The efficacy of Fufangbanmao capsules combined with chemotherapy in the treatment of patients with metastatic colorectal cancer / 中华消化杂志

ABSTRACT

Objective To investigate the efficacy and side effects of Fufangbanmao capsules combined with FOLFOX-4 (Oxaliplatin + 5-fluorouracil /Calcium folinate) regimen in the treatment of metastatic colorectal cancer (MCC). Methods A total of 107 patients with previously untreated MCC, who were admitted to the hospital between April 2006 and October 2008, were randomly divided into combination group (n = 54) and chemotherapy group (n = 53). In combination group, patients received Fufangbanmao capsules (750 mg twice daily) and FOLFOX4 regimen (oxaliplatin 85 mg/m2 day 1, infusion of CF 200 mg/m2 for 2 hours followed by bolus 5-FU 400 mg/m2 and a 22-hour infusion of 5-FU 600 mg/m2 ). Whereas the patients in chemotherapy group were treated with FOLFOX4 regimen. Results The effective rate was 44. 4% in combination group and 37. 7% in chemotherapy group with no significant difference (P = 0. 481). The median time to progression (TTP) was 11. 6 and 7. 9 months in combination group and chemotherapy group, respectively, with significant difference (P=0. 020). The difference was found in improvement of quality of life (QOL) between combination group and chemotherapy group (57. 4% vs 32. 1 % , P=0. 008). The side effects in two groups included gastrointestinal toxicities, neuropathy, alopecia and bone marrow suppression. However, Ⅲ/Ⅳ neutropenia was significantly less in combination group(37. 0%) when compared with chemotherapy group (58. 5%, P = 0. 043). Conclusions In first-line treatment of MCC, Fufangbanmao capsules combined with FOLFOX4 regimen showed synergic and enhanced effect for improving TTP and QOL, and also reduced the incidence of neutropenia.