Fufangbanmao Capsules Combined With XELOX(Capecitabine Plus Oxaliplatin) For Advanced Colorectal Cancer: A Clinical Observation And Study

Objective:The present study focused on the short-term efficacy of combining Fufangbanmao capsules with XELOX (Capecitabine Plus Oxaliplatin) in the treatment of advanced colorectal cancer and investigated the occurrence of its adverse reactions.Methods:Data of 90 inpatients or outpatients wih histologically confirmed advanced colorectal cancer receiving XELOX (capecitabine 1000 mg/m2 bid po, days 1 to 14 plus oxaliplatin 130 mg/m2 ivdrip days 1, repeated every 3 weeks) chemotherapy in Gastrointestinal Surgery and Oncology of Shandong Provincial Hospital affiliated to Shandong University from October 2013 to October 2015 was collected. Patients’age ranges from 18 to 79, KPS from 60 to 100, stage from III to IV. The patients were randomly assigned to two groups. Group A was treated with Fufangbanmao capsules (750mg po,2 times daily) combined and XELOX chemotherapy. Group B was only treated with XELOX chemotherapy. The primary endpoint was to compare the incidence of adverse reactions between Group A and Group B. The secondary endpoints were to compare the efficacy and quality of life between Group A and Group B. Accroding to the effect standard and toxic grading standard suggested by RECIST 1.1 and NCI-CTC 3.0 were evaluated after treating for two cycles. Statistical analysis was performed using the SPSS 20.0.Results:There were 87 patients completed the study. Three patients were removed from the study (0 in Group A and 3 in Group B) due to accidental death, poor compliance or poverty. The baseline characteristics (such as sex、KPS、pathology, et al) were generally similar compared 45 patients in Group A and 42 patients in Group B(P>0.05).1. The incidence of HFS in Group A and Group B were 28.9%、19.0%, there were no significant differences among the two groups(P>0.05).2. The incidence of neutrocytopenia in Group A and Group B were 31.1%、57.1%, there were significant differences among the two groups(P<0.05). The incidence of anemia in Group A and Group B were 6.7%、21.4%, there were no significant differences among the two groups(P>0.05). The incidence of thrombopenia in Group A and Group B were 8.9%、21.4%, there were no significant differences among the two groups(P>0.05).3. The incidence of nausea and vomiting in Group A and Group B were 33.3%、40.5%, there were no significant differences among the two groups(P>0.05). The incidence of constipation in Group A and Group B were 6.7%、4.8%, there were no significant differences among the two groups(P>0.05). The incidence of diarrhea in Group A and Group B were 24.4%、23.8%, there were no significant differences among the two groups(P>0.05). The incidence of abdominal pain in Group A and Group B were 4.4%、9.5%, there were no significant differences among the two groups(P>0.05).4. The incidence of oral mucositis in Group A and Group B were 2.2%,2.4%, there were no significant differences among the two groups(P>0.05). The incidence of liver renal toxicity in Group A and Group B were 13.3%、16.7%, there were no significant differences among the two groups(.P>0.05). The incidence of peripheral neurotoxicity in Group A and Group B were 6.7%、11.9%, there were no significant differences among the two groups(P>0.05).5. The ORR in Group A and Group B were 4.2%、35.7%, there were no significant differences among the two groups(.P>0.05). The median time to progression in Group A and Group B were 9.6moths、8.9moths, there were no significant differences among the two groups(P>0.05).6. The improvement rate of KPS in Group A and Group B were 57.8%、33.3%, there were significant differences among the two groups(P<0.05).Conclusion:1. The application of Fufangbanmao capsules in XELOX chemotherapy can decreased incidence of chemotherapy-induced neutrocytopenia during treatment period of advanced colorectal cancer.2. Fufangbanmao capsules combined with XELOX chemotherapy for advanced colorectal cancer did not increase the incidence of chemotherapy-induced hand-foot syndrome, nausea, vomiting, abdominal pain, constipation, diarrhea, oral mucositis, liver renal toxicity, peripheral neurotoxicity or other adverse reactions.3. Fufangbanmao capsules combined with XELOX or XELOX showed a similar efficacy in treating advanced colorectal cancer.4. Fufangbanmao capsules combined with XELOX chemotherapy for advanced colorectal cancer can improve patients’life quality.