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Investigational New Drugs

, Volume 30, Issue 2, pp 787–793 | Cite as

Phase II study of combination chemotherapy with biweekly cetuximab and irinotecan for wild-type KRAS metastatic colorectal cancer refractory to irinotecan, oxaliplatin, and fluoropyrimidines

  • Kohei Shitara
  • Satoshi Yuki
  • Motoki Yoshida
  • Daisuke Takahari
  • Setsuo Utsunomiya
  • Tomoya Yokota
  • Yozo Sato
  • Yoshitaka Inaba
  • Masahiro Tajika
  • Hiroki Kawai
  • Hidekazu Yamaura
  • Mina Kato
  • Kentaro Yamazaki
  • Yoshito Komatsu
  • Kei Muro
PHASE II STUDIES

Summary

The aim of this study is to prospectively evaluate the efficacy of combination chemotherapy with every second week cetuximab and irinotecan in patients with pretreated metastatic colorectal cancer harboring wild-type KRAS. Patients with wild-type KRAS metastatic colorectal cancer that had progressed after chemotherapy with irinotecan, oxaliplatin, and fluoropyrimidine were included. Cetuximab was administered at 500 mg/m2 biweekly with irinotecan. The primary endpoint was response rate. The pharmacokinetics of cetuximab was also evaluated in 5 patients. From May 2009 to February 2010, a total of 31 patients were enrolled from five institutions. One patient was not eligible. Among the 30 patients who were treated with biweekly cetuximab plus irinotecan, partial response was observed in 9 patients. The objective response rate was 30.0% (95% confidence interval [CI], 14.7%–49.4%) and the disease control rate (complete response, partial response, or stable disease) was 76.7% (95% CI, 57.7%–90.0%). The median progression-free survival was 5.3 months and median overall survival was 10.8 months. Grade 3 skin toxicity was observed in 3 patients (10.0%) and one treatment related death due to pneumonia was observed. Combination chemotherapy with biweekly cetuximab and irinotecan was effective for pretreated metastatic colorectal cancer with wild-type KRAS.

Keywords

Colorectal cancer Chemotherapy Cetuximab Biweekly Irinotecan 

Notes

Acknowledgments

None declared.

Funding

None.

Conflict of interest statement

None declared.

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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Kohei Shitara
    • 1
  • Satoshi Yuki
    • 2
  • Motoki Yoshida
    • 3
  • Daisuke Takahari
    • 1
  • Setsuo Utsunomiya
    • 4
  • Tomoya Yokota
    • 1
  • Yozo Sato
    • 5
  • Yoshitaka Inaba
    • 5
  • Masahiro Tajika
    • 6
  • Hiroki Kawai
    • 6
  • Hidekazu Yamaura
    • 5
  • Mina Kato
    • 5
  • Kentaro Yamazaki
    • 7
  • Yoshito Komatsu
    • 8
  • Kei Muro
    • 1
  1. 1.Department of Clinical OncologyAichi Cancer Center HospitalNagoyaJapan
  2. 2.Department of GastroenterologyHokkaido University Graduate School of MedicineSapporoJapan
  3. 3.Cancer Chemotherapy CenterOsaka Medical CollegeOsakaJapan
  4. 4.Department of GastroenterologyNagoya Kyoritsu HospitalNagoyaJapan
  5. 5.Department of Diagnostic and Interventional RadiologyAichi Cancer Center HospitalNagoyaJapan
  6. 6.Department of GastroenterologyAichi Cancer Center HospitalNagoyaJapan
  7. 7.Department of GastroenterologyShizuoka Cancer CenterShizuokaJapan
  8. 8.Department of Cancer ChemotherapyHokkaido University Hospital Cancer CenterSapporoJapan

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