Advances in Chemotherapy for Castration Resistant Prostate Cancer
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1 Advances in Chemotherapy for Castration Resistant Prostate Cancer Daniel P. Petrylak, MD Director, Genitourinary Oncology Co Director, Signal Transduction Program Yale Comprehensive Cancer Center
2 Sequencing CRPC therapy 2010 Metastatic, minimally symptomatic CRPC Symptomatic or poorprognosis CRPC Progression after docetaxel chemotherapy Survival benefit Secondary hormonal Rx Docetaxel Mitoxantrone Best supportive care not known 3 months not known Zoledronic acid with CRPC (metastatic disease)
3 Sequencing CRPC therapy 2013 Metastatic, minimally symptomatic CRPC Symptomatic or poorprognosis CRPC Progression after docetaxel chemotherapy 2010 Survival benefit Secondary hormonal Rx Docetaxel Mitoxantrone Best supportive care not known 3 months not known 2013 Survival benefit Abiraterone Cabazitaxel Sipuleucel-T Docetaxel acetate 4 months 3 months 4 months 2.5 months MDV months Denosumab or Zoledronic acid with CRPC (metastatic disease) RAD 223?
4 Questions for Study Is docetaxel more effective than cabazitaxel? What are the mechanisms of docetaxel resistance? Is it rational to continue combination studies? Does sequence have an effect on docetaxel efficacy and toxicity?
5 Randomize Randomize Docetaxel HRPC Trials TAX N=1006 SWOG N=770 *Warfarin and aspirin Mitoxantrone 12 mg/m 2 Prednisone 10 mg q day Q 21 days up to 10 cycles Docetaxel 30 mg/m 2 /wk Prednisone 10 mg q day 5 on; 1 off x 6 cycles Docetaxel 75 mg/m 2 Prednisone 10 mg q day Q 21 days up to 10 cycles Mitoxantrone 12 mg/m 2 Prednisone 5 mg bid Q 21 days Docetaxel 60 mg/m 2 d 2 Estramustine 280 mg d1-5* Dexamethasone 20 mg, tid d 1 & 2 1. Tannock et al. N Engl J Med 2004:351; Petrylak et al. N Engl J Med 2004;351:
6 Overall Survival 100% 80% D+E M+P # at Risk # of Deaths Median in Months % HR: 0.80 (95% CI 0.67, 0.97), p = % 20% 0% Months Petrylak et NEJM 2004
7 Docetaxel q 3 wk Weekly Docetaxel
8 Docetaxel Docetaxel
9 Evidence for Angiongenesis as a Target for Prostate Cancers Microvessel density correlates with prognosis in radical prostatetectomy specimens Elevated levels of VEGF correlate with prognosis in CRPCa bfgf expressed in epithelial and stromal cells Imids have single agent activity in castration resistant disease.
10 VENICE Study Design Multinational, multicenter, double blind, randomized study R A N Docetaxel plus Pred q3w 600 pts + Aflibercept 6 mg/kg IV, over 1hr, day 1, q 3 weeks maipc D Stratification factor : ECOG PS (0,1 vs 2) O M I Z E 1: 1 Disease Progression Docetaxel plus Pred q3w 600 pts + Placebo day 1, q 3 weeks Death Safety data monitored by and DMC (Q 6 months) Treatment planned until PD, consent withdrawn, or unacceptable toxicity Follow up until death 10
11 Aflibercept (N=612) Placebo (N=612) Stratified HR P value Median OS (mos) (95.6% CI) 22.1 ( ) 21.2 ( ) 0.94 ( ) 0.38 PSA response (%) (95% CI) 68.6 ( ) 63.5 ( ) Time to SRE (mos) (95% CI) PFS (mos) (95% CI) 15.3 ( ) 15.0 ( ) 0.94 ( ) ( ) 6.2 ( ) 0.94 ( ) 0.31 Grade 3-4 AE 76.9% 48.5% AEs leading to discontinuation 43.9% 20.9%
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13 Study Design Chemotherapynaïve patients with progressive metastatic CRPC Randomization Treatment phase 21-day cycles until disease progression LEN+DP Lenalidomide 25 mg on days 1 14 Docetaxel 75 mg/m 2 on day 1 Prednisone 5 mg BID on days 1 21 PBO+DP Placebo on days 1 14 Docetaxel 75 mg/m Stratification factors: 2 on day 1 Prednisone 5 mg BID on days 1 21 ECOG PS score Geographic region Type of disease progression (rising PSA versus tumor progression) Follow-up Up to 5 years Follow-up for survival every 90 days for up to 5 years following study treatment discontinuation Endpoints: Primary: overall survival (OS) Secondary: progression-free survival (PFS); objective response rate; safety DP, docetaxel + placebo; LEN, lenalidomide; PBO, placebo; BID, twice daily; ECOG, Eastern Cooperative Oncology Group; PS, performance status; PSA, prostate-specific antigen. 13
14 Efficacy Results: Overall Survival PBO+DP Median overall survival: LEN+DP arm: 77 weeks PBO+DP arm: median not reached (P = ) LEN+DP Hazard ratio: 1.53 (95% CI )
15 Efficacy Results: Progression-free Survival Median progression-free survival: LEN+DP arm: 45 weeks PBO+DP arm: 46 weeks (P = ) Hazard ratio: 1.32 (95% CI ) PBO+DP LEN+DP
16 Treatment Exposure LEN+DP N = 525 PBO+DP N = 521 Median number of cycles (range) 6 (1 30) 8 (1 30) Median relative dose intensity (range) 93.4 (17 105) 96.9 (14 103) Dose reductions, n (%) LEN/PBO 78 (14.9) 41 (7.9) Docetaxel 109 (20.8) 81 (15.5) All dose reductions were due to adverse events, except for 2 dose reductions of docetaxel due to other reasons
17 Safety Results: Adverse Events Main grade 3 TEAEs, n (%) Hematologic LEN+DP PBO+DP N = 525 N = 521 Neutropenia 114 (21.7) 85 (16.3) Febrile neutropenia 62 (11.8) 24 (4.6) Anemia 33 (6.3) 27 (5.2) Leukopenia 24 (4.6) 18 (3.5) Non-hematologic Fatigue 43 (8.2) 32 (6.1) Diarrhea 37 (7.0) 12 (2.3) Asthenia 29 (5.5) 17 (3.3) Pulmonary embolism 34 (6.5) 8 (1.5) Dyspnea 22 (4.2) 9 (1.7) Pneumonia 24 (4.6) 6 (1.2) TEAEs, treatment-emergent adverse events.
18 Safety Results: Deaths n (%) Deaths during treatment or 28 days from last LEN/PBO dose LEN+DP PBO+DP P value N = 525 N = (3.4) 13 (2.5) Death from malignant disease 5 (1.0) 2 (0.4) Death from toxicity 2 (0.4) 1 (0.2) Death because of other cause 11 (2.1) 10 (1.9) Deaths 28 days from last LEN/PBO dose 109 (20.8) 78 (15.0) Death from malignant disease 94 (17.9) 72 (13.8) Death because of other cause 13 ( 2.5) 5 ( 1.0) Unknown 2 ( 0.4) 1 ( 0.2)
19 Phase III Study of Docetaxel + Placebo VS Docetaxel + Atrasentan in Patients with Hormone-Refractory Prostate Cancer (S0421) Stratification: Type of progression PS:0-1 vs 2-3 Prior RP Total ALK-PO4 < 5 vs. 5 XULN Bisphos. R A N D O M I Z E Docetaxel 75 mg/m2 Q3 wks Prednisone 10 mg Placebo Docetaxel 75 mg/m2 Q3 wks Prednisone 10mg Atrasentan 10 mg
20 Efficacy Results: Overall Survival Median Overall Survival: LEN + DP: mo PBO + DP: median not reached (p=0.0017) Hazard ratio: 1.53 (95% CI ) 20
21 100% 80% SWOG S0421: Overall Survival At Risk Docetaxel + Atrasentan 498 Docetaxel + Placebo 496 Deaths Median in Months yr survival 37% 38% 60% 40% 20% 0% 0 At Risk Months After Registration
22 Baseline Bone Markers have Previously Been Shown to be Prognostic and Response Biomarkers NTX BAP NTX Cook RJ et al. Clin Cancer Res 2006;12: Lipton A et al. Cancer. 2008; 113:
23 Figure 3 Serum Markers of Bone Metabolism are Predictive of Atrasentan Benefit in CRPC Patients with the highest bone marker levels (upper 25%ile across all markers, n=47): - Have a very poor prognosis HR = 4.3, p< but have a significant survival benefit from atrasentan HR=0.33; interaction p = Lara PN et al. ASCO Abstract 4547.
24 Phase 3 Trial of Docetaxel +/- Dasatinib Eligibility Criteria Patients with metastatic CRPC Evidence of progression R A N D O M I Z E N=1,500 Docetaxel 75 mg/m 2 q3w + Dasatinib 100 mg po qd + Prednisone 5 mg po bid Docetaxel 75 mg/m 2 q3w + Placebo po qd + Prednisone 5 mg po bid Primary endpoint: Overall survival Stratification factors Performance status Baseline bisphosphonate use Urine N-telopeptide level
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27 Clusterin as a Therapeutic Target for Cancer Expression in human cancer Expressed in kidney, bladder, ovary, lung, colorectal and breast cancers Prostate Cancer Increased expression with higher Gleason Grade Increased expression after hormone therapy Overexpression confers resistance to hormone, chemo and radiation therapy in vitro and in vivo Inhibiting clusterin expression increases sensitivity to hormone therapy, radiation therapy and chemotherapy Clusterin increases after Androgen Ablation and in CRPC Steinberg, Clin Cancer Res, 1997; July, Prostate, 2002; Redondo, Am J Path, 2000; Miyake, Urology, 2000; Parczyk, J Can Res Clin Oncol, 1994; July, Mol Can Thera, 2004; Miyake, Can Res, 2000; Miyake Clin Can Res, 2000; Zellweger, Clin Can Res, 2002
28 Relative % Clusterin mrna OGX-011: Dose Dependent Target Effects Inhibition of Clusterin mrna Inhibition of Clusterin Protein: IHC Score= N = No NHT <2M NHT 40 mg 80 mg 160 mg 320 mg 480 mg 640 mg Inhibition of Clusterin Protein: IHC Score Apoptotic Index Chi KN, Clin Cancer Res, 14:833, 2008
29 Randomized Phase II: Docetaxel +/- OGX-011 for CRPC Variable HR (95% CI) P OGX-DOC DOC PS 0 PS 1 Bone/node only Other metastases 0.50 ( ) ( ) < ( ) 0.01 Chi KN, J Clin Oncol, 28: 4247, 2010
30 SYNERGY Study First-Line Docetaxel +/- OGX-011 (Custirsen) Metastatic CRPC North America, Europe (N=800) 1:1 Custirsen 640 mg IV weekly Docetaxel 75 mg/m² q 3 wk + prednisone Docetaxel 75 mg/m² q 3 wk + prednisone Primary endpoint: Overall survival HR = 0.725, Power 90%, Alpha = 0.05, critical HR = 0.82 Primary data completion date: Dec, 2013 Secondary endpoints: PFS, PSA, patient reported outcomes, serum clusterin, safety
31 Phase III Trials of Docetaxel Combinations Docetaxel/Pred vs Docetaxel Combined With: Status Results DN-101 Terminated early Negative GVAX Terminated early Negative Bevacizumab Completed Negative VEGF-Trap Completed Negative Atrasentan Completed Negative ZD4054 Completed Negative Dasatinib Completed Negative Lenalidomide Completed Negative Custersin (OGX-011) On-going Pending To date, no combination improves on docetaxel and pred
32 Cabazitaxel Pre-Clinical Development Objectives for compound selection: Same potency as docetaxel against sensitive tumor models More potent than docetaxel against tumor models resistant to chemotherapy including docetaxel Screening procedure (~450 derivatives) Activity on tubulin polymerisation as initial screen In vitro activity against tumour cell lines sensitive to docetaxel In vitro activity against docetaxel-resistant tumor cell lines Tumor model developed by Rhone Poulenc induced resistance to docetaxel
33 TROPIC: Phase III Registration Study 146 Sites in 26 Countries mcrpc patients who progressed during and after treatment with a docetaxel-based regimen (N=755) Stratification factors ECOG PS (0, 1 vs. 2) Measurable vs. non-measurable disease cabazitaxel 25 mg/m² q 3 wk + prednisone* for 10 cycles (n=378) *Oral prednisone/prednisolone: 10 mg daily. Primary endpoint: OS Secondary endpoints: Progression-free survival (PFS), response rate, and safety mitoxantrone 12 mg/m² q 3 wk + prednisone* for 10 cycles (n=377) Inclusion: Patients with measurable disease must have progressed by RECIST; otherwise must have had new lesions or PSA progression 3
34 Primary Endpoint: Overall Survival (ITT Analysis) Proportion of OS (%) Median OS (months) Hazard Ratio 95% CI P-value MP <.0001 CBZP Number at risk 0 0 months 6 months 12 months 18 months 24 months 30 months MP CBZP
35 Subgroup Overall Survival Analysis Factor Hazard ratio (95% CI) f a v o r s C B Z P f a v o r s M P All patients 0.70 ( ) ECOG status: 0, ( ) ECOG status: ( ) Measurable disease: No 0.72 ( ) Measurable disease: Yes 0.68 ( ) No. of prior chemo: ( ) No. of prior chemo: ( ) Age: < ( ) Age: ( ) Rising PSA: No 0.88 ( ) Rising PSA: Yes 0.65 ( ) Total docetaxel dose: <225 mg/m² 0.96 ( ) Total docetaxel dose: 225 to 450 mg/m² 0.60 ( ) Total docetaxel dose: 450 to 675 mg/m² 0.83 ( ) Total docetaxel dose: 675 to 900 mg/m² 0.73 ( ) Total docetaxel dose: 900 mg/m² 0.51 ( ) Progression: During last docetaxel treatment 0.65 ( ) Progression: <3 months since last docetaxel dose 0.70 ( ) Progression: 3 months since last docetaxel dose 0.75 ( )
36 Most Frequent Grade 3 Treatment-Emergent AEs* Safety Population MP (n=371) CBZP (n=371) All grades (%) Grade 3 (%) All grades (%) Grade 3 (%) Any adverse event Febrile neutropenia Diarrhea Fatigue Asthenia Back pain Nausea Vomiting Hematuria Abdominal pain *Sorted by decreasing frequency of events grade 3 in the CBZP arm. 3
37 On-Study Laboratory Abnormalities Safety Population Hematology MP (n=371) CBZP (n=371) All Grades (%) Grade 3 (%) All Grades (%) Grade 3 (%) Anemia Leukopenia Neutropenia Thrombocytopenia Biochemistry Alkaline Phosphatase ALAT ASAT Hyperbilirubinemia Creatinine
38 Taxanes may also be Antiandrogens! Tubulin-Targeting Chemotherapy Impairs Androgen Receptor Activity in Prostate Cancer Meng-Lei Zhu et al. Cancer Res; 70(20);
39 Goodman et al Proc ASCO 2012
40 Waterfall plot showing maximum PSA falls after docetaxel administration in patients previously treated with abiraterone acetate. Mezynski J et al. Ann Oncol 2012;annonc.mds119 The Author Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please journals.permissions@oup.com.
41 Kaplan Meier plot showing overall survival (A) and time to PSA progression (B). Mezynski J et al. Ann Oncol 2012;annonc.mds119 The Author Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please journals.permissions@oup.com.
42 DOCETAXEL RESISTANT PROSTATE CANCER CELL LINE MODEL DOCETAXEL ADMINISTRATION 10nM 100nM 1000nM DU145 LNCap PC3 22RV1 DU145 22RV1 DU145 22RV1 DU145 22RV1 (Domingo et al In preparation for Publication 2009)
43 EXPRESSION PROFILING OF CYTOKERATIN AND DEVELOPMENTAL GENES _x_at KRT _x_at KRT _at DKK _at KRT _at CTNNB _x_at NOTCH _at NOTCH2NL _s_at NOTCH _s_at NOTCH _at GLI _s_at NOTCH _s_at GLI _s_at NOTCH _s_at NOTCH _s_at PTCH _s_at GLI _at PTCH _at PTCH1 Cytokeratins Developmental Transcription Factors
44 DOCETAXEL RESISTANCE & PROSTATE CANCER STEM CELLS MDR Sensitive Cell Deregulated developmental pathways Stem markers Docetaxel Resistant Cell Epithelial markers Mesenchymal Markers Apoptosis deregulation Cell cycle deregulation (Domingo et al In preparation for Publication 2009)
45 pck19-gfp PLASMID GENERATION Promoter CK19 GFP 5 UTR 3 UTR (Domingo et al In preparation for Publication 2009)
46 Tumor Cells Stable Transfected with pck19+gfp Plasmid Dapi GFP Note that a GFP Negative Cell is Present in the Cell Clone
47 BF FITC MERGE Tumor Cells Stable Transfected with pck19+gfp Plasmid Live Imaging Hours Asymmetric Cell Division & Differentiation
48 BF FITC Merge Cancer Stem Cells Display a Drug Resistance Phenotype Live Imaging Hours (Docetaxel 10 nm) 0h 12h 24h 36h 48h
49 % Colonies In vitro effects of Hedgehog and NOTCH inhibition DU145 HLA+ DU145 HLA- 22RV1 HLA+ 22RV1 HLA Control D C CE D + C D + CE D + CE + C Control D C CE D + C D + CE D + C + CE 22RV1 HLA + 22RV1 HLA - DU145 HLA + DU145 HLA -
50 % Tumours % Tumours In vivo effects of Hedgehog and NOTCH inhibition DU145 22RV1 Control D D + C D + DBZ D + C + DBZ Control D D + C D + DBZ D + C + DBZ weeks weeks Tumour Latency (weeks; Mean ± SD) Tumour Latency (weeks; Mean ± SD) Control D D + C D + DBZ D + C + DBZ Control D D + C D + DBZ D + C + DBZ 5.9± ± ± ± ±0.6* 5.4± ± ± ± ±2.2 *
51 % Cells HUMAN TUMOR SAMPLES METASTATIC PROSTATE CANCER CKs CKs - CKs Merge CK18+CK Patients DAPI TF1
52 CYTOKERATIN NEGATIVE CELLS ARE ALSO AR NEGATIVE MERGE DAPI AR CKs
53 Conclusions Further manipulation of docetaxel based chemotherapy is unlikely to provide therapeutic improvements Docetaxel/prednisone is still the standard of care for first line chemotherapy for metastatic disease Markers for drug resistance are being identified.
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