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.

Autor: Morris MJ; Memorial Sloan Kettering Cancer Center, New York, New York, USA., de Bono J; The Institute of Cancer Research and Royal Marsden Hospital, London, UK., Nagarajah J; Radboud University Medical Center, Nijmegen, the Netherlands., Sartor O; Mayo Clinic, Rochester, Minnesota, USA., Wei XX; Dana-Farber Cancer Institute, Boston, Massachusetts, USA., Nordquist LT; XCancer, Omaha, Nebraska, USA., Koshkin VS; Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA., Chi KN; University of British Columbia, Vancouver, British Columbia, Canada., Krause BJ; Rostock University Medical Center, Rostock, Germany., Herrmann K; University Hospital Essen, Essen, Germany., Rahbar K; University Hospital Muenster, Muenster, Germany., Vickers A; RTI Health Solutions, Manchester, UK., Mirante O; Advanced Accelerator Applications, a Novartis company, Geneva, Switzerland., Ghouse R; Advanced Accelerator Applications, a Novartis company, Geneva, Switzerland., Fizazi K; Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France., Tagawa ST; Weill Cornell Medicine, New York, New York, USA.
Jazyk: angličtina
Zdroj: Cancer [Cancer] 2024 Oct 15; Vol. 130 (20), pp. 3426-3435. Date of Electronic Publication: 2024 Jun 21.
DOI: 10.1002/cncr.35438
Abstrakt: Background: [ 177 Lu]Lu-PSMA-617 ( 177 Lu-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 ( 177 Lu-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.)
Databáze: MEDLINE
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