Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis.
Crit Rev Oncol Hematol
; 201: 104416, 2024 Sep.
Article
in En
| MEDLINE
| ID: mdl-38871262
ABSTRACT
Overall survival (OS) is the most meaningful endpoint in clinical trials. However, owing to their limitations, surrogate endpoints are commonly used and validation studies are required to assess their reliability. Analysis of phase III randomized controlled trials (RCTs) of advanced gastroesophageal cancer (AGC) with > 100 patients, correlation coefficients (r), and determination coefficients (R²) between OS and surrogates were evaluated through meta-analyses. Progression-free survival (PFS), time to progression (TTP), and objective response rate (ORR) were examined to determine their correlations with OS. Analysis of 65 phase III RCTs (29,766 subjects) showed a moderate correlation between PFS/TTP and OS (r = 0.77, R² = 0.59), while ORR correlation was low (r = 0.56, R² = 0.31). Excluding immunotherapy trials improved the PFS/TTP and OS correlations (r = 0.83, R² = 0.70). These findings suggest the potential use of PFS/TTP in AGC phase III investigations, disregarding the use of ORR as a surrogate endpoint.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Stomach Neoplasms
/
Esophageal Neoplasms
/
Randomized Controlled Trials as Topic
/
Clinical Trials, Phase III as Topic
Limits:
Humans
Language:
En
Journal:
Crit Rev Oncol Hematol
Journal subject:
HEMATOLOGIA
/
NEOPLASIAS
Year:
2024
Document type:
Article
Country of publication: