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A feasibility study of gefitinib in association with capecitabine (CAP) and oxaliplatin (OXA) as first-line treatment in patients with advanced colorectal cancer (ACRC)
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2004
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Cancer ManagementCap-oxa RegimenPathologyFirst-line TreatmentPharmacotherapyTwelve PtsFeasibility StudyAdvanced Colorectal CancerFirst Safety AnalysisTumor BiologyOncologyGastrointestinal OncologyMetronomic TherapyRadiation OncologyCancer ResearchMolecular OncologyColorectal CancerCancer TreatmentPharmacologyLung CancerMedicineCancer Growth
3748 Background: EGF-receptor (EGF-R) is commonly overexpressed in epithelial tumors including ACRC and has thus become the target of various molecular therapeutic approaches. Gefitinib (Iressa), an EGF-R tyrosine kinase inhibitor, demonstrated activity in lung and head and neck cancer, but its clinical activity in ACRC is still unknown. We designed this trial to assess the safety and efficacy of Iressa in association with CAP-OXA regimen as first-line treatment in pts affected by metastatic colorectal cancer Methods: From October 2002 21 pts were included in a two steps trial (m:f:12/9, median age 66 yrs (54–73). Actually the twelve pts planned for first safety analysis are evaluable for toxicity and response. CAP was orally administered (1000 mg/m2) twice a day continuously for 15 days and OXA was administered (120 mg/m2) as a 2-hour infusion on day 1, repeated every 3 weeks for six courses. Gefitinib has been given orally, once daily, at 250 mg, continuously from day 1.Pts on response at the end of the treatment continued to receive gefitinib until progression or unacceptable toxicity. Results: 40 cycles were totally administered. The most common side-effect was Diarrhea (14/40 cycles: one G4, two G3 and five G2).Acneiform skin lesion (NCI-CTC grade 1–2 in four and one pts respectively) was frequent, but often disappeared or decreased under continued therapy with Iressa. Further major side-effects included Nausea/Vomiting G1–2 in 12/40 cycles, thrombocytopenia G1–2 6/40 cycles, neutropenia G2–3 4/40 cycles. 82,5% of cycles were given at full dose, while 17,5 were given at full dose but delayed; no reduction of dose was performed. 12 pts are evaluable for efficacy according to an intent-to-treat analysis: 1 CR, 5 PR, 1 SD, 3 PD and 2 withdrawn for SAE (asthenia, diarrhea, and vomiting). Conclusions: Iressa in combination with Cape and Oxa is a feasible regimen in ACRC with an acceptable toxicity profile and an interesting, although preliminary, activity. Further studies are required to assess the potential of Iressa as treatment option in ACRC. Accrual will continue up to 35 patients as planned. No significant financial relationships to disclose.