We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
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.
- Authors
Chibaudel, Benoist; Maindrault‐Gœbel, Frédérique; Bachet, Jean‐Baptiste; Louvet, Christophe; Khalil, Ahmed; Dupuis, Olivier; Hammel, Pascal; Garcia, Marie‐Line; Bennamoun, Mostefa; Brusquant, David; Tournigand, Christophe; André, Thierry; Arbaud, Claire; Larsen, Annette K; Wang, Yi‐Wen; Yeh, C. Grace; Bonnetain, Franck; Gramont, Aimery
- Abstract
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.
- Subjects
COLON cancer treatment; IRINOTECAN; FOLINIC acid; FLUOROURACIL; BEVACIZUMAB; THERAPEUTICS
- Publication
Cancer Medicine, 2016, Vol 5, Issue 4, p676
- ISSN
2045-7634
- Publication type
Article
- DOI
10.1002/cam4.635