首页 / 院系成果 / 成果详情页

Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial 期刊论文

编号：

68120B0EA4181BADAA9E92BCD3408279
作者：

Cui, Jiujie(崔玖洁)^[1,2]Qin, Shukui(秦叔逵)^[3]Zhou, Yuhong(周宇红)^[4]Zhang, Shuang^[5];Sun, Xiaofeng^[6,7,8];Zhang, Mingjun^[9];Cui, Jiuwei(崔久嵬)^[10]Fang, Weijia(方维佳)^[11]Gu, Kangsheng(顾康生)^[12]Li, Zhihua(李志花)^[13]Wang, Jufeng(王居峰)^[11]Chen, Xiaobing(陈小兵)^[11]Yao, Jun^[12];Zhou, Jun(周军)^[13]Wang, Gang^[14];Bai, Yuxian(白玉贤)^[15]Xiao, Juxiang(肖菊香)^[16]Qiu, Wensheng(邱文生)^[17]Wang, Bangmao(王邦茂)^[18]Xia, Tao^[19];Wang, Chunyue^[20];Kong, Li^[21];Yin, Jiajun^[22];Zhang, Tao(张涛)^[23]Shen, Xionghu(沈雄虎)^[24]Fu, Deliang(傅德良)^[25]Gao, Chuntao^[26];Wang, Huan^[27];Wang, Quanren^[27];Wang, Liwei(王理伟)^[1,2]
语种：

英文
期刊：

SIGNAL TRANSDUCTION AND TARGETED THERAPY ISSN：2095-9907 2024 年 9 卷 1 期 ; SEP 19
收录：
摘要：

Liposomal irinotecan has shown promising antitumor activity in patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have undergone prior gemcitabine-based therapies. This randomized, double-blind, parallel-controlled, multicenter phase 3 study (NCT05074589) assessed the efficacy and safety of liposomal irinotecan HR070803 combined with 5-fluorouracil (5-FU) and leucovorin (LV) in this patient population. Patients with unresectable, locally advanced, or metastatic PDAC who had previously received gemcitabine-based therapies were randomized 1:1 to receive either HR070803 (60 mg/m2 anhydrous irinotecan hydrochloride, equal to 56.5 mg/m2 free base) or placebo, both in combination with 5-FU (2000 mg/m2) and LV (200 mg/m2), all given intravenously every two weeks. The primary endpoint of the study was overall survival (OS). A total of 298 patients were enrolled and received HR070803 plus 5-FU/LV (HR070803 group, n = 149) or placebo plus 5-FU/LV (placebo group, n = 149). Median OS was significantly improved in the HR070803 group compared to the placebo group (7.4 months [95% CI 6.1-8.4] versus 5.0 months [95% CI 4.3-6.0]; HR 0.63 [95% CI 0.48-0.84]; two-sided p = 0.0019). The most common grade >= 3 adverse events in the HR070803 group were increased gamma-glutamyltransferase (19.0% versus 11.6% in placebo group) and decreased neutrophil count (12.9% versus 0 in placebo group). No treatment-related deaths occurred in the HR070803 group, while the placebo group reported one treatment-related death (abdominal infection). HR070803 in combination with 5-FU/LV has shown promising efficacy and manageable safety in advanced or metastatic PDAC in the second-line setting, representing a potential option in this patient population.
推荐引用方式
GB/T 7714：

Cui Jiujie,Qin Shukui,Zhou Yuhong, et al. Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial [J].SIGNAL TRANSDUCTION AND TARGETED THERAPY,2024,9(1).
APA：

Cui Jiujie,Qin Shukui,Zhou Yuhong,Zhang Shuang,&Wang Liwei.(2024).Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial .SIGNAL TRANSDUCTION AND TARGETED THERAPY,9(1).
MLA：

Cui Jiujie, et al. "Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial" .SIGNAL TRANSDUCTION AND TARGETED THERAPY 9,1(2024).
入库时间：

2025/2/19 14:45:56
更新时间：

2025/2/21 12:42:40

浏览次数：9  下载次数：0

分享到：

浏览次数：9

下载次数：0

打印次数：0