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

Author:

Morris Michael J.1ORCID,de Bono Johann2,Nagarajah James3,Sartor Oliver4,Wei Xiao X.5,Nordquist Luke T.6,Koshkin Vadim S.7ORCID,Chi Kim N.8,Krause Bernd J.9,Herrmann Ken10,Rahbar Kambiz11,Vickers Adrian12,Mirante Osvaldo13,Ghouse Ray13,Fizazi Karim14,Tagawa Scott T.15ORCID

Affiliation:

1. Memorial Sloan Kettering Cancer Center New York New York USA

2. The Institute of Cancer Research and Royal Marsden Hospital London UK

3. Radboud University Medical Center Nijmegen the Netherlands

4. Mayo Clinic Rochester Minnesota USA

5. Dana‐Farber Cancer Institute Boston Massachusetts USA

6. XCancer Omaha Nebraska USA

7. Helen Diller Family Comprehensive Cancer Center University of California San Francisco San Francisco California USA

8. University of British Columbia Vancouver British Columbia Canada

9. Rostock University Medical Center Rostock Germany

10. University Hospital Essen Essen Germany

11. University Hospital Muenster Muenster Germany

12. RTI Health Solutions Manchester UK

13. Advanced Accelerator Applications a Novartis company Geneva Switzerland

14. Institut Gustave Roussy University of Paris‐Saclay Villejuif France

15. Weill Cornell Medicine New York New York USA

Abstract

AbstractBackground[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).MethodsPost 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).ResultsIn 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.ConclusionsIn 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.

Publisher

Wiley

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