医学
吉西他滨
耐火材料(行星科学)
内科学
安慰剂
双盲
肿瘤科
随机对照试验
胰腺癌
安慰剂对照研究
癌症
病理
物理
替代医学
天体生物学
作者
L. Wang,S. Qin,Y. Zhou,S. Zhang,X. Sun,Zhiqiang Chen,J. Cui,P. Zhao,KRISTINE D. GU,Z. Li,J. Wang,X. Chen,J. Yao,L. Shen,J. Zhou,G. Wang,Y. Bai,Q. Wang,H. Wang
标识
DOI:10.1016/j.annonc.2022.08.063
摘要
Irinotecan liposome plus 5-FU/LV is one of the standard therapy for metastatic pancreatic cancer(mPC) with failed to gemcitabine-based therapy. HR070803 is a liposome formulation of irinotecan and this study aimed to investigate the efficacy and safety of HR070803 plus 5-FU/LV versus placebo plus 5-FU/LV as the second-line treatment in patients with locally advanced pancreatic cancer(LAPC) or mPC who failed to gemcitabine-based therapy. Patients (pts) were randomly assigned (1:1) to receive HR070803 56.5 mg/m2 (based on irinotecan free base) plus 5-FU/LV 2000/200mg/m2 (arm A) or placebo plus 5-FU/LV 2000/200mg/m2 (arm B). Randomization was stratified by serum albumin level, treatment history of fluorouracil, treatment history of gemcitabine. The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival(PFS), objective response rate(ORR) and safety profile, etc. The analysis was based on 228 deaths, with a cutoff date of Nov 18, 2021. From January 2018 to May 2021, 298 pts were randomly assigned. At a median follow-up of 12.81 months, the primary endpoint with mOS of 7.39 months (95%CI: 6.05-8.41) and 4.99 months (95%CI: 4.27-6.01) in arm A and arm B has met (HR =0.63, 96.4% CI: 0.48-0.84; P=0.0019). Secondary endpoint mPFS was 4.21 months (95%CI: 2.92-5.59) vs. 1.48 months (95%CI: 1.41-1.58) (HR =0.36, 95% CI: 0.27-0.48; P<0.0001), and ORR was 12.75% (95%CI: 7.86-19.20) vs. 0.67% (95%CI: 0.02-3.68) (P<0.0001). In the safety population of 296 pts, the most common grade ≥3 AEs in arm A were γ-GGT elevations (19.05%) and neutropenia (12.93%). The incidence of all grade and grade≥3 diarrhea was 45.58% and 4.08%, neutropenia was 33.33% and 12.93%, cholinergic syndrome was 1.36% and 0% in arm A. HR070803 plus 5-FU/LV demonstrated a highly statistically significant and clinically meaningful improvement in OS in treatment of locally advanced or metastatic PC with prior gemcitabine-based therapy. Along with a manageable safety profile, these data suggest HR070803 plus 5-FU/LV is a new treatment selection for the population.
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