Efficacy and safety of Huachansu combined with adjuvant chemotherapy in resected colorectal cancer patients: A prospective, open label, randomized phase II study

Abstract

Abstract Background Although some studies in China have suggested Huachansu (HCS) combined with chemotherapy is effective in the treatment of various cancers, there are few studies on colorectal cancer (CRC), especially in postoperative adjuvant chemotherapy. The aim of this study was to test the hypothesis that HCS combined with adjuvant chemotherapy would improve survival probability in resected CRC patients. Methods This was a prospective, open label, randomized phase II study. Patients with stage III or high-risk stage II resected CRC were randomly assigned to the chemotherapy and HCS + chemotherapy groups. The Chemotherapy group was treated with the FOLFOX regimen for ≥ 6 cycles or the CAPEOX regimen for ≥ 4 cycles. The HCS + chemotherapy group was treated with HCS on the basis of the chemotherapy group. The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints were 3-year overall survival (OS) and toxicity. Results A total of 250 patients were included in this study (126 chemotherapy, 124 HCS + chemotherapy). There were significant differences in 3-year DFS between the two groups (median 28.7 versus 31.6 months respectively; P = 0.027), but no significant differences in 3-year OS between the two groups (median 32.7 versus 34 months, respectively; P = 0.146). No patients experienced grade 4 adverse events, and the rates of leukopenia, neutropenia and diarrhea in the HCS + chemotherapy group were lower than that those in the chemotherapy group. Conclusion HCS combined with adjuvant chemotherapy after radical resection for patients with stage III or high-risk stage II CRC was demonstrated to be an effective and feasible treatment.