肽受体放射性核素治疗中国晚期胃肠胰神经内分泌瘤患者的前瞻性Ⅱ期临床研究  

Peptide receptor radionuclide therapy in Chinese patients with metastatic gastroenteropancreatic neuroendocrine tumors:a prospective phaseⅡstudy

作　　者：李嘉瑞 张盼盼[1] 谢卿[2] 王风[2] 丁香香 陆明[1] 于江媛[2] 沈琳[1] Li Jiarui;Zhang Panpan;Xie Qing;Wang Feng;Ding Xiangxiang;Lu Ming;Yu Jiangyuan;Shen Lin(Department ofGastrointestinal Oncology,State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers,Beijing KeyLaboratory of Carcinogenesis and Translational Research,Peking University Cancer Hospital&Institute,Beijing 100142,China;Department of Nuclear Medicine,Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education),PekingUniversity Cancer Hospital&Institute,Beijing 100142,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所消化肿瘤内科消化系肿瘤整合防治全国重点实验室恶性肿瘤转化研究北京市重点实验室,北京100142 [2]北京大学肿瘤医院暨北京市肿瘤防治研究所核医学科恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142

出　　处：《肿瘤综合治疗电子杂志》2024年第3期105-109,共5页Journal of Multidisciplinary Cancer Management(Electronic Version)

摘　　要：目的前瞻性研究肽受体放射性核素(177Lu-Dotatate)治疗中国晚期胃肠胰神经内分泌瘤(gastroenteropancreatic neuroendocrine tumor,GEP-NET)患者的有效性和安全性。方法本研究为前瞻性、单臂、单中心Ⅱ期临床研究,纳入2018年2月至2023年5月北京大学肿瘤医院收治的入组分化良好、生长抑素受体阳性、经过治疗进展的晚期GEP-NET患者32例。入组的患者均接受每8~12周1次,每次150~200 mCi的177Lu-Dotatate治疗。主要研究终点为客观缓解率(overall response rate,ORR)和安全性,次要研究终点为无进展生存(progressive free survival,PFS)时间。结果32例患者接受177Lu-Dotatate的平均累积剂量为(623±171)mCi,其中2例患者无法评价疗效(1例失访,1例未完成治疗)。在可评估疗效的30例患者中,ORR为53.3%,疾病控制率为93.3%,中位PFS时间为24.5个月(95%CI为17.0~31.9个月),中位总生存时间未达到。除2例(6.7%)患者出现3级血液学毒性,其余患者均未出现≥3级不良事件。结论肽受体放射性核素治疗中国晚期GEP-NET患者有效率高,且安全性良好,是一种十分有前景的治疗手段。Objective To prospectively evaluate the efficacy and safety of peptide receptor radionuclide therapy with 177Lu�Dotatate in Chinese patients with metastatic gastroenteropancreatic neuroendocrine tumors(GEP-NETs).Method This clinical trial was a prospective,single arm,single center phaseⅡstudy.A total of 32 patients with advanced,progressive,well-differentiated,somatostatin-receptor positive GEP-NETs were enrolled from February 2018 to May 2023 in Peking University Cancer Hospital.All enrolled patients received 177Lu-Dotatate treatment at a dose of 150-200 mCi every 8-12 weeks.The primary endpoints included overall response rate(ORR)and safety.The secondary endpoint was progressive free survival(PFS)time.Result The average cumulative dose of 177Lu-Dotatate administered to 32 patients was(623±171)mCi.Two patients were unable to evaluate the efficacy(1 case was lost to follow-up,1 case did not complete the treatment).Among 30 evaluable patients,the ORR was 53.3%,and the disease control rate was 93.3%.The median PFS time was 24.5 months(95%CI was 17.0-31.9 months),and the median overall survival time had not yet been reached.Except only two patients(6.2%)experienced grade 3 hematologic toxicities,no patient had grade 3 or higher adverse events.Conclusion Peptide receptor radionuclide therapy is an encouraging treatment option with high efficacy and acceptable toxicity for Chinese patients with advanced GEP-NETs.

关 键 词：胃肠胰神经内分泌瘤 肽受体放射性核素治疗 肽受体放射性核素 生长抑素受体 临床试验 

分 类 号：R735[医药卫生—肿瘤]