Therapeutic Effect Of Kanglaite Injection Combined With Chemotherapy On Advanced Pancreatic Cancer Patients With Spleen Deficiency And Qi Stagnation

Objective To evaluate the clinical efficacy and safety of Kanglaite injection combined with chemotherapy in the treatment of advanced pancreatic cancer patients with spleen deficiency and qi stagnation.Methods Patients with advanced pancreatic cancer,who is spleen deficiency and qi stagnation,were randomly assigned(1:1)to treatment group or control group.In the control group,gemcitabine-based chemotherapy regimens(GS/GX)were prescribed to the patients.Chemotherapy consisted of gemcitabine plus S-1 or CAP(gemcitabine 1,000 mg/m2 on days 1 and 8 plus S-1 60,80,or 100 mg/d or CAP 2000,2500,3000mg/d according to body-surface area on days 1 through 14 of a 21-day cycle).In the treatment group,patients were administered the aforementioned chemotherapy regimens combined with kanglaite injection(200 ml/d on days 1 through 14 of a 21-day cycle).The efficacy,improvement of TCM clinical symptoms,quality of life score,overall survival(OS),progression-free survival(PFS)and adverse events were compared between the two groups.Results Between January 2015 and December 2018,a total of 88 patients were randomly assigned to treatment group(n=44)or control group(n=44).No significant difference of ORR(27.72%:20.45%)and DCR(81.82%:75.00%)was observered between the treatment group and control group.However,improvement of TCM clinical symptoms and karnofsky performance.status score of the treatment group were superior to the control group.And hematologic and GI toxicities were less severe in the treatment group than in the control group.After treatment,the improvement of patients in the treatment group was significantly better than that in the control group(P<0.05).In additon,the median PFS was 6.7 months(95%CI,5.5 to 7.9)in the treatment group and 5.6 months(95%CI,3.3 to 7.9)in the control group,(HR)=0.648[95%CI,0.421-0.998],P<0.05,for noninferiority;The median OS was 10.9 months(95%CI,9.2 to 12.6)in the treatment group and 10.2 months(95%CI,9.6 to 10.8)in the control group,(HR)=0.879[95%CI,0.540-1.430],P<0.05,for inferiority.The control group was significantly decreased the incidence rates of myelosuppression and hepatic and renal dysfunction and digestive reaction in the control group was lower than the treatment group,especially on the Grade 3 or 4 TEAEs and SAEs(P<0.05).Conclusion Gemcitabine-based chemotherapy regimens(GS/GX)combined with kanglaite injection can significantly improve the KPS score and TCM clinical symptoms of advanced pancreatic cancer patients compared to chemotherapy alone.Meanwhile,it can reduce the toxicity and side effects of chemotherapy and prolong the PFS of patients.