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Clinical Trial
. 2008 Nov 1;14(21):7074-9.
doi: 10.1158/1078-0432.CCR-08-1014.

A phase II study of gefitinib, 5-fluorouracil, leucovorin, and oxaliplatin in previously untreated patients with metastatic colorectal cancer

George A Fisher  1 , Timothy Kuo, Meghan Ramsey, Erich Schwartz, Robert V Rouse, Cheryl D Cho, Joanne Halsey, Branimir I Sikic
Affiliations
Clinical Trial

A phase II study of gefitinib, 5-fluorouracil, leucovorin, and oxaliplatin in previously untreated patients with metastatic colorectal cancer

George A Fisher et al. Clin Cancer Res. .

Abstract

Purpose: We investigated the gefitinib, 5-fluorouracil (5-FU), leucovorin and oxaliplatin (IFOX) regimen as first-line therapy in patients with metastatic colorectal cancer.

Experimental design: Eligible patients had stage IV colorectal adenocarcinoma, and had not received prior chemotherapy for metastatic disease. Each cycle consisted of 14 days. Cycle 1 consisted of oxaliplatin, leucovorin, and 5-FU (FOLFOX-4). All subsequent cycles consisted of FOLFOX-4 with gefitinib at 500 mg orally daily throughout the 14-day cycle.

Results: Forty-five patients were enrolled and were assessable for toxicity. Forty-three patients were assessable for response. Thirty-one of the 43 patients (72%) had either a complete or partial response by the Response Evaluation Criteria in Solid Tumors. Median overall survival was 20.5 months. Median time to progression was 9.3 months. Commonly encountered grade 3 or 4 toxicities included diarrhea in 67% of patients and neutropenia in 60%. Grade 2 acneiform skin rash typical of gefitinib occurred in 60% of patients.

Conclusions: IFOX is an active first-line regimen in patients with metastatic colorectal adenocarcinoma, showing higher response rates but also increased toxicities compared with FOLFOX-4 alone in a similar patient population.

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Figures

Figure 1
Figure 1
Overall survival for the 43 assessable patients (median 20.5 months).
Figure 2
Figure 2
Overall survival for responders vs. non-responders among the 43 assessable patients.
Figure 3
Figure 3
Overall survival according to tumor EGFR expression status for the 41 patients with known EGFR expression by immunohistochemical assay.
See this image and copyright information in PMC

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