Efficacy, Safety, and Cost of Therapy of the Traditional Chinese Medicine, Catalpol, in Patients Following Surgical Resection for Locally Advanced Colon Cancer

Abstract

BACKGROUND The aim of this study was to evaluate the efficacy, safety, and cost of treatment of the traditional Chinese herbal medicine, catalpol, in patients following surgical resection for locally advanced colon cancer. MATERIAL AND METHODS The 345 patients who had undergone surgical resection for locally advanced colon adenocarcinoma, were divided into three groups: a placebo-treated group (n=115); patients treated with an intraperitoneal injection of 10 mg/kg catalpol twice a day for 12 weeks (treatment group) (n=115); patients treated with 5 mg/kg intravenous bevacizumab twice a week for 12 weeks (control group) (n=115). Serum levels of carbohydrate antigen 19-9 (CA 19-9), carcinoembryonic antigen (CEA), matrix metalloproteinases-2 (MMP-2), and matrix metalloproteinases-9 (MMP-9) were measured. Patient overall survival (OS), cancer-free survival (CFS), adverse effects, and cost of therapy were evaluated. Statistical analysis included the Wilcoxon rank sum test and Tukey's test for clinicopathological response at 95% confidence interval (CI). RESULTS Patients in the catalpol-treated group had significantly reduced serum levels of CA 19-9 (p=0.0002, q=3.202), CEA (p=0.0002, q=3.007), MMP-2 (p£0.0001, q=6.883), and MMP-9 (p<0.0001, q=3.347). Only non-fatal adverse effects occurred in the catalpol treatment group (p<0.0001, q=5.375). OS and CFS were significantly increased in the catalpol treatment group compared with the placebo group (p<0.0001 q=7.586). The cost of catalpol treatment compared favorably with other treatments (p<0.0001, q=207.17). CONCLUSIONS In this preliminary study, treatment with the Chinese herbal medicine, catalpol, showed benefits in clinical outcome, at low cost, and with no serious complications.

Figure 1

Diagrammatic illustration of the staging of colon cancer. A: Stage I. B: Stage II. C: Stage III. D: Stage IV, with lymph node involvement. Source: http://symptoms-colon-cancer.blogspot.in.

Figure 2

Flowchart showing the study design, including treatment with catalpol. Study population: 345. Confidence limit: 95±5%. Sample size (n)=115.

Figure 3

Non-fatal adverse events in the study. For all groups, n=115. For statistical analysis, non-fatal adverse effects were considered to be 1; no adverse effect considered to be 0. Non-fatal adverse events were significantly associated with the catalpol treatment group (p<0.0001, q=5.375), compared with the control group (p<0.0001, q=24.242). p<0.05 and q>3.314 were considered to be significant.

Figure 4

Fatal adverse events in the study. For all groups, n=115. For statistical analysis, fatal adverse effects were considered to be 1; no adverse effect considered to be 0. Only treatment with bevacizumab resulted in fatal adverse events (p<0.0001, q=42.071). p<0.05 and q>3.314 were considered to be significant.

Figure 5

Recurrence of colon cancer following treatment. The response to the outcomes of each treatment followed the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines [22]. For all groups, n=115. For statistical analysis, the percentage of recurrence of colon cancer in patients was considered to be 1; no recurrence of colon cancer in patients was considered to be 0. The percentage of cases of recurrence of colon cancer in patients was increased in the placebo group (p<0.0001, q=8.655) and the catalpol treatment group (p=0.0052, q=3.541) compared with the bevacizumab treatment group. p<0.05 and q>3.314 were considered to be significant.

Figure 6

Overall survival (OS) associated with treatment. For all groups, n=115. For statistical analysis, survival was considered to be 1; patient death was considered to be 0. The catalpol treatment group significantly improved OS compared with the placebo group (p 0.0001, q=0.586), but did not have significantly improved OS when compared with the control group (p=0.3434, q1.362). p<0.05 and q>3.314 were considered to be significant.

Figure 7

Comparative treatment costs. All data are shown as the mean ± standard deviation (SD), n=115. The bootstrap method of analysis was used. p<0.05 and q>3.314 were considered to be significant.