https://scholars.lib.ntu.edu.tw/handle/123456789/375950
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.author | YU-LIN LIN | en |
dc.creator | Ko, A.H. and Tempero, M.A. and Shan, Y.-S. and Su, W.-C. and Lin, Y.-L. and Dito, E. and Ong, A. and Wang, Y.-W. and Yeh, C.G. and Chen, L.-T. | - |
dc.date.accessioned | 2018-09-10T09:39:59Z | - |
dc.date.available | 2018-09-10T09:39:59Z | - |
dc.date.issued | 2013 | - |
dc.identifier.uri | http://www.scopus.com/inward/record.url?eid=2-s2.0-84883169930&partnerID=MN8TOARS | - |
dc.identifier.uri | http://scholars.lib.ntu.edu.tw/handle/123456789/375950 | - |
dc.description.abstract | 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 ?70, 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 (OS 3-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 OS 3-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. ? 2013 Cancer Research UK. All rights reserved. | - |
dc.language | en | en |
dc.relation.ispartof | British Journal of Cancer | en_US |
dc.source | AH | - |
dc.subject.classification | [SDGs]SDG3 | - |
dc.subject.other | gemcitabine; irinotecan; pep 02; unclassified drug; abdominal pain; adult; aged; anemia; anorexia; article; asthenia; clinical article; controlled study; diarrhea; fatigue; female; human; hyponatremia; leukopenia; male; metastasis; monotherapy; multicenter study; multiple cycle treatment; nausea; neutropenia; overall survival; pancreas adenocarcinoma; pancreas cancer; phase 2 clinical trial; priority journal; progression free survival; Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Camptothecin; Disease-Free Survival; Drug Combinations; Female; Humans; Liposomes; Male; Middle Aged; Pancreatic Neoplasms; Salvage Therapy; Sucrose; Treatment Outcome | - |
dc.title | A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer | - |
dc.type | journal article | en |
dc.identifier.doi | 10.1038/bjc.2013.408 | - |
dc.relation.pages | 920-925 | - |
dc.relation.journalvolume | 109 | - |
dc.relation.journalissue | 4 | - |
item.fulltext | no fulltext | - |
item.openairetype | journal article | - |
item.openairecristype | http://purl.org/coar/resource_type/c_6501 | - |
item.grantfulltext | none | - |
item.cerifentitytype | Publications | - |
crisitem.author.orcid | 0000-0001-5574-7062 | - |
顯示於: | 腫瘤醫學研究所 |
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