@article{ATM24400,
author = {Fausto Petrelli and Michele Ghidini and Antonio Costanzo and Valentina Rampulla and Antonio Varricchio and Gianluca Tomasello},
title = {Surrogate endpoints in immunotherapy trials for solid tumors},
journal = {Annals of Translational Medicine},
volume = {7},
number = {7},
year = {2019},
keywords = {},
abstract = {In a systematic review published in European Journal of Cancer, Nie et al. analyzed the role of objective response (ORR), disease control and progression-free survival (PFS) as surrogate endpoints in phase II and III studies with immunotherapy [anti-PD(L)1 agents] in solid tumors (1). As expected, across 43 trials available for inclusion, no surrogate endpoint was validated using standard statistical criteria, because neither RECIST-based ORR, nor PFS were able to capture the final overall survival (OS) gain used generally for authority approval. As stated by authors, anti-PD-1/PD-L1 drugs may induce an initial increase in the tumor volume, and the delayed antitumor activity can, thereafter, produce a late shrinkage of the tumor volume. This may cause pseudo-progression and explains why ORR and PFS correlate weakly with survival.},
issn = {2305-5847}, url = {https://atm.amegroups.org/article/view/24400}
}