

F.Scotté HEGP Cancérologie 21
COM.CAB.11.03.03 03/2011

Innovative way to follow our patient This slide deck is being provided in response to an
at Home: PROCHE program at HEGP distribute, or otherwise disseminate this slide deck.

Hospital 1- Physician sends Medical Call Center
patient enrollment
form to call center
nurse
2- Call center
nurse calls
Patient
patient to
collect
toxicity data

4- Call center
nurse sends 3- Call center receives
5- After physician’s validation, lab work results
pharmacist prepares the patient data
chemotherapy to the
pharmacy

6- Oncology team is ready for patient arrival.
Chemotherapy is waiting for patient

COM.CAB.11.03.03 03/2011

Results: Patient Length of Stay unsolicited request and is intended only for

As a result of PROCHE program, patient length of stay was
reduced by 21%, from 247 min in Sept 09 to 186 min in Mar 10
(-51 min per patient stay).
247 min 186 min

131 min

131 min
79 min

116 min 107 min

Before PROCHE With PROCHE

COM.CAB.11.03.03 03/2011

A shared purpose… members of the media. Do not copy, print,

‘To provide a world class, patient-focused cancer
service for the prostate cancer patients and the
wider health community and in doing so support the
development and discovery of treatment and
supportive cancer care’

Is this what we want?

24

COM.CAB.11.03.03 03/2011


Insights into the Dynamics of Survival in
Advanced Prostate Cancer: Highlights of
TROPIC Study


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COM.CAB.11.03.03 03/2011

Identifying the Unmet Medical Need in Second- This slide deck is being provided in response to an
Line Treatment distribute, or otherwise disseminate this slide deck.

• Despite a survival benefit with first-line chemotherapy with docetaxel,
mHRPC patients inevitably progress, most within 9 months1-5
• <50% of patients with mHRPC receive second-line therapy6
• However, many mHRPC patients have a good performance status
and desire additional treatment7
• Only options were palliative chemotherapy, supportive care, or
investigational agents8

• Following progression on docetaxel6,9:
• There was no approved agent after disease progression
• No agent demonstrated an improvement in overall survival (OS)
1. Petrylak DP, et al. N Engl J Med. 2004;351(15):1513-1520.
2. Tannock IF, et al. N Engl J Med. 2004;351(15):1502-1512.
3. Oudard S, et al. J Clin Oncol. 2005;23(15):3343-3351.
4. Nelius T, et al. BJU Int. 2006;98(3):580-585.
5. Nelius T, et al. Onkologie. 2005;28(11):573-578.
6. Garmey EG, et al. Clin Adv Hematol Oncol. 2008;6(2):118-132.
7. Fitzpatrick JM, et al. Eur Urol Suppl. 2009;8(9):738-746.
8. Rosenberg JE, et al. Cancer. 2007;110(3):556-563.
9. Sternberg CN, et al. J Clin Oncol. 2009;27(32):5431-5438.

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COM.CAB.11.03.03 03/2011

Cabazitaxel: A Next Generation Taxane unsolicited request and is intended only for

X Y
Y O
X
Docetaxel -OH -OCCH3

Cabazitaxel -OCH3 -OCH3

Both extracted from
needles of the
European Yew tree
Taxus baccata
These two radicals confer very
specific properties to cabazitaxel
99th AACR annual meeting, San Diego, April 2008 (abstract #3227)

COM.CAB.11.03.03 03/2011


Cabazitaxel: Tubulin-Targeting Drug unsolicited request and is intended only for

Cabazitaxel
Microtubule Stabilizer1,2
Promotes tubulin assembly
Stabilizes microtubules against
depolymerization
Inhibits mitotic progression

Cabazitaxel was selected out of 450
molecules for its specific properties:
Greater penetration of the blood
brain barrier compared with
docetaxel and paclitaxel in an in vivo
preclinical model3
Active in vitro and in vivo on
Courtesy of sanofi-aventis Web site: http://www.oncology.sanofi-
tumors resistant to Taxotere3 aventis.com/tcl/cp/en/layout.jsp?scat=4BF14C98-DE0C-4464-A2F1-
6AA9C9D806A4. Accessed March 22, 2010.

1. Engels FK et al. Br J Cancer 2005;93:173-177; 2. Greenberger LM, Sampath D. Resistance to taxanes. In: Teicher BA, ed. Cancer Drug Discovery
and Development: Cancer Drug Resistance. Totowa, New Jersey: Humana Press; 2006:329-358; 3. Mita AC et al, Clin Cancer Res. 2009, 15, 723-730

COM.CAB.11.03.03 03/2011

Overview of TROPIC Study unsolicited request and is intended only for

Phase III TROPIC Study: 146 Sites in 26 Countries1

1. de Bono JS, Oudard S, Ozguroglu M, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.

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Overall Survival unsolicited request and is intended only for

Adapted from: de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.

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COM.CAB.11.03.03 03/2011

No Worsening of Performance Status (PS) unsolicited request and is intended only for

DOF.TROPIC.CSR/p91/Fig10
de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.

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Adverse Events unsolicited request and is intended only for

• The most common toxic effects of cabazitaxel were hematological1
• The most frequent hematological grade 3 or higher adverse events were
neutropenia, leukopenia, and anemia 1

• The most common nonhematological grade 3 or higher adverse event was diarrhea,
which was managed expectantly1

• Grade 3 peripheral neuropathy was uncommon (reported in three [1%] patients in each
group) 1
• Overall, peripheral neuropathy (all grades) was reported during the study in 52 (14%) patients in
the cabazitaxel group and 12 (3%) in the mitoxantrone group1

• Peripheral edema (all grades) occurred in 34 (9%) patients in each group. 1

• 18 (5%) patients treated with cabazitaxel and nine (2%) treated with mitoxantrone died
within 30 days of the last infusion.1
• The most frequent cause of death in the cabazitaxel group was neutropenia and its clinical
consequences. 1

1. de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.

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Overall Survival unsolicited request and is intended only for

• Patients in the cabazitaxel arm had significantly improved overall
survival compared with those in the mitoxantrone arm1
• 15.1 months median overall survival vs 12.7 months with mitoxantrone
(HR=0.70, p < 0.0001) 1

• In the United States, Israel, Curaçao and Brazil, where cabazitaxel is
approved, it was the first drug to demonstrate overall survival in
prostate patients previously treated with docetaxel. Cabazitaxel has
been filed in Europe and is pending review.
• The overall survival benefit with cabazitaxel was consistent across all
subgroups, including patients who progressed during docetaxel treatment
and those who had received high doses of docetaxel1

1. de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.

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Assessing Patient Eligibility
for Cabazitaxel


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Criteria To Be Considered in This slide deck is being provided in response to an

Cabazitaxel Eligibility members of the media. Do not copy, print,

• Metastatic HRPC progressing during or after docetaxel

• Health status of the patient
– More than chronological age

• Predictors of rapid progression

COM.CAB.11.03.03 03/2011

TROPIC: Similar Survival Benefit in Young and This slide deck is being provided in response to an

Older Patients members of the media. Do not copy, print,

Factor Subgroup Patient Hazard Ratio Favors Favors
Number (95% CI) CBZP MP
Age <65 295 0.81 (0.62-1.05) X -
Age ≥65 460 0.66 (0.53-0.81) X -

*The protocol was amended after the first 59 patients were enrolled in order to
mandate that eligible patients had to have received >225 mg/m² of docetaxel.

De Bono et al. Lancet, 2010, 376:1147-54

COM.CAB.11.03.03 03/2011


SIOG Recommendations for Senior Men unsolicited request and is intended only for

• Treatment recommendations for older men with
prostate cancer should be based on health status
(mainly driven by comorbidities)
• And patient preferences
• Not on chronological age

Droz JP et al, Crit Rev Oncol Hematol. 2010, 73: 61-91
Droz JP et al. BJU Int. 2010, 106: 462-69

COM.CAB.11.03.03 03/2011

Consider Switching to Second-Line This slide deck is being provided in response to an
Chemotherapy at First Signs of Progression distribute, or otherwise disseminate this slide deck.

Key Indicators of Progression on Docetaxel

1. Eisenhauer EA, et al. Eur J Cancer. 2009;45(2):228-247.
2. de Bono JS, Oudard S, Ozguroglu M, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.
3. Fitzpatrick JM, et al. Eur Urol Suppl. 2009;8(9):738-746.

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COM.CAB.11.03.03 03/2011


Final thoughts from the panel

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Questions? unsolicited request and is intended only for

When given the microphone,
please share your name, media
outlet, and identify which panel
member you are addressing

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COM.CAB.11.03.03 03/2011


NEW PERSPECTIVES:
A Multidisciplinary Approach
To Managing Advanced Prostate
Cancer

COM.CAB.11.03.03 03/2011

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