Real-world Study Of PEG-rhG-CSF For The Prophylaxis Of Chemotherapy-induced Neutropenia In Patients With Gynecologic Malignancy

Objective:To compare the effectiveness and safety of different times of PEG-rhG-CSF,the 24 hours and 48 hours after chemotherapy,for the prophylaxis of chemotherapy-induced neutropenia(CIN)in patients with gynecologic malignancy.To analyze the risk factors of CIN and febrile neutropenia(FN)in patients with prophylactic PEG-rhG-CSF.Methods:This is a prospective,real-world study that included 109 patients with gynecologic malignancy who received chemotherapy at Qilu Hospital of Shandong University from January to December 2019.Patients in the experimental group were administered PEG-rhG-CSF 24 hours after chemotherapy,and patients in the control group were administered 48 hours after chemotherapy.The effectiveness and safety of the two groups was compared.The Logistic regression analyzed the risk factors of CIN and FN in patients with prophylactic PEG-rhG-CSF.Results:1.109 patients were enrolled and completed 306 chemotherapy cycles,of which 71 patients in the experimental group completed 190 chemotherapy cycles and 38 patients in the control group completed 116 chemotherapy cycles.2.CIN occurred in 52 chemotherapy cycles,with an incidence of 17%.The CIN rate was 21.1%in the experimental group and 10.3%in the control group(P=0.016).In experimental group,23 chemotherapy cycles occurred grade ?/? neutropenia,the incidence rate was 12.1%and the average duration time was 2.5 7±1.24 days.In control group,9 chemotherapy cycles occurred grade ?/? neutropenia,the incidence rate was 7.7%and the average duration time was 2.67 ± 1.00 days.The difference between two groups was not statistically significant.3.Febrile neutropenia occurred in 11 chemotherapy cycles with an incidence of 3.6%;in which 8 cases occurred in the experimental group and 3 cases occurred in the control group.There was no statistical difference between the two groups(P=0.459).4.A total of 21 chemotherapy cycles were delayed due to CIN.The delay rate was 6.9%,with an average delay time of 3.90±3.53 days.Chemotherapy delay rate was 8.9%in the experimental group and 3.4%in the control group(P=0.065);the average delay time were 4.24±3.78 days and 2.50±1.91 days,respectively.A total of 10 chemotherapy cycles resulted in drug dose reduction due to CIN,the incidence rate was 3.3%,and the dose reduction rates were 4.2%and 1.7%,respectively(P=0.329).5.A total of 11 cycles were hospitalized for CIN,with an incidence of 3.6%and an average hospitalization time of 4.55±0.69 days.The hospitalization rates were 3.7%and 3.4%(P=0.914),and the average time of hospitalization were 4.43 ± 0.79 days and 4.75± 0.50 days,respectively(P=0.485).6.A total of 19 patients suffered bone pain.The incidence of bone pain were 14.1%(10/71)in the experimental group and 23.7%(9/38)in the control group.There was no significant difference in bone pain between the two groups(P=0.208).In addition,no side effects such as spleen rupture and severe allergic reactions were observed.7.The average age of patients with CIN was 56.29 ± 11.85 years old,and the average age of patients without CIN was 52.27± 12.57 years old.The difference between the two groups was statistically significant(P=0.036).The average BMI of patients with CIN was 21.42± 2.89kg/m2,and the average BMI of patients without CIN was 23.16± 3.56kg/m2,(P=0.001).The CIN rate were 21.1%in experimental group and 10.3%in control group(P=0.016).The CIN rate were 31.43%in patients with KPS score<80 and 17.83 in patients with KPS score>80(P=0.016).In addition,the CIN rate were 26.17%in patients who had previously received 1-3 courses of chemotherapy and 12.06%in patients who had received more than 3 courses of chemotherapy(P=0.002).The average age of patients with FN was 59.91±10.35 years,and the average age of patients without FN was 52.69±12.54 years(P=0.064).The average BMI value of patients with FN was 19.73±1.77 kg/m2,the average BMI value of patients without FN was 22.98±3.42kg/m2(P=0.002).The rate of FN were 14.29%in patients whose KPS score<80 and 2.21%in patients whose KPS score>80,the difference was statistically significant(P=0.004).The FN rate in patients who had received 1-3 courses of chemotherapy was 6.54%,and in patients who had received more than 3 courses of chemotherapy was 2.01%(P=0.042).Conclusions:1.In patients with gynecological malignancy,the incidence of CIN was higher in patients whose PEG-rhG-CSF was administered 24 hours after chemotherapy compared with 48 hours after chemotherapy;there was no significant difference in the incidence of FN,delayed chemotherapy,drug dose reduction and adverse reactions;For patients who received myelosuppressive chemotherapy,it is recommended to administer PEG-rhG-CSF 48 hours after the chemotherapy;for some patients who cannot be administered in the prescribed time,it is safe,effective and convenient to administer PEG-rhG-CSF 24 hours after chemotherapy.2.The risk factors of CIN include:the patient's BMI,the number of previous chemotherapy cycles and the time of secondary prevention after chemotherapy;The risk factors of FN include:BMI,KPS score,and the number of previous chemotherapy cycles.