Francesco Bertoldo. Metabolic Bone Diseases and Osteoncology Unit DRUG INDUCED S OSTEOPOROSIS: ANDROGEN DEPRIVATION THERAPY

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1 DRUG INDUCED S OSTEOPOROSIS: ANDROGEN DEPRIVATION THERAPY Francesco Bertoldo Metabolic Bone Diseases and Osteoncology Unit Department of Medicine University di Verona

2 EPIDEMIOLGY OF PROSTATE CANCER Prostate cancer represents the fourth most common cancer The 1irst most frequently diagnosed malignancy in men. It is estimated that 1 man out of 7 will be diagnosed with prostate cancer during his lifetime. In 2013 there were 1.4 million incident cases of prostate cancer and 293,000 prostate cancer- related deaths (Global Burden 2013), In Europe, 416.7/100,000 new cases of prostate cancer have been diagnosed in 2012, with rates increasing continuously. (Ferlay 2013)(Arnold 2015). ( ttp:// professional/cancer- statistics/ data type/prostate- cancer source:

3 ANDROGEN DEPRIVATION THERAPY is considered the gold standard therapy for locally advanced or metasta$c androgen- dependent prostate cancer (s- TESTOSTERONE < 50 ng/dl) ANDROGEN DEPRIVATON THERAPY: Surgical castration Long-acting LHRH agonists (such as goserelin, leuprolide, triptorelin) LHRH antagonists, ( degarelix), either alone or in combination with as flutamide, nilutamide, or bucalutamide, (total, androgen blockade: CAB) Indica7on for ADT Pa$ents with metasta$c disease In pts with locally advanced tumors with nega$ve lymph nodes Adjuvant therapy in place of radiotherapy before prostatectomy Pa$ents with localized prostate cancer who are unfit for surgery or radia$on. MEDIAN DURATION OF ADT (ranging from 5-10 yrs) - Radical prostatectomy low risk : 17 yrs - Radical prostatectomy intermediate risk :12 yrs - Radiotherapy low risk : 11 yrs

4 PSA / tumour burden Ini$al diagnosis and therapy ADT Cancer treatment induced bone loss Preven7on of SREs Preven7on of bone mets Death SRE Bone mets Castra$on- resistant Time

5 Monolagas S. et al

6

7 CANCER TREATMENT INDUCED BONE LOSS Rate of BMD Loss Normal men Late menop. women 0.5% 1% Early menop. women Aromatase Inhibitor Bone Marrow transpl 2 % 2.6% 3.3% Androgen deprivation 5-6% AI + GNrh agonist Ovarian failure due chemiother 7.0% 7.6% Lumbar spine BMD (% /year Bone Loss)

8 ADT pa$ents Page 8 AC Lassemiante et al. Endocrine 2014

9 Lassemillante ACM et al. Endocrine 2015

10 Adjusted risk ra7o of fracture for pa7ents under ADT as compared to pa7ents not under ADT RR 1.17 (CI 95% ) Serpa Neto A. et al BMC Urology 2010,10:9

11 FRACTUR-FREE SURVIVAL AMONG PATIENTS WITH PROSTATE CANCER ACCORDING TO ANDROGEN-DEPRIVATION THERAPY Shahinian VB et al

12 Shahinian VB et al

13 Androgen Depriva$on Therapy Increases Fracture Risk 50 Fracture incidence, % pa$ents orchiectomy - orchiectomy Years Daniell HW, et al. J Urol. 1997;157:

14 Shao YH et al. BJU 2013.

15 Survival in Prostate Cancer Patients with and without fractures Cumulative Proportion of Survival NO FX Oefelein MG, J Urol 2002 Mesi

16 Shao YH et al. BJU 2013.

17

18 Shahinian VB et al. JGIM 2013

19 Coleman R et al.

20 ESCEO

21 Greenspan S J Clin Oncol 2008

22 Bone target agents: effects on BMD in Men with ADT Induced Bone Loss Lumbar spine 4.7% 4.2% 4% 4.6% 5.3% 4.1% 4.8% Total Hp Risedronate 35mg Alendronate 70 mg) Zoledronate 4 mg once y Zoledronate 4mg/ 3 mo DNB 60 mg/6 mo ). % from baseline % 2% 2% 1.1% 1.1% 3.2% 0 Spine Ishizako K 2007 Smith NEJM 2009 Michaelson MD 2007; Satoh T 2009 Hip Smith MR 2003; Campbell 2010 Bhoopalam 2009

23 Serpa Neto A et al

24 Serpa Neto A et al

25 Prevention of Cancer Treatment Induced Bone Loss (CTIBL) HALT- PC ( ): Denosumab in ADT- Treated Prostate Cancer Key elegibility Criteria Prostate cancer subjects on ADT Subjects 70 years of age or < 70 with T- score < No previous IV and limited oral BP use Planned N = 1226 RANDOMIZATION Denosumab 60 mg SC, Day 1 of Months 6, 12, 18, Placebo 60 mg SC, Day 1 of Months 6, 12, 18, Follow- up End of study Study Month Screen/Randomize Treatment Follow- up/eos Primary Endpoint: Percentage Change in Lumbar Spine BMD at Month 24 Secondary Objec7ves: Efficacy of denosumab compared with placebo on: Fractures and BMD at nonvertebral sites Smith M et al. N Engl J Med, 361:745-55, 2009.

26 Primary/Secondary End Point: BMD Lumbar Spine Total Hip * * * Placebo (n = 734) Denosumab (n = 734) * * 6.7% difference * at 24 mo a * 2 * * * Placebo (n = 734) Denosumab (n = 734) * 4.8% difference at 24 mo * Study Month *P.001 at all measured sites a Primary end point Smith MR, Egerdie B, Toriz NH, et al. N Engl J Med. 2009;361: Copyright 2009 MassachuseWs Medical Society. All rights reserved Study Month

27 Denosumab reduces the Risk of New Vertebral Fractures Placebo (n = 673) SC Denosumab (n = 679) Month Incidence of New Vertebral Fracture RR 0.15 P =.004 RR 0.31 P =.004 RR 0.38 P = Subject Incidence RR = relative risk. Nb patients 1. 9 % 0. 3 % 3. 3 % 1. 0 % 3. 9 % 1. 5 % Smith MR, Egerdie B, Toriz NH, et al. N Engl J Med. 2009;361: Copyright 2009 Massachusetts Medical Society. All rights reserved.

28 TOREMIFENE (SERM) REDUCES FRACTURE RISK IN MEN RECEIVING ANDROGEN DEPRIVATION THERAPY FOR PROSTATE CANCER Incidence new fracture (%) 10_ 9 _ 8 _ 7 _ 6_ 5 _ RRR 50% (CI ) P< years RRR 38% (CI ) P _ New vertebral fx all fractures Smith MR, J Urol 2010

29 Key Messages and Open Issues Osteoporosis and fragility fractures (associated to sarcopenic obesity) are the major adverse effects of ADT. Risk of fracture are related to the number of doses, duration of ADT, age and baseline risk factors. The identification of at-high risk subjects is mandatory Zoledronic acid and oral BPs have been shown to be effective in preventing/ increasing ADT-induced bone loss although data on fracture rate are lacking. Doses and schedule are not defined. Denosumab 60 mg/6 mo. significantly reduces vertebral fracture risk. Significant gaps and barriers remain among prostate cancer specialists regarding the assessment, treatment and monitoring of bone disease in these patients, Multidisciplinary units including bone experts could be advisable in order to overcome barriers to care for and better identify at-risk subjects.

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