國家衛生研究院 NHRI:Item 3990099045/7401
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    题名: A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
    作者: Ko, AH;Tempero, MA;Shan, YS;Su, WC;Lin, YL;Dito, E;Ong, A;Wang, YW;Yeh, CG;Chen, LT
    贡献者: National Institute of Cancer Research
    摘要: Background:PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Methods:Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status greater than or equal to70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS3-month). Results: A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. Conclusion:PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
    日期: 2013-08
    關聯: British Journal of Cancer. 2013 Aug;109(4):920-925.
    Link to: http://dx.doi.org/10.1038/bjc.2013.408
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0007-0920&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000323417100014
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84883169930
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