전립선암의 치료 삼성서울병원 혈액종양내과 박세훈
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1 전립선암의치료 삼성서울병원혈액종양내과박세훈
2 Prostate Cancer Statistics ~186,000 new cases and 28,000 prostate cancer related deaths in the US in American Cancer Society,
3 Prostate Cancer Is Not a Rare Disease % seeing a medical oncologist (from Dx to death) 1 Prostate t Breast Colorectal l Lung Stage I 12% 76% 35% 48% Stage II 12% 83% 62% 70% Stage III 14% 85% 83% 76% Stage IV 31% 92% 80% 79% Unstaged 11% 64% 41% 51% 1 National Cancer Institute, 2005
4 Latent Prostate Cancer at Autopsy 100 ucasia n men with PC auto psy % of Ca Age (years) 1 Sakr WA, Eur Urol 1996
5 Prostate Cancer Statistics Fifth M/C male cancer in Korea 1 highly hl dependent d on the androgen receptor AR expressed in most tumors 2 AR overexpression predicts for resistance to ADT 1 Park SH, J Korean Med Sci 2010 (in press) 2 Sharifi N, Clin Cancer Res 2008
6 Adrenal Androgen Axis 1 Debes & Tindall, N Engl J Med 2004
7 CASE #1: 61-yo male 무증상 건강검진시 PSA 7.31 ng/ml DRE: <50 gm, firm, symmetric TRUS: 48.2 cc, Rt peripheral zone nodule Bx: adenoca (3+3=6/10)
8 CASE #1: 61-yo male
9 Early Diagnosis Can Be Possible Screening program for early detection 1 Digital rectal exam (DRE) PSA serum levels TRUS +/ Bx (if palpable mass and/or PSA >4 ng/ml) DRE rarely needed dexcept for cases with borderline PSA Whether PSA testing decreases mortality is heavily debated d 23 2,3 1 Thompson IM J Natl Cancer Inst Thompson IM, J Natl Cancer Inst Schroder F, N Engl J Med Andriole G, N Engl J Med 2009
10 Prostate Cancer Screening ACS guidelines 1 PSA testing q6mowith or without DRE PSA >4.0 ng/ml requires further evaluation 1 Brawley OW, CA Cancer J Clin 2010
11 Prognosis of Prostate Cancer Life expectancy Stage Grade PSA level (or velocity) Performance status
12 Staging of Prostate Cancer
13 Gleason Grading System Very well differentiated (grade 1) to very poorly differentiated t d (grade 5) 1 Sum of primary (1 5) & secondary (1 5) 1 Gleason DF, Urol Pathol 1977; JAMA 1998
14 Early Prostate Cancer Treat? Or Observe?
15 Nomograms & Predictive Models D Amico nomogram 1 Partin tables tbl 2 MSKCC Prostate Cancer Nomograms 3 Preop nomograms 4 1 D Amico AV, J Clin Oncol Partin AW, JAMA Stephenson AJ, N Natl Cancer Inst 2006
16 Recurrence Risk Models
17 Treatment Strategies for Early Stage Prostate Cancer
18 Overdetection May Lead to Overtreatment More suitable for observation alone 1 T1 T2 AND, Aged 70 years AND, Gleason score <6 AND, Baseline PSA <10 ng/ml AND, PSADT > 10 years 1 Choo R, Int J Radiat Oncol Biol Phys 2001
19 Treatment Options for Prostate Cancer Observation (i.e., active surveillance) DRE, PSA Repeat TRUS Bx yearly Radical prostatectomy Radiotherapy Hormone therapy
20 CASE #1: 61-yo male Active surveillance (with annual Bx) PSA21 ng/ml Gleason 4+4=8/ Radical prostatectomy 시행후 PSA 0.4 ng/ml 까지감소 PSA 42 ng/ml 로상승하였으나영 상검사상재발의소견없고무증상
21 Advanced Prostate Cancer Treat immediately? Or deferred therapy?
22 CASE #1: 61-yo male Gleason 3+3=6/10 Gleason 3+3=6/10 Gleason 4+4=8/ Diagnosed to have prostate ca Goserelin Radical + bicalutamide prostatectomy
23 Biochemical Recurrence PSA failure Options include additional local ltherapy, hormonal therapy, or observation
24 PSA Levels & Velocity Baseline PSA > 10 ng/ml and PSA velocity independent predictors of shorter time to first bone metastasis (P <.001) and OS 1 A With Died atients W s or Who rtion of P etastases Propor Bone Me PSA < 7.7 ng/ml PSA ng/ml PSA > 24.0 ng/ml Yrs Since Random Assignment 1 Smith MR, J Clin Oncol 2005 B With o Died Patients W es or Who ortion of P Metastase Propo Bone M PSADT < 6.3 mos PSADT mos PSADT > 18.8 mos Yrs Since Random Assignment
25 CASE #1: 61-yo male PSA 58.7 ng/ml 전신통증
26 Hormonal Therapy for Prostate Cancer Any treatment that ultimately results in suppression of androgen activity is called androgen deprivation therapy (ADT) Can be achieved by suppressing secretion of the testicular androgens (castration, LHRH agonists), by inhibiting the action of circulating androgens (anti androgens), or both (complete androgen blockade)
27 ADT Improves Survival INT Eisenberger M, N Engl J Med 1998
28 PSA Changes after ADT S9346: PSA 4 ng/ml after 7 mo of ADT is a strong predictor of survival Median At Risk Deaths in Mos PSA < PSA PSA > Patients (% %) P < No. at risk: Mos After End of Induction PSA 0.2 ng/ml < PSA PSA > Hussain M, J Clin Oncol
29 CASE #1: 61-yo male Palliative radiotherapy to painful area PSA ng/ml Goserelin + bicalutamide 투여후 PSA 12 ng/ml 까지감소함 PSA441ng/ml > >hormone withdrawal 후 29.4 ng/ml 까지감소 PSA ng/ml Docetaxel/pd 항암화학요법을시작함
30 Natural History of Prostate Cancer Hormone-dependent Hormone-dependent prostate cancer prostate cancer Hormone thx Hormone-refractory prostate cancer Chemothx Metastasis Prevention PSA Progressive Castrate Nonmetastatic Hormone sensitive Time Therapy: RP GnRH Agonist 1 Stavridi F, Cancer Treat Rev 2009 Castrate resistant Salvage
31 Changes in Gene Expression with Progression of Prostate Cancer Hormone-dependent prostate cancer PSA AR PTEN PI3K/Akt MAPK Bcl 2 EGFR PDGFR HSP27 Hormone thx Hormone-dependent prostate cancer Hormone-refractory prostate cancer Chemothx 1 Stavridi F, Cancer Treat Rev 2009
32 Eventually, All Pts Treated with Hormone Therapy Become Resistant Castrate resistant PC (CRPC) Tumor progression despite castrate levels l of androgen Hormone refractory PC (HRPC) Tumors no longer responding to hormones Androgen Independent PC (AIPC) Tumors no longer rely on AR or androgen signaling for growth and survival
33 CASE #2: 68-yo male 60 pack-years smoker HBV+, DM, hypertension 골전이를동반한전립선암진단되 어 Goserelin + bicalutamide 투약 PSA 수치는 4~8 ng/ml 정도로유지됨 PSA 52.8 ng/ml
34 CASE #2: 68-yo male
35 Most Asymptomatic HRPC Pts Are NOT Eager to Begin Chemotherapy For symptomatic HRPC pts 1 Consider chemotherapy h for pts with general e symptoms s and/or rapidly apdy progressive disease Analyses of 6,638 HRPC pts (SEER) 2 Those who married, on ADT, hdrt had RT, saw a medical oncologist, had fewer comorbidities, or with M1 disease 1 Tannock IF, Ann Oncol Grabner M, ASCO 2010
36 Pain Predicts Survival in HRPC Pooled analysis of 3 phase III HRPC studies (N = 599) 1 Surviv val Prob bability Pain score < 17 (median OS:17.6 mos) Pain score 17 (median OS: 10.2 mos) 1 Halabi S, J Clin Oncol Mos
37 Antitubulin Agent Mitoxantrone Disrupting tubulin formation, either by stabilizing or destabilizing it, to cause cell cycle arrest and Bcl 2 phsophorylation Bcl 2 is expressed in 80~90% of HRPC 1 Mitoxantrone No survival benefit but significant relief of symptoms, when compared to corticosteroids 2,3 1 Yoshino T Clin Cancer Res Yoshino T, Clin Cancer Res Osoba D, J Clin Oncol Tannock IF, J Clin Oncol 1996
38 Docetaxel Is the Current Standard Chemotherapy for HRPC SWOG 9916 (N=674) 1 & TAX327 (N=1006) 2 OS (%) Mitoxantrone t + prednisone (235 deaths; median: 15.6 mos) P =.02 Docetaxel + estramustine (217 deaths; median: 17.5 mos) Mos After Enrollment 48 Propo ortion Ali ive Docetaxel 3-wkly Docetaxel wkly Mitoxantrone Yrs 1 Petrylak DP, N Engl J Med Tannock IF, N Engl J Med 2004
39 Docetaxel Is the Current Standard Chemotherapy for HRPC Docetaxel + estramustine ti Mitoxantrone OS, mo PSA response, % Response, % TAX Docetaxel Docetaxel q3wk weekly Mitoxantrone OS, mo PSA response, % Response, % Petrylak DP, N Engl J Med Tannock IF, N Engl J Med 2004
40 CASE #2: 68-yo male Palliative RT 30 Gy to T12-L4 Docetaxel/pd for 10 cycles PSA 수치는 3.0 ng/ml 까지감소하였다가 다시 102 ng/ml, 197 ng/ml 까지상승 mitoxantrone/pd 시작함
41 Current Issues in HRPC Therapy Docetaxel (+/ pd) for earlier disease Docetaxel (+/ pd) + X Therapy after docetaxel failure (2nd line) Cytotoxic chemotherapy: docetaxel (reuse), mitoxantrone, satraplatin, ti cabazitaxel, epothilones, vinflunine i Differentiating agents: high dose calcitriol (DN 101) VEGF pathway blockers: bevacizumab, aflibercept, sorafenib, sunitinib, cediranib, axitinib Endothelin receptor (ETaR) blocker: artrasentan Better androgen blockers: MDV3100, abiraterone Immunotherapy (or vaccines)
42 Recent Phase III Trials in First-Line Therapy for HRPC Drug Mechanism N Endpoint Status Bevacizumab Angiogenesis 1020 OS Completed Aflibercept Angiogenesis 1200 OS Completed Abiraterone Adrenal androgen 1000 OS Ongoing MDV 3100 Androgen receptor 1200 OS Ongoing Atrasentan Endothelin 930 OS Ongoing Zibotentan Endothelin 1000 OS Ongoing DN-101 Calcitriol 900 OS Primary endpoint: OS Patients with HRPC No prior therapy Medically-fit R Docetaxel + prednisone + DRUG X Docetaxel + prednisone + placebo or BSC
43 Definition of PD after Docetaxel Rising PSA with nodal or visceral lesions 1 Growth of measurable (nodal/visceral) l)disease Reappearance or new lesion(s) with 2 bone lesions 2 Clinical v PSA progression 3 OS for pts discontinued based on clinical PD was 30.5 mo v for pts discontinued using PSAWG criteria i was 18.6 mo 1 Scher HI J Clin Oncol Scher HI, J Clin Oncol Scher HI, J Clin Oncol Ning YM, ASCO GU 2010
44 Criteria Defining HRPC Progression Prostate Cancer Clinical Trials Working Group 2 1 Variable PSA Target tlesions Primary site prostate or prostate bed Bone Other disease sites Description Obtain sequence of rising PSA levels (min 1-wk intervals) Min 2.0 ng/ml starting value Estimate PSA-DT before therapy, if 3 values available 4 wks apart Nodal or visceral progression sufficient for trial entry independent of PSA level Measurable lesions not required for entry Soft-tissue ti (nodal or visceral) lesions recorded d as target t or nontarget t (RECIST) Only lymph nodes 2 cm should be used to assess change in size Record nodal and/or visceral disease separately Recordprevious treatmentof primary tumor Assess presence or absence of disease using directed pelvic imaging CT, MRI, PET/CT, endorectal MRI, transrectal ultrasound Progression: appearance of 2 new lesions Confirm ambiguous results with other imaging modalities (CT or MRI) Treated epidural lesions and no other epidural progression 1 Scher HI, J Clin Oncol 2008
45 Recent Phase III Trials in Second-Line Therapy for HRPC Drug Comparator N Endpoint Status Ixabepilone Mitoxantrone 1020 OS Completed XRP6258 Mitoxantrone 720 OS Completed Sunitinib Placebo 819 OS Ongoing MDV 3100 Androgen receptor 1200 OS Ongoing Atrasentan Endothelin 930 OS Ongoing DN-101 Calcitriol 900 OS Sipuleucel-T Placebo 512 OS Primary endpoint: OS Patients with HRPC Docetaxel failed Medically-fit R DRUG X Placebo or BSC
46 Satraplatin (SPARC Trial) Proportio on Event Free (% %) Satraplatin + prednisone Satraplatin Placebo Placebo + prednisone Median, wks % 17% 16% 7% HR: 0.67 (95% CI: ) Log rank P < PFS, weeks At Risk Satraplatin Placebo Sternberg CN, J Clin Oncol 2009
47 Cabazitaxel XRP6258 (TROPIC) showed better survival outcomes 1 Primary endpoint: OS Cabazitaxel + pd HRPC (n=755) progressed after first-line docetaxel Until PD Mitoxantrone + pd 1 De Bono JS, ASCO 2010
48 Cabazitaxel XRP6258 (TROPIC) showed better survival outcomes 1 Prop portion of OS (%) Cabazitaxel/prednisone Mitoxantrone/prednisone HR: 0.74 (95% CI: ; P <.0001) Outcome, Mos Cabazitaxel/ Prednisone (n = 378) Mitoxantrone/ Prednisone (n = 377) Median PFS Median TTP Tumor assessment PSA assessment Pain assessment Not reached 0 Pts at Risk, n Mos MP CBZP De Bono JS, ASCO 2010
49 Cabazitaxel XRP6258 (TROPIC) showed better survival outcomes 1 roportion of OS (%) 100 ) Median OS Cabazitaxel/prednisone 15.1 mos Mitoxantrone/prednisone 12.7 mos P Mos 6 Mos 12 Mos 18 Mos 24 Mos 30 Mos Pts at Risk, n MP CBZP De Bono JS, ASCO 2010
50 Cabazitaxel XRP6258 (TROPIC) showed better survival outcomes 1 1 De Bono JS, ASCO 2010
51 VEGF Targeted Drugs Anti-VEGF antibodies VEGF VEGF trap (bevacizumab) (aflibercept) Anti-VEGFR antibodies (IMC-1121B) P P P P VEGFR-1 P P P P VEGFR-2 Ribozymes Endothelial cell Small-molecule VEGFR tki (sorafenib, sunitinib, axitinib )
52 Bevacizumab CALGB Primary endpoint: OS Docetaxel + pd (n=526) HRPC Until PD Docetaxel + pd + bevacizumab (n=524) 1 Kelly WK, ASCO 2010
53 At Artrasentant Atrasentan 10 mg (n = 89) Screening Atrasentan t mg (n = 95) Open-label atrasentan extension Placebo (n = 104) Randomization TTP (%) Disease progression or study close placebo Atrasentan 10 mg Atrasentan 2,5 mg 1 Carducci MA, Cancer Days
54 At Artrasentant Ph3 M (DART) 1 essing Probab bility of Not Progr Atrasentan 0.2 Placebo Placebo Atrasentan Events, n (%) 267 (56.3) 227 (48.6) Median time to DP, days Stratified HR: (95% CI: ) Stratified P = Nelson JB, Cancer 2008 Days Since Randomization SWOG 0421 : Docetaxel + artrasentan or placebo (n=930)
55 High-Dose Calcitriol Inhibits cancer cell proliferation and sensitizes cancer cells to cytotoxic agents 1 ASCENT 2,3 250 HRPC pts randomized to docetaxel + DN 101 or placebo PSA response 63% v 52% (p=0.073) OS 24.5 mo v 16.4 mo ASCENT II Discontinued early (n=953) 4 1 Beer TM Anticancer Res Beer TM, Anticancer Res Beer TM, J Clin Oncol Beer TM, Cancer Scher HI, ASCO 2010
56 Abiraterone Suppresses Adrenal Steroids Oral irreversible inhibitor of CYP17 1 Inhibits androgen productions in testis, adrenal & prostate. ng/dl Lower limit of sensitivity Testosterone No rise at progression 0 Start of At treatment e t Days progression DHEA nmol/l Start of treatment Androstenedione No rise at progression At Days progression Estradiol MW = N ol/l nm No rise at progression ρm mol/l RO β-Acetoxy-17-(3-pyridyl)androsta-5,16-diene 1 Ryan C, ASCO Start of treatment At Days progression Days post treatment
57 Abiraterone Suppresses Adrenal Steroids CTC decline associated with improved OS 1 Proba ability Time to PSA Progression Median TTP 231 days Phase I/II study (chemo naive) Phase II study (post-docetaxel) Median TTP 399 days Days 1 de Bono JS, ASCO 2008
58 MDV3100 Small molecule AR antagonist without agonist activity when AR is overexpressed 1 25% 0% -25% -50% -75% -100% After 12 wks of MDV Scher HI, Cancer Scher HI, ASCO 2008
59 Sipuleucel-T l Day 1 Leukapheresis Day 2-3 sipuleucel-t is manufactured Day 3-4 Patient is infused Apheresis Center Doctor s Office 1 Kantoff P, ASCO GU 2010
60 Sipuleucel-T l First ph3 study revealed marginally significant TTP benefit (12 v 10 wks, p=0.052), 1 leading to second study 2 OS TTP 512 HRPC pts Asymptomatic or minimally symptomatic 25.8 wk 14.6 wk Sipuleucel-T l R HR P=0.017 P=0.628 Placebo 21.7 wk 14.4 wk 1 Small EJ, J Clin Oncol Kantoff P, ASCO GU 2010
61 Sipuleucel-T l IMPACT Percent Survival P = (Cox model) HR = [95% CI: 0.614, 0.979] Median Survival Benefit = 4.1 Mos. Provenge (n = 341) Median Survival: 25.8 Mos. Placebo (n = 171) Median Survival: 21.7 Mos Survival (Months) 1 Petrylak DP, ASCO 2010
62 Sipuleucel-T l 1 Petrylak DP, ASCO 2010
63 Multiple Agents Being Tested in HRPC S O CI N HN OH F Aza-epothilone B Ixabepilone EpothiloneB S N 1 O O O OH 2 Patupilone O OH O O OH H 3 C H 3 C CI O O CF 3 O O Erlotinib 3 O NH N N O O N O O Gefitinib 3 O NH N N NH N H N H Sorafenib 4 N CH 3 1 Rosenberg JE, Cancer Beardsley F, ASCO Blackledge G, JUo Urol Dahut WL, Clin Cancer Res Christos N, Cancer Res 2004 Bortezomib 5
64 Bone Is the M/C Metastatic Sites Src The vicious cycle of bone metastases and tumor cell growth in the bone marrow microenvironment [1] PTHrP IL-6 PGE 2 TNF M-CSF RANKL BMP PDGF FGFs IGFs TGF-β Src 1 Roodman GD, N Engl J Med 2004
65 Bone Lesion Is Prevalent 5-Yr World Prevalence, Thousands Frequency of Bone Metastases in Cancers 1 Median Survival, Mos Myeloma Renal More lyti ic Melanoma Bladder Thyroid Lung Breast More blastic Prostate Coleman RE, Cancer Treat Rev 2001
66 Prostate Cancer Patients Are at Risk 1.0 Fractur re 0.9 No GnRH agonist (n = 7774) Propo ortion Without GnRH agonist < 1 yr (n = 1368) GnRH agonist 1 yr (n = 2519) Yrs 1 Smith MR, J Clin Oncol 2005
67 Bisphosphonate O OH R 1 OH P C P O OH R 2 OH Inhibitors of bone loss Potency varies greatly depending on R1 & R2 side chains Relative R 1 R 2 Potency Etidronate OH CH 3 1 Clodronate Cl Cl no N 10 Tiludronate H S Cl 10 Pamidronate OH (CH 2 ) 2 NH Alendronate OH (CH 2 ) 3 NH Risedronate H CH 2 N 5000 Ibandronate OH (CH 2 ) 2 -N-(CH 2 ) 4 -CH 3 N 10,000 CH 3 Zoledronic acid OH N N 100,000 1 Cook RJ, Clin Cancer Res 2006
68 Zoledronate for Bone Lesions Zometa 039 Trial 1 ZEUS 2 Ev vents/100 0 Patients Placebo P =.001 Zoledronic acid Patients with high-risk prostate cancer: Gleason sum 8-10, pn+, or PSA >20 ng/ml at diagnosis; no bone metastases (N = 1433) Primary endpoint: first bone metastasis R A N D O M I Z E Zoledronic acid every 3 mos for 48 mos Placebo every 3 mos for 48 mos Mos 1 Saad F, J Natl Cancer Inst Wirth M, ASCO 2008
69 Denosumab A monoclonal antibody that binds the RANK ligand, which regulates activation, growth & apoptosis of osteoclasts 1 Mean Changes in BMD From Baseline to Mo Lumbar Spine 10 Total Hip in e g n a h C t n e rc e P in e g n a C h t n e rc e P e lin e s a B m ro F D M B e lin e s a B m ro F D M B Bone HG, J Clin Endocrinol Metab e in 8 Denosumab e lin g e 6 n s a a 4 Denosumab Difference at 24 mos, h B C percentage points t m n o Difference at 24 mos, e F ro percentage points Placebo rc D -2 e P M -4 Placebo B Mos Mos Femoral Neck 10 Distal Third of e in 8 Radius e lin g e 6 Denosumab n s a a 4 h B Denosumab Difference at 24 mos, C 2 t m Difference at 24 mos, 3.9 percentage points n ro e 0 F 5.5 percentage points rc D -2 Placebo e Placebo P M B Mos Mos 24 36
70 Denosumab Denosumab reduced the incidence of vertebral fracture, as well as mortality 1 Placebo Denosumab New Vertebra al Fract ture (% %) P =.004 P =.004 P = Smith MR, N Engl J Med Mos
71 Conclusions: Early Prostate Cancer Radical prostatectomy or radiotherapy Consider life expectancy & risk factors Active surveillance may be an option Biochemical failure does not always lead to additional therapy Consider baseline PSA & PSA velocity ADT is highly active Castration, LHRH agonists, or anti androgens Consider adverse effects
72 Conclusions: HRPC Docetaxel/pd is the first line standard for pts with metastatic, progressive, and symptomatic HRPC Studies evaluating docetaxel based combination andsecond line therapy are underway Cabazitaxel is the first approved option for pts who progress after docetaxel Sipuleucel T is the first approved immunotherapy for HRPC Always consider bone health
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