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However the specification documents were unclear which led to criteria adjustments and inconsistent conclusions. In the mid-1990s, an International Working Party was created to simplify and standardize response criteria; it then published RECIST in 2000. These new criteria have been widely adopted and embraced by the regulatory authorities. [1]
The immune-related response criteria, first published in 2009, [1] arose out of observations that immuno-oncology drugs would fail in clinical trials that measured responses using the WHO or RECIST Criteria, because these criteria could not account for the time gap in many patients between initial treatment and the apparent action of the immune ...
The major efficacy outcome measure was progression-free survival (PFS) based on assessment by blinded independent central review (BICR) using modified RECIST 1.1 in which lymph nodes and bone lesions were not target lesions and a progressively growing new tumor nodule within a pre-existing tumor mass must meet specific criteria to be considered ...
The major efficacy measure was progression-free survival (PFS) using RECIST 1.1 response criteria and assessed by blinded independent central review. [6] The median PFS was 14.9 months for participants receiving binimetinib plus encorafenib, and 7.3 months for the vemurafenib monotherapy arm (hazard ratio 0.54, 95% CI: 0.41, 0.71, p<0.0001). [6]
The overall response rate was assessed by an independent review committee according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The overall response rate was 33% (95% confidence interval [CI]: 23.3, 43.8), with 11% complete and 22% partial response rates. Among the 29 responding participants, the response duration ranged from ...
Benign liver tumors generally develop on normal or fatty liver, are single or multiple (generally paucilocular), have distinct delineation, with increased echogenity (hemangiomas, benign focal nodular hyperplasia) or absent, with posterior acoustic enhancement effect (cysts), have distinct delineation (hydatid cyst), lack of vascularization or show a characteristic circulatory pattern ...
Eftilagimod alpha ("efti" in short) is a soluble LAG-3 fusion protein that activates antigen-presenting cells.It is a 160 kDa protein consisting of the four extracellular domains of LAG-3 fused to the Fc region of an IgG1(LAG-3Ig).
The results of PALOMA-2 trial, published in November 2016, showed significantly longer progression-free survival in patients on palbociclib in combination with letrozole, compared to patients on letrozole and placebo. Progression-free survival was assessed by radiologically-confirmed disease progression by RECIST criteria or death during the ...