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Annals of Oncology Advance Access published online on July 30, 2008
Annals of Oncology, doi:10.1093/annonc/mdn401
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

A phase II randomized multicenter trial of gefitinib plus FOLFIRI and FOLFIRI alone in patients with metastatic colorectal cancer

A. Santoro1, A. Comandone2, L. Rimassa1, C. Granetti3, V. Lorusso4, C. Oliva2, M. Ronzoni5, S. Siena6, M. Zuradelli1, E. Mari7, T. Pressiani1 and C. Carnaghi1,*

1 Unità Operativa di Oncologia e Ematologia, Istituto Clinico Humanitas, Rozzano
2 Oncologia, Ospedale Gradenigo, Turin
3 Oncologia Medica, Azienda Ospedaliera S. Croce, Cuneo
4 Oncologia Medica, Istituto Oncologico, Bari
5 Servizio di Oncologia, Istituto Scientifico Universitario San Raffaele
6 Divisione di Oncologia Medica Falck, Ospedale Niguarda Ca'Granda, Milan
7 Research & Development, AstraZeneca, Basiglio, Italy

* Correspondence to: C. Carnaghi, Via Manzoni 56, 20089 Rozzano, Milan, Italy. Tel: +39-02-82244073; Fax: +39-02-82244590; E-mail: carlo.carnaghi{at}humanitas.it

Background: Gefitinib inhibits the epidermal growth factor receptor tyrosine kinase and preclinical studies indicate that it may enhance CPT-11 cytotoxicity. This randomized phase II trial investigates the feasibility and efficacy of gefitinib and 5-fluorouracil, folinic acid, irinotecan (FOLFIRI) in patients with metastatic colorectal cancer.

Patients and methods: Patients were randomized to FOLFIRI ± gefitinib 250 mg daily p.o. Patients randomized to FOLFIRI + gefitinib without disease progression after 6 months continued to receive gefitinib alone until disease progression.

Results: From October 2002 to September 2004, 100 patients were enrolled. Twenty-three patients (47.9%) in the FOLFIRI arm and 23 (45.1%) in the FOLFIRI + gefitinib arm experienced an objective response. The median progression-free survival and overall survival were 8.3 and 18.6 months in the FOLFIRI arm, and 8.3 and 17.1 months in the FOLFIRI + gefitinib arm, respectively. In the combination arm, grades 3–4 adverse events were experienced by 35 (67.3%) patients versus 25 patients (52.1%) in the FOLFIRI arm; 12 patients (23.1%) withdrew for an adverse event in the FOLFIRI + gefitinib arm and 5 (10.4%) in the FOLFIRI arm.

Conclusions: These data show that adding gefitinib to FOLFIRI does not improve the efficacy of FOLFIRI regimen. These disappointing results could be related to the high toxicity observed that led to significant dose reductions and delays.

colorectal cancer, EGFR, FOLFIRI, gefitinib, metastatic

Received for publication February 18, 2008. Revision received May 22, 2008. Accepted for publication May 23, 2008.


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