| ObjectiveBy observing the traditional Chinese medicine used in chemotherapy with beacizumab bead sheet resistance to therapy of patients with advanced colorectal cancer clinical effect,compared with the pure chemotherapy combined beacizumab bead single group of progression-free surial and adverse reaction,the objective evaluation of the effectiveness and safety,for traditional Chinese medicine in the treatment of advanced colorectal cancer chemotherapy and targeted drug effectiveness to provide new evidence for sure.MethodsClinical retrospective cohort study was used in this case and exclusion criteria,collect on January l,2014-December 31,2017,the first affiliated hospital of guangzhou university of TCM hospital of guangdong province,foshan city,guangdong province people’s hospital,people’s hospital oncology inpatient chemotherapy combined beacizumab bead sheet resistance to first-line treatment of patients with mCRC,all patients were confirmed by pathology.The patients were divided into treatment group and control group according to whether they took traditional Chinese medicine.The treatment group was treated with traditional Chinese medicine combined with chemotherapy and bevacizumab,while the control group was treated with chemotherapy alone combined with bevacizumab.Observe the disease progression,change the chemotherapy regimen,continue to observe the disease progression or death.Clinical baseline characteristics were assessed before enrollment.Primary endpoint indicators:progression-free survival(PFS1,PFS2,TT2PD);Secondary end points:overall survival(OS),objective response rate(ORR),and disease control rate(DCR),safety,and toxicity.ResultsSubjects were from the oncology department of the first affiliated hospital of guangzhou university of traditional Chinese medicine,guangdong provincial hospital of traditional Chinese medicine,guangdong provincial people’ s hospital and foshan municipal people’s hospital from January 1,2014 to December 31,2017.The follow-up period was up to February 1,2019.A total of 105 cases were included,including 55 cases in the treatment group and 50 cases in the control group.1.Main and terminal indexThe first progression-free survival period(PFS1)was 10.1 months(95%ci 7.3-13.5)vs in the treatment group and the control group.8.1 months(95%ci:6.1-11.2),the difference between the two groups was not statistically significant(P=0.09>0.05),but the survival curve showed that PFS1 in the treatment group was longer than that in the control group.There was no significant difference in the second progressional survival between the PFS2 groups(P=0.661>0.05).The median PFS2 in the treatment group was 22.7 months,while the number of outcomes in the control group was too small to calculate the median outcome time.The time to secondary disease progression was TT2PD compared to 24.7 months vs.At 21 months,there was no significant difference between the two groups(P=0.376)0.05).2.Secondary endpoint index(1)OS.The difference between the two groups in total survival was not statistically significant(P=0.108>0.05),and the median outcome time could not be calculated due to the small number of outcome samples.(2)ORR andd DCR.ORR of objective response rate and disease control rate was 32.36%vs.32.00%,P=0.684>0.05.The DCR of recent disease control rate was 90.91%vs.88.00%,P=0.753>0.05.There was no significant difference between the two groups.(3)Toxicity and security evaluation.Safety studies have shown that the incidence of adverse reaction appeared on the overall and degree of the treatment group is better than that of control group,the incidence of bone marrow suppression of comparison for(18.18%vs.40.00%),differences between groups with statistical significance(P=0.046<0.05),and the treatment group in Ⅲ-Ⅳ bone marrow suppression in shows obvious advantages.There was no significant difference between the two groups in terms of delayed diarrhea,hepatorenal toxicity,skin and mucosal toxicity,hypertension and fatigue,but there was no increase in hepatorenal toxicity,and no new adverse reactions occurred.ConclusionTraditional Chinese medicine(TCM)has a tendency to prolong progression-free survival time in chemotherapy combined with targeted treatment of advanced colorectal cancer with bevacizumab,and can effectively alleviate some toxic effects in chemotherapy and targeted treatment of bevacizumab,such as myelosuppression,with good tolerance and safety,and improve the quality of life of patients. |
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