1766MO - Health-related quality of life (HRQoL) in nonmetastatic hormone-sensitive prostate cancer (nmHSPC) patients (pts) with high-risk biochemical recurrence (BCR) from the EMBARK study

Background

Enzalutamide (ENZ) + leuprolide acetate (L) and ENZ alone delayed metastasis-free survival (MFS) vs placebo (P) + L in high-risk BCR nmHSPC in the phase 3 EMBARK (NCT02319837) trial. Pt-reported outcomes (PROs) provide a pt perspective on disease/treatment (Tx) experience not captured by clinical assessment.

Methods

nmHSPC pts with high-risk BCR (prostate-specific antigen [PSA] doubling time ≤9 months, screening PSA ≥2 ng/mL above nadir post radiotherapy or ≥1 ng/mL post radical prostatectomy) were randomized (1:1:1) to ENZ + L, ENZ alone, and P + L. PROs were assessed at baseline (BL) and every 12 weeks until development of metastasis or death. The main objectives were to assess Tx effects in time to first and confirmed (at next visit) clinically meaningful deterioration (TTFD/TTFCD) as measured with the Brief Pain Inventory Short Form (BPI-SF) worst pain and Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score using predefined thresholds. Other objectives were: Tx effects in TTFD and TTFCD measured by the European Organisation for Research and Tx of Cancer QoL Questionnaire-Prostate 25 (QLQ-PR25) and European QoL 5-Dimensions 5-Levels (EQ-5D-5L) visual analogue scale (VAS). Comparisons were made for ENZ + L vs P + L and ENZ alone vs P + L. Intent-to-treat population was analysed.

Results

At BL, 327–332 pts per group completed the PRO questionnaire; completion rates were 85–95%. No significant differences in TTFD or TTFCD were seen among Tx groups vs P + L in FACT-P total score, BPI-SF worst pain, or EQ-5D-5L VAS. In QLQ-PR25, TTFCD for sexual activity was significantly longer with ENZ alone vs P + L; TTFCD for hormone Tx-related symptoms was significantly shorter with ENZ + L vs P + L (Table). Table: 1766MO

∗p<0.05

Conclusions

ENZ + L or ENZ alone improved MFS without negatively impacting global HRQoL or clinical pain progression, vs P + L in nmHSPC pts. Sexual activity may be better preserved with ENZ alone vs P + L.

Clinical trial identification

NCT02319837.

Editorial acknowledgement

Medical writing and editorial assistance were provided by Vibha Dhamija (MSc), Olga Klibanov (PharmD), and Rucha Kurtkoti (MS) from IQVIA, funded by the study sponsors.

Legal entity responsible for the study

Astellas Pharma Inc. and Pfizer Inc.

Funding

This study was funded by Astellas Pharma Inc. and Pfizer Inc., the co-developers of enzalutamide.

Disclosure

S.J. Freedland: Financial Interests, Personal, Speaker, Consultant, Advisor, Paid for study and received compensation for consulting: Astellas Pharma; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Bayer, Pfizer, Janssen, Merck, Sanofi, Myovant; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Sanofi; Other, Personal, Steering Committee Member: Astellas Pharma, Pfizer, Janssen. U.F.F. De Giorgi: Financial Interests, Personal, Advisory Board: Pfizer, BMS, MSD, PharmaMar, Astellas, Bayer, Ipsen, Novartis, Eisai, Janssen; Financial Interests, Personal, Invited Speaker: Roche, BMS, Clovis Oncology, AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca, Sanofi, Roche. A. Rannikko: Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen, Orion; Financial Interests, Personal, Membership or affiliation: Ida Montin Foundation, Orion Research Foundation; Financial Interests, Institutional, Research Grant: HUS Helsinki University Hospital, Cancer Foundation Finland, Academy of Finland, Jane and Aatos ErikkoFoundation, Finland. C. Pieczonka: Other, Institutional, Funding: Pfizer; Financial Interests, Personal, Speaker, Consultant, Advisor: Cellvax, Myovant, Dendreon, Bayer, Janssen, Pfizer, Blue Earth, Eli Lilly, Daiichi Sankyo, Merck, AstraZeneca, Sun; Other, Personal, Advisory Board: Myovant, Bayer, Janssen, Astellas, Pfizer, Sun, Merck, AstraZeneca, Dendreon; Other, Personal and Institutional, Writing Engagement: Pfizer, Astellas. R. Tutrone: Other, Institutional, Funding: Astellas, Pfizer, Merck, Biotechne, Lilly, Point Biopharma, Bayer, Novartis; Financial Interests, Personal, Speaker, Consultant, Advisor: Nymox Corp, Biotechne; Other, Personal and Institutional, Speaker’s Bureau: Myovant, Astellas, Pfizer; Financial Interests, Personal, Stocks/Shares: Nymox, Novartis. B. Venugopal: Other, Personal and Institutional, Writing Engagement: Pfizer; Other, Institutional, Sponsor/Funding: Exelixis, Ipsen, Pfizer, Merck, Tavanta; Financial Interests, Personal, Speaker, Consultant, Advisor: Eisai; Other, Personal, Financially compensated role: BMS, Eisai, EUSA pharma, Ipsen, Merck; Other, Personal, Advisory Board: Eisai. H. Woo: Other, Personal and Institutional, Stocks/Shares, Data analytics company. Remuneration by way of share options: Prospection Pty Ltd; Other, Personal, Speaker, Consultant, Advisor, Presentation honoraria: Bayer, Astellas, Cipla, Janssen; Other, Personal, Other, Proctoring honoraria: Boston Scientific Corporation; Other, Personal, Advisory Board, Honoraria: Astellas; Other, Personal, Non remunerated activity, Board Director - unpaid: Royal Australasian College of Surgeons, Urological Society of Australia and New Zealand, Australian and New Zealand Urogential and Prostate Cancer Trials Group, Australasian Urological Foundation. M. Ramirez Backhaus: Other, Personal, Speaker, Consultant, Advisor, Consulting fees; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events; payment for expert testimony; support for attending meeting and travel: Janssen; Other, Personal, Speaker, Consultant, Advisor, Consulting fees; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Bayer; Other, Personal, Speaker, Consultant, Advisor, Consulting fees; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events; support for attending meeting, travel: Astellas. S. Supiot: Other, Institutional, Funding: Astellas; Other, Institutional, Research Grant: AstraZeneca, Janssen, Novartis AAA, Bayer, Reflexion Medical, Boston Scientifics; Financial Interests, Personal, Speaker, Consultant, Advisor: Astellas, AstraZeneca, Janssen, Ipsen, Takeda, Ferring, Novartis AAA, Bayer, MSD; Other, Personal, Financially compensated role: Astellas, AstraZeneca, Janssen, Ipsen, Takeda, Ferring, Novartis AAA, Bayer, MSD; Other, Personal, Advisory Board: Astellas, Janssen, Ipsen, Novartis AAA, Bayer; Other, Personal, Other, Support for attending meetings and/or travel: Reflexion Medical, Boston Scientifics, Astellas, AstraZeneca, Janssen, Ipsen, Takeda, Ferring, Novartis AAA, Bayer, MSD, Reflexion Medical, Boston Scientifics. A. Lantz: Other, Institutional, Research Grant: Prostate Cancer Foundation Sweden, AhrénsFoundation, Åke WibergsFoundation. A. Ganguli: Other, Personal and Institutional, Full or part-time Employment: Astellas; Other, Personal, Stocks/Shares: AbbVie. J. Ivanova: Other, Personal, Stocks/Shares: Pfizer; Other, Personal and Institutional, Full or part-time Employment: Pfizer. P. Kral: Other, Personal and Institutional, Speaker, Consultant, Advisor: Astellas. F. Saad: Financial Interests, Personal, Advisory Board: Astellas, Bayer, BMS, Janssen, Sanofi, Pfizer, Myovant, Novartis, AstraZeneca, Merck, Myovant; Financial Interests, Institutional, Local PI: Novartis, Astellas, Bayer, Janssen, Sanofi, BMS, Amgen, Pfizer, Merck; Financial Interests, Institutional, Coordinating PI: AstraZeneca. N.D. Shore: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boston Scientific, Clovis Oncology, Cold Genesys, Dendreon, Exact Imaging, Exact Sciences, FerGene, Genesis Care Us, Invitae, Janssen, MDxhealth, Merck, Myovant, Myriad, Nymox, Pacific Edge, Pfizer, Propella, PreView, Sanofi Genzyme, Speciality Networks, Sesen Bio, Tolmar, Urogen, Clarity, Lantheus, Lilly, Photocure, Telix, Photocure, Vaxiion, Asieris, Alessa Therapeutics, Akido, Arquer, Fize medical, GConcology, Genentech, Guardant, Ferring, Foundation Medicine, Immunitybio, Incyte, Minomic, NGM, Nonagen, Novartis, PlatformQ, Profound, Promaxo, Protara, Vessi; Financial Interests, Personal, Member of Board of Directors: Photocure. All other authors have declared no conflicts of interest.