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Article summary:
1. This phase II, single-arm trial evaluated the efficacy and safety of guadecitabine in peripheral T-cell lymphoma (PTCL) patients.
2. The overall response rate was 40%, with 10% complete responses. Median progression free survival and overall survival were 2.9 and 10.4 months respectively.
3. Translational sub-studies included cell free plasma DNA sequencing and functional genomic screening to identify response predictors, such as RHOAG17V mutations associated with improved PFS, and TP53 variants associated with response to HMA treatment.
Article analysis:
The article is a detailed report on a phase II clinical trial evaluating the efficacy and safety of guadecitabine in peripheral T-cell lymphoma (PTCL) patients, which includes translational sub-studies to identify response predictors. The study design is appropriate for a phase II trial, with 20 patients expected to be registered on the study in 24 months, and the maximum standard error for the ORR after six cycles of induction considered suitable precision for a pilot study. The results are presented clearly and accurately, with an overall response rate of 40%, median progression free survival of 2.9 months, median overall survival of 10.4 months, and various mutations associated with improved PFS or response to HMA treatment identified through translational sub-studies.
The article appears to be reliable and trustworthy; it is well written and provides detailed information about the study design, patient characteristics, treatments administered, outcome measures assessed, statistical analyses performed, data sharing statement provided etc., as well as clear descriptions of methods used for tumor/plasma DNA mutational analyses including sequencing depths achieved for ctDNA libraries etc., expression profiling performed using RNA sequencing data from primary tumors etc., CRISPR screening conducted using an epigenetically-targeted CRISPR/Cas9 library etc.. Furthermore, accession numbers are provided for RNA sequencing data reported in this paper so that readers can access these data if they wish to do so.
In conclusion, this article appears to be reliable and trustworthy; it provides detailed information about the study design as well as clear descriptions of methods used for tumor/plasma DNA mutational analyses including sequencing depths achieved for ctDNA libraries etc., expression profiling performed using RNA sequencing data from primary tumors etc., CRISPR screening conducted using an epigenetically-targeted CRISPR/Cas9 library etc