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

  • Claus-Henning Köhne
  • Ralf Hofheinz
  • Laurent Mineur
  • Henry Letocha
  • Richard Greil
  • Josef Thaler
  • Eva Fernebro
  • Erick Gamelin
  • Lucy DeCosta
  • Meinolf Karthaus
Original Paper

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.

Keywords

Chemotherapy Fully human monoclonal antibody Metastatic colorectal cancer Panitumumab 

Supplementary material

432_2011_1061_MOESM1_ESM.pdf (58 kb)
Supplementary material 1 (PDF 58 kb)

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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Claus-Henning Köhne
    • 1
  • Ralf Hofheinz
    • 2
  • Laurent Mineur
    • 3
  • Henry Letocha
    • 4
  • Richard Greil
    • 5
  • Josef Thaler
    • 6
  • Eva Fernebro
    • 7
  • Erick Gamelin
    • 8
  • Lucy DeCosta
    • 9
  • Meinolf Karthaus
    • 10
    • 11
  1. 1.Department of Hematology and OncologyOnkologie Klinikum OldenburgOldenburgGermany
  2. 2.Day Treatment Centre at the Interdisciplinary Tumour Centre MannheimUniversitätsmedizin MannheimMannheimGermany
  3. 3.Radiology and Oncology CentreInstitut Sainte-CatherineAvignonFrance
  4. 4.Department of OncologyCounty HospitalVästeråsSweden
  5. 5.Third Medical DepartmentUniversity Hospital SalzburgSalzburgAustria
  6. 6.Department of Hematology and Medical OncologyKlinikum Wels-GrieskirchenWelsAustria
  7. 7.Department of OncologyUniversity HospitalLundSweden
  8. 8.Department of Medical Oncology and OncopharmacologyCentre Paul PapinAngersFrance
  9. 9.Biostatistics, Amgen LimitedUxbridgeUK
  10. 10.Department of Hematology, Oncology and Palliative MedicineKlinikum NeuperlachMunichGermany
  11. 11.Department of Hematology, Oncology and Palliative MedicineKlinikum HarlachingMunichGermany

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