Meta-Analysis of Candidate Surrogate End Points in Advanced Prostate Cancer

• DOI: 10.1056/evidoa2200195
• Publication Date: 2023-03-27T16:00:07Z
• Authors: Laila A. Gharzai; Ralph Jiang; Elizabeth M. Jawo...; Krystal Morales R...; Robert T. Dess; William C. Jackson; Holly E. Hartman; Rohit Mehra; Amar U. Kishan; Abhishek A. Solanki; Edward M. Schaeffer; Felix Y. Feng; Nicholas G. Zaorsky; Alejandro Berlin; Lee Ponsky; Jonathan Shoag; Yilun Sun; Matthew J. Schipper; Jorge Garcia; Daniel E. Spratt
• Keywords: Clinical endpoint; Surrogate endpoint; Progression-free survival

BACKGROUND: The Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) working group identified metastasis-free survival as a valid surrogate end point for overall (OS) patients with localized prostate cancer. No comparably validated points exist advanced METHODS: We searched trials cancer, defined node-positive, metastatic castration-sensitive, nonmetastatic, or castration-resistant Eligible randomized reported OS and one more intermediate clinical points, including biochemical failure (BF), failure, failure–free (BFS), progression-free (PFS), radiographic PFS. Candidacy surrogacy was assessed by using second condition meta-analytic approach; R2 weighted inverse variance log hazard ratio R2>0.70. RESULTS: A total 143 (n=75,601 patients) were included. candidate met criteria (R2 BF [n=28,922], 0.42 [95% confidence interval (CI), 0.18 to 0.64]; BFS [n=25,741], 0.57 CI, 0.37 0.73]; [n=22,616], 0.31 0.075 0.56]; PFS [n=52,639], 0.50 0.35 0.63]; [n=52,548], 0.63]). Within preplanned subgroups according castration-sensitive disease treatment type, neither nor consistently surrogacy. Sensitivity analyses showed that candidacy all tested did not change over time. CONCLUSIONS: Our aggregate screening method cancer commonly used are clear OS. (Funded Foundation National Institute.)