The Clinical Study Of Pegylated Recombinant Human Granulocyte Colony-stimulating Factor On Neutropenia In The Treatment Of Breast Cancer Patients With Chemotherapy

AIM:To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor on neutropenia in the treatment of breast cancer patients with chemotherapy.METHODS:This research focused on the primary treated breast cancer patients, and a randomized, open, positive control study design was used. All patients received the same chemotherapy schemes. Fifty eight patients who fit the requiments were randomly divided into 3 groups:PGCSF 100?g/kg group (n=19), PGCSF 6mg group (n=22) and HEX group (n=17). After neoadjuvant or adjuvant chemotherapy with the same dosage for 4 cycles (trial groups, PGCSF groups) or 1 cycle (control group, HEX group), patients were studied as follows.PGCSF two dosage group patients were given a single subcutaneous administration. HEX group were given 5 ?g/kg/d of HEX once daily by subcutaneous injection for 14 days. The HEX administration would be stopped when the ANC was higher than 5�109/L after two consecutive examinations. HEX group was only carried out the first cycle of administration and the first administration schedule could be repeated to the fourth cycle in PGCSF groups. The incidence rate and duration of neutropenia were observed. The time returning back to normal of ANC was observed. The adverse events and the various therapeutic drugs used during treatment were recorded. The efficacy and safety of PGCSF in the treatment of breast cancer patients with chemotherapy were evaluated.1. The main curative index:The main curative index were the duration of above third-degree neutropenia in the first cycle (defined as the duration of ANC< 1.0�109/L).The duration of above third-degree neutropenia in PGCSF 6mg group, PGCSF 100?g/kg group and HEX group was 0.95(�1.05),1.00(�1.05),2.65(�1.46), respectively. The longest duration of above third-degree neutropenia in PGCSF 6mg group and 100?g/kg were 3 days, however it was 5 days in HEX group. Compared with HEX group, PGCSF 100ug/kg group and 6 mg group could shorten the duration of above third-degree neutropenia in the primary treated breast cancer patients treated with chemotherapy (P< 0.01).2. Secondary efficacy index1) The duration of above fourth-degree neutropenia in the first cycle (defined as the duration of ANC< 0.5�109/L).The duration of above fourth-degree neutropenia in PGCSF 6mg group, PGCSF 100?g/kg group and HEX group was 0.45(�0.74),0.58(�0.96) and 1.35(�1.46), respectively. The longest duration of above third-degree neutropenia in PGCSF 6mg group was 2 days,3 days in PGCSF 100?g/kg group, and 4 days in HEX group. Compared with HEX group, PGCSF 100?g/kg group and 6 mg group could shorten the duration of above fourth-degree neutropenia in the primary treated breast cancer patients treated with chemotherapy (P< 0.05).(2) The incidence rate of third-degree neutropenia in the first cycle. The incidence rate of third-degree neutropenia in PGCSF 6mg group, PGCSF 100?g/kg group and HEX group was 54.55%,52.63% and 88.24%, respectively. Compared with HEX group, PGCSF 100?g/kg group and 6 mg group could significantly reduce the incidence rate of third-degree neutropenia in the primary treated breast cancer patients treated with chemotherapy (P< 0.05).(3) The incidence rate of fourth-degree neutropenia in the first cycle. The incidence rate of fourth-degree neutropenia in PGCSF 6mg group, PGCSF 100?g/kg group and HEX group was 31.82%,31.58% and 58.82%, respectively. There was no difference between three groups (P> 0.05).(4) Recovery time of ANC from the lowest level to normal(ANC? 2.0�109/ L)The recovery time from the lowest level to normal of ANC in PGCSF 6mg group, PGCSF 100?g/kg group and HEX group was 1.32�0.99 days,1.37�1.01 days and 4.71�3.95 days, respectively. The longest recovery time in both PGCSF groups were 3 days, and 14 days in HEX group. Compared with HEX group, PGCSF 100?g/kg group and 6 mg group could significantly shorten the recovery time in the primary treated breast cancer patients treated with chemotherapy (P< 0.05).3. The rescue use of G-CSF:There were 5 cases in 58 patients who accepted G-CSF treatment as rescue use. There were 4 cases in HEX group and the average rescue time was 2.75 days. There was 1 case in PGCSF 100?g/kg and the rescue time was 3 days.4. The adverse events happened in the first cycleThe incidence rate of adverse events was 100% in the first cycle. The adverse events which exceeded 20% were gastrointestinal reaction such as nausea (34.5%), vomiting (25.9%), abdominal pain (25.9%), abdominal distension (22.4%), constipation (20.7%), diarrhea (20.7%); blood system:white blood cells decrease (70.7%), the ANC decrease (65.5%), PLT increase (24.1%), etc., where the fever (20.7%) was also higher.5. Vital signs, physical examination and ECOG scoreVital signs, physical examination and ECOG score were checked in screening period, before and after the first cycle of chemotherapy. The results show that the body weight, body surface area, breathing, body temperature, blood pressure, heart rate and other vital signs were normal. The respiratory rate, heart rate, systolic blood pressure and diastolic blood pressure in all the test groups were not different in the first cycle before and after chemotherapy.Conclusion:PGCSF is safe and effective on neutropenia in the treatment of breast cancer patients with chemotherapy. The appropriate dosage of PGCSF is 6mg.