PEPCOL: a GERCOR randomized phase II study of nanoliposomal irinotecan PEP02 (MM-398) or irinotecan with leucovorin/5-fluorouracil as second-line therapy in metastatic colorectal cancer

详细信息    查看全文

• 作者：Benoist Chibaudel ; Fré ; dé ; rique Maindrault-Gœbel ; Jean-Baptiste Bachet ; Christophe Louvet ; Ahmed Khalil ; Olivier Dupuis ; Pascal Hammel ; Marie-Line Garcia ; Mostefa Bennamoun ; David Brusquant ; Christophe Tournigand ; Thierry André ; Claire Arbaud ; Annette K Larsen ; Yi-Wen Wang ; C. Grace Yeh ; Franck Bonnetain and Aimery de Gramont
• 关键词：Colorectal cancer ; MM398 ; nanoliposomal irinotecan ; PEP02 ; phase II
• 刊名：Cancer Medicine
• 出版年：2016
• 出版时间：April 2016
• 年：2016
• 卷：5
• 期：4
• 页码：676-683
• 全文大小：120K
• ISSN：2045-7634

文摘

A multicenter, open-label, noncomparative, randomized phase II study (PEPCOL) was conducted to evaluate the efficacy and safety of the irinotecan or PEP02 (MM-398, nanoliposomal irinotecan) with leucovorin (LV)/5-fluorouracil (5-FU) combination as second-line treatment in patients with metastatic colorectal cancer (mCRC). Patients with unresectable mCRC who had failed one prior oxaliplatin-based first-line therapy were randomized toirinotecan with LV/5-FU (FOLFIRI) or PEP02 with LV/5-FU (FUPEP; PEP02 80 mg/m² with LV 400 mg/m² on day 1 and 5-FU 2400 mg/m² on days 1–2). Bevacizumab (5 mg/kg, biweekly) was allowed in both arms. The primary endpoint was 2-month response rate (RR). Fifty-five patients were randomized (FOLFIRI, n = 27; FUPEP, n = 28). In the intent-to-treat population (n = 55), 2-month RR response rate was observed in two (7.4%) and three (10.7%) patients in the FOLFIRI and FUPEP arms, respectively. The most common grade 3–4 adverse events reported in the respective FOLFIRI and FUPEP arms were diarrhea (33% vs. 21%), neutropenia (30% vs. 11%), mucositis (11% vs. 11%), and grade 2 alopecia (26% vs. 25%). FUPEP has activity and acceptable safety profile in oxaliplatin-pretreated mCRC patients.