Open Access
Table 2
Two approved CAR-T therapies using SAT/ECA studies for relapsed or refractory diffuse large B-cell lymphoma with ≥2 prior lines of therapy.
Axicabtagene ciloleucel | Tisagenlecleucel | |
---|---|---|
SAT | ZUMA-1 study (n = 101) [6] | JULIET study (n = 115) [7] |
Almost 2 dozen of medical centers in U.S. and Israel. | Over a dozen of medical centers from U.S. and other countries. | |
ECA | SCHOLAR-1 study (n = 636) [8] | CORAL study (n = 297) [9] |
Observational cohorts from two large medical centers and participants of two previous phase-III RCTs. | Observational cohorts from the Lymphoma Academic Research Organization (LYSARC) in France. | |
Key endpoints | Complete response, overall response, progression events, and overall survival. | |
Bias mitigation | Multivariable regression including propensity score analysis. | |
Sensitivity analysis of definition of SoC. | ||
Residual confounding biases | ||
Patient-level | Unable to control time trends due to use of a historical ECA. | |
Concern over unobserved confounders. | ||
Non-random missingness in ECAs. | ||
System-level | Unable to adjust because of use of the post-intervention measurement only design. |
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