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.
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.
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DOI：
10.3390/cancers13051121
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发表时间：
2021-03-05
期刊：
影响因子：
5.2
通讯作者：
Satoh T
中科院分区：
文献类型：
--
作者：
Inagaki C;Maeda D;Hatake K;Sato Y;Hashimoto K;Sakai D;Yachida S;Nonomura N;Satoh T
基于下一代测序（NGS）的检测方法被广泛应用于临床实践，因为日本全民医疗保健系统对2019年6月完成标准治疗的癌症患者进行了报销。为了阐明全民医疗保健系统下NGS检测的临床应用，我们回顾性分析了在我院接受NGS检测的患者。由于NGS检测的报销仅限于完成标准治疗的患者，许多患者在获得结果之前经历了临床疾病进展；因此，他们不能使用NGS结果来做出治疗决定。为了更好地利用NGS检测结果，需要对晚期癌症患者更广泛地报销NGS检测。为患者提供良好的临床试验和标签外药物是使其受益于NGS检测的必要条件。此外，本研究表明，披露假定的生殖系发现在临床实践中是可行的。下一代测序（NGS）检测是日本常规护理的一部分，因为它由日本全民医疗保健系统报销；然而，报销仅限于完成标准治疗的患者。我们回顾性调查了221例在我院接受基础一期CDX （F1CDx）治疗的患者。每个F1CDx结果在分子肿瘤委员会（MTB）评估治疗建议。根据患者的偏好，假定的生殖系发现也在MTB进行评估，并在诊所公布。总共有204名患者接受了F1CDx治疗，195名患者完成了分析；13.8%的患者因病情进展未能收到报告。在168名接受结果的患者中，41.6%至少有一项可操作的改变，3.6%接受了基因组匹配的治疗。在24名患者中提名了假定的生殖系发现，其中16.7%的患者联系了遗传学顾问。NGS检测应在临床过程中尽早进行，以最大限度地提高临床效益。对NGS检测的更广泛报销将加强对患者的精准肿瘤学治疗。获得临床试验影响到受益于NGS的患者数量。此外，披露假定的生殖系发现在临床实践中是可行的。
Next-generation sequencing (NGS)-based assay is widely used in clinical practice due to its reimbursement by Japan’s universal health-care system for cancer patients who finished standard treatment in June 2019. To clarify the clinical utility of the NGS assay under the universal health-care system, we retrospectively analyzed patients who underwent NGS assay at our hospital. Since reimbursement of the NGS assay is restricted to patients who complete standard treatment, many patients experience clinical disease progression before receiving results; therefore, they could not use the NGS results for making a therapeutic decision. Broader reimbursement of NGS assays for advanced cancer patients is needed for making optimum use of the NGS assay results. Providing good access to clinical trials and off-label agents is necessary for enabling patients to benefit from NGS assay. Additionally, this study revealed that the disclosure of presumed germline findings is feasible in clinical practice. 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.
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