Phase II study of bevacizumab in combination with capecitabine as first line treatment in elderly patients with metastatic colorectal cancer (MCC)

Abstract

e15074 Background: The aim of this prospective study was to evaluate efficacy and safety of bevacizumab in combination with capecitabine as first line treatment in elderly patients with MCC. Methods: 40 elderly patients (median age 75 years) with MCC have been treated with bevacizumab in combination with capecitabine as their first line therapy. Regimen consisted of bevacizumab 7.5 mg mg/kg on day 1 plus capecitabine 1000 mg/m2 on day 1–14 followed by 7 days rest. Results: The median follow up time at time of ASCO will be 12 months. Median number of 9 cycles was administrated, ranging from 1 to 23. 3 patients (7.5 %) had complete response, 19 patients (47.5 %) had partial response, 11 patients (27.5 %) had stable disease, 1 patient (2.5 %) progressed according to RECIST criteria and 6 patients (15%) were not evaluated yet. Until this report 15 of 40 patients progressed and 9 of 40 patients died. Median time to progression is 6.37 months. Median overall survival will be reported at ASCO 2009 meeting. The most common hematological adverse events were mild (grade I and II): anemia (27.5%) neutropenia (22.5%), and thrombocytopenia (20%). The most common non-hematological toxicity were mild as well (grade I and II): hand-foot syndrome (70%), arterial hypertension (52.5%), proteinuria (45%), hyperbilirubinemia (45%), diarrhea (25%), loss of appetite (23.5%), fever (22.5%), fatigue (17.5%), tearing (17.5%), and nail changes (12.5%). Grade 3 and 4 adverse events occurred rarely: hand-foot syndrome (12.5%), deep vein thrombosis (7.5%), fever (5%), and arterial hypertension (2.5%). Conclusions: This prospective phase II study has demonstrated that bevacizumab in combination with capecitabine as first line treatment in elderly patients with metastatic colorectal cancer is an effective and well-tolerated regimen. [Table: see text]