Clinical Utility of Next-Generation Sequencing-Based Panel Testing under the Universal Health-Care System in Japan: A Retrospective Analysis at a Single University Hospital

Abstract

Next-generation sequencing (NGS) assay is part of routine care in Japan owing to its reimbursement by Japan’s universal health-care system; however, reimbursement is limited to patients who finished standard treatment. We retrospectively investigated 221 patients who underwent Foundation One CDX (F1CDx) at our hospital. Every F1CDx result was assessed at the molecular tumor board (MTB) for treatment recommendation. Based on patients’ preferences, presumed germline findings were also assessed at the MTB and disclosed at the clinic. In total, 204 patients underwent F1CDx and 195 patients completed the analysis; however, 13.8% of them could not receive the report due to disease progression. Among 168 patients who received the results, 41.6% had at least one actionable alteration, and 3.6% received genomically matched treatment. Presumed germline findings were nominated in 24 patients, and 16.7% of them contacted a geneticist counselor. The NGS assay should be performed earlier in the clinical course to maximize the clinical benefit. Broader reimbursement for the NGS assay would enhance the delivery of precision oncology to patients. Access to clinical trials affects the number of patients who benefit from NGS. Additionally, the disclosure of presumed germline findings is feasible in clinical practice.

Clinical utility of comprehensive genomic profiling tests for advanced or metastatic solid tumor in clinical practice

“…The other patient characteristics (age, gender, ECOG-PS, number of prior systemic therapies, and distance from patient's homes to the NCCH) were not associated with receiving genomically matched therapy. 10,11 Our rate of 12.2% seems to be higher than those previously reported at the other sites in Japan. A major reason for this is that the largest number of IND trials (mainly industry sponsored trials) are conducted at our site in Japan.…”

“…NRG1 fusion found in 1 patient was only detected by the OncoGuide™ NCC Oncopanel System, and RAF1 rearrangement found in 1 patient was only detected by the FoundationOne® CDx Cancer Genomic Profile. Kikuchi et al (2021) and Inagaki et al (2021) reported that 11.1% (21 of 189 patients) and 3.6% (6 of 221 patients) of patients received genomically matched therapy after CGP tests, respectively 10,11 . Our rate of 12.2% seems to be higher than those previously reported at the other sites in Japan.…”

Combined Focused Next-Generation Sequencing Assays to Guide Precision Oncology in Solid Tumors: A Retrospective Analysis from an Institutional Molecular Tumor Board

“…Additionally, in some cases, insurance companies agreed to cover expenses for off-label treatment only conditionally after failure of several lines of therapy, a situation in which patients are often unlikely to draw clinical benefit. Our preliminary data therefore support the notion that NGS testing should be taken into consideration rather early in the course of a disease in order to avoid the waiving of possible matched therapies due to compromised patient performance status after several lines of therapy [ 61 ].…”

Targeted Treatment of Non-Small Cell Lung Cancer: Focus on Capmatinib with Companion Diagnostics

“…These studies prompted FoundationOne CDx to become a companion diagnostic for capmatinib for MET-dysregulated NSCLC. [34][35][36] Utilization of FoundationOne CDx as a companion diagnostic for other driver mutations in other solid tumors is currently being investigated, with mixed results suggesting potential applications in glioma and breast but limited utility in pancreatic ductal adenocarcinoma. [37][38][39]…”