Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
61
Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy. Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were \<45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle. Dosing time: 48 h after chemotherapy.
Bejing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Time frame: through first cycle of PEG-rhG-CSF,an average of 1 month
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
Time frame: through second cycle of PEG-rhG-CSF,an average of 1 month
The incidence of febrile neutropenia in cycles 1 and 2
Febrile neutropenia (FN) is defined as oral temperature \>38.3 ° C (underarm temperature \>38.1 ° C) or continuous measurement of oral temperature \>38 ° C (underarm temperature \>37.8 ° C) in 2 h, and ANC \<0.5×10\^9/L, or expected to be \<0.5×10\^9/L
Time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
The ANC recovery time in cycles 1 and 2
Defined as the patients who appear ANC\<2.0×10\^9/L，from the first day of chemotherapy, to the time of ANC≥ 2.0×10\^9/L, take the median.
Time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
The incidence of infection
Time frame: up to 30 days after the patient study completion
The incidence of antibiotic use
Time frame: up to 30 days after the patient study completion
Incidence of chemotherapy dose adjustment due to neutropenia
Time frame: through the study completion,an average of 3 months
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Chemotherapy delay time
Time frame: through the study completion,an average of 3 months
Incidence of chemotherapy delay caused by neutropenia
Time frame: through the study completion,an average of 3 months
The duration of febrile neutropenia in cycles 1 and 2
Time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month