OBJECTIVETo study the effects of Chinese materia medica (CMM) combined chemotherapy on the recurrence, metastasis, and the disease free survival (DFS) of stage II and III colorectal cancer (CC) patients after radical cure.

METHODSRecruited were 366 inpatients and outpatients with stage II and III colorectal cancer (CC) from Changhai Hospital, Second Military Medical University, and Tumor Department of Longhua Hospital, Shanghai University of Traditional Chinese Medicine from January 2002 to December 2008. A non-randomized concurrent control method was adopted. Patients were assigned to the combination group (treated by CMM + chemotherapy, 189 cases) and the chemotherapy group (177 cases) according to whether they were willing to receive the CMM treatment for more than 6 successive months. By using follow-ups at clinics, by letter, and by telephone, the DFS, 1-, 2-, 3-, and 5-year DFS ratios were observed. The correlations between DFS and the gender, age, tumor location, staging of clinical pathology, pathological type, chemotherapeutic cycle, radiotherapy, CMM treatment, end point event (recurrence and metastasis) were analyzed.

RESULTSThe recurrence or metastasis occurred in 145 cases (39. 61%) of the 366 patients. Of them, local recurrence occurred in 17 cases (11.72%), liver metastasis in 45 cases (31.03%), lung metastasis in 52 cases (35.86%), and metastasis in other parts in 53 cases (36.55%). Results of one-factor analysis showed six factors such as the tumor location, pathological type, staging of clinical pathology, chemotherapeutic cycle, radiotherapy, and CMM treatment were correlated with the DFS, showing statistical difference (P<0.01, P<0.05). Results of multifactor analysis showed staging of clinical pathology, chemotherapeutic cycle, and CMM treatment were correlated with the DFS, showing statistical difference (P<0.01). Results of stratified study on the staging of clinical pathology indicated that the primary tumor location (P=0.016) and the pathological type (P=0.047) were the independent predictors for DFS of stage II CC. The median DFS of the two groups could not be calculated. Results of stratified study on the stages of clinical pathology indicated that CMM treatment (P=0.000) and chemotherapeutic cycle (P=0.017) were independent predictors for DFS of stage III CC. As for comparing the composition ratio of the two therapeutic cycles, results showed the baselines of the chemotherapeutic cycle of the two groups were balanced. Further comparison showed the median DFS for the chemotherapy group at stage III was 24. 16 months, while it could not be calculated in the combination group. The DFS, 1-, 2-, 3-, and 5-year DFS ratios were 92%, 72%, 61%, and 59%, respectively in the stage III CC combination group, while they were 74%, 50%, 36%, and 20%, respectively in the stage IlI CC chemotherapy group.

CONCLUSIONCMM combined chemotherapy could prolong the DFS of stage III CC patients after radical cure.