First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer

PurposePanitumumab monotherapy is approved for KRAS wild-type (WT) metastatic colorectal cancer (mCRC) progressing after standard chemotherapy. This study evaluated first-line panitumumab plus FOLFIRI in patients with mCRC.MethodsIn this phase II, single-arm study, panitumumab (6 mg/kg) and FOLFIRI...

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Main Authors: Köhne, Claus-Henning (Author) , Hofheinz, Ralf-Dieter (Author)
Format: Article (Journal)
Language:English
Published: 2012
In: Journal of cancer research and clinical oncology
Year: 2011, Volume: 138, Issue: 1, Pages: 65-72
ISSN:1432-1335
DOI:10.1007/s00432-011-1061-6
Online Access:Verlag, Volltext: http://dx.doi.org/10.1007/s00432-011-1061-6
Verlag, Volltext: https://doi.org/10.1007/s00432-011-1061-6
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Author Notes:Claus-Henning Köhne, Ralf Hofheinz, Laurent Mineur, Henry Letocha, Richard Greil, Josef Thaler, Eva Fernebro, Erick Gamelin, Lucy DeCosta, Meinolf Karthaus
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Summary:PurposePanitumumab monotherapy is approved for KRAS wild-type (WT) metastatic colorectal cancer (mCRC) progressing after standard chemotherapy. This study evaluated first-line panitumumab plus FOLFIRI in patients with mCRC.MethodsIn this phase II, single-arm study, panitumumab (6 mg/kg) and FOLFIRI [irinotecan (180 mg/m2) and leucovorin (400 mg/m2) followed by a 5-fluorouracil 400 mg/m2 bolus and a 2,400-3,000 mg/m2 continuous infusion] were administered every 14 days until progression. Data were analysed descriptively overall and by tumour KRAS status.Results KRAS data were available for 145/154 (94%) patients: 59% KRAS WT and 41% mutant (MT); mean follow-up was 39.5 versus 35.8 weeks, respectively. Objective responses occurred in 49% of patients: 56% versus 38% in the KRAS WT versus MT groups [(18% difference (95% CI 1-35%); odds ratio 2.1 (95% CI 1.0-4.4)]; median duration of response was 13.0 versus 7.4 months. More patients in the WT group underwent R0 resection (8% vs. 5%); median progression-free survival also favoured this group (8.9 vs. 7.2 months). The most common adverse events (any grade) were integument toxicities (98%), diarrhoea (79%) and stomatitis/oral mucositis (51%).ConclusionsAs expected, consistently favourable efficacy was observed in patients with KRAS WT versus MT tumours receiving first-line panitumumab plus FOLFIRI treatment.
Item Description:First online: 30 September 2011
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Physical Description:Online Resource
ISSN:1432-1335
DOI:10.1007/s00432-011-1061-6