Correlation analyses of radiographic progression-free survival with clinical and health-related quality of life outcomes in metastatic castration-resistant prostate cancer: Analysis of the phase 3 VISION trial Journal Article


Authors: Morris, M. J.; de Bono, J.; Nagarajah, J.; Sartor, O.; Wei, X. X.; Nordquist, L. T.; Koshkin, V. S.; Chi, K. N.; Krause, B. J.; Herrmann, K.; Rahbar, K.; Vickers, A.; Mirante, O.; Ghouse, R.; Fizazi, K.; Tagawa, S. T.
Article Title: Correlation analyses of radiographic progression-free survival with clinical and health-related quality of life outcomes in metastatic castration-resistant prostate cancer: Analysis of the phase 3 VISION trial
Abstract: Background: [177Lu]Lu–PSMA-617 (177Lu-PSMA-617) plus protocol-permitted standard of care (SOC) prolonged overall survival (OS) and radiographic progression-free survival (rPFS) versus SOC in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 VISION study, in addition to beneficial effects on symptomatic skeletal events (SSEs) and health-related quality of life (HRQOL). Methods: Post hoc analyses used the full analysis set from the VISION study (N = 831) overall and by randomized treatment arm (177Lu-PSMA-617 plus SOC, n = 551; SOC, n = 280). Correlations were determined between OS and rPFS and between rPFS or OS and time to SSE or to worsening HRQOL (Functional Assessment of Cancer Therapy–Prostate [FACT-P] and 5-level EQ-5D [EQ-5D-5L]). Correlation analyses used an iterative multiple imputation copula-based approach (correlation coefficients [rho] of <0.3 were defined as weak, ≥0.3 and <0.5 as mild, ≥0.5 and <0.7 as moderate, and ≥0.7 as strong). Results: In the overall population, rPFS correlated strongly with OS (rho, ≥0.7). Correlations between rPFS or OS and time to SSE without death were weak or mild. Time to worsening in the FACT-P total score and emotional and physical well-being domains correlated mildly or moderately with rPFS and moderately with OS. Correlation coefficients for time-to-worsening EQ-5D-5L scores were mild to moderate for both rPFS and OS. Correlation coefficients were similar between treatment arms. Conclusions: In this analysis of the VISION study, rPFS correlated strongly with OS but not with time to SSE or worsening HRQOL. These findings require further investigation. © 2024 The Author(s). Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.
Keywords: adult; controlled study; major clinical study; overall survival; radiation dose; outcome assessment; progression free survival; quality of life; multiple cycle treatment; clinical assessment; bisphosphonic acid derivative; health care quality; scoring system; glucocorticoid; radiography; phase 3 clinical trial; abiraterone; denosumab; brief pain inventory; enzalutamide; health-related quality of life (hrqol); intention to treat analysis; human; male; article; metastatic castration resistant prostate cancer; metastatic castration-resistant prostate cancer (mcrpc); european quality of life 5 dimensions 5 level questionnaire; vipivotide tetraxetan lutetium lu 177; functional assessment of cancer therapy prostate; <sup>177</sup>lu-psma-617; radiographic progression-free survival (rpfs)
Journal Title: Cancer
Volume: 130
Issue: 20
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2024-10-15
Start Page: 3426
End Page: 3435
Language: English
DOI: 10.1002/cncr.35438
PUBMED: 39031642
PROVIDER: scopus
PMCID: PMC11851234
DOI/URL:
Notes: Source: Scopus
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  1. Michael Morris
    586 Morris