Bones, Hot Flashes, and ADT Use with Chemotherapy and Timing

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1 Bones, Hot Flashes, and ADT Use with Chemotherapy and Timing Thomas E. Keane, MD Professor and Chairman Department of Urology Medical University of South Carolina

2 Common Adverse Events Associated with ADT

3 ToxiciDes of ADT Hot Flashes, sexual dysfuncdon and many other complicadons of therapy are seen in greater than 90% of men on ADT Higano CS. J Clin Oncol. 2012;30: Nguyen PL, et al. Eur Urol. 2015;67:825-36

4 Strategies to MiDgate Side effects of ADT IntermiYent ADT Reducing the duradon of ADT AnDandrogen monotherapy Exercise therapy Crook JM, et al. N Eng J Med 2012;367: Smith MR, et al. J Clin Oncol 2004;22: Bolla M, et al. N Engl J Med 2009;360: Cormie P, et al. Prostate Cancer ProstaDc Dis 2013;16;170-5

5 IntermiYent vs. ConDnuous ADT Crook et al (2012): RCT 1386 pts with BCR a_er primary or salvage XRT IntermiYent vs condnuous ADT Median overall survival: 8.8 yrs intermiyent vs 9.1 yrs condnuous (HR1.02) 7 year disease related death rate 18% intermiyent vs 1 condnuous (HR 1.23) IntermiYent ADT for men with rising PSA a_er definidve radiotherapy does not result in inferior survival compared to condnuous ADT. Crook et al N Engl J Med 2012; 267:89-903

6 IntermiYent vs. ConDnuous ADT Quality of Life: No difference in funcdonal domains (physical, role, global health) IntermiYent therapy had beyer symptom scores Hot flashes (P <0.001) Desire for sexual acdvity (P < 0.001) Urinary symptoms (P = 0.006) Crook et al N Engl J Med 2012; 267:89-903

7 IntermiYent vs. ConDnuous ADT Magnan et al (2015) Meta- analysis of 15 trials from padents with recurrent prostate cancer IntermiYent vs. ConDnuous ADT Primary Outcomes Overall Survival Cancer Specific Survival Progression Free Survival Hazard Ra<o 1.02 (95% CI ) 1.02 (95% CI ) 0.94 (95% CI ) Magnan S, et al. JAMA Oncol. 2015;1:1261-9

8 IntermiYent vs. ConDnuous ADT A large phase 3 trial of padents with metastadc diseases: survival with intermiyent ADT is not comparable to that with condnuous therapy N = 3040 Follow- up 9.8 yrs Median survival 5.8 yrs CADT vs 5.1 years IADT Sub- group analysis: padents with minimal disease median survival of 7.1 yrs CADT vs 5.2 rs IADT loss of almost 2 years of life in the IADT group could not be ruled out. ConDnuous androgen therapy was significantly beyer in the minimal disease group, with a 23% reladve increase in risk of death with intermiyent androgen therapy Hussain M, et al. N Eng J Med 2013;368:1314

9 IntermiYent vs. ConDnuous ADT Survival is worse in IAD for padents with metastadc disease compared to CAD Median OS differences of 8-10 months in CAD vs. IAD Lack of stadsdcally significant inferiority of IAD does not equal clinically insignificant differences Combined data from RCTs does not support large or durable effect on QOL Hussain M, et al. J Clin Oncol. 2016; 34:280-5

10 Hot Flashes and ADT Over 50% of men on ADT experience hot flashes ADT lowers set point resuldng in easier acdvadon. Allan CA, et al. Endocr Relat Cancer. 2014;21: Nguyen PL, et al. Eur Urol. 2015;67:825-36

11 Management of Hot Flashes Medroxyprogesterone acetate Irani J, et al. Lancet Oncol 2010;11: Harding C, et al. BJU Int 2009;103: Ashamalla H, et al. Int J Radiat Oncol Biol Phys 2011;79:

12 Management of Hot Flashes Adverse events

13 Management of Hot Flashes Acupuncture: Twice weekly sessions for 6 weeks 12 acupuncture sites Needles le_ in place for 45 minutes Men with prostate cancer on ADT treated with acupuncture - reducdon in severity of hot flash score from % - greater than 50% reducdon in daily number of hot flashes Hirsch L, Goldstein L. Canadian Journal of Urology 2015; 22:7938

14 Management of Hot Flashes Acupuncture: Proposed mechanism of acdon: Acupuncture sdmulates release of serotonin and norepinephrine in hypothalamic regulatory center Modulates peripheral autonomic nervous system

15 Management of Hot Flashes Acupuncture: RCT comparing 12 weeks of acupuncture versus venlafaxine in breast cancer padents on hormone therapy with tamoxifen Walker et al. J Clin Oncol. 2010;28:634-40

16 ADT and Bone Health ADT accelerates bone loss in men Bone mineral density decreases 5-10% at 1 yr and begins within 6-9 months of ADT inidadon Increase bone turnover = increase fracture risk Up to a 21% reladve increase in clinical fractures on ADT Smith MR, et al. J Clin Oncol 2005;23: Shahinian VB, et al. N Engl J Med. 2005;352:154-64

17 Fracture Risk Assessment Tool (FRAX) For men with a 10 year risk of hip fracture >3% based on this tool, a baseline bone mineral density scan should be obtained before inidadng ADT, followed by a scan a_er 1 year of therapy for men on long- term ADT

18 ADT and Bone Health- PrevenDon 1200 mg calcium and IU vitamin D No RCT have been performed to evaluate whether supplementadon improves bone mineral density for padents on ADT However, it is reasonable to recommend 1200 mg calcium and IU/day vitamin D (NaDonal Osteoporosis FoundaDon) Bisphosphonates Denosumab SERMs

19 ADT and Bone Health- PrevenDon Bisphosphonates (zoledronic acid, alendronate): Klotz LH et al. Eur Urol 2013;63:927-35

20 ADT and Bone Health- PrevenDon Bisphosphonates (zoledronic acid, alendronate): Meta- analysis of 15 trials and 2634 subjects: bisphosphonates as a class prevented fractures and osteoporosis (RR 0.8 and 0.39 respecdvely) Serpa Neto A, et al. Prostate Cancer ProstaDc Dis

21 Denosumab: humanized monoclonal andbody against NF- KB Blocks maturadon of preosteoclasts to osteoclasts Prevents bone resorpdon Healthplexus.net /ardcle/bone- biology- and- role- rankranklopg- pathway

22 Smith MR, et al. N Engl J Med 2009;361: ADT and Bone Health- PrevenDon Denosumab: RCT of 1468 men: - increased lumbar spine BMD at 24 months by 5.6% vs 1% loss in the placebo - decreased incidence in new vertebral fractures at 3 years (1.5% vs 3.9%, RR 0.38)

23 ADT and Bone Health- PrevenDon SelecDve estrogen receptor modulators (raloxifene, toremifine) SERMS improve mean BMD and reduce incidence of new fractures by 50% compared to placebo in men on ADT However not FDA approved due to increased incidence in venous thromboembolic events Smith MR, et al. J Urol 2010;184:

24 ADT and bone health- prevendon NCCN guidelines For men with a 10 year risk of hip fracture >3% based on the FRAX algorithm 1200 mg calcium, IU vitamin D AND either - denosumab 60mg SQ every 6 months OR - zolendronic acid 5mg IV annually OR - alendronate 70 mg PO weekly

25 Personalized ADT for the Specific PaDent Cardiac Obesity and testosterone Fsh High volume metasta<c disease Docetaxel Significant LUTS

26 Sources of Androgen Production LHRH Agents Androgens are produced at 3 sites: - Testes - Adrenal gland - Prostate tumor cells (NEW DISCOVERY!) Anti-Androgens Androgen pathway blockers help block here

27 Abiraterone Androgen synthesis inhibitor (CYP17 inhibitor) IndicaDons Approved by the FDA: April 2011 post chemo, December 2012 pre chemo Interferes with steroidal hormone biosynthesis pathway CombinaDon with prednisone for the treatment of mcrpc who have received prior chemotherapy w/docetaxel CombinaDon with prednisone for the treatment of mcrpc who had not received prior cytotoxic chemotherapy ACTH Abiraterone CYP17: 17α-hydroxylase CYP17: C17,20-lyase Cholesterol Pregnenolone Progesterone 17α- OH- Pregnenolone 17α- OH- Progesterone DHEA Androstenedione Testosterone DHT Androgen Receptor Gaya, JM et al. Expert Review Anticancer Therapy. 2013:13: Abiraterone acetate [prescribing information]

28 Abiraterone Phase 3 Trial: COU-AA-301 Initiated in April 2008 Post-docetaxel mcrpc Up to 2 prior therapies ECOG PS 0-1 Medical or surgical castration, testosterone < 50 ng/dl n = 1158 R 2:1 Abiraterone acetate 1000 mg/day (4 x 250 mg tablets) PO; 5 mg prednisone/prednisolone BID Placebo plus 5 mg prednisone/prednisolone BID Primary endpoint: Overall survival Secondary endpoints: Progression-free survival (PFS), Proportion achieving 50% PSA reduction, time to PSA progression, QOL de Bono JS, et al. N Engl J Med. 2011;364:

29 Abiraterone Phase 3 Trial COU-AA-302 Initiated in April 2009 Asymptomatic or mildly symptomatic mcrpc Progression after previous antiandrogen withdrawal ECOG PS 0-1 Medical or surgical castration, testosterone < 50 ng/dl n = 1000 R 1:1 Abiraterone acetate 1000 mg/day (4 x 250 mg tablets) PO; 5 mg prednisone/prednisolone BID Placebo plus 5 mg prednisone/prednisolone BID Primary endpoints: OS and PFS Secondary endpoints: Time to opiate use, time to chemo, time to first ECOG PS deterioration, time to PSA progression Ryan et al. N Engl J Med ;368:

30 Enzalutamide Androgen receptor blocker FDA Approved: Post August 2012;Pre September 2014 Indications mcrpc with recurrence or metastasis mcrpc in patients who had received prior docetaxel May be used in men who are not candidates for chemotherapy Trials: AFFIRM (post-docetaxel) Post approval study PREVAIL (pre-docetaxel) Pre approval study STRIVE (vs. bicalutamide with CRPC) completed Hoffman-Censits, J. Can J Urol April 2014 (Volume 21, Supplement 1), Beers T NEJM 2014; 371: July 31, 2014

31 Prevail extended analysis Reduced risk of radiographic progression by 68% or death by 23% rpfs was 20 months vs 5.4 for placebo Median OS vs 31.3 for placebo. Evaluated longer term efficacy/safety up to the pre- specified number of deaths in the final analysis. 20 m for rpfs, 9 m for OS, 4 m for safety A/E back pain, consdpadon, fadgue and arthralgia

32 STRIVE Enzalutamide vs Bicalutamide in men with Pca progressing on ADT. 198pts in each arm. PFS- Overall- (PSA, Radiographic or death) 19.4 vs 5.7m p< Time to PSA progression NA vs 8.3 m p< % - PSA response> 50% 81.3 vs DuraDon of RPFS- Na vs 8.3m Best overall so_ Dssue response % 60 vs 14 AEs and QOL no difference

33 Before 2010, the last agent approved for the treatment of CRPC was docetaxel Sipuleucel- T [8] Denosumab [9] LHRH agonists [1,2] Zoledronic Acid [4] Cabazitaxel [7] Abiraterone Post [10] Mitoxantrone [3] Docetaxel [5,6] Enzalutamide Post [11] Reversible AR blockers [1,2] Abiraterone Pre [13] Radium- 223 [12] Enzalutamide Pre [14] 1. The Leuprolide Study Group. NEJM 1984;311: Crawford ED, et al. NEJM. 1989;321: Tannock IF, et al. J Clin Oncol. 1996;14: Saad F, et al JNCI 2002;94: Petrylak DP, et al. NEJM. 2004;351: Tannock IF, et al. NEJM. 2004;351: de Bono JS, et al. Lancet. 2010;376: Kantoff PW, et al. NEJM. 2010;363: Fizazi K, et al. Lancet. 2011;377: de Bono JS, et al. NEJM. 2011;364: Scher HI, et al. NEJM Sep 27;367(13): Parker et al. NEJM. 2013;369: Beer T et al ASCO GU San Francisco, CA 14. Beer T NEJM 2014; 371:

34 New concept Should these advances be applied to Hormone SensiDve Prostate Cancer and if so: Which agents and when?

35 Discussion Topics E3805 (CHAARTED) data review Comparison with GETUG- AFU 15 Who really should receive Docetaxel? The high vs. low volume/risk disease debate Safety and toxicity consideradons

36 STRATIFICATION E3805 CHAARTED: ChemoHormonal Therapy vs. Androgen AblaDon for MetastaDc Prostate Cancer Extent of Mets -High vs Low Age 70 vs < 70yo ECOG PS vs 2 CAB> 30 days -Yes vs No SRE Prevention -Yes vs No Prior Adjuvant ADT 12 vs > 12 months R A N D O M IZ E ARM A: ADT + Docetaxel 75mg/m2 every 21 days for maximum 6 cycles ARM B: ADT (androgen depriva<on therapy alone) ADT allowed up to 120 days prior to randomizadon IntermiYent ADT dosing was not allowed Standard dexamethasone premedicadon but NO DAILY PREDNISONE Evaluate every 3 weeks while receiving docetaxel and at week 24 then every 12 weeks Original design n=568 for high volume disease Adjustments for allowance of low volume disease and projected OS based on S9346 data n=780 Evaluate every 12 weeks Follow for <me to progression and overall survival Chemotherapy at inves<gator s discre<on at progression Sweeney C et al. ASCO 2014; Abstract LBA2.

37 Probability E3805 CHAARTED: ChemoHormonal Therapy vs. Androgen AblaDon for MetastaDc Prostate Cancer N=790 men accrued 07/28/06-11/21/12 Planned interim analysis at 53% informadon met 10/13 01/16/14 median follow- up 29 months 136 (110 high volume) deaths ADT alone vs. 101 (82 high volume) deaths ADT+D 83.6% vs. 83.2% of deaths from prostate cancer HR=0.61 ( ) p= Median OS: ADT + D: 57.6 months ADT alone: 44.0 months Primary endpoint Overall survival 0.0 Sweeney C et al. ASCO 2014; Abstract LBA OS (Months)

38 Probability Probability E3805 CHAARTED: ChemoHormonal Therapy vs. Androgen AblaDon for MetastaDc Prostate Cancer OS by extent of metasta<c disease at start of ADT >4 bone lesions and >1 lesion in any bony structure beyond the spine/pelvis OR visceral disease p= HR=0.60 ( ) Median OS: ADT + D: 49.2 months ADT alone: 32.2 months p= HR=0.63 ( ) Median OS: ADT + D: Not reached ADT alone: Not reached High volume OS (Months) 0.0 Low volume Arm OS (Months) TOTAL DEAD ALIVE MEDIAN Sweeney C et al. ASCO 2014; Abstract LBA2. A B

39 HR=0.72 ( ) p=0.005 Median OS: ADT + D: 22.9 months ADT alone: 12.9 months HR=1.01 ( ) p=0.955 Median OS: ADT + D: 58.9 months ADT alone: 54.2 months Biochemical PFS Overall Survival Gravis et al. Lancet Oncol. 2013; 14:

40 Key Differences between GETUG- AFU 15 and CHAARTED GETUG- 15 CHAARTED N Docetaxel cycles Up to 9 (median 8) 6 Gleason % 68.6% PSA median (ng/ml) ADT 25.8; ADT+D 26.7 ADT 50.5; ADT+D 56.0 High volume/risk 21.6% % 2,3 DisconDnuaDons early for toxicity 20.3% 12.5% Treatment related deaths 4 (2.1%) 1 (0.3%) but 8 (2%) unknown Median followup 50 months (data cutoff July 31, 2011) 29 months Subsequent docetaxel with CRPC (%) ADT (62); ADT+D (28) ADT 129/174 (74.1) ; ADT+D 49/145 (33.8) Subsequent potent AR therapy with CRPC (%) ADT (<15); ADT+D (<16) ADT 79/174 (45.5); ADT+D 92/145 (62.8) 1. Glass TR et al. J Urol 2003; 169:164-9; 2. Eisenberger M et al. N Engl J Med 1998; 339: ; 3. Millikan RE et al. J Clin Oncol 2008; 26:

41 Summary of Factors that may have Contributed to Different Results between GETUG- AFU 15 and CHAARTED Study size/stadsdcal power Prognosis and staging definidons and disease risk/volume were different Toxicity e.g. deaths and early discondnuadons and the use of other subsequent therapies were different

42 Grade 3-5 Hematologic Toxicity from TAX327 in mcrpc vs. GETUG- AFU 15 vs. CHAARTED Toxicity TAX327 (%) GETUG- AFU 15 (%) CHAARTED (%) Neutropenia 32 32* 12 Febrile neutropenia 3 7* 6 Death ^ *A_er 56% accrual and 4 treatment- related deaths, DSMC recommended GCSF days 5-10 with Grade ¾ neutropenia rate decline from 41% to 15%, febrile neutropenia decline from 8% to 6% and no more deaths. ^2% of deaths were unknown Key Conclusion: Tough to interpret toxicity data with incomplete informadon on growth factors and prophylacdc andbiodcs, but, is there some a sense that docetaxel may surprisingly be more toxic in mhspc? Tannock IF et al. N Engl J Med 2004; 351:

43 Docetaxel PK varies with CastraDon State 10 non- castrate and 20 castrate men with similar demographics Clearance of Docetaxel in castrate men was 100% increased with 2 fold reducdon in AUC Erythromycin breath test indicated hepadc CYP3A4 acdvity, for Docetaxel metabolism, was not different Castrate rats have higher AUC of Docetaxel in liver compared to intact animals 50% decrease in Docetaxel clearance associated with >430% increase in odds of grade ¾ neutropenia* Franke RM et al. J Clin Oncol 2010; 28: ; *Bruno R et al. J Clin Oncol 1998; 16:

44 What are the ImplicaDons of these PK Differences? Between Different Trials May explain some of the greater hematologic toxicity but also survival benefit observed in castradon- sensidve compared to castradon- resistant trials Why was there greater hematologic toxicity in GETUG- AFU 15 compared to CHAARTED? How many padents were non- castrate vs. castrate in each trial? GETUG- AFU 15: 47% inidated ADT within 15 days of enrollment CHAARTED: inidated ADT median 1.1 months to enrollment How much GCSF was used in each trial? For the Prac<cing Clinician Consider waidng undl a_er 1-2 months of ADT or castrate testosterone levels have been reached before stardng Docetaxel? Use GCSF, at least for the first couple cycles, undl castrate

45 STAMPEDE: Docetaxel and/or Zoledronic Acid in Hormone- Naive Metasta<c PCa First overall survival analysis of pa<ents enrolled in the following 4 study arms: Standard of care (SOC; n = Zoledronic acid (ZDA) + SOC (n = 1,184) 593) Docetaxel (Doc) + SOC (n = 592) Doc + ZDA + SOC (n = 593) SoC Doc + SoC ZDA + SoC Doc + ZDA + SoC Median overall survival Hazard ra<o (p- value) Median failure- free survival 67 mo Ref* 21 mo 77 mo 80 mo 72 mo 0.76 (0.003) 0.93 (0.44) 0.81 (0.02) 37 mo 21 mo 37 mo Hazard ra<o (p- value) Ref* 0.62 (<0.1 x ) 0.62 (<0.1 x ) 0.93 (0.26) * Pairwise comparisons to control SOC study arm were calculated for each research arm. Docetaxel, and not ZDA, improves overall survival compared to SoC Docetaxel + ZDA improves survival but offers no obvious benefit over Docetaxel alone James ND et al. Proc ASCO 2015;Abstract 5001.

46 QuesDon? If toxicity is greater with the use of Docetaxel in the pre- castrate state might not efficacy also be? We need a trial.

47 A PHASE II STUDY OF DOCETAXEL BEFORE MEDICAL CASTRATION WITH DEGARELIX IN PATIENTS WITH NEWLY DIAGNOSED METASTATIC PROSTATIC ADENOCARCINOMA. N = 50 padents Enrolling men with newly diagnosed treatment naïve metastadc prostate cancer of all volume statuses. >>> S 8 CT Primary Endpoint ProporDon of men who maintain a PSA < 0.2 ng/ml at 40 weeks on study(7 months ADT) AddiDonal Endpoints Toxicity, PSA response to Docetaxel alone, Dme to development of castradon resistance, overall survival, correladng genomics with response.

48 Clinical consideradons for the use of ADT: A hormonal therapy algorithm History of CVD? Coronary artery disease Myocardial ischaemia and infarcdon Cerebrovascular accident Angina pectoris Coronary artery bypass YES Degarelix >50% lower CVD risk over one year 1 NO PSA >20 ng/ml or metastases? YES Degarelix Longer PSA PFS 2 No clinical flare 3 BeYer S- ALP control 4 BeYer bone pain control 5 NO PaDents with Met- HSPCA for Chemo/ADT YES Degarelix- Maybe Castrate in 48 hrs Either if none of above No 1. Albertsen PC, et al. Eur Urol 2014;65:565 73; 2. Boccon- Gibod L, et al. Therap Adv Urol 2011;3:127 40; 3. Klotz L, et al. BJU Int 2008; 102:1531 8; 4. Schroder FH, et al. BJU Int 2010;106:182 7; 5. Shore N, et al. Presented at SUO 2012;Poster 84; 6. Anderson J, et al. Urol Int 2013;90:321 8; 7. Mason M, et al. Clin Oncol 2013;25:190 6; 8. Axcona K, et al. BJU Int 2012;110:1721 8

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