Recombinant human endostatin combined with immune checkpoint inhibitors for the treatment of non-small cell lung cancer:a real-world retrospective study
Objective To evaluate the efficacy and safety of recombinant human endostatin injection combined with immune checkpoint inhibitors(ICIs)in the first-line treatment of non-small cell lung cancer(NSCLC).Methods A retrospective analysis was performed on 484 patients with unresectable NSCLC who received at least 4 cycles of anti-tumor therapy in Yuebei People's Hospital from January 2020 to January 2022,and they were divided into 3 groups according to the treatment methods.Among the 85 cases of the E+ICI group,there were 58 males and 27 females,aged 68(61,76)years,and they were treated with recombinant human endostatin injection+ICIs.Recombinant human endostatin injection was injected 210 mg each time with continuous chemotherapy pump for 3 d,once every 3 weeks;ICIs were used according to the operating instructions;recombinant human endostatin injection and ICIs did not allow dose reduction.Among the 351 cases of the C+ICI group,there were 256 males and 95 females,aged 61(51,70)years,and they were treated with chemotherapy+ICls.The chemotherapy drugs included carboplatin(AUC=5)or cisplatin 75 mg/m2,gemcitabine 1 g/m2,docetaxel 75 mg/m2,and pemetrexed 500 mg/m2 or paclitaxel 175 mg/m2.The dose of chemotherapy drugs was adjusted according to clinical routine,and the patients with less than 75％standard dose were excluded.Among the 48 cases of the ICI group,there were 37 males and 11 females,aged 72(68,78)years,and they received ICIs monotherapy.After 4 to 6 cycles of palliative treatment,the E+ICI group was given maintenance treatment with the same dose of recombinant human endostatin injection and ICIs,and the C+ICI group and ICI group were given ICI maintenance treatment once a month until the disease progressed or the intolerant toxicity occurred.The primary endpoints were progression-free survival(PFS)and overall survival(OS),and the secondary endpoints were objective response rate(ORR)and PFS and OS in the elderly subgroup.x2 test,Kruskal-Wallis H test,and Log-rank test were used.Results The PFS(mPFS:8.12 months vs.8.96 months,P=0.131)and OS(mOS:16.32 months vs.17.28 months,P=0.160)of the E+ICI group and C+ICI group were similar.The PFS and OS of the E+ICI group were superior to those of the ICI group(mPFS:8.12 months vs.6.16 months,P=0.009;mOS:16.32 months vs.10.10 months,P=0.001).The ORRs of the E+ICI group,C+ICI group,and ICI group were 52.94％,48.43％,and 35.42％,respectively,with no statistically significant difference(P=0.142).The incidence of treatment-related adverse events(AEs)above grade 3 in the E+ICI group was lower than that in the C+ICI group.There were 41 cases ≥70 years old in the E+ICI group,111 cases in the C+ICI group,and 27 cases in the ICI group,respectively.Among the elderly patients(≥70 years old),the mPFS and mOS in the E+ICI group were higher than those in the ICI group(10.08 months vs.6.16 months,P=0.003;16.68 months vs.10.03 months,P＜0.001).Conclusion Recombinant human endostatin injection combined with ICIs is well tolerated in the treatment of NSCLC,and its efficacy is comparable to that of chemotherapy combined with ICIs,but superior to ICIs monotherapy.
Non-small cell lung cancerRecombinant human endostatin,Immune checkpoint inhibitorsReal-world study
万方数据
维普
