Health-related quality-of-life (HRQoL) analysis from a randomized phase II trial of androgen signaling inhibitors with or without androgen deprivation therapy (ADT) for castration-sensitive prostate cancer: LACOG 0415.

Authors

null

Andrey Soares

Hospital Israelita Albert Einstein and Centro Paulista de Oncologia-Oncoclínicas, São Paulo, Brazil

Andrey Soares , Diogo Assed Bastos , Fabio A. B. Schutz , Eduardo Cronemberger , Murilo Luz , Suelen P. S. Martins , David Queiroz Borges Muniz , Flavio Mavignier Carcano , Oren Smaletz , Fábio A Peixoto , Andrea Juliana Gomes , Felipe Melo Cruz , Fabio Andre Franke , Daniel Herchenhorn , Rosemarie Gidekel , Taiane Francieli Rebelatto , Rafaela Gomes , Vinicius Carrera Souza , Andre P. Fay , Fernando C. Maluf

Organizations

Hospital Israelita Albert Einstein and Centro Paulista de Oncologia-Oncoclínicas, São Paulo, Brazil, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil, Beneficência Portuguesa de São Paulo, São Paulo, Brazil, Centro Regional Integrado de Oncologia, Fortaleza, Brazil, Hospital Erasto Gaertner, Curitiba, PR, Brazil, CEPHO-Centro de Pesquisa Clínica em Hematologia e Oncologia, Santo André, Brazil, Instituto do Câncer do Estado de São Paulo (ICESP), São Paulo, Brazil, Hospital de Câncer de Barretos, Barretos, Brazil, Hospital Israelita Albert Einstein, São Paulo, Brazil, Instituto COI de Educação Pesquisa e Gestão em Saúde, Rio De Janeiro, Brazil, Liga Norte Riograndense Contra O Câncer, Natal, Brazil, Instituto Brasileiro de Controle do Câncer, São Paulo, Brazil, Oncosite Centro de Pesquisa Clínica de Ijuí, Ijuí, Brazil, Oncologia D'OR/Instituto D'OR de Ensino e Pesquisa, Rio De Janeiro, Brazil, Janssen Latin America, Buenos Aires, Argentina, Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil, Oncologia D`Or, Salvador, Brazil, PUCRS School of Medicine, and Grupo Oncoclínicas, Porto Alegre, Brazil

Research Funding

Pharmaceutical/Biotech Company
Janssen Cilag

Background: LACOG0415 is a 3-arm randomized trial evaluating ADT with abiraterone acetate plus prednisone (ADT+AAP), apalutamide alone (APA) or apalutamide with AAP (APA+AAP) for patients with locally-advanced, high-risk biochemical recurrence or metastatic castration-sensitive prostate cancer (ASCO 2020). In this trial, ADT+AAP and APA+AAP achieved the primary endpoint of percentage of patients with PSA ≤ 0.2 ng/mL at week 25. Apalutamide alone showed a high PSA decline > 50% rate, but did not achieve the pre-specified PSA threshold. Here we report patient-reported outcome data using Functional Assessment of Cancer Therapy-Prostate (FACT-P). Methods: HRQoL was measured in the overall population using the FACT-P questionnaire, comprising 5 subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SFWB), and prostate cancer subscale (PCS). Scores for each patient were measured at baseline and every four weeks until week 25. Questionnaire completion was defined as ≥ 1 question answered at an assessment time point. Analysis of HRQoL change from baseline and deterioration included only patients with baseline and ≥ 1 postbaseline score. Differences greater than 10-points in FACT-P total score and differences greater than 3-points in PWB, FWB, EWB, SFWB, and PCS scores were considered clinically significant. The time-to-event endpoint was estimated by Kaplan-Meier method and compared by stratified log-rank test. Results: 128 patients were included in LACOG0415 trial and 122 of them completed the HRQoL assessments (ranging from 95.3% at baseline to 79.7% at week 25). FACT-P and all subscales scores were similar for all three arms at baseline. There were no meaningful differences in FACT-P scores at baseline and at week 25 between the 3 arms. The subscales scores also showed no statistically differences at baseline and at week 25. Time to FACT-P deterioration did not show any statistically difference between three arms (P=0.3371). Conclusions: ADT free alternatives with APA alone or APA+AAP did not show meaningful differences in HRQoL in patients with advanced castration-sensitive prostate cancer compared to ADT+AAP. The short follow-up period limited the ability to explore differences in HRQoL after 25 weeks. Larger studies with longer follow-up are needed to further evaluate HRQoL with ADT-free strategies. Clinical trial information: NCT02867020

Health-related quality of life (HRQoL).

Difference between HRQoL baseline scores and HRQoL at week 25 scores, mean change from baselineADT+AAPAPA aloneAAP+APA
Physical well-being0.620.46-0.60
Functional well-being-0.070.231.16
Emotional well-being1.011.991.46
Social well-being-1.16-0.92-0.07
Prostate cancer subscale1.610.761.47
FACT-G0.411.732.00
FACT-P1.733.004.62

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2021 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session: Prostate Cancer - Advanced Disease

Track

Prostate Cancer - Advanced

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Clinical Trial Registration Number

NCT02867020

Citation

J Clin Oncol 39, 2021 (suppl 6; abstr 64)

DOI

10.1200/JCO.2021.39.6_suppl.64

Abstract #

64

Poster Bd #

Online Only

Abstract Disclosures