The Results of the First Global Prostate Cancer Consensus Conference - - PowerPoint PPT Presentation

Fernando Cotait Maluf

Associate Director – Oncology Center - Beneficência Portuguesa, São Paulo Member of Steering Comite – Oncology Center – Albert Einstein Hospital , São Paulo Director – Oncology Center – Santa Lúcia Hospital, Brasília

The Results of the First Global Prostate Cancer Consensus Conference for Developing Countries (PCCCDC)

Confict of Interest None for this talk

• This unique conference provided guidelines for the most

frequent cancer in men specifically for areas of resources limitations (70-75% of the world’s population).

• The methodology applied in the global consensus for

developing countries was similar to one used for Advanced Prostate Cancer Consensus Conference (APCCC).

• Voting members included leader opinion physicians from different

specialties: urologists, medical oncologists, radiation oncologists, radiologists and pathologists from developing countries in Latin America, Africa, Middle East, Asia and Eastern Europe.

• Physicians were generally aware of the costs of diagnostics, follow-up, and

treatment tools

• For all the following questions that refered to an area of limited resources

the recommendations should take into account cost-effectiveness as well as the possible therapies with easier and broader access.

• 2. LOCALIZED LOW-RISK

(AND VERY LOW RISK) PROSTATE CANCER

• 1. Active surveillance
• 2. Radical prostatectomy (only open approach is available)
• 3. External beam radiation (No IMRT available)
• 4. External beam radiation plus ADT (No IMRT available)
• 5. Some form of ADT (particularly if no local treatment is feasible)
• 6. All of the above
• 7. Abstain

2.2.4 What is your treatment recommendation for an otherwise healthy patient diagnosed with low risk prostate cancer in an area with limited resources ?

68.60% 24.42% 2.33% 0.00% 0.00% 4.65% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 1 2 3 4 5 6 7

• 1. Radical prostatectomy (open only)
• 2. Hormonal therapy
• 3. Cobalt radiotherapy
• 4. Combination of hormonal therapy and cobalt radiotherapy
• 5. Abstain

2.2.17 In Institutions where there is no conformal external beam radiotherapy availability of IMRT technique, robotic/laparoscopic surgery nor focal therapy or brachytherapy, which treatment is recommended for patients with life expectancy of > 10-15 years, with low risk prostate cancer, who has declined active surveillance or who had disease progression on active surveillance?

100.00% 0.00% 0.00% 0.00% 0.00%

0.00% 20.00% 40.00% 60.00% 80.00% 100.00% 120.00% 1 2 3 4 5

• 1. Yes, the majority of patients
• 2. Yes, the minority of patients
• 3. No
• 4. Abstain

2.2.19 In Institutions where there is only cobalt radiotherapy technique, patients with prostate cancer can be treated with external radiotherapy?

6.10% 10.98% 80.49% 2.44%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3 4

• 3. LOCALIZED INTERMEDIATE-

RISK PROSTATE CANCER

(Consider intermediate favorable and intermediate)

1. Radical prostatectomy (Robot platform not available) 2. Hormonal therapy alone 3. External beam radiotherapy alone (IMRT not available) 4. Combination of hormonal therapy and external beam radiotherapy (IMRT not available) +/- Brachytherapy 5. Brachytherapy 6. Active surveillance 7. Abstain

3.2.2 Which treatment is recommended for patients with life expectancy of > 10-15 years with the diagnosis of intermediate risk prostate cancer with Gleason score 3 + 4, PSA < 20ng/mL, and disease confined to the prostate in an area of limited resources ?

90.70% 0.00% 4.65% 4.65% 0.00% 0.00% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% 1 2 3 4 5 6 7

1. Radical prostatectomy (Robot platform not available) 2. Hormonal therapy alone 3. External beam radiotherapy alone (IMRT not available) 4. Combination of hormonal therapy and external beam radiotherapy (IMRT not available) +/- Brachytherapy 5. Brachytherapy 6. Active surveillance 7. Abstain 3.2.4 Which treatment is recommended for patients with life expectancy of > 10-15 years with the diagnosis of intermediate risk prostate cancer with Gleason score 4 + 3, PSA < 20ng/mL, and disease confined to the prostate in an area of limited resources ?

88.10% 0.00% 0.00% 11.90% 0.00% 0.00% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% 1 2 3 4 5 6 7

• 1. Yes, the majority of patients
• 2. Yes, the minority of patients
• 3. No
• 4. Abstain

3.2.18 In Institutions where there is only cobalt radiotherapy technique, patients with intermediate-risk localized prostate cancer can be treated with external radiotherapy?

4.76% 10.71% 83.33% 1.19%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3 4

• 4. HIGH-RISK AND LOCALLY

ADVANCED PROSTATE CANCER

4.2.9 In Institutions where there is no availability of IMRT technique, what is your recommendation for patients with the diagnosis of high-risk prostate cancer with clinical T3/T4 and/or clinical N+?

1. Radical prostatectomy + lymph node dissection 2. Hormonal therapy 3. Conformal external beam radiotherapy 4. Combination of hormonal therapy and conformal external beam radiotherapy 5. Combination of hormonal therapy, conformal external beam radiotherapy + brachytherapy 6. Active surveillance 7. No treatment and investigation only in case of symptoms suggesting progression of disease and then individualize treatment 8. Abstain

8.64% 3.70% 0.00% 79.01% 8.64% 0.00% 0.00% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3 4 5 6 7 8

4.2.10 In Institutions where there is no availability of IMRT technique and conformal external beam radiotherapy, what is your recommendation for patients with the diagnosis of high-risk prostate cancer with Gleason score 8-10 and/or PSA > 20ng/mL and disease confined to the prostate?

1. Radical prostatectomy + lymph node dissection 2. Hormonal therapy 3. Cobalt radiotherapy 4. Combination of hormonal therapy and cobalt radiotherapy 5. Active surveillance 6. No treatment and investigation only in case of symptoms suggesting progression of disease 7. Abstain

82.35% 10.59% 0.00% 4.71% 0.00% 1.18% 1.18%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3 4 5 6 7

4.2.11 In Institutions where there is only conventional radiotherapy technique, patients with high-risk disease confined prostate cancer can be treated with external radiotherapy?

• 1. Yes, the majority of patients
• 2. Yes, the minority of patients
• 3. No
• 4. Abstain

78.31% 12.05% 9.64% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3 4

4.2.12 In Institutions where there is only cobalt radiotherapy technique, patients with high-risk disease confined prostate cancer can be treated with external radiotherapy ?

• 1. Yes, the majority of patients
• 2. Yes, the minority of patients
• 3. No
• 4. Abstain

3.70% 8.64% 83.95% 3.70%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3 4

1. ADT by LHRH agonist alone (+/- first generation AR antagonist) 2. ADT by LHRH antagonist alone (+/- first generation AR antagonist) 3. ADT by Orchiectomy alone 4. ADT + abiraterone 5. Any form of intermittent ADT 6. Bicalutamide 50mg monotherapy 7. Bicalutamide 150mg monotherapy 8. Abstain

4.2.28 In case the option for exclusive hormonal therapy is made for the treatment of high-risk prostate cancer with clinical T3/T4 and/or clinical N+, what would be your preference in an area of limited resources ?

15.66% 1.20% 81.93% 0.00% 1.20% 0.00% 0.00% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3 4 5 6 7 8

• 7. M1 CASTRATION-NAÏVE

PROSTATE CANCER

7.2.2 What hormone therapy scheme do you recommend in the majority of men presenting with de novo low-volume (as defined by CHARTED [no visceral metastases and no appendicular bone metastases]) metastatic castration-sensitive/naive prostate cancer in an area of limited resources ? 1. Continuous ADT by LHRH agonist alone (+/- first generation AR antagonist) 2. Continuous ADT by LHRH antagonist alone (+/- first generation AR antagonist) 3. ADT by Orchiectomy alone 4. Any form of intermittent ADT 5. Any form of continuous ADT plus abiraterone 6. Any form of continuous ADT plus docetaxel 7. Any form of continuous ADT (+/- first generation AR antagonist) 8. Abstain

21.43% 1.43% 64.29% 5.71% 1.43% 1.43% 4.29% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 1 2 3 4 5 6 7 8

7.2.4 What hormone therapy scheme do you recommend in the majority of men presenting with de novo high-volume (as defined by CHAARTED [visceral metastases and/or ≥4 bone lesions with ≥1 beyond vertebral bodies and pélvis]) metastatic castration-sensitive/naive prostate cancer in an area of limited resources ? 1. Continuous ADT by LHRH agonist alone (+/- first generation AR antagonist) 2. Continuous ADT by LHRH antagonist alone (+/- first generation AR antagonist) 3. ADT by Orchiectomy alone 4. Any form of intermittent ADT 5. Any form of continuous ADT plus abiraterone 6. Any form of continuous ADT plus docetaxel 7. Any form of continuous ADT (+/- first generation AR antagonist) 8. Abstain

1.35% 0.00% 16.22% 0.00% 8.11% 74.32% 0.00% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 1 2 3 4 5 6 7 8

1. Abiraterone 1000mg plus prednisone 5mg/d 2. Abiraterone 1000mg plus prednisone 10mg/d 3. Abiraterone 250mg with fatty food plus prednisone 10mg/d 4. Abiraterone 250mg with fatty food plus prednisone 5mg/d 5. Abstain (including I do not use abiraterone in this situation)

7.2.16 If you use castration plus abiraterone in men with castration-sensitive/ naive disease which abiraterone regimen do you recommend for the majority of patients in an area of limited resources ?

23.68% 1.32% 1.32% 52.63% 21.05%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 1 2 3 4 5

• 8. M1 CASTRATION-RESISTANT

PROSTATE CANCER

8.2.3 What is your preferred first-line mCRPC treatment option in the majority of asymptomatic or minimally symptomatic men who did NOT receive Docetaxel

• r Abiraterone in the castration-sensitive/naive setting if full doses of

abiraterone and enzalutamide as well as radium 223 are not available ?

• 1. Abiraterone 250mg with fatty foods
• 2. Docetaxel
• 3. Platinum based chemotherapy
• 4. Mitoxantrone
• 5. DES
• 6. Ketoconazole/prednisone
• 7. Corticosteroids
• 8. Abstain

45.45% 45.45% 0.00% 0.00% 3.90% 0.00% 1.30% 3.90%

0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 45.00% 50.00% 1 2 3 4 5 6 7 8

8.2.4 What is your preferred treatment choice for second-line endocrine manipulation when Abiraterone and/or Enzalutamide are NOT available in this setting and you decide not to recommend chemotherapy?

• 1. First generation AR antagonist
• 2. Ketoconazole
• 3. DES
• 4. Corticosteroids
• 5. Other
• 6. Abstain

86.59% 1.22% 6.10% 2.44% 1.22% 2.44%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% 1 2 3 4 5 6

8.2.6 What is your preferred first-line mCRPC treatment option in the majority of symptomatic men who did NOT receive Docetaxel or Abiraterone in the castration-sensitive/naive setting if full doses of abiraterone and enzalutamide are not available ? 1. Abiraterone 250mg with fatty foods 2. Docetaxel 3. Mitoxantrone 4. DES 5. Ketoconazole/prednisone or Corticosteroids 6. Radium-223 if exclusively bone metastases 7. Abstain

10.13% 86.08% 0.00% 0.00% 1.27% 2.53% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% 1 2 3 4 5 6 7

8.2.25 Each of the following drugs is on the WHO essential medicines list and/or you are able to source them at an affordable price from generic

• manufacturer. Which would you consider to be appropriate treatment options

in the setting of limited healthcare resources and in men with mCRPC who are progressing on or after Docetaxel? Mitoxantrone

• 1. Yes
• 2. No
• 3. Abstain

85.00% 12.50% 2.50%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3

8.2.25 Each of the following drugs is on the WHO essential medicines list and/or you are able to source them at an affordable price from generic

• manufacturer. Which would you consider to be appropriate treatment options

in the setting of limited healthcare resources and in men with mCRPC who are progressing on or after Docetaxel? Abiraterone 250mg with fatty foods

• 1. Yes
• 2. No
• 3. Abstain

93.98% 6.02% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% 1 2 3

8.2.25 Each of the following drugs is on the WHO essential medicines list and/or you are able to source them at an affordable price from generic

• manufacturer. Which would you consider to be appropriate treatment options

in the setting of limited healthcare resources and in men with mCRPC who are progressing on or after Docetaxel? DES

• 1. Yes
• 2. No
• 3. Abstain

78.48% 21.52% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3

8.2.25 Each of the following drugs is on the WHO essential medicines list and/or you are able to source them at an affordable price from generic

• manufacturer. Which would you consider to be appropriate treatment options

in the setting of limited healthcare resources and in men with mCRPC who are progressing on or after Docetaxel? Ketoconazole/corticosteroids

• 1. Yes
• 2. No
• 3. Abstain

85.71% 12.99% 1.30%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3

8.2.25 Each of the following drugs is on the WHO essential medicines list and/or you are able to source them at an affordable price from generic

• manufacturer. Which would you consider to be appropriate treatment options

in the setting of limited healthcare resources and in men with mCRPC who are progressing on or after Docetaxel? Corticosteroids

• 1. Yes
• 2. No
• 3. Abstain

88.16% 10.53% 1.32%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% 1 2 3

8.2.25 Each of the following drugs is on the WHO essential medicines list and/or you are able to source them at an affordable price from generic

• manufacturer. Which would you consider to be appropriate treatment options

in the setting of limited healthcare resources and in men with mCRPC who are progressing on or after Docetaxel? Bicalutamide 150mg

• 1. Yes
• 2. No
• 3. Abstain

84.81% 13.92% 1.27%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3

8.2.76 In men with mCRPC who have been treated with multiple agents and there is no clinical trial available, do you recommend best supportive care at what point ?

• 1. After second-line treatment
• 2. After third-line treatment
• 3. After fourth-line treatment
• 4. After fifth-line treatment
• 5. Abstain

4.00% 9.33% 24.00% 45.33% 17.33%

0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 45.00% 50.00% 1 2 3 4 5

8.2.77 In men with mCRPC who have been treated with multiple agents and there is no clinical trial available, do you recommend best supportive care at what point in an area of limited resources ?

• 1. After second-line treatment
• 2. After third-line treatment
• 3. After fourth-line treatment
• 4. After fifth-line treatment
• 5. Abstain

12.99% 45.45% 12.99% 10.39% 18.18%

0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 45.00% 50.00% 1 2 3 4 5

9.0 USE OF OSTEOCLAST-TARGETED THERAPY FOR SRE/SSE PREVENTION FOR ADVANCED PROSTATE CANCER (NOT FOR OSTEOPOROSIS/BONE LOSS)

9.11 Which osteoclast-targeted therapy do you recommend for men with mCRPC and bone metastases for SRE/SSE prevention in an area of limited resources ?

• 1. Zoledronic acid
• 2. Denosumab
• 3. Either Zoledronic acid or Denosumab
• 4. Another osteoclast-targeted therapy
• 5. Vitamin D and calcium supplementation only
• 6. I do not use osteoclast-targeted therapy in this setting
• 7. Abstain

77.46% 2.82% 12.68% 0.00% 1.41% 5.63% 0.00%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 1 2 3 4 5 6 7

9.12 When you use osteoclast-targeted therapy (zoledronic acid or denosumab) in men with mCRPC, what treatment frequency do you recommend in an area of limited resources ?

• 1. Every 12 months
• 2. Every 6 months
• 3. Every 3 months
• 4. Every month
• 5. I do not use osteoclast-targeted therapy in this setting
• 6. Abstain

1.32% 5.26% 75.00% 13.16% 3.95% 1.32%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 1 2 3 4 5 6

Conclusions/Recommendations in Areas of Limited Resources 1’

• Active surveillance is the preferred option in very low and low risk PC patients with higher

life expectancy

• Radical prostatectomy is the preferred option for low risk PC who had progression on

active surveillance or for intermediate risk disease (particularly when robotic surgery, IMRT, and conformal XRT are not available) (consensus)

• Cobalt radiation technique is not accepted as reasonable option for the treatment of

localized and locally advanced disease (consensus)

• Combination of hormonal therapy and conformal external beam radiotherapy (even if no

IMRT available) is the preferred choice for high risk PC ( clinical T3/T4 and/or N+) (consensus). Orchiectomy is preferred form of hormonal therapy (consensus)

• Radical prostatectomy is the preferred option for high-risk prostate cancer with Gleason

score 8-10 and/or PSA > 20ng/mL and disease confined to the prostate when there is no availability of IMRT technique nor conformal external beam radiotherapy (consensus)

• Orchiectomy alone is the preferred option for metastatic castration sensitive low volume

PC

• Orchiectomy associated with docetaxel is preferred option for metastatic castration

sensitive high volume PC

Conclusions/Recommendations in Areas of Limited Resources 2’

• Orchiectomy associated with docetaxel is preferred for metastatic castration resistant PC if

abiraterone is not available (consensus)

• In the case low dose abiraterone is available either docetaxel or abiraterone 250mg QD are
• ptions to be considered
• Mitoxantrone, DES, high dose bicalutamide, and ketoconozale/corticosteroids are options

to be considered if no life prolong agents are available for metastatic castration resistant PC (consensus)

• Zoledronic acid every 3 months is the preferred osteoclast-targeted therapy option for

metastatic castration resistant PC with bone metastases to prevent SRE/SSE (consensus)

Conclusions/Recommendations in Areas of Limited Resources 3’

Developing vs Developed Countries

Linha divisória Países desenvolvidos Países subdesenvolvidos

Developing vs Developed Countries

Linha divisória Países desenvolvidos Países subdesenvolvidos

Thank you ! (maluffc@uol.com.br)