(177)Lu-Dotatate的3期临床试验中肠神经内分泌肿瘤。
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haddad Strosberg J, G,沃林E, Hendifar,姚明J, Chasen B, Mittra E,昆兹PL, Kulke MH, Jacene H,布什内尔D O 'Dorisio TM, Baum RP, Kulkarni人力资源,事务所Caplin M, Lebtahi R, Hobday T, Delpassand E·范·卡特森E,本森,Srirajaskanthan R,帕维尔M,莫拉J,柏林J, Grande E,里德N, Seregni E,奥伯格K, Lopera塞拉米,澳网P, Thevenet T,不杰,Ruszniewski P, Kwekkeboom D, Krenning E
(177)Lu-Dotatate的3期临床试验中肠神经内分泌肿瘤。
郑传经地中海J。2017年1月12日,376 (2):125 - 135。doi: 10.1056 / NEJMoa1607427。
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28076709 (在PubMed]
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背景:先进的中肠神经内分泌肿瘤患者疾病进展有一线生长抑素类似物治疗期间有有限的治疗选择。这个随机,对照试验评估的有效性和安全性镏- 177(陆(177))患者-Dotatate先进,进步,somatostatin-receptor-positive中肠神经内分泌肿瘤。方法:我们随机选取了229名患者细胞分化、转移中肠神经内分泌肿瘤接受(177)Lu-Dotatate(116名患者)的剂量7.4 GBq每8周(四个静脉输液,加上最好的支持性护理包括octreotide长效可重复的(政治)管理肌内的剂量30毫克)((177)Lu-Dotatate组)或octreotide守护神独自(113名患者)注射的剂量肌内60毫克每4周(对照组)。主要终点是无进展生存。次要终点包括客观缓解率、总生存期,安全,副作用概要文件。最后分析总体存活率将在未来中指定的协议;一个指定临时总体存活率进行了分析和报道。data-cutoff日期的结果:主要分析、估计的无进展生存在月20为65.2%(95%可信区间(CI), 50.0 - 76.8) (177) Lu-Dotatate组和10.8%(95%可信区间,3.5至23.0),对照组。响应率为18% (177)Lu-Dotatate组与对照组的3% (P < 0.001)。在计划期间分析总体存活率,14例死亡发生在(177)Lu-Dotatate组和26日在对照组(P = 0.004)。 Grade 3 or 4 neutropenia, thrombocytopenia, and lymphopenia occurred in 1%, 2%, and 9%, respectively, of patients in the (177)Lu-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame. CONCLUSIONS: Treatment with (177)Lu-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR among patients with advanced midgut neuroendocrine tumors. Preliminary evidence of an overall survival benefit was seen in an interim analysis; confirmation will be required in the planned final analysis. Clinically significant myelosuppression occurred in less than 10% of patients in the (177)Lu-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials.gov number, NCT01578239 ; EudraCT number 2011-005049-11 .).
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