Metastatic Castration Resistant Prostate Cancer peer c.pdf · Metastatic Castration Resistant...
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Metastatic Castration Resistant Prostate Cancer Must we treat asymptomatic disease?
Avivit Peer
Oncology Institute
Rambam Health Care Campus
Haifa, Israel
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Dis
eas
e B
urd
en
Castration
1st-line therapies
Local therapy
2nd-line hormonal therapy
2nd-line therapies
Disease continuum in prostate cancer
2
Asymptomatic
CRPC
Metastatic
Hormone-sensitive
Symptomatic
Time
Non-metastatic
HEIDENREICH A, ET AL. EUR UROL. 2013;64(2):260-265.
Additional therapies
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Asymptomatic mcPCa Mild Symptomatic mcPCa Very Symptomatic mcPCa
Early vs Late treatment
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A. Orsola. European Urology 2014
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Stratification into 2 groups:
• Group 1: asymptomatic/no pain (BPI-SF 0-1), PSA < 80 ng/mL and Gleason score < 8
– AA + P: 124/546 subjects (23%)
– P: 140/542 subjects (26%)
• Group 2: any of the following – mildly symptomatic mild pain (BPI-SF ≥ 2), PSA ≥ 80 ng/mL or Gleason score ≥ 8
– AA + P: 422/546 subjects (77%)
– P: 402/542 subjects (74%)
Miller K, et al. Poster (#775) presented at the 31st Annual EAU Congress, 11-15 March 2016, Munich, Germany
The Phase 3 COU-AA-302 Study of Abiraterone Acetate in Men With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: Stratified Analysis Based on
Pain, Prostate-Specific Antigen and Gleason Score
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AA + P Significantly Prolonged OS and rPFS versus P Alone in Groups 1 (asymptomatic, PSA < 80 GS < 8)
and Groups 2 (mildly symptomatic, PSA ≥ 80, GS ≥ 8)
Median OS Group 1 AA + P: 53.6 months P: 41.8 months HR=0.61 (95% CI: 0.43-0.87) p=0.0055
Median OS Group 2 AA + P: 31.2 months P: 28.4 months HR=0.84 (95% CI: 0.72-0.99) p=0.0321
Median rPFS Group 1 AA + P: 27.6 months P: 11.1 months HR=0.41 (95% CI: 0.30-0.57) p<0.0001
Median rPFS Group 2 AA + P: 13.7 months P: 8.2 months HR=0.59 (95% CI: 0.50-0.70) p<0.0001
Miller K, et al. Poster (#775) presented at the 31st Annual EAU Congress, 11-15 March 2016, Munich, Germany
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Time to Chemotherapy use and Time to Opiate use versus P Alone in Groups 1 and 2
Median time to chemotherapy use Group 1
AA + P: 37.0 months P: 24.3 months
HR=0.64 (95% CI: 0.46-0.89) p=0.0073
Median time to chemotherapy use Group 2
AA + P: 23.3 months P: 14.5 months
HR=0.71 (95% CI: 0.60-0.85) p=0.0001
Median time to opiate use Group 1
AA + P: NR P: 41.0 months
HR=0.69 (95% CI: 0.48-0.99) p=0.0409
Median time to opiate use Group 2
AA + P: 30.5 months P: 19.3 months
HR=0.70 (95% CI: 0.59-0.84) p=0.0001
Miller K, et al. Poster (#775) presented at the 31st Annual EAU Congress, 11-15 March 2016, Munich, Germany
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WCDT
Presented By Scott Tomlins at 2015 ASCO Annual Meeting
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Slide 42
Presented By Robert Dreicer at 2015 ASCO Annual Meeting
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Why Earlier?
- rPFS √
- OS √ - Time to chemotherapy √ - Time to opiate use √
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So, how early is early enough?
M, 59, mCRPC
PSMA-PET/CT uptake in:
• Primary tumor in prostate
• Pelvic LNs (up to 12mm)
• Lytic lesions lt. pelvis & T6.
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M, 65, Prostate Ca, Rising PSA Ga68 PSMA
LN metastases SUVmax 10.3
T9 vertebral met SUVmax 11.14
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What is the real volume of the disease? Bone scan flare following initiation of NHT
1.2015 4.2015 06.2015
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Background
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Feb 2018
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Slide 5
SPARTAN Phase III study
Presented By Eric Small at 2018 Genitourinary Cancers Symposium
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66 YM, CRPC , Rising PSA Negative bone scan, chest+abdomanal CT
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Slide 8
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Slide 9
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Slide 11
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PROSPER Study Design
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Subgroup Analysis of MFS
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Time to PSA Progression
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Slide 16
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