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Mini oral session - Genitourinary tumours, prostate

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

Date

22 Oct 2023

Session

Mini oral session - Genitourinary tumours, prostate

Topics

Tumour Site

Prostate Cancer

Presenters

Stephen Freedland

Citation

Annals of Oncology (2023) 34 (suppl_2): S954-S1000. 10.1016/S0923-7534(23)01946-4

Authors

S.J. Freedland1, M.E. Gleave2, U.F.F. De Giorgi3, A. Rannikko4, C. Pieczonka5, R. Tutrone6, B. Venugopal7, H. Woo8, M. Ramirez Backhaus9, S. Supiot10, A. Lantz11, A. Ganguli12, J. Ivanova13, P. Kral14, S. Huang15, F. Saad16, N.D. Shore17

Author affiliations

  • 1 Department Of Urology, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, 90048 - Los Angeles/US
  • 2 Vancouver Prostate Centre, University of British Columbia Faculty of Medicine, V6T 1Z3 - Vancouver/CA
  • 3 Department Of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014 - Meldola/IT
  • 4 Department Of Urology, Helsingin yliopistollinen keskussairaala, Helsinki/FI
  • 5 Associated Medical Professionals Of Ny, PLLC, Syracuse/US
  • 6 Clinical Research, Chesapeake Urology Research Associates, 21204 - Towson/US
  • 7 Medical Oncology Department, BWSCC - Beatson West of Scotland Cancer Centre - NHS Greater Glasgow and Clyde, G12 0YN - Glasgow/GB
  • 8 Australian Clinical Trials Pty Ltd, Australian National University, Canberra/AU
  • 9 Servicio De Urología, Instituto Valenciano de Oncologia IVO, Valencia/ES
  • 10 Ico, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 11 Department Of Urology, Karolinska University Hospital, 171 64 - Solna/SE
  • 12 Global (global Heor), Astellas Pharma USA, 60062 - Northbrook/US
  • 13 Global Value And Evidence, Pfizer, 10017 - New York/US
  • 14 Patient Centered Solutions, IQVIA, 831 04 - Bratislava/SK
  • 15 Department Of Urology, Kaohsiung Medical University Hospital, 80756 - Kaohsiung City/TW
  • 16 Division Of Urology, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, H2X 3J4 - Montreal/CA
  • 17 Uro-oncology Department, Carolina Urologic Research Center/GenesisCare US, 29572 - Myrtle Beach/US

Resources

This content is available to ESMO members and event participants.

Abstract 1766MO

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

PRO Months, median HR (95% CI)
ENZ + L ENZ P + L ENZ + L vs P + L ENZ vs P + L
BPI-SF
Worst pain
TTFD 13.9 16.6 19.4 1.08 (0.89–1.30) 1.09 (0.90–1.31)
TTFCD 80.0 60.9 66.3 0.82 (0.65–1.04) 1.02 (0.82–1.28)
FACT-P
FACT-P total score
TTFD 8.3 8.4 11.1 1.14 (0.95–1.36) 1.17 (0.98–1.39)
TTFCD 38.8 30.6 36.5 1.04 (0.85–1.28) 1.16 (0.95–1.41)
QLQ-PR25
Sexual activity
TTFD 2.9 2.9 2.9 1.12 (0.93–1.35) 0.92 (0.76–1.11)
TTFCD 3.0 5.6 3.0 1.09 (0.89–1.32) 0.76* (0.62–0.94)
Hormonal Tx
TTFD 2.8 2.9 2.8 1.09 (0.93–1.28) 0.95 (0.81–1.12)
TTFCD 2.9 3.0 2.9 1.19* (1.01–1.40) 1.06 (0.90–1.25)
EQ-5D-5L
VAS
TTFD 8.3 8.4 11.1 1.09 (0.91–1.30) 1.15 (0.97–1.38)
TTFCD 44.6 38.9 52.4 1.02 (0.82–1.26) 1.16 (0.94–1.43)

∗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.

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