國家衛生研究院 NHRI:Item 3990099045/12078
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    题名: Phase III randomized study of second line ADI-peg 20 (A) plus best supportive care versus placebo (P) plus best supportive care in patients (pts) with advanced hepatocellular carcinoma (HCC)
    作者: Abou-Alfa, GK;Qin, SK;Ryoo, BY;Lu, SN;Yen, CJ;Feng, YH;Lim, HY;Izzo, F;Colombo, M;Sarker, D;Bolondi, L;Vaccaro, GM;Harris, WP;Chen, ZD;Hubner, R;Meyer, T;Bomalaski, JS;Lin, CC;Chao, Y;Chen, LT
    贡献者: National Institute of Cancer Research
    摘要: Background: Arginine (Ar) depletion is a putative target in HCC, which lacks the citrulline (Ci) to Ar repleting enzyme argininosuccinate synthetase. A is an Ar degrading enzyme cloned from M. hominis and produced in E. coli and conjugated with polyethylene glycol. Methods: Pts with histologically proven advanced HCC and Child-Pugh (CP) up to B7 who failed or were intolerant to prior systemic therapy, were 2:1 randomized to A 18 mg/m2vs P IM injection weekly. The study was stratified by the combination of geographic region (Asia vs Other) and prior treatment status (sorafenib (S) vs other (O) failure). The primary endpoint was overall survival (OS) with secondary endpoints progression-free survival (PFS), safety and Ar and Ci levels correlatives. The study was planned for 422 A and 211 P, with 93% power to detect a 1.6 months (m) increase in median OS (4 to 5.6 m; 1-sided α = 0.025). Results: 635 pts were enrolled: median age 61, 82% male, 60% Asian, 52% hepatitis B, 26% hepatitis C, 13% alcohol and 7% NASH, 76% stage IV and 30% vascular invasion, CP A 90.6%, 70% progressed on S, 11.2% on O and 18.8% did not tolerate either. The mean number of doses was 14 for A and 17 for P. Median OS was 7.8 m for A vs 7.4 for P (p = 0.884, HR=1.022 (95% CI: 0.847, 1.233)) and median PFS 2.6 vs 2.6 (p = 0.075, HR=1.175 (95% CI: 0.964, 1.432)). The most common grade 3 and above AEs in both groups were fatigue (A: 1.9% and P: 3.3%), and decreased appetite (A: 1.9%, and P: 1.4%). Hypersensitivity reactions including anaphylaxis occurred in 2.1% pts on A. There were 15% deaths on A arm within 30 days of last dose vs 10.4% on P (progressive disease 83%, GI hemorrhage 8%, unknown/other 9%) Pts with Ar depletion for >8 weeks had a median OS of 12.3 m compared to 7.3 m (P = 0.0032) for ≤ 4 weeks. Similarly, pts with Ci increase for >8 weeks had a median OS of 11.6 m, compared to 3.5 m (P<0.0001) for ≤4 weeks. Conclusions: A did not demonstrate an OS benefit in the population of advanced HCC with failed prior systemic therapy. A was well tolerated. An OS benefit associated with prolonged Ar depletion was noted. Strategies to enhance prolonged arginine depletion and/or synergize the effect of A are underway
    日期: 2016-05
    關聯: Journal of Clinical Oncology. 2016 May;34(15, Suppl. S):Abstract number 4017.
    Link to: http://dx.doi.org/10.1200/JCO.2016.34.15_suppl.4017
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0732-183X&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000404665405243
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