The Evolving Scenario in the Assessment of Radiological Response for Hepatocellular Carcinoma in the Era of Immunotherapy: Strengths and Weaknesses of Surrogate Endpoints
, Ciro Celsa 1,2,†, Michela Antonucci 3, Marta Peri 2, Maria Vittoria Grassini 1, Gabriele Rancatore 1, Carmelo Marco Giacchetto 1, Roberto Cannella 3, Lorena Incorvaia 2, Lidia Rita Corsini 2, Piera Morana 1, Claudia La Mantia 1, Giuseppe Badalamenti 2, Giuseppe Brancatelli 3, Calogero Cammà 1 and Giuseppe Cabibbo 1,*Round 1
Reviewer 1 Report
Well written and fairly comprehensive critical review on the topic of clinical endpoints used in HCC clinical trials and their surrogacy for OS. Authors notably point out the importance of confirming the proportionality assumption when applying Cox regression in clinical trials and also the relevance of underlying liver function in clinical trials involving HCC patients. Figure 1, which illustrates the Italian HCC treatment guidelines, is of tangential relevance to this article and may be omitted if space is an issue.
Reviewer 2 Report
In this study Giuffrida et al. performed a narrative review of the most common clinical and radiological endpoints for trial design in patients receiving immunotherapy for hepatocellular carcinoma. The authors managed to successfully include in the manuscript all the recent evidence and highlight the respective future research perspectives. The manuscript is well-written, with appropriate structure and informative tables and figures. Despite the fact that previous studies have re-adressed this topic, the quality of the present paper renders it appropriate for publication.
