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/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%).
Conclusions
As expected, consistently favourable efficacy was observed in patients with KRAS WT versus MT tumours receiving first-line panitumumab plus FOLFIRI treatment.
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Acknowledgments
This work was supported by Amgen (Europe) GmbH, Zug, Switzerland. Medical writing support [funded by Amgen (Europe) GmbH] provided by Dawn Batty (Bioscript Stirling Ltd); manuscript preparation assistance provided by Emma Thomas (Amgen). Pamela Ward and David Eaton: study management; Marco Schupp: study design/initiation; Karin Blakolmer: critical review of the data/manuscript (all Amgen employees).
Conflict of interest
CHK has acted as a consultant/advisor to Amgen Ltd, Merck KG Damstadt & Roche Ltd; HL has acted as a consultant/advisor for Amgen Ltd & Roche Ltd; RH, JT & MK have received honoraria from Amgen Ltd, JT has also received research funding and MK has also acted as an advisor for this company; EG & LDC are employees of Amgen Ltd and also own shares in this company.
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Köhne, CH., Hofheinz, R., Mineur, L. et al. First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer. J Cancer Res Clin Oncol 138, 65–72 (2012). https://doi.org/10.1007/s00432-011-1061-6
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DOI: https://doi.org/10.1007/s00432-011-1061-6