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

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TitrePEPCOL: 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
Type de publicationJournal Article
Year of Publication2016
AuteursChibaudel B, Maindrault-Goebel F, Bachet J-B, Louvet C, Khalil A, Dupuis O, Hammel P, Garcia M-L, Bennamoun M, Brusquant D, Tournigand C, Andre T, Arbaud C, Larsen AK, Wang Y-W, C. Yeh G, Bonnetain F, de Gramont A
JournalCANCER MEDICINE
Volume5
Pagination676-683
Date PublishedAPR
Type of ArticleArticle
ISSN2045-7634
Mots-clésColorectal cancer, MM398, nanoliposomal irinotecan, PEP02, Phase II
Résumé

{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 80mg/m(2) with LV 400mg/m(2) on day 1 and 5-FU 2400mg/m(2) on days 1-2). Bevacizumab (5mg/kg, biweekly) was allowed in both arms. The primary endpoint was 2-month response rate (RR). Fifty-five patients were randomized (FOLFIRI
DOI10.1002/cam4.635