Advanced Prostate Cancer. SAMO Masterclass 17 th of March 2017 PD Dr. med. Aurelius Omlin

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1 Advanced Prostate Cancer SAMO Masterclass 17 th of March 2017 PD Dr. med. Aurelius Omlin

2 Conflicts of Interest Research Support: TEVA, Janssen Advisory Rolle: Astra Zeneca, Astellas, Bayer, Janssen, Pfizer, Sanofi Aventis, Roche Travel Support: Astellas, Bayer, Sanofi Aventis

3 Overview Castration-sensitive/naive Prostate Cancer (CNPC) Castration-resistant Prostate Cancer (CRPC) Osteoprotective Therapy Staging and Treatment Monitoring

4 Some Important Figures Prostate Cancer Breast Cancer New diagnoses 6182 New diagnoses 5861 Median age at diagnosis 69.2y Median age at diagnosis 63.6y Mortality 1340 Mortality 1384 Prostate Cancer Centres CH wenige Breast Cancer Centres CH* 17 Clinical Trial: Prostate Neoplasms Clinical Trial: "Breast Neoplasms" Bundesamt für Statistik *Krebsliga Schweiz (

5 Case 1 76 y old patient, back pain, PS 1 PSA 822 ALP 683 Bone scintigraphy : Multiple bone metastases Which therapy do you recommend? Options: 1. Androgen deprivation therapy (ADT) 2. ADT + Docetaxel 3. ADT + Docetaxel + Xgeva

6 Prostate Cancer Localised Prostate Cancer Advanced Prosate Cancer: Castration-sensitive/naive Advanced Prostate Cancer: Castration-resistant M0 ADT M0 Local Therapy (RT/OP/Active Surveillance) Salvage RT PSA Rise M1 ADT +/- Docetaxel 1st-line 2nd-line 3rd-line De Novo M1 ADT: Androgen Deprivation Therapy M0: By imaging noch evidence of metastases M1: Metastases detected by imaging

7 Androgen Deprivation Therapy (ADT) GnRH Agonist Goserelin Leuprorelin GnRH Antagonist Degarelix 10% Orchiectomy 90%

8 Androgen Deprivation Therapy (ADT) Orchiectomy GnRH Agonist GnRH Antagonist Advantage Rapid Testosterone decline 1 Single procedure Disadvantage Major psychological issue Irreversible Local complications Easy application Local reactions rare Rapid Testosterone decline Possibly improved safety profile in men with preexisting cardiovasc. disease*** Initial Testosterone flare Local reactions Costs Costs Recent case KSSG: CHF 5500 per 3 months CHF 498 for 3 months* + Bicalutamide CHF 210 (30 days) per 3 months CHF 449 initial dose + CHF (for 2 months) : * Goserelin ** Degarelix ***Albertsen PC, Eur Urol. 2014;65(3):

9 Chemo-hormonal Therapy Castration-sensitive/naïve men (mostly M1) R A N D O M I S E D ADT ADT + Docetaxel 75mg/m2 Every 21 d x 6/9 Zyklen GETUG-15 n=385 Accrual: ECOG-ACRIN n=790 Accrual: STAMPEDE n= 2962 Accrual: Gravis Lancet Oncol 2013 Sweeney NEJM 2015 James Lancet 2015

10 Result Overview GETUG-15 N=385 ECOG-ACRIN Group CHAARTED N=790 STAMPEDE N=1776 ADT ADT+Doc ADT ADT+Doc ADT ADT+Doc Median overall survival (mos) in M1 48.6m 62.1m* 44m 57.6m 45m 60m mos in High-Volume*** 35.1m 39.8m** 32.2m**** 49.2m mos in M0 + M1 pts NA NA NA NA NA 71m NA 81m * Statististically not significant: HR 0.88 (95% CI, ) ** GETUG-15: 47% high-volume, statististically not significant: HR 0.78 (95% CI, ) *** High-volume: Visceral metastases or 4 bone lesions with 1 beyond the vertebral bodies and pelvis **** In CHAARTED: 64% high-volume Gravis Lancet Oncol 2013 Gravis Eur Urol 2016 Sweeney NEJM 2015 James Lancet 2015

11 ADT + Docetaxel Overall Survival Metaanalysis M1 Patients M0 Patients Vale Lanc Onc 2015

12 Expected ASCO 2017 Castration-sensitive/naïve men (mostly M1) R A N D O M I S E D ADT ADT + Abiraterone + Prednisone Latitude* n=1209 Accrual: STAMPEDE n > 1000 Accrual: *For inclusion: 2 high-risk prognostic factors: Gleason score of greater than or equal to ( 8) 3 or more lesions on bone scan presence of measurable visceral disease

13 STAMPEDE Trial Open for Accrual! Practise changing! ASCO 2017! +?

14 Overview Castration-sensitive/naive Prostate Cancer (CNPC) Chemo-hormonal Therapy: Standard for M1 patients fit for chemotherapy Which subgroups should receive chemo-hormonal therapy? How should these patients be followed-up? Impact on subsequent treatments? Castration-resistant Prostate Cancer (CRPC) Osteoprotective Therapy Staging and Treatment Monitoring

15 Prostate Cancer Localised Prostate Cancer Advanced Prosate Cancer: Castration-sensitive/naive Advanced Prostate Cancer: Castration-resistant M0 ADT M0 Local Therapy (RT/OP/Active Surveillance) Salvage RT PSA Rise M1 ADT +/- Docetaxel 1st-line 2nd-line 3rd-line mos 32-35m mos 18-20m mos 10-12m De Novo M1 ADT: Androgen Deprivation Therapy M0: By imaging noch evidence of metastases M1: Metastases detected by imaging

16 Treatment Options 2017 ADT +/- Docetaxel Docetaxel Cabazitaxel Abirateron Enzalutamid Radium-223 Studien Tumour Volume (PSA) Castration-sensitive/naive Castration-resistant

17 Abiraterone Mechanism of Action I Enzalutamid

18 Mechanism of Action II Docetaxel Cabazitaxel Radium-223 Weaver Cancer Cell Taxane 2005 treatment Weaver Cancer Cell 2005

19 How to choose a first-line treatment? Yes Fit for chemotherapy? No Visceral metastases Visceral metastases Yes No Yes No Docetaxel Abiraterone? * Enzalutamid Yes Symptomatic No BSC? Steroid? AR Antagonist? Enzalutamid Abiraterone* Yes Symptomatic No Docetaxel Radium-223*? Yes Time to CRPC <12m No Radium-223* Abiraterone* Enzalutamid BSC? Steroid? AR Antagonist? Docetaxel Abiraterone* Enzalutamid Abiraterone* Enzalutamid * CH: not approved in case of visceral metastases pre-docetaxel (abiraterone only)

20 Asymptomatic Abiraterone (No viszeral metastases) Enzalutamid Docetaxel CRPC 2017 Options 1st-line after ADT only Symptomatic Docetaxel Radium-223* Evtl. Enzalutamid Evtl. Abiraterone (No viszeral metastase) 1st line after chemo-hormonal therapy Asymptomatic Symptomatic Abiraterone Enzalutamid Cabazitaxel (in case of rapid PD after chemohormonal therapy) Docetaxel Re-Challenge (depending on time from chemo-hormonal therapy) Cabazitaxel (in case of rapid PD after chemo-hormonal therapy) Docetaxel Re-Challenge (depending on time from chemo-hormonal therapy) Evtl. Abiraterone Evtl. Enzalutamid Radium-223* Trials: IMPROVE SAKK 08/14: Enzalutamid +/- Metformin EORTC-1333: Enzalutamid +/- Radium-223 SAKK 96/12 (Denosumab) 2 nd -line 3rd-line Docetaxel Cabazitaxel (20mg/m2 oder 25mg/m2) Abiraterone Enzalutamid Radium-223* Trials: Pro-Plat (weekly Carboplatin) CAINTA SAKK 96/12 (Denosumab) Patients in good PS: Cabazitaxel Abiraterone Enzalutamid Radium-223 * Docetaxel Re-Challenge *Radium: Bone metastases, symptomatic, no visceral or bulky LN metastases

21

22 Standard (US) only! Sipuleucel-T vs Placebo mos: 25.8m vs 21.7m Negative Phase III Ipilimumab vs Placebo (vor Docetaxel) mos 28.7m vs 29.7m 2% Deaths in Ipilimumab Arm Ipilimumab vs Placebo (nach Docetaxel) mos 11.2m vs 10m 1% Deaths im Ipilimumab Arm Promising: Pembrolizumab post Enzalutamid 3/10 Patients with PSA decline and/or soft tissue response Immunotherapy? Kantoff et al. NEJM 2010 Beer et al. J Clin Oncol Kwon et al. Lanc Onc 2014 Graff Oncotarget 2016 und ESMO 2016

23 Overview Castration-sensitive/naive Prostate Cancer (CNPC) Castration-resistant Prostate Cancer (CRPC) A number of active treatment options Optimal sequence is unclear (A->B->C oder B->C->A.) No validated predictive factors No «personalised» therapy Osteoprotective Therapy Staging and Treatment Monitoring

24 Prevention of the risk of Skelettal Complications Gartrell Nat Rev Clin Onc 2014

25 Effect of approved drugs on SRE/SSE in CRPC Drug SRE/SSE HR (95% CI) Zoledronic acid vs Placebo 16 vs 10.6m 0.64 ( ) Denosumab vs Zoledronic acid SRE: 20.7 vs 17.1m SSE: NR vs 24.2m 0.82 ( ) Abiraterone + P vs Prednisone Post-chemo: 25 vs 20.3m 0.62 ( ) Pre-chemo: NA Enzalutamide vs Placebo Post-chemo: 16.7 vs 13.3m 0.69, P = Pre-chemo, Pat without SRE after 12 Months: 84% vs 73% Radium-223 vs Best standard of care SSE: 15.6 vs 9.8m SSE Pat on Zoledronic acid + Radium-223: 19.6 vs 10.2m Docetaxel + Zoledronic acid vs Docetaxel SRE = Skeletal related event SSE = Symptomatic skeletal event NA 0.72 ( ) 0.66 ( ) 0 49 ( ) SSE: 13.6m vs 11.2m 0.78 ( ) Saad JNCI 2002 Fizazi Lancet 2011 De Bono NEJM 2011 Scher NEJM 2012 Beer NEJM 2014 Parker NEJM 2014 James JAMA Onc 2016

26 Recommendation: Osteoprotective Therapy 2017 Situation Castration-sensitive/naive prostate cancer, bone or no bone metastases and ADT Recommendation Ca and Vitamin D substitution For osteoporosis or increased risk of fractures: Bisphosphonate: for osteoporosis (e.g. Zoledronic acid 5mg/year) Denosumab (60mg, 6-monthly) CRPC, no bone metastases Ca and Vitamin D substitution For osteoporosis or increased risk of fractures: Bisphosphonate: for osteoporosis (e.g. Zoledronic acid 5mg/year) Denosumab (60mg, 6-monthly) CRPC and bone metastases Calcium and Vitamin D substitution Dental check before starting bone targeting agents Consider if no contra-indications: Denosumab (120mg, 4 w) Zoledronic acid (4mg, 4 w), cave: creatinine clearance! SAKK 96/12 Trial Saylor European Urology 2012

27 Overview Castration-naive Prostate Cancer (CNPC) Castration-resistant Prostate Cancer (CRPC) Osteoprotective Therapy Important difference between castration-sensitive/naïve and CRPC Optimal timing, duration, frequency of denosumab/zoledronic acid unclear! Staging and Treatment Monitoring

28 Staging and Treatment Monitoring Assessment of disease status o Bone only vs visceral disease o «oligometastatic» vs extensive metastatic disease Monitoring of antitumour activity o Dynamics of disease evolution o CRPC drugs are expensive! Prevention of complications o E.g. epidural disease and spinal cord compression o Development of visceral metastases o Urinary retention o

29 Update Prostate Cancer Clinical Trial Working Group 2016 In daily practice: Staging: Always before start of a new therapy Monitoring: Risk-adapted (see also APCCC recommendations Annals of Oncology 2015) Scher et al. JCO 2016 Gillessen et al. Annals of Oncology 2015

30 Criteria for Progression Generally 2 out of 3 criteria should be fulfilled: PSA progression Radiological progression Clinical progression Cave: PSA alone not reliable in advanced prostate cancer Progression in bone, flare is not uncommon (first 3 months!) Bone pain in elderly patients may be non-cancer related Unequivocal visceral progression (e.g. liver), requires no other criteria, consider biopsy! Scher et al. JCO 2016 Gillessen et al. Annals of Oncology 2015

31 Overview Castration-naive Prostate Cancer (CNPC) Castration-resistant Prostate Cancer (CRPC) Osteoprotective Therapy Staging and Treatment Monitoring Not the same as in other tumours Because of bone predominant disease, assessment of progression is not trivial

32 Thank you very much for your attention!

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