Feasibility and utility of a panel testing for 114 cancer‐associated genes in a clinical setting: A hospital‐based study

Abstract

Next‐generation sequencing ( NGS ) of tumor tissue (ie, clinical sequencing) can guide clinical management by providing information about actionable gene aberrations that have diagnostic and therapeutic significance. Here, we undertook a hospital‐based prospective study ( TOP ‐ GEAR project, 2nd stage) to investigate the feasibility and utility of NGS ‐based analysis of 114 cancer‐associated genes (the NCC Oncopanel test). We examined 230 cases (comprising more than 30 tumor types) of advanced solid tumors, all of which were matched with nontumor samples. Gene profiling data were obtained for 187 cases (81.3%), 111 (59.4%) of which harbored actionable gene aberrations according to the Clinical Practice Guidelines for Next Generation Sequencing in Cancer Diagnosis and Treatment (Edition 1.0) issued by 3 major Japanese cancer‐related societies. Twenty‐five (13.3%) cases have since received molecular‐targeted therapy according to their gene aberrations. These results indicate the utility of tumor‐profiling multiplex gene panel testing in a clinical setting in Japan. This study is registered with UMIN Clinical Trials Registry ( UMIN 000011141).

Genomic alterations in STK11 can predict clinical outcomes in cervical cancer patients

“…Somatic mutations and copy number alterations were categorized into four evidence levels. In the present study, gene aberrations with evidence levels 1Ae3A were judged as actionable mutations for molecular-targeted drugs [27].…”

Precision Medicine in Soft Tissue Sarcoma Treatment

“…With the ongoing progress in genome sequence analysis technology, the whole genomes of malignant diseases including STS have been revealed [99,100], and it is now possible to use genomic analyses in practical medicine [3]. The prospective analysis of panel testing by next-generation sequencing (NGS) in Japan (TOP-GEAR) project obtained the gene-profiling data of 42 sarcoma patients (including both STS and bone sarcoma patients), who comprised 22% of 187 patients with solid tumors [101]. The high rates of STS patient enrollment in the prospective panel testing study suggests that there is a great need for comprehensive genome profiling in STS investigations as well as investigations of other solid tumors.…”

Clinical Benefit and Agenda for Clinical Sequencing Using Cancer Panel Testing: A Retrospective Clinical Study

“…Tumor mutational burden (TMB), which is related to response immune checkpoint therapy, was also analyzed in NCC oncopanel and FoundationOne ® CDx (11,13). TMB was classi ed as 2 categories, High-TMB and Low-TMB.…”

“…FoundationOne ® CDx and MSK-IMPACT, which are comprehensive genome pro ling tests for all solid tumors, have been approved by the U.S.FDA and used for the clinical sequencing of over 10,000 patients (9,10). In Japan, a total of 230 patients with advanced solid tumors underwent clinical sequencing using the NCC Oncopanel as part of the TOP-GEAR project at the National Cancer Center Hospital (UMIN000011141), and the genetic tests revealed that 13% of the patients were candidates for novel targeted therapy (11). In this context, the use of the NCC Oncopanel as well as the FoundationOne ® CDx has been covered under Japan's national health insurance since June 2019.…”

“…In this context, the use of the NCC Oncopanel as well as the FoundationOne ® CDx has been covered under Japan's national health insurance since June 2019. Thus, there have been few evaluations of the feasibility and utility of clinical sequencing in cancer treatment in Japan (11,12). At our hospital, clinical sequencing has been introduced for cancer patients as an application of precision oncology.…”