National Cancer Center Hospital East, Kashiwa, Japan.
Saitama Cancer Center, Saitama, Japan.
Int J Clin Oncol. 2023 Jul;28(7):827-840. doi: 10.1007/s10147-023-02345-7. Epub 2023 May 22.
Clinical trials have reported the efficacy of tropomyosin receptor kinase (TRK) inhibitors against neurotrophic receptor tyrosine kinase (NTRK) fusion gene-positive advanced solid tumors. The accumulated evidence of tumor-agnostic agent has made since TRK inhibitors were approved and used in clinical practice. Therefore, we have revised the 'Japan Society of Clinical Oncology (JSCO)/Japanese Society of Medical Oncology (JSMO)-led clinical recommendations on the diagnosis and use of tropomyosin receptor kinase inhibitors in adult and pediatric patients with neurotrophic receptor tyrosine kinase fusion-positive advanced solid tumors, cooperated by the Japanese Society of Pediatric Hematology/Oncology (JSPHO)'.
Clinical questions regarding medical care were formulated for patients with NTRK fusion-positive advanced solid tumors. Relevant publications were searched by PubMed and Cochrane Database. Critical publications and conference reports were added manually. Systematic reviews were performed for each clinical question for the purpose of developing clinical recommendations. The committee members identified by JSCO, JSMO, and JSPHO voted to determine the level of each recommendation considering the strength of evidence, expected risks and benefits to patients, and other related factors. Thereafter, a peer review by experts nominated from JSCO, JSMO, and JSPHO, and the public comments among all societies' members was done.
The current guideline describes 3 clinical questions and 14 recommendations for whom, when, and how NTRK fusion should be tested, and what is recommended for patients with NTRK fusion-positive advanced solid tumors.
The committee proposed 14 recommendations for performing NTRK testing properly to select patients who are likely to benefit from TRK inhibitors.
临床试验已经报道了原肌球蛋白受体激酶(TRK)抑制剂对神经营养受体酪氨酸激酶(NTRK)融合基因阳性晚期实体瘤的疗效。自 TRK 抑制剂获得批准并在临床实践中使用以来,积累了大量针对肿瘤不可知药物的证据。因此,我们修订了“日本临床肿瘤学会(JSCO)/日本肿瘤内科学会(JSMO)主导的关于成人和儿科患者神经滋养受体酪氨酸激酶融合阳性晚期实体瘤中使用原肌球蛋白受体激酶抑制剂的诊断和使用的临床建议,由日本儿科血液学/肿瘤学会(JSPHO)合作”。
针对 NTRK 融合阳性晚期实体瘤患者制定了医疗护理相关的临床问题。通过 PubMed 和 Cochrane Database 搜索相关出版物。手动添加关键出版物和会议报告。针对每个临床问题进行系统评价,目的是制定临床建议。JSCO、JSMO 和 JSPHO 的委员会成员根据证据强度、对患者的预期风险和收益以及其他相关因素,对每个推荐的级别进行了投票。之后,由 JSCO、JSMO 和 JSPHO 提名的专家进行同行评议,并对所有学会成员进行公开意见征求。
当前指南描述了 3 个临床问题和 14 项建议,内容涉及 NTRK 融合检测的对象、时间和方法,以及 NTRK 融合阳性晚期实体瘤患者的推荐治疗方案。
委员会提出了 14 项建议,旨在正确进行 NTRK 检测,以选择可能从 TRK 抑制剂中获益的患者。