Gefitinib in Combination with Oxaliplatin and 5-Fluorouracil in Irinotecan-Refractory Patients with Colorectal Cancer: A Phase I Study of the Arbeits gemeinschaft Internistische Onkologie (AIO)Hartmann J.T. · Pintoffl J.P. · Kröning H. · Bokemeyer C. · Holtmann M. · Höhler T.
a Abteilung Onkologie/Hämatologie/Immunologie/Rheumatologie/Pulmologie, Südwestdeutsches Tumorzentrum – Comprehensive Cancer Center Tübingen, Eberhard-Karls-Universität Tübingen, bOnkologische Praxis, Magdeburg, c Universität Mainz, Germany
Background: The aim of the study was to establish the recommended dose and to evaluate the safety of gefitinib plus FUFOX regimen in irinotecan-refractory colorectal carcinoma (CRC). Patients and Methods: Patients with advanced CRC progressing on fluoropyrimidine/irinotecan-based chemotherapy and with an ECOG performance level 0–2 were enrolled. Four dose levels with sequential dose escalation of oral gefitinib and FUFOX were tested. Each cycle consisted of 5 weeks with gefitinib given daily to weekly FUFOX ×4 to be repeated at day 36. Results: Eighteen patients were enrolled. No dose-limiting toxicity (DLT) was observed at the dose levels L1–L3. At L4 diarrhea was the major DLT requiring treatment interruption in 3 patients. Other grade 3/4 toxicities were observed with skin rash, paresthesia, anemia, and nausea/vomiting (n = 1 each). Grade 1/2 toxicities consisted of diarrhea (n = 9), mucositis (8), skin rash (10), paresthesia (10), nausea (7) as well as leukopenia (2) and fever (1). Clinical benefit was seen in 11 of 16 evaluable patients (69%): 4 patients showed partial response (25%), 7 stable disease (44%). Median time to progression was 219 days (range 50–387 days). Conclusion: Gefitinib at a dose of 250 mg daily in combination with weekly 5-fluorouracil at 2,000 mg/m2 or gefitinib at a dose of 500 mg daily with 5-fluorouracil at 1,600 mg/m2 plus oxaliplatin has an acceptable safety profile.
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