Optimizing Outcomes in Advanced Prostate Cancer

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2 Optimizing Outcomes in Advanced Prostate Cancer Module 3: Focus on Recent CRPC Guidelines and Advanced Hormone-Sensitive Disease Sébastien J. Hotte, MD, MSc (HRM), FRCPC Medical Oncologist and Head, Phase I Program, Juravinski Cancer Centre, Hamilton, Ontario Associate Professor, Dept Of Oncology, McMaster University Co-Chair, GU DSG CCO-PEBC

3 Conflict of Interest Disclosures Research funding: Oncogenex, Novartis, GSK, Amgen, Roche, Astellas, Janssen, Sanofi, Bayer Consultant/Honoraria: Novartis, Janssen, Astellas, Pfizer, GSK, Sanofi, Bayer

4 Learning Objectives Review the most recent ASCO and CUA- CUOG guidelines on the management of CRPC Discuss the recent clinical trial data on the optimal management of newly diagnosed metastatic hormonesensitive prostate cancer Discuss the role of early chemotherapy for high risk nonmetastatic hormone-sensitive prostate cancer

5 Prostate Cancer: Recent CRPC Guidelines

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7 Androgen-Deprivation Therapy: Continuous androgen deprivation (pharmaceutical or surgical) should be continued indefinitely regardless of additional therapies Benefit: Harm: Evidence strength: Recommendation strength: Moderate Moderate Weak Moderate

8 Therapies in Addition to ADT with Demonstrated Survival & Quality-of-Life Benefits: Abiraterone acetate and Prednisone should be offered Enzalutamide should be offered Benefit: Harm: Evidence strength: Recommendation strength: Moderate Low Strong Strong

9 Therapies in Addition to ADT with Demonstrated Survival & Quality-of-Life Benefits: Radium-223 should be offered to men with bone metastases Benefit: Harm: Evidence strength: Recommendation strength: Moderate Low Strong Strong

10 Therapies in Addition to ADT with Demonstrated Survival & Quality-of-Life Benefits: Docetaxel and Prednisone should be offered Benefit: Harm: Evidence strength: Recommendation strength: Moderate Moderate Strong Moderate

11 Therapies with demonstrated survival benefit and unclear quality-of-life benefit: Cabazitaxel and Prednisone may be offered to men who experience progression with Docetaxel Benefit: Harm: Evidence strength: Recommendation strength: Moderate Moderate to high Strong Moderate

12 Therapies with quality-of-life benefit without demonstrated survival benefit: Mitoxantrone plus Prednisone may be offered Benefit: Harm: Evidence strength: Recommendation strength: Low High Weak Weak

13 Therapies with biologic activity and unknown survival or quality-of-life benefit: Antiandrogens (eg, Bicalutamide, Flutamide, Nilutamide) may be offered. (Benefit: low; harm: low; evidence strength: weak; recommendation strength: weak) Ketoconazole may be offered. (Benefit: low; harm: moderate; evidence strength: weak; recommendation strength: weak) Low-dose corticosteroid monotherapy may be offered. (Benefit: low; harm: low; evidence strength: weak; recommendation strength: weak)

14 Palliative Care Services Palliative care should be offered to all patients, particularly to those exhibiting symptoms or quality-of-life (QOL) decrements, regardless of treatment type Benefit: Harm: Evidence strength: Recommendation strength: Moderate None Moderate Strong

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16 2015 CUA-CUOG Guideline Management of CRPC What is Castration-Resistant Prostate Cancer? disease progression despite castrate levels of testosterone and may present as either a continuous rise in serum PSA levels, progression of pre-existing disease, and/or the appearance of new metastases What does it encompass? from pts without metastases or symptoms with rising PSA despite ADT to pts with metastases and significant debilitation due to cancer symptoms

17 2015 CUA-CUOG Guideline Asymptomatic or minimally symptomatic: pain that is relieved by acetaminophen or a non-steroidal anti-inflammatory Symptomatic: require regular pain medication opioid/narcotics)* treatment

18 2015 CUA-CUOG Guideline NON-MET CRPC There is no standard of care and no approved regimen in M0 CRPC Detection of mets Pts with PSADT < 8 mos: image every 3-6 mos Pts with PSADT > 12 mos: image every 6-12 mos Imaging Commonly with bone scans, abdominal/pelvic CT and chest X-ray MRI and PET still unclear

19 2015 CUA-CUOG Guideline MET CRPC (asymptomatic or minimally symptomatic) Anti-androgen (AA) should be discontinued Introduction of, or changes to, 1st generation AA or use of Corticosteroids with or without Ketoconazole may be considered Abiraterone acetate 1000 mg/day plus Prednisone 5 mg/twice daily is recommended as first-line therapy (Level 1, Grade A). Enzalutamide 160 mg/day is recommended as first-line therapy (Level 1, Grade A). Treatment with Docetaxel 75 mg/m2 every 3 weeks plus 5 mg oral Prednisone twice daily can be offered (Level 1, Grade A).

20 2015 CUA-CUOG Guideline Met CRPC (with symptoms) Treatment with Docetaxel 75 mg/m2 every 3 weeks plus 5 mg oral Prednisone twice daily is recommended (Level 1, Grade A). Radium-223 every 4 weeks for 6 cycles is recommended in patients with pain due to bone metastases and who do not have visceral metastases (Level 1, Grade A). Abiraterone acetate 1000 mg/day plus Prednisone 5 mg twice daily or Enzalutamide 160 mg/day may be considered as first-line therapy in patients who cannot receive or refused Docetaxel (Expert opinion).

21 2015 CUA-CUOG Guideline Met CRPC (who progress after Docetaxel-based chemo) Options with survival benefit Cabazitaxel (25 mg/m 2 ) plus Prednisone (5 mg/day) (Level 1, Grade A) Abiraterone acetate (1000 mg per day) plus Prednisone (5 mg twice daily) (Level 1, Grade A) Enzalutamide (160 mg/day) (Level 1, Grade A) Radium-223 q 4 weeks for 6 cycles (Level 1 Grade A) Options with unknown survival benefit Docetaxel plus Prednisone re-exposure in patients who have had a previous favorable response to Docetaxel may be reasonable (Expert Opinion). Mitoxantrone plus Prednisone may be offered for palliative pain relief (Grade C).

22 2015 CUA-CUOG Guideline CRPC with Bone mets (includes pre/post chemo settings) Denosumab (120 mg subcutaneous) or Zoledronic acid (4 mg intravenous) every 4 weeks, along with daily calcium and vitamin D supplementation, is recommended to prevent disease-related skeletal complications (Level 1, Grade A). Treatment with Zoledronic acid should not be used in men with baseline creatinine clearance <30 ml/min. Optimal duration of Zoledronic acid and Denosumab in men with CRPC and bone metastases is undefined. The risk of ONJ appears to be related to time on bone-targeted therapy; therefore caution should be taken in using these agents more than 2 years.

23 Prostate Cancer: HSPC

24 Question Which of the following non-crpc prostate cancer patients are candidates for Docetaxel therapy? a) 68 year old man with localized, Gl 9 prostate cancer and PSA of 34 being treated with IMRT and ADT b) 71 year old man with newly diagnosed metastatic prostate cancer with 2 bone metastases on bone scan c) 63 year old man with newly diagnosed metastatic prostate cancer with liver metastases d) All of the above e) 2 and 3 f) 3 only

25 ECOG 3805 (CHAARTED): Chemo-Hormonal vs Androgen Ablation Randomized Trial in Extensive Disease 3-year OS: 69.0% vs. 52.5% 3-year OS in pts with a high extent of metastatic disease: 63.4% vs. 43.9% Patients with a high extent of metastatic disease accounted for most of the benefit in the OS from Docetaxel plus ADT NEJM August ;(8):

26 Primary Endpoint: Overall Survival A All Patients 100 Hazard ratio for death with ADT+docetaxel, 0.61 (95% CI, ) P<0.001 Patients Surviving (%) ADT+docetaxel (median overall survival, 57.6 mo) ADT alone (median overall survival, 44.0 mo) No. at Risk ADT+docetaxel ADT alone Months

27 OS by Extent of Metastatic Disease at Start of ADT High Volume 100 Hazard ratio for death with ADT+docetaxel, 0.60 (95% CI, ) P<0.001 Low Volume Patients with Low-Volume Disease 100 ADT+docetaxel (median overall survival, NR) Patients Surviving (%) ADT+docetaxel (median overall survival, 49.2 mo) ADT alone (median overall survival, 32.2 mo) Patients Surviving (%) ADT alone (median overall survival, NR) Hazard ratio for death with ADT+docetaxel, 0.60 (95% CI, ) P=0.11 No. at Risk ADT+docetaxel ADT alone Months No. at Risk ADT+docetaxel ADT alone Months In patients with high volume metastatic disease, there is a 17 month improvement in median overall survival from 32.2 months to 49.2 months. We projected 33 months alone in the ADT alone arm with collaborations of SWOG9346 team. Presented By Christopher Sweeney at 2014 ASCO Annual Meeting

28 High Volume Disease 4 bone lesions and 1 lesion in any bony structure beyond the spine/pelvis OR Visceral disease

29 GETUG-AFU 15 TRIAL DESIGN Stratification : - Prior systemic TT - Glass risk group R A N D O M I Z A T I O N Arm A Arm B ADT + Docetaxel D: 75 mg/m 2 q3 up to 9 cycles ADT alone ADT: - LHRH agonist - or maximum androgen blockade - or orchiectomy Lancet Oncology February (2);149-58

30 OVERALL SURVIVAL Median follow-up 81.3 months [ ] Low Volume High Volume Median OS ADT alone: 35.1 [ ] ADT + D: 39 [ ] HR: 0.8 [ ] p=0.35 Median OS ADT alone: NR [61.8- NR] ADT + D: 83.1 [ NR] HR: 1.0 [ ] p=0.87

31 Comparison of GETUG 15 & ECOG 3805 GETUG ECOG Total Sample Size High Volume dz 183 (47.5%) 514 (65%) Median F/U 83 months 29 months Received Post-Protocol Docetaxel Received Post-Protocol Abi or Enz ADT only Arm: 80% ADT-Doce Arm: 45% ADT only Arm: NR ADT-Doce Arm: NR ADT only Arm: 33% ADT-Doce Arm: 12% ADT only Arm: 20% ADT-Doce Arm: 33% Presented by Eric J. Small, MD Genitourinary Cancers Symposium

32 CONCLUSIONS (GETUG) PFS improved by Docetaxel in mhspc (GETUG 15 and CHAARTED) Overall survival after a median follow-up of 82.9 months: No improvement in low volume mhspc (GETUG 15/ CHAARTED) Discrepancy in OS results for high-volume mhspc Explaining the OS discrepancy: Salvage Docetaxel more frequent in GETUG-15 (80%)??? GETUG 15 underpowered in high volume mhspc? Other trials to come soon (Stampede)

33 Docetaxel and/or Zoledronic acid for hormonenaïve prostate cancer: First overall survival results from STAMPEDE (NCT ) STAMPEDE: RCT using novel multi-arm, multi-stage design for men with high-risk locally advanced or metastatic PCa starting on ADT 3 comparisons reported: Standard of care (SOC) (ADT for 3+ years), Docetaxel (75mg/m2 plus Pred), Zoledronic acid (ZA) (4mg) Primary outcome: Survival 2:1:1:1 to SOC:D:Z:D+Z with N=2,962

34 Presented By Nicholas James at 2015 ASCO Annual Meeting

35 Inclusion Criteria Newly Diagnosed: Any of: Metastatic Node-positive 2 of: Stage T3/4 PSA 40 ng/ml Gleason 8-10 All Patients: Fit for all protocol treatment Fit for follow-up WHO performance status 0-2 Written informed consent Relapsing after previous RP or RT with 1 of: PSA 4 ng/ml & rising with doubling time <6 m PSA 20 ng/ml Node positive Metastatic Full Criteria: Presented By Nicholas James at 2015 ASCO Annual Meeting

36 Outcome Measures Primary Outcome Measure: Overall Survival Secondary Outcome Measures: Failure-free survival Toxicity Quality of Life Skeletal related events Cost effectiveness FFS Definition: First line of: PSA failure Local failure Lymph node failure Distant metastases Prostate cancer death PSA Failure Definition: PSA failure 50% 24 week nadir + 50% and >4 ng/ml PSA fall of 50% Failure at t=0 Presented By Nicholas James at 2015 ASCO Annual Meeting

37 STAMPEDE: All Docetaxel & Zoldronic Acid Comparisons Presented By Nicholas James at 2015 ASCO Annual Meeting

38 Patient Characteristics 1% WHO PS 2 [s] 21% WHO PS 1 [s] 65 yr Median Age (min 40, max 84) 61% Metastatic (85% bony mets) 15% N+M0 24% N0M0 [s] [s] 98% LNRH analogues [s] 29% Planned for RT (72% of N0M0 pts) 6% Previous local therapy Balanced by arm [s] Stratification factors + hospital + NSAID/aspirin [s] Presented By Nicholas James at 2015 ASCO Annual Meeting

39 Presented By Nicholas James at 2015 ASCO Annual Meeting Docetaxel: Failure-Free Survival

40 Presented By Nicholas James at 2015 ASCO Annual Meeting Docetaxel: Survival

41 Zoledronic Acid + Docetaxel: Failure-Free Survival Presented By Nicholas James at 2015 ASCO Annual Meeting

42 Zoledronic Acid + Docetaxel: Survival Presented By Nicholas James at 2015 ASCO Annual Meeting

43 Treatment Effect by Metastatic Status: FFS Pre-Planned Analysis Presented By Nicholas James at 2015 ASCO Annual Meeting

44 Treatment Effect by Metastatic Status: Overall Survival Pre-Planned Analysis Presented By Nicholas James at 2015 ASCO Annual Meeting

45 Presented By Nicholas James at 2015 ASCO Annual Meeting Docetaxel: Survival M1 Patients

46 Grade 3+ Adverse Events Ever Reported Presented By Nicholas James at 2015 ASCO Annual Meeting

47 Presented By Nicholas James at 2015 ASCO Annual Meeting Use of Life-Prolonging Therapy for Progression

48 Conclusions Docetaxel improves survival for hormone-naïve prostate cancer Zoledronic Acid does not improve survival Adding both improves survival but offers no obvious benefit over adding just Docetaxel Multi-arm, multi-stage trials are practicable and efficient Docetaxel should be: Considered for routine practice in suitable men with newlydiagnosed metastatic disease Considered for selected men with high-risk non-metastatic disease in view of substantial prolongation of failure-free survival Presented By Nicholas James at 2015 ASCO Annual Meeting

49 How Similar are the Men Participating in these Studies? Median Age % Mets at Presentation % High Risk GETUG 64 71% 52% CHAARTED 63 75% 65% STAMPEDE 65 Most of them Unknown * High volume disease was defined as visceral metastases and/or 4 bone metastases with at least one metastasis beyond the pelvis or vertebral column These trials DO NOT represent men with slowly progressive disease who develop metastases several years after diagnosis (+/- local treatment)

50 Forest Plot of Overall Survival for the 3 Studies (Thanks to Dr. Eitan Amir) Presented By Ian Tannock at 2015 ASCO Annual Meeting

51 Recommendation #1 Men with high-risk metastatic prostate cancer, especially those presenting with metastases at or soon after diagnosis, who are judged fit to receive chemotherapy, should be offered 6 cycles of Docetaxel in addition to ADT Presented By Ian Tannock at 2015 ASCO Annual Meeting

52 Role of Chemotherapy for Localized High- Risk PC (M0) After Radiation Therapy

53 Role of chemotherapy for localized high-risk PC (M0) after radiation therapy GETUG-12 (Fizazi et al; Lancet Oncol, 2015) ADT +/- 4 cycles Docetaxel/Estramustine (N=413) RFS: 199 events: HR=0.71 ( ) OS: 91 deaths: too early STAMPEDE (Not all M0 men had RT) ADT +/- 6 cycles Docetaxel/Prednisone (N=689) RFS: 229 events; HR=0.57 ( ) OS: 93 deaths; HR=1.01 but too early

54 Presented By Howard Sandler at 2015 ASCO Annual Meeting

55 Top Accruing Sites Cross Cancer Institute 32 Tom Baker Cancer Centre 32 London Regional Cancer Program 20 McGill University 19 Ottawa Hospital Regional Cancer Centre 17 Peter MacCallum Cancer Centre 15 UT-Southwestern 15 (Others with 10 or more: Fox Chase, Christiana CCOP, Northeast RO Center, Umich, Wash U) Presented By Howard Sandler at 2015 ASCO Annual Meeting

56 RTOG 0521 Stage Gleason Score PSA Any T Stage 9 < T2 8 < R a n d o m i z e ARM 1 Androgen Suppression (24 months) + External RT (8 weeks) ARM 2 Androgen Suppression (24 months) + External RT (8 weeks) + Docetaxel beginning 4 weeks after RT (6 cycles) Presented By Howard Sandler at 2015 ASCO Annual Meeting

57 Characteristic Arm 1 and Arm 2 (N = 563) Risk Category (stratification) (%) Gleason 9, PSA 150, Any T-stage 53 Gleason 8, PSA <20, T2 21 Gleason 8, PSA , Any T-stage 10 Gleason 7, PSA , Any T-stage 16 Gleason Score, no. (%) Serum PSA, ng/ml, Median (Q1-Q3) 15 (7-34) Age, Median 66 ct3-t4 27% pn0 33% Presented By Howard Sandler at 2015 ASCO Annual Meeting

58 Conclusions For the first time, improvement in overall survival observed with (tolerable) adjuvant chemotherapy for localized, highrisk, hormone-sensitive prostate cancer Cumulative incidence of DM reduced The potential role of Docetaxel in hormone-sensitive prostate cancer is consistent with and supported by our data and other studies, such as STAMPEDED and CHAARTED. This analysis is relatively early and additional follow-up will likely be enlightening. Presented By Howard Sandler at 2015 ASCO Annual Meeting

59 Role of chemotherapy for localized high-risk PC (M0) after radiation therapy GETUG-12 (Fizazi et al; Lancet Oncol, 2015) ADT +/- 4 cycles Docetaxel/Estramustine (N=413) RFS: 199 events: HR=0.71 ( ) OS: 91 deaths: too early STAMPEDE (Not all M0 men had RT) ADT +/- 6 cycles Docetaxel/Prednisone (N=689) RFS: 229 events; HR=0.57 ( ) OS: 93 deaths; HR=1.01 but too early RTOG 0521 ADT +/- 6 cycles Docetaxel/Prednisone (N=563) RFS: 221 events: HR=0.76 ( ) OS: 102 deaths: HR=0.70 ( )

60 Recommendation #2 Men with localized M0 prostate cancer who are able to receive local treatment with radiotherapy should not be offered Docetaxel in addition to ADT This opinion might change with longer follow-up of the GETUG-12, STAMPEDE, and RTOG 0521 trials Presented By Ian Tannock at 2015 ASCO Annual Meeting

61 Question The following non-crpc prostate cancer patients are candidates for Docetaxel therapy: 68 year old man with localized, Gl 9 prostate cancer and PSA of 34 being treated with IMRT and ADT RTOG 0521: not yet but depends on how early an adopter you are, or the patient in front of you. 71 year old man with newly diagnosed metastatic prostate cancer with 2 bone mets on BS CHAARTED/GETUG suggests YES. STAMPEDE strengthens that. 63 year old man with newly diagnosed metastatic prostate cancer with liver mets CHAARTED and STAMPEDE say YES. All of the above MAYBE see above. 2 and 3 YES as of this ASCO. 3 only DEFINITELY, but from STAMPEDE, can be less advanced than this and still benefit.

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