与CYT107 ELYPSE-7:一项随机安慰剂对照活动花絮阶段试验探索恢复lymphopenic转移性乳腺癌患者的CD4 +淋巴细胞计数。

文章的细节

引用

复制到剪贴板

Tredan O, Menetrier-Caux C, Ray-Coquard我,加林G, Cropet C, Verronese E, Bachelot T, Rebattu P, Heudel PE、凯西P, Chabaud年代,Croughs T,杜邦P, Cadore AC, Clapisson G,戴尔嘎多,Bardin-dit-Courageot C, Rigal C, N 'Kodia, Gilles-Afchain L, M率,Perol D,凄凉的司法院,Caux C

与CYT107 ELYPSE-7:一项随机安慰剂对照活动花絮阶段试验探索恢复lymphopenic转移性乳腺癌患者的CD4 +淋巴细胞计数。

安杂志。2015年7月,26 (7):1353 - 62。doi: 10.1093 / annonc / mdv173。Epub 2015年4月7日。

PubMed ID

25851629 (在PubMed

]

文摘

背景:淋巴细胞减少血液毒性的预测因素,发展先进的癌症包括转移性乳腺癌和早期死亡(MBC)。CYT107是重组白介素7 (IL-7) (Cytheris,现在Revimmune),耐受性良好,能够扩大人类淋巴细胞池。本研究的目的是确定最优时间表交付CYT107并评估它对临床终点的影响。病人和方法:这种安慰剂对照、双盲阶段活动花絮是在MBC进行< 1500 / microl患者淋巴细胞与卡培他滨治疗。使用一个2×2的阶乘设计,20名患者被随机分配到4个武器接受化疗前(i): CYT107或安慰剂;(2)在化疗期间:CYT107或安慰剂。主要终点是CD4 +计数变化之前和期间化疗。次要终点是血液毒性、安全性、总体响应,无进展生存(PFS)和总生存期(OS)。量化和功能循环免疫细胞的能力也被评估。结果:化疗前当管理,CYT107诱导显著增加CD4 + [CYT107 + 148.1%和+ 9.9%,安慰剂组,(Wilcoxon, P = 0.002)]和CD8 + t细胞计数,包括幼稚和记忆的子集。 When CYT107 was administered during chemotherapy, the magnitude of CD4+ and CD8+ increase was less important. No modulation of immune cell functional competence was observed. CYT107 was well tolerated with no related >/=grade 3 adverse events except 1 fatal suspected unexpected serious adverse reaction (SUSAR) of uncertain relationship. Of the 12 cases evaluable for response, 6 of 7 patients (86%) receiving CYT107 before chemotherapy achieved a response or stabilization, whereas two of five patients (40%) receiving placebo achieved the same result. No significant difference was observed for PFS or OS. CONCLUSION: In lymphopenic MBC, CYT107 increases CD4+ and other T-cell subset counts without altering their function. A larger clinical trial to demonstrate its impact on clinical outcome is warranted. CLINICALTRIALSGOV IDENTIFIER: NCT01362107.

DrugBank数据引用了这篇文章

药物

白介素- 7