Efficacy and safety of PEGylated recombinant human granulocyte stimulating factor in the prevention of neutropenia during concurrent chemoradiotherapy.

Abstract

e18018 Background: This randomized controlled prospective study aims to explore the efficacy and safety of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. Methods: Patients who met the eligibility criteria were divided into two groups according to the randomized principle of 2:1: the experimental group (patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy) and the control group (patients did not use PEG-rhG-CSF for prevention and were given 5 ug / kg rhG-CSF when ANC < 1✕109). TP combination regimen was used for concurrent chemotherapy, specifically as follows: paclitaxel 150mg / m2 (day 1), cisplatin 35mg / m2 (day 1-2), repeated every three weeks. The PTV dose was 45 Gy in 1.8 Gy daily fractions, with five fractions per week. SPSS 25.0 software was used for statistical analysis of the data, t-test was used for measurement data, and χ2 test Fisher exact test was used for enumeration data. P < 0.05 was considered statistically significant. Results: As of September 2019, 30 patients were enrolled into this study, including 18 in the experimental group and 12 in the control group. One of the 18 patients in the test group (5.6%) had a Grade 3/4 neutropenia. Ten of the 12 patients in the control group (83.3%) developed Grade 3/4 neutropenia. The incidence of Grade 3/4 neutropenia in the two groups was statistically significant (P < 0.001, Table 1). The incidence of FN was 5.6% in the experimental group and 8.3% in the control group (P = 1.000). The incidence of delayed chemotherapy course was 11.1% in the experimental group and 58.3% in the control group (P = 0.013). The incidence of delayed chemotherapy course in the two groups was statistically significant (Table 1). As shown in Figure 4, the experimental group had a completion time of radiotherapy for 46.7 days, while the control group had 49.0 days (P = 0.278). Conclusions: Although the results of bone marrow function and overall survival are still to be obtained, it can be initially seen from the intermediate-term data that the use of PEG-rhG-CSF primary prevention reduced the granulocytopenia and the delay of the chemotherapy course during the concurrent chemoradiotherapy TP regimen for cervical cancer, which has the value of further completing this study. [Table: see text]