Capecitabine (XEL) and oxaliplatin (OX) in combination with bevacizumab (BEV) in the management of elderly patients with advanced colorectal cancer (ACRC): Preliminary outcomes on safety and efficacy.

Background: Older individuals always experience enhanced susceptibility to the side effects of cytotoxic chemotherapy. The aim of the study was to evaluate impact of BEV in combination with OX and XEL in ACRC elderly patients. Methods: 56 (29 male, 27 female) elderly patients with ACRC (median age: 71; range: 66-80) were enrolled. Comprehensive Geriatric Assessment (CGA) was performed to assess eligibility for chemotherapy. The dose of IRI and XEL was adjusted according to Kintzel-Dorr formula. Primary endpoint: clinical response rates (RR) according to WHO criteria. Secondary endpoints: toxicity profile using NCI-CTC v2.0 and quality of life (QoL) score measured through EORTC QLQ-C30 questionnaires. All patients were evaluated for toxicity according to the ECOG Common Toxicity Criteria. BEV adverse reactions were not experienced by any patients. Results: Based on CGA, 48 patients were included into groups I, according to Balducci's classification of frailty and treated with OX (100 mg/m2) + BEV (7.5 mg/Kg) on day 1, and XEL (fixed dose of 1000 mg b.i.d) assumed orally from day 2 to day 15, every 3 weeks for 6 months. None of the pts needed any delay in drugs delivery. Tumor response rates observed were 48% (CR+PR). Clinical benefit, including SD, was 77%. No grade 4 toxicity was experienced. QoL score improvement was noted in all pts after treatment. Conclusions: In elderly ACRC patients the dose reduction of XEL through fixed daily dose administration of 1000 mg b.i.d. allows to reach a good tolerability profile with a significant reduction of all grades toxicity compared to dosage calculated according to patients' body surface. We have employed a fixed dose of XEL to obviate the inherent difficulties in dosing with different tablet sizes and to improve compliance with oral chemotherapy assumption in patients with a worse IADL profile. This regimen seems to be active and safe and authors believe that dose reduction improves tolerability without a decrease in efficacy. DFS and OS is under evaluation