| Objective: To explore the efficacy and safety of “Fuzheng Jiedu Quyu Method” in maintenance treatment for metastatic colorectal cancer(m CRC)by retrospective study.Methods: Patients with m CRC who were admitted to our hospital and Tianjin Cancer Hospital from January 1,2015 to December 31,2019 Patients who entered the maintenance treatment stage were evaluated as CR,PR or SD.after 4-6 months of first-line chemotherapy.In this study,125 patients were divided into control group: reduce or change medications for maintenance therapy(Bevacizumab/chemotherapy/chemotherapy+Bevacizumab)and treatment group: on the basis of reducing or changing drugs for maintenance treatment combined with traditional Chinese medicine(TCM)according to whether the patients used the prescriptions guided by “Fuzheng Jiedu Quyu Method”.The clinical pathological data of patients were collected,and the progression-free Survival(PFS),Overall Survival(OS),Karnofsky performance score(KPS),TCM syndrome score of colorectal cancer,Oxaliplatininduced Peripheral Neuropathy(OIPN)and safety evaluation of patients in the two groups were compared.Analysis was performed on the influence of patient’s gender,age,location of the primary tumor,pathological type,differentiation degree,number of distant metastases,liver and lung metastasis,TNM stages,KPS score,TCM syndrome types,maintenance therapy drugs and cycles on the prognosis of patients.To further analyze the dominant population characteristics of maintenance therapy for advanced CRC.Results: 125 patients with m CRC were included in this study,including 63 patients in the treatment group and 62 patients in the control group.In baseline characteristics,there were not statistically significant differences between the two groups,indicating comparability.Primary endpoint: Prescriptions guided by “Fuzheng Jiedu Quyu Method” prolonged the m PFS in maintenance therapy for m CRC,m PFS of the treatment group was 10.7 months,and that of the control group was 9.2 months,with statistically significant difference,P=0.042,P< 0.05.Secondary endpoints:(1)OS: m OS in the treatment group was longer than that in the control group(21.1 vs.19.4 months),but not statistically significant(P=0.676,P > 0.05).(2)KPS score: The KPS score of the treatment group was higher than before,with statistical significance(P<0.05),while the control group was not(P >0.05).The improvement of KPS score between the two groups was significantly improved in the treatment group,which suggested a statistically significant difference with P < 0.05.(3)TCM Symptom Score: Compared with the control group,the scores of TCM symptoms of CRC in the treatment group had effects on fatigue(P=0.025,P <0.05),poor appetite(P=0.026,P<0.05),nausea and vomiting(P=0.007,P<0.05)and abdominal distension(P=0.038,P < 0.05),and the difference was statistically significant.In terms of dry mouth,abdominal pain,diarrhea,astriction and blood in the stool,without significant difference(P>0.05).The total score of TCM symptoms of CRC was improved more significantly in the treatment group,and the remission rate was 65.0% vs.46.8% compared with the control group.According to the Rank-sum test,the difference was significant(P=0.015,P<0.05).(4)Oxaliplatin-induced peripheral neuropathy: According to the intra-group comparison before and after treatment,the OIPN grades decreased in both groups(P<0.05).The improvement of OIPN between the two groups,with an effective rate of 73.7% vs.50.0%,the treatment group was superior to the control group(P<0.05).(5)Safety: There were no treatment-related deaths in 2 groups,most of the adverse reactions with degrees 1～2,3～4 degree treatment-related adverse events included 2 cases(3.2%)of decreased hemoglobin,and 1 case(1.6%)of nausea and vomiting in the treatment group.1 case(1.6%)of serum transaminase increased,2 cases(3.2%)of hemoglobin decreased,1 case(1.6%)of nausea and vomiting,and 1 case(1.6%)of hypertension in the control group.The incidence of nausea and vomiting(P=0.038 < 0.05)and diarrhea(P=0.025< 0.05)between the two groups were statistically significant.The incidence of blood and circulatory system,liver and kidney toxicity,and hand-foot syndrome were no statistically significant.(6)Prognostic factors analysis: Kaplan Meier univariate analysis indicated that liver metastases,location of the primary tumor,tumor stage,duration of maintenance therapy,whether to use TCM were the prognostic factors of patients,Multivariate Cox regression analysis found that use of TCM in treatment,maintenance treatment > 4 cycles are prognosis related protection factors;the tumor located on the right side,liver metastases and stage ⅣC are prognostic risk factors.Conclusion: Prescriptions of “Fuzheng Jiedu Quyu Method” as maintenance therapy can prolong PFS and alleviate oxaliplatin-induced peripheral neuropathy in patients with m CRC,which has the advantages of improving patients’ physical condition and relieving clinical symptoms,and with good security.Prognostic analysis found that patients who underwent maintenance treatment >4 cycles and used TCM during the treatment were favorable prognostic factors.Without liver metastasis,the tumor located on the left side and stage ⅣA and B were the benefit populations for maintenance treatment of m CRC. |
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