Metronomic (M), capecitabine (C), and oxaliplatin (O) plus bevacizumab (B) as treatment of advanced colorectal cancer (ACRC) in very elderly people (M-COB): Efficacy and safety (E&S) evaluation—A 2-year monitoring

Background: A limit to delivery of cytotoxic chemotherapy in elderly people with cancer, is severe toxicity as principal side effect of treatment. We designed in 2009 a treatment schedule to evaluate E&S of combination of three drugs O, C plus B in ACRC very old patients in a metronomic mode (M-COB) Methods: 75 (37 f -38 m) very elderly patients with advanced colorectal cancer (median age:76; range: 70-82) were enrolled. Comprehensive Geriatric Assessment (CGA) was performed to all pts to assess eligibility for chemotherapy. Treatment schedule was: O (65 mg/m2) + B (7.5 mg/Kg) on day 1 (O doses was adjusted by Kintzel-Dorr formula). C (fixed dose of 1,000 mg bid) was delivered from day 2 to day 15 every 3 weeks for 12 cycles. Primary endpoints: toxicity profile (NCI-CTC v2.0) and QoL score (EORTC QLQ-C30). Secondary endpoints:. Clinical Response Rate (CRR) by WHO ‘s criteria. All patients were evaluated for main toxicity (Hemat, G.I., HFS, N&V) by ECOG Common Toxicity Criteria. Results: 76 patients were included into groups I Balducci's classification, for frailty assessement. A 50.1% tumor response rate(TRR) was observed both with a 86.7% Clinical Benefit (CB). No one pts experienced grade 4 toxicity. QoL score improvement was noted in all pts after treatment. Median PFS was 12.3 months with a 6 months PFS rate of 82%. Median OS was 23.5 months with a 12 months survival probability of 78.8%. Conclusions: We choose fixed dose of C in order to reduce main toxicity as shown in std treatment of aged pts with ACRC. Nevertheless this don’t impact on efficacy of treatment. Finally the high rate of clinical benefit encourage further enrollement of patients.In conclusion this schedule seem to be active and safe because improves tolerability without any decrease of efficacy in this kind of patients.