Inaki Anri, Yoshimura Kenichi, Murayama Toshinori, Imai Yasuhito, Kuribayashi Yoshikazu, Higuchi Tetsuya, Jinguji Megumi, Shiga Tohru, Kinuya Seigo
Department of Nuclear Medicine, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University.
Department of Biostatistics, Innovative Clinical Research Center, Kanazawa University Hospital.
J Med Invest. 2017;64(3.4):205-209. doi: 10.2152/jmi.64.205.
Objective Pheochromocytoma and paraganglioma (PPGLs) are rare neuroendocrine tumors derived from the adrenal medulla or extra-adrenal paraganglioma from extra-adrenal chromaffin tissue. Although malignant PPGLs has miserable prognosis, the treatment strategy remains to be established. An internal radiation therapy using [I]meta-iodobenzylguanidine (I-mIBG) called MIBG therapy has been attempted as one of the systemic treatment of malignant PPGLs. The aim of this study is therefore to evaluate the safety and the efficacy of MIBG therapy for refractory PPGLs. Methods Patients with refractory PPGLs will be enrolled in this study. The total number of patients for registration is 20. The patients receive a fixed dose of 7,400 MBq of I-mIBG. Adverse events are surveyed during 20 weeks after I-mIBG injection and all severe adverse events will be documented and reported in detail in accordance with the Common Terminology Criteria for Adverse Events (CTCAE). Examination and imaging diagnosis are performed in 12 weeks after I-mIBG injection for the evaluation of therapeutic effect in accordance with the Response Evaluation in Solid Tumours (RECIST). Conclusion The current study is the first multi-institutional prospective study of MIBG therapy and thereby will play a significant role in improving the patients' prognosis of refractory PPGLs. J. Med. Invest. 64: 205-209, August, 2017.
目的 嗜铬细胞瘤和副神经节瘤（PPGLs）是源自肾上腺髓质或肾上腺外嗜铬组织的肾上腺外副神经节瘤的罕见神经内分泌肿瘤。尽管恶性PPGLs预后不佳，但治疗策略仍有待确定。使用[I]间碘苄胍（I-mIBG）的内照射疗法即MIBG疗法已被尝试作为恶性PPGLs的全身治疗方法之一。因此，本研究的目的是评估MIBG疗法治疗难治性PPGLs的安全性和疗效。方法 难治性PPGLs患者将纳入本研究。登记患者总数为20例。患者接受固定剂量7400 MBq的I-mIBG。在注射I-mIBG后20周内调查不良事件，所有严重不良事件将按照不良事件通用术语标准（CTCAE）详细记录和报告。在注射I-mIBG后12周进行检查和影像诊断，以根据实体瘤疗效评价标准（RECIST）评估治疗效果。结论 本研究是首次关于MIBG疗法的多机构前瞻性研究，因此将在改善难治性PPGLs患者的预后方面发挥重要作用。《医学调查杂志》64: 205 - 209，2017年8月。
