| Objective:To evaluate the efficacy and safety of PEGylated recombinant human granulocyte colony-stimulating factor(PEG-rh G-CSF)in primary prevention of neutropenia induced by platinum-containing dual-drug chemotherapy in elderly patients with advanced lung cancer.Methods:A randomized,controlled,open study.From December 2018 to December 2019,60 elderly patients with stage IIIb-IV lung cancer were diagnosed in the Department of Respiratory and critical Care Medicine,affiliated Hospital of Inner Mongolia Medical University.Patients were enrolled according to the random number table method and randomly divided into 2 groups according to 1:1.Both groups were treated with platinum-containing dual-drug chemotherapy.The test group was given a single subcutaneous injection of 6mg with PEG-rh G-CSF within 24-48 hours after the first cycle of chemotherapy.Blood routine examination was performed every 3 days in both groups.If white blood cell count(WBC)<4.0×10~9/L and/or absolute neutrophil count(ANC)<4.0×10~9/L,the risk of therapeutic use of recombinant human granulocyte colony stimulating factor(rh G-CSF)was assessed,and non-intervention or treatment with rh G-CSF was selected according to the presence of adverse factors until the above myelosuppression was corrected.Observation indicators include the incidence and duration of 3/4 degree neutropenia,the incidence of febrile neutropenia(FN),the use of antibiotics,the incidence of delayed chemotherapy and dose reduction,and incidence of granulocyte colony stimulating factor(G-CSF)related adverse reactions and quality of life scores.Results:1.Efficacy:The incidence of neutropenia(13.3%)in the test group was significantly lower than that in the control group(43.3%),and the difference was statistically significant(P=0.010).Compared with the control group,the completion rate of 4?6 cycles of chemotherapy in the test group increased significantly(33.3%vs.60%,P=0.038).However,there was no statistically significant between the test group and the control group in the duration of 3/4degree neutropenia(both 3.00 days),the delayed rate of chemotherapy(13.3%vs.16.6%),the incidence of dose reduction(13.3%vs.20.0%),and the median progression-free survival time(6.4 months vs.6.6 months).2.Safety and quality of life:There was no statistically significant in the incidence of FN(6.7%vs.3.3%)and the utilization rate of antibiotics(10.0%vs.6.7%)between the test group and the control group.The adverse reactions of the two groups mainly included bone pain,fever,dizziness,headache and fatigue,in which bone pain was the most common,and NCI grade was1?2 grade,no 3?4 grade.The total adverse reaction rate related to PEG-rh G-CSF monotherapy was 45.4%,while that of rh G-CSF monotherapy in the control group was 47.3%,and the difference was not statistically significant.In the test group,the score of quality of life(QOL)after chemotherapy(42.73±7.00)was significantly higher than that before chemotherapy(35.93±5.60),it was also significantly higher than the QOL score of the control group after chemotherapy(34.23±6.55),and the difference was statistically significant(P<0.001).There was no statistically significant in QOL score before and after chemotherapy in the control group.Conclusion:PEG-rh G-CSF primary prophylaxis is effective and safe in the treatment of 3/4 degree neutropenia caused by platinum-containing dual-drug chemotherapy in elderly patients with advanced lung cancer,and can significantly improve the quality of life of patients after chemotherapy. |
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