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

Koehne, Claus-Henning; Hofheinz, Ralf; Mineur, Laurent; Letocha, Henry; Greil, Richard; Thaler, Josef; Fernebro, Eva LU ; Gamelin, Erick; DeCosta, Lucy and Karthaus, Meinolf (2012) In Journal of Cancer Research and Clinical Oncology 138(1). p.65-72
Abstract
Purpose Panitumumab 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. Methods In this phase II, single-arm study, panitumumab (6 mg/kg) and FOLFIRI [irinotecan (180 mg/m(2)) and leucovorin (400 mg/m(2)) followed by a 5-fluorouracil 400 mg/m(2) bolus and a 2,400-3,000 mg/m(2) 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... (More)
Purpose Panitumumab 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. Methods In this phase II, single-arm study, panitumumab (6 mg/kg) and FOLFIRI [irinotecan (180 mg/m(2)) and leucovorin (400 mg/m(2)) followed by a 5-fluorouracil 400 mg/m(2) bolus and a 2,400-3,000 mg/m(2) 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%). Conclusions As expected, consistently favourable efficacy was observed in patients with KRAS WT versus MT tumours receiving first-line panitumumab plus FOLFIRI treatment. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Chemotherapy, Fully human monoclonal antibody, Metastatic colorectal, cancer, Panitumumab
in
Journal of Cancer Research and Clinical Oncology
volume
138
issue
1
pages
65 - 72
publisher
Springer
external identifiers
  • wos:000300344500007
  • scopus:84857050570
ISSN
1432-1335
DOI
10.1007/s00432-011-1061-6
language
English
LU publication?
yes
id
254cce28-3a88-42c1-95da-d82ee9a9d5a7 (old id 2409693)
date added to LUP
2012-04-02 09:31:51
date last changed
2017-09-24 03:09:35
@article{254cce28-3a88-42c1-95da-d82ee9a9d5a7,
  abstract     = {Purpose Panitumumab 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. Methods In this phase II, single-arm study, panitumumab (6 mg/kg) and FOLFIRI [irinotecan (180 mg/m(2)) and leucovorin (400 mg/m(2)) followed by a 5-fluorouracil 400 mg/m(2) bolus and a 2,400-3,000 mg/m(2) 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%). Conclusions As expected, consistently favourable efficacy was observed in patients with KRAS WT versus MT tumours receiving first-line panitumumab plus FOLFIRI treatment.},
  author       = {Koehne, Claus-Henning and Hofheinz, Ralf and Mineur, Laurent and Letocha, Henry and Greil, Richard and Thaler, Josef and Fernebro, Eva and Gamelin, Erick and DeCosta, Lucy and Karthaus, Meinolf},
  issn         = {1432-1335},
  keyword      = {Chemotherapy,Fully human monoclonal antibody,Metastatic colorectal,cancer,Panitumumab},
  language     = {eng},
  number       = {1},
  pages        = {65--72},
  publisher    = {Springer},
  series       = {Journal of Cancer Research and Clinical Oncology},
  title        = {First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer},
  url          = {http://dx.doi.org/10.1007/s00432-011-1061-6},
  volume       = {138},
  year         = {2012},
}