A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer

A. H. Ko, M. A. Tempero, Y. S. Shan, W. C. Su, Y. L. Lin, E. Dito, A. Ong, Y. W. Wang, C. G. Yeh, L. T. Chen

研究成果: Article同行評審

122 引文 斯高帕斯(Scopus)

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 ≥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.

原文English
頁(從 - 到)920-925
頁數6
期刊British Journal of Cancer
109
發行號4
DOIs
出版狀態Published - 2013 八月 20

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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