Francesco Massari Oncologia Medica Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi

Size: px

Start display at page:

Download "Francesco Massari Oncologia Medica Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi"

Roberta Harrington
6 years ago
Views:

Azienda Ospedaliero Universitaria di Bologna Policlinico S.

1 Prostata: Oral Communications Emerging strategies and controversial topics in advanced prostate cancer Francesco Massari Oncologia Medica Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi UPDATES and NEWS from the Genitourinary Cancers Symposium - Milano,

2 Disclosures No pertinent C.O.I. with this presentation Advisory Boards/Honoraria/Consultant for: Astellas BMS Janssen Ipsen Pfizer Roche

Advanced Prostate Cancer: Oral Presentations PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant

3 Advanced Prostate Cancer: Oral Presentations PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC). Abs #3 SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmcrpc). Abs #161 Addition of docetaxel to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Long-term survival, quality-adjusted survival, and costeffectiveness analysis. Abs #162 A phase 2 study of olaparib and durvalumab in metastatic castrate-resistant prostate cancer (mcrpc) in an unselected population. Abs #163

4 Advanced Prostate Cancer: Oral Presentations PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC). Abs #3 SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmcrpc). Abs #161 Addition of docetaxel to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Long-term survival, quality-adjusted survival, and costeffectiveness analysis. Abs #162 A phase 2 study of olaparib and durvalumab in metastatic castrate-resistant prostate cancer (mcrpc) in an unselected population. Abs #163

5 Abstract #3 - PROSPER Hussain M et al Genitourinary Cancers Symposium

PROSPER: Study Design Primary endpoint MFS: defined as time from randomization to radiographic progression or death within 112 days of treatment discontinuation

6 PROSPER: Study Design Primary endpoint MFS: defined as time from randomization to radiographic progression or death within 112 days of treatment discontinuation Secondary endpoint Safety, Time to PSA progression, Time to use new antineoplastic therapy, OS, PSA Response, Quality of Life Hussain M et al Genitourinary Cancers Symposium

7 PROSPER: Baseline Patient Characteristics Median duration of therapy was 18.4 months for Enzalutamide and 11.1 months for placebo Hussain M et al Genitourinary Cancers Symposium

8 PROSPER: Adverse Events of Special Interest Baseline history of cardiovascular disease, hypertension, diabetes mellitus, hyperlipidemia or age > 75 years Hussain M et al Genitourinary Cancers Symposium

9 PROSPER: Progression Event by Type Hussain M et al Genitourinary Cancers Symposium

10 PROSPER: Primary Endpoint MFS Hussain M et al Genitourinary Cancers Symposium

11 PROSPER: Secondary Endpoint Hussain M et al Genitourinary Cancers Symposium

12 Conclusions In men with M0 CRPC and rapid PSA doubling time (median 3.7 months), enzalutamide resulted in a clinically meaningful and statistically significant 71% reduction in the relative risk of developing M1 CRPC Median MFS was 36.6 months with Enzalutamide vs months with placebo (HR 0.29; p<0.0001) Hussain M et al Genitourinary Cancers Symposium

13 Advanced Prostate Cancer: Oral Presentations PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC). Abs #3 SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmcrpc). Abs #161 Addition of docetaxel to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Long-term survival, quality-adjusted survival, and costeffectiveness analysis. Abs #162 A phase 2 study of olaparib and durvalumab in metastatic castrate-resistant prostate cancer (mcrpc) in an unselected population. Abs #163

14 Abstract #161 - SPARTAN Small EJ et al Genitourinary Cancers Symposium

15 SPARTAN Study Smith MR et al., NEJM 2018

16 SPARTAN: Study Design Primary endpoint MFS Secondary endpoint Time to Metastasis, PFS, Time to symptomatic progression, OS, Time to cytotoxic chemotherpy Small EJ et al Genitourinary Cancers Symposium

17 SPARTAN: Patient Characteristics Small EJ et al Genitourinary Cancers Symposium

18 SPARTAN: Primary Endpoint MFS 72% risk reduction of distant progression or death Small EJ et al Genitourinary Cancers Symposium

19 SPARTAN: Secondary Endpoint Smith MR et al., NEJM 2018

20 SPARTAN: Adverse Events Smith MR et al., NEJM 2018

21 SPARTAN: Quality of Life..but in an asymptomatic population, are these instruments enough sensitive to capture the psychological benefit of the decline in PSA? Small EJ et al Genitourinary Cancers Symposium

22 Conclusions Among men with non metastatic castrationresistant prostate cancer, metastasis free survival and time to symptomatic progression were significantly longer with apalutamide than with placebo. Small EJ et al Genitourinary Cancers Symposium

23 What is the impetus for wanting to treat patients with M0 CRPC? The patient perspective Fear of the rising PSA and not doing anything about it The clinician perspective..i know they have metastases anyway.. Treating early might delay symptoms and might delay use of chemotherapy Treatment earlier might prolong survival (in mhspc CHAARTED STAMPEDE LATITUDE) But.. Treating asymptomatic patients carries a certain burden of proof wherein benefit must clearly outweigh risk

24 What constitutes clinical benefit? Curing men Prolonging survival duration Improving quality of lie Delaying or preventing SREs has been an approvable endpoint

25 SPARTAN and PROSPER How sure are we that we have made progress?

Francesco Massari Oncologia Medica Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi

Focus sulla malattia metastatica ormonosensibile (mhspc) ADT e Chemioterapia: quando e a chi? Francesco Massari Oncologia Medica Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi