https://scholars.lib.ntu.edu.tw/handle/123456789/375950
Title: | A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer | Authors: | YU-LIN LIN | Issue Date: | 2013 | Journal Volume: | 109 | Journal Issue: | 4 | Start page/Pages: | 920-925 | Source: | British Journal of Cancer | 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. |
URI: | http://www.scopus.com/inward/record.url?eid=2-s2.0-84883169930&partnerID=MN8TOARS http://scholars.lib.ntu.edu.tw/handle/123456789/375950 |
DOI: | 10.1038/bjc.2013.408 | SDG/Keyword: | 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 |
Appears in Collections: | 腫瘤醫學研究所 |
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