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.
作者
李嘉瑞
张盼盼
谢卿
王风
丁香香
陆明
于江媛
沈琳
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)
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)
