Risk of renal side effects with ADT. E. David Crawford University of Colorado, Aurora, CO, USA

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2 Risk of renal side effects with ADT E. David Crawford University of Colorado, Aurora, CO, USA

3 ADT: A key treatment for advanced prostate cancer John Hunter 1780-castration 1904: First RP 1938: Acid Phos. 1940: Huggins - endocrine control. Advent of orchiectomy and estrogen treatment (Nobel Prize for this discovery) 1970s: Steroidal and non-steroidal AAs available Nobel Prize: Andrzej Schally, Roger Guillemin 1980s Long-acting synthetic LHRH agonists 2003 First GnRH blocker (abarelix) launched The future New androgen receptortargeted drugs. AA vaccines, biomarkers, genetic research 1920s: RT for PC using radium 1867: First perineal prostatectomy performed 1960s and 70s: Synthetic estrogens developed 1960s: RT established as important treatment for PC 2004: Docetaxel in combination with prednisone approved 1995: Cryosurgery accepted as a treatment option for recurrent cancer after RT 2008: Degarelix approved in US 2009: ARSI Developed ARSI, androgen receptor signaling inhibitor; AA, antiandrogen; LHRH, luteinizing hormone releasing hormone

4 Adverse effects of ADT Decreased libido and sexual dysfunction Hot flashes Gynecomastia Reduced testicle size Anemia Fatigue Decreases in bone mineral density Metabolic changes Weight gain Decreased muscle mass Increased insulin resistance Nguyen P, et al. Eur Urol 2014; In press.

5 Other adverse effects of ADT? Increased incidence of cardiovascular events 1-3 Higher risk of pneumonia 4 Acute kidney injury 5,6 1. Keating N, et al. J Nat Cancer Inst 2010;102:39-46; 2. Van Hemelrijck M, et al. J Clin Oncol 2010;28: Jespersen CG, et al. Eur Urol 2014;65:704-9; 4. Chung S-D, et al. PLOS One 2014;9:e Lapi F, et al. JAMA 2013;310:289-96; 6. Gandaglia G, et al. Eur Urol 2014; In press

6 Acute Kidney Injury (AKI): Characteristics and impact AKI is characterized by a rapid and sustained reduction of glomerular filtration rate Results in the retention of metabolic waste products and dysregulation of fluid, electrolyte and acid-base homeostasis 1 AKI is associated with prolonged hospitalization, substantial health-care spending and high in-hospital mortality Discharged patients are at higher-risk of long-term mortality and development of de novo chronic kidney disease 2,3 Survival of patients with AKI requiring dialysis is only 10-20% at 10 years 4 1. Schiffl H, Lang SM. Ind J Nephrol 2013;23: ; 2. Chertow GM, et al J Am Soc Nephrol 2005;16: Chawla LS, et al. Kidney Int 2011;79:1361-9; 4. Schiffl H, et al. Clin Kidney J 2012;5:

7 AKI and PCa: Two recent reports Lapi F, et al. JAMA 2013;310: Gandaglia G, et al. Eur Urol 2014; In press

8 UK Clinical Practice Research Datalink: Nested case-control analysis 10,250 men newly diagnosed with non-metastatic PCa AKI cases were randomly matched with up to 20 controls on age, calendar year of PCa diagnosis, and duration of follow-up ADT was categorized into 6 mutually exclusive groups: Gonadotropin-releasing hormone agonists Oral antiandrogens Combined androgen blockade Bilateral orchiectomy Estrogens Any combination of the above 1. Lapi F, et al. JAMA 2013;310:289-96

9 Demographic and clinical characteristics (1) AKI cases were associated with: Excessive alcohol use Ever smoking BMI >30 kg/m 2 Several comorbidities 1. Lapi F, et al. JAMA 2013;310:289-96

10 Demographic and clinical characteristics (2) Hospitalisations Metastases Prostatectomy Chemotherapy Non-diuretic hypertensives Numerous other drugs 1. Lapi F, et al. JAMA 2013;310:289-96

11 AKI associated with current use of ADT Exposure to ADT Cases, n (%) (N=232) Controls, n (%) (N=2721) Adjusted OR* (95% CI) Never 40 (17.2) 842 (30.9) 1 [ref] Current (within 90 days) 168 (72.4) 1420 (52.2) 2.48 ( ) Past (>90 days ago) 24 (10.3) 459 (16.9) 1.25 ( ) *Adjusted for differences in patient demographic and clinical characteristics 1. Lapi F, et al. JAMA 2013;310:289-96

12 AKI and type of ADT Type of ADT Cases n (%) Controls n (%) Adjusted OR* (95% CI) Never 40 (17.2) 842 (30.9) 1 [ref] Current Combined androgen blockade Estrogen Other combination therapies Oral antiandrogens GnRH agonists Bilateral orchiectomy 43 (18.5) 5 (2.2) 19 (8.2) 10 (4.3) 85 (36.6) 6 (2.6) 208 (7.6) 15 (0.6) 69 (2.5) 112 (4.1) 949 (34.9) 67 (2.5) 4.50 ( ) 4.00 ( ) 4.04 ( ) 2.18 ( ) 1.93 ( ) 1.84 ( ) *Adjusted for differences in patient demographic and clinical characteristics 1. Lapi F, et al. JAMA 2013;310:289-96

13 US SEER Medicare database: Competing-risks regression analyses 69,292 men diagnosed with non-metastatic PCa Propensity-score methodology matched ADT vs no ADT patients ADT consisted of either gonadotropin-releasing hormone agonists or bilateral orchiectomy Five- and ten-year AKI rates were estimated (median follow-up 7.1 years) SEER, Surveillance Epidemiology and End Results 1. Gandaglia G, et al. Eur Urol 2014; In press

14 Higher cumulative incidence of AKI with GnRH agonists than orchiectomy Time from AKI rates, % (95% CI) diagnosis or ADT initiation No ADT GnRH agonists Bilateral orchiectomy 5 years 13.6 ( ) 18.8 ( ) 15.1 ( ) 10 years 24.9 ( ) 31.1 ( ) 26.0 ( ) p< Gandaglia G, et al. Eur Urol 2014; In press

15 Multivariable competing-risks regression analysis predicting AKI Exposure to ADT HR 95% CI P value No ADT 1 [ref] GnRH agonist <0.001 Bilateral orchiectomy Age, year, race, marital status, population density, education and CCI were all independent predictors of AKI GnRH agonists were also associated with an increased risk of CKF (HR=1.50; 95% CI ; p<0.001) CCI, Charlson Comorbidity Index; CKF, chronic kidney failure 1. Gandaglia G, et al. Eur Urol 2014; In press

16 AKI with ADT: Potential mechanisms Castrate testosterone levels Hyperglycemia and dyslipidemia Loss of the vasodilatory effects of testosterone on renal vessels Interstitial tubular membrane thickening Disrupted glomerular function AKI Lapi F, et al. JAMA 2013;310: Molinari C, et al. J Physiol 2002;543:365-72; Kambham N, et al. Kidney Int 2001;59:

17 Atherosclerotic plaque disruption may explain different ADT-related AKI risks T cells express GnRH receptors and the activation of lymphocytes represents an important event in atherosclerotic plaque rupture 1-3 Plaque rupture could consequently lead to ischemic renal injury, eventually resulting in AKI In patients with baseline CV comorbidities, the 10-year AKI rate was higher (45.3% vs 27.1%; HR=1.23 [95% CI ] p<0.001) 4 1. Chen HF, et al. J Clin Endocrinol Metab 1999;84:743 50; 2. Tanriverdi F, et al. Clin Exp Immunol 2005;142: Dixit VD, et al. Biol Reprod 2003;68:2215 2; 4. Gandaglia G, et al. Eur Urol 2014; In press

18 AKI and GnRH antagonists? Local obstruction due to PCa can lead to kidney injury Urinary tract events may be in part a manifestation of kidney injury AKI has not been specifically reported as an adverse event in clinical trials of ADT Incidence of urinary tract events lower with degarelix vs GnRH agonists 1 1. Klotz L, et al. Eur Urol 2014; In press

19 Urinary tract events with GnRH agonists and antagonists (pooled analysis) HR=0.61 (95% CI ) p<0.001 HR adjusted for age, disease stage, (log) PSA and testosterone by Cox regression 1. Klotz L, et al. Eur Urol 2014; In press

20 Weighing agonists vs antagonists: Positive attributes Agonist 3 12 months Antagonist FSH PSA ALP Testosterone levels No surges Cardiovascular risks ALP, alkaline phospatase

21 Weighing agonists vs antagonists: Positive attributes Agonist 3 12 months Antagonist FSH PSA ALP Testosterone levels No surges Cardiovascular risks Acute Renal Injury ALP, alkaline phospatase

22 Summary ADT with GnRH agonists but not orchiectomy increases the risk of AKI T cell-mediated disruption of atherosclerotic plaques is a potential mechanism Further studies evaluating patients prospectively enrolled in randomized trials are needed to assess the association between ADT and AKI

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