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Clinical and Translational Oncology

, Volume 15, Issue 9, pp 705–711 | Cite as

Panitumumab and irinotecan every 3 weeks is an active and convenient regimen for second-line treatment of patients with wild-type K-RAS metastatic colorectal cancer

  • A. CarratoEmail author
  • A. Gómez
  • P. Escudero
  • M. Chaves
  • F. Rivera
  • E. Marcuello
  • E. González
  • C. Grávalos
  • M. Constenla
  • J. Luis Manzano
  • F. Losa
  • J. Maurel
  • R. Dueñas
  • B. Massuti
  • J. Gallego
  • J. Aparicio
  • A. Antón
  • E. Aranda
Research Article

Abstract

Purpose

To evaluate the efficacy and safety profile of the combination of panitumumab and irinotecan every 3 weeks in a phase II trial as second-line treatment in patients with advanced wild-type (WT) K-RAS colorectal cancer (CRC).

Methods

Fifty-three patients received 9 mg/kg of panitumumab followed by 350 mg/m2 of irinotecan every 21 days until disease progression, unacceptable toxicity or consent withdrawal.

Results

Median age of patients included was 67 years. All patients had previously received 5-fluorouracil, 84 % oxaliplatin and 8 % irinotecan as first-line treatment. Patients received a median of five infusions of panitumumab and irinotecan. On an intention-to-treat analysis, 12 patients (23 %) achieved partial responses and 22 patients (41 %) achieved disease stabilization. Median progression-free survival and overall survival were 4.5 and 15.1 months, respectively. The most frequent treatment-related severe toxicities per patient were diarrhoea (35.8 %), followed by skin rash (32.1 %), asthenia (18.9 %) and neutropenia (13.2 %). A significant association between clinical response and incidence and grade of skin toxicity was observed (p = 0.0032).

Conclusion

This study shows that the administration of panitumumab plus irinotecan every 3 weeks is safe, active and feasible as second-line treatment in patients with advanced WT K-RAS CRC.

Keywords

Colorectal cancer Epidermal growth factor receptor (EGFR) inhibitors Monoclonal antibodies Prospective trial Topoisomerase I inhibitors 

Notes

Acknowledgments

The authors thank the patients and the medical and nursing staff of all the participating institutions: Also, the authors acknowledge Inmaculada Ruiz de Mena from TTD Data Center and Marta Llorens and Xavier Núñez from TFS Trial Form Support for monitoring, statistics and data management. This research, including data collection, analysis and medical writing services, was funded by Amgen. The authors also thank Dr. Beatriz Gil-Alberdi from HealthCo (Madrid, Spain) for her assistance in the preparation of the manuscript. Supported by the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD), Madrid, Spain.

Conflict of interest

Alfredo Carrato, consultant or advisory role (Amgen, Merck Serono) and research funding (Amgen). Fernando Rivera, consultant or advisory role (Amgen) and research funding (Amgen). Enrique Aranda, consultant or advisory role (Roche and Merck Serono). All remaining authors have declared no conflict of interest.

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Copyright information

© Federación de Sociedades Españolas de Oncología (FESEO) 2012

Authors and Affiliations

  • A. Carrato
    • 1
    Email author
  • A. Gómez
    • 2
  • P. Escudero
    • 3
  • M. Chaves
    • 4
  • F. Rivera
    • 5
  • E. Marcuello
    • 6
  • E. González
    • 7
  • C. Grávalos
    • 8
  • M. Constenla
    • 9
  • J. Luis Manzano
    • 10
  • F. Losa
    • 11
  • J. Maurel
    • 12
  • R. Dueñas
    • 13
  • B. Massuti
    • 14
  • J. Gallego
    • 15
  • J. Aparicio
    • 16
  • A. Antón
    • 17
  • E. Aranda
    • 2
  1. 1.Medical Oncology DepartmentRamón y Cajal University HospitalMadridSpain
  2. 2.Medical Oncology DepartmentReina Sofía HospitalCórdobaSpain
  3. 3.Medical Oncology DepartmentClínico Lozano Blesa University HospitalZaragozaSpain
  4. 4.Medical Oncology DepartmentVirgen del Rocío University HospitalSevillaSpain
  5. 5.Medical Oncology DepartmentMarqués de Valdecilla University HospitalSantanderSpain
  6. 6.Medical Oncology DepartmentSanta Creu i Sant Pau HospitalBarcelonaSpain
  7. 7.Medical Oncology DepartmentVirgen de las Nieves HospitalGranadaSpain
  8. 8.Medical Oncology DepartmentDoce de Octubre University HospitalMadridSpain
  9. 9.Medical Oncology DepartmentPontevedra Hospital ComplexPontevedraSpain
  10. 10.Medical Oncology DepartmentCatalán Oncology Institut, German Trias I Pujol HospitalBadalonaSpain
  11. 11.Medical Oncology DepartmentL′Hospitalet General HospitalBarcelonaSpain
  12. 12.Medical Oncology DepartmentClínic HospitalBarcelonaSpain
  13. 13.Medical Oncology DepartmentJaén Hospital ComplexJaenSpain
  14. 14.Medical Oncology DepartmentAlicante General HospitalAlicanteSpain
  15. 15.Medical Oncology DepartmentElche University General HospitalElcheSpain
  16. 16.Medical Oncology DepartmentLa Fe University HospitalValenciaSpain
  17. 17.Medical Oncology DepartmentMiguel Servet HospitalZaragozaSpain

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