Oncology · 1 h ago
Real-world progression-free survival correlates with overall survival in metastatic breast cancer
A retrospective cohort study of 19,164 patients with metastatic breast cancer used US Flatiron Health data to assess whether intermediate endpoints could serve as surrogates for overall survival. Real-world progression-free survival showed strong correlations with overall survival at both the patient and group-effect levels; other treatment-derived endpoints did not meet both criteria.
- Cohort included 19,164 patients with metastatic breast cancer.
- Median overall survival was 36.3 months.
- Only rwPFS met both surrogacy criteria against overall survival.
- Validation was based on retrospective data from one US database.
Researchers conducted a retrospective cohort study using the nationwide US Flatiron Health database, including 19,164 patients with metastatic breast cancer. They assessed four intermediate clinical endpoints—real-world progression-free survival (rwPFS), time to next line of therapy (TTNT), time to last first-line treatment administration (TTLA), and time to end of first-line therapy (TTEFL)—against overall survival (OS). Surrogacy was evaluated using correlations between individual endpoint and OS outcomes, and between group effects on the endpoint and OS.
Median OS was 36.3 months (95% CI, 35.6–37.2). For the first criterion, rwPFS, TTNT, and TTLA each showed high correlation with OS. For the second criterion, group effects were strongly correlated with OS only for rwPFS, with R² of at least 0.7 across subgroup comparisons.
The findings support rwPFS as a potential surrogate for OS in real-world data analyses of metastatic breast cancer and provide a framework for evaluating such endpoints. The retrospective analysis used one US database, and the reported validation is specific to this population and setting; the results do not establish surrogacy across other cancer types or clinical-trial contexts.
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JNCI: Journal of the National Cancer Institute: Novel framework for the validation of intermediate clinical endpoints in oncology real-world data ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.