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PFS Valid Surrogate Endpoint for Overall Survival in Frontline DLBCL

Jason Harris
Published: Tuesday, Jul 10, 2018

Qian Shi, PhD

Qian Shi, PhD

Progression-free survival (PFS) appears to be a surrogate endpoint for overall survival (OS) in patients undergoing first-line treatment for diffuse large B-cell lymphoma (DLBCL), according to results from a large pooled analysis of 13 multicenter, randomized, controlled trials.1

Investigators with the Surrogate Endpoints for Aggressive Lymphoma (SEAL) group used linear regression (R2WLS) and Copula bivariable (R2Copula) models to assess the correlation of trial-level surrogacy with treatment effect estimates for PFS, PFS at 24 months (PFS24), and OS. To demonstrate surrogacy, either R2WLS or R2Copula had to be ≥0.80 and and neither estimate could be <0.7. The prespecified lower-bound of the 95% CI was set at >0.6.

Trial-level surrogacy for PFS met the predefined criteria (R2WLS = 0.83; 95% CI, 0.57-0.94 and R2Copula = 0.85; 95% CI, 0.73-0.98), and investigators found that PFS strongly correlated with OS at the patient level. The rank correlation coefficient ρ between PFS and OS was 0.85 (95% CI, 0.84-0.86) for patient-level correlation.

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