P.A. 65 anni In terapia anti ipertensiva da 4 anni. Non ha mai eseguito il PSA Da qualche mese dolore alla spalla sx che sia

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Meagan Shepherd
6 years ago
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3 Dicembre 2012 P.A. 65 anni In terapia anti ipertensiva da 4 anni (sartanico) Non ha mai eseguito il PSA Da qualche mese dolore alla spalla sx che sia accentua coi movimenti Si rivolge al curante che prescrive Rx standard

4 Dicembre 2012 All Rx: area ovalare di addensamento di circa 3 cm compatibile con lesione secondaria alla testa omerale Scintigrafia ossea: tre cinque lesioni lesioni (omero (omero sx, L3, sx, IV costa D2, D12, sx) L3, IV costa sx) PSA = 43 Visita urologica con biopsia: GS 9 (5+4) TAC addome: negativa

5 Opzioni iterapeuticheti AA per 4 settimane + ADT AA per 4 settimane + ADT+ ac zoledronico (o denosumab) BAT BAT + ac zoledronico (o denosumab) Ac zoledronico (o denosumab)

6 Opzioni iterapeuticheti AA per 4 settimane + ADT AA per 4 settimane + ADT+ ac zoledronico (o denosumab) BAT BAT + ac zoledronico (o denosumab) Ac zoledronico (o denosumab) ADT + Docetaxel

7 The history Feb 2013: GETUG 15 publication

8 mos HR P value ADT+D ADT 54.2

9 The history Feb 2013: GETUG 15 publication

10 The history Feb 2013: GETUG 15 publication June 2014: first CHAARTED presentation

13 The history Feb 2013: GETUG 15 publication June 2014: first CHAARTED presentation

14 The history Feb 2013: GETUG 15 publication June 2014: first CHAARTED presentation Feb 2015: updated GETUG 15 presentation

16 The history Feb 2013: GETUG 15 publication June 2014: first CHAARTED presentation Feb 2015: updated GETUG 15 presentation

17 The history Feb 2013: GETUG 15 publication June 2014: first CHAARTED presentation Feb 2015: updated GETUG 15 presentation June 2015: STAMPEDE (arm C) presentation

18 STAMPEDE ti trial Newly diagnosed high risk patients T3/4 N0 M0 with: At least two of:psa 40ng/ml or Gleason sum score 8 10 And intention to treat with radical radiotherapy (unless there is a contraindication; exemption must be sought in advance of consent, after discussion with MRC CTU) Newly diagnosed metastatic or nodal disease Stage T any N+ M0 or Tany N any M+ Previously treated relapsing patients with either PSA 4ng/ml and rising with doubling time < 6 months PSA 20ng/ml N+ M+

19 STAMPEDE Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy

22 The history Feb 2013: GETUG 15 publication June 2014: first CHAARTED presentation Feb 2015: updated GETUG 15 presentation June 2015: STAMPEDE (arm C) presentation

23 CHAARTED GETUG 15 STAMPEDE (all) STAMPEDE (M1) Recruitment period Patients Median age 64 yrs 64 yrs 65 yrs NR Mt Mets 100% 100% 61% 100% Visceral 16% 13% NR NR

24 66% high hvolume Visceral mets and/or 4 bone mets (at last 1 beyond pelvis and vertebral column) 22% high risk (Glass definition) Appendicular Disease = 0. Absent = 1. Present Logrank = HR 1 p< n=155 Performance <1 Status Logrank = p<0.001 CHAARTED GETUG 15 (updated) 39%M0/ 61% M1 STAMPEDE (all) 1 100% M1 STAMPEDE (M1) Follow up 29 m Gleason s 82.9 m PSA NR NR <8 Surn PSA/clinical i l PFS 21 m vs 15 m Logrank 23 = m vs 13 m Logrank = m vs 21 m NR p=0.03 p=0.071 HR 0.56 HR 0.70 HR 0.73 HR=1.28 n=60 8 HR=2.01 n=96 OS ADT+D D vs ADT 57 m vs 44 m 61 m vs 46 m 77 m vs 67 mos 65 m vs 43 m Group 1 HR 0.61 HR 0.90 Group 2 Group HR HR 0.73 p= p= 0.44 p= p= <65 HR=1.75 n=42 65 HR=3.0 n=167

25 66% high hvolume Visceral mets and/or 4 bone mets (at last 1 beyond pelvis and vertebral column) 22% high risk (Glass definition) 100% M1 CHAARTED GETUG 15 (updated) STAMPEDE (all) STAMPEDE (M1) Follow up 29 m 82.9 m NR NR PSA/clinical i l PFS 21 m vs 15 m 23 m vs 13 m 37 m vs 21 m NR HR 0.56 HR 0.70 HR 0.73 OS ADT+D D vs ADT 57 m vs 44 m 61 m vs 46 m 77 m vs 67 mos 65 m vs 43 m HR 0.61 HR 0.90 HR 0.76 HR 0.73 p= p= 0.44 p= p= 0.002

26 66% high hvolume Visceral mets and/or 4 bone mets (at last 1 beyond pelvis and vertebral column) 22% high risk (Glass definition) 100% M1 CHAARTED GETUG 15 (updated) STAMPEDE (all) STAMPEDE (M1) Follow up 29 m 82.9 m NR NR PSA/clinical i l PFS 21 m vs 15 m 23 m vs 13 m 37 m vs 21 m NR HR 0.56 HR 0.70 HR 0.73 OS ADT+D D vs ADT 57 m vs 44 m 61 m vs 46 m 77 m vs 67 mos 65 m vs 43 m HR 0.61 HR 0.90 HR 0.76 HR 0.73 p= p= 0.44 p= p= 0.002

27 Post progression treatments Experimental arm Control arm GETUG15 CHAARTED STAMPEDE GETUG15 CHAARTED STAMPEDE Docetaxel 28% 12% 14% 62% 33% 41% Abiraterone 15%* 23% 35% 15%* 20% 30% /Enzalutamide * Enrolled in clinical trials vs placebo

28 Side effects TAX 327 GETUG CHAARTED STAMPEDE Anemia NR Thrombocytopenia 1 <1 NR Neutropenia Febrile neutropenia Fatigue NR

32 Post progression therapies Chemotherapy 198 Bisphosphonate 95 Abiraterone patients t patients do not report receiving any curative therapies post-failure-free survival event. The majority of patients reporting being on chemotherapy are on docetaxel

33 Chemo is the new standard for a quote of M1 HSPC (selection criteria i identification is a challenge) g) The adoption of CHAARTED strategy could impact on intermittent ADT diffusion

mcrpc 2014 TRA EVOLUZIONE E RIVOLUZIONE: COME ORIENTARSI NEL LABIRINTO DELLE TERAPIE

mcrpc 2014 TRA EVOLUZIONE E RIVOLUZIONE: COME ORIENTARSI NEL LABIRINTO DELLE TERAPIE IL CARCINOMA PROSTATICO, UNA MALATTIA ETEROGENEA? RAZIONALE E RISULTATI DEL TRATTAMENTO CHEMIOTERAPICO ASSOCIATO ALL