First clinical experience of orally active epidermal growth factor receptor inhibitor combined with simplified FOLFOX6 as first-line treatment for metastatic colorectal cancer

摘要: BACKGROUND. Gefitinib, an orally active inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, combined with chemotherapy, has shown efficacy as second-line treatment for advanced colorectal cancer (CRC). Gefitinib FOLFOX6 (oxaliplatin plus folinic acid and 5-fluorouracil) was tested a first-line therapy. METHODS. Patients metastatic EGFR-positive CRC received gefitinib at dose 250 mg/day simplified FOLFOX6. continued maintenance in nonprogressing patients. Responses were assessed by Response Evaluation Criteria Solid Tumors (RECIST) criteria adverse events the National Cancer Institute Common Toxicity (NCI-CTC) scale. RESULTS. A total 56 patients recruited. There 26 men 30 women, median age 57.5 years. The Eastern Cooperative Oncology Group (ECOG) performance status follows: 0 39 patients, 1 12 2 5 Thirty-nine (69.6%) had stage IV disease diagnosis, 92.9% liver involvement, 46.4% ≥2 sites. All evaluated safety, 53 response: 40 (71.4%; 95% confidence interval [95% CI], 57.8%–82.6%) complete or partial responses, 11 (19.6%) stable disease. Median time to progression 7 months (range, 2.1–33.0 months; CI, 6.2–9.0 months). Radical surgery thermoablation sites performed 14 (25%). NCI-CTC grade 3–4 occurred 36 (64.3%): diarrhea 9 (16.1%), hematologic toxicity 13 (23.2%). Four (7.1%) withdrawn drug-related events. CONCLUSIONS. The regimen promising manageable CRC. 2007. © 2007 American Society.