Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis

Study Overview
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Brief Summary
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This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.

Detailed Description
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Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy. The primary outcome is the incidence of FN rate and proportion of patients completing chemotherapy on schedule, the second outcomes are the incidence of 3-4 grade of neutropenia, FN-related hospitalization and antibiotic use, incidence of reduction and delay of chemotherapy dose, safety and pharmacoeconomics of PEG-rhG-CSF.

Official Title
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Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary Prophylaxis Versus Secondary Prophylaxis of Chemotherapy Induced Neutropenia in Patients Receiving Chemotherapy With High-risk FN: a Real World Study

Conditions
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Chemotherapy-induced Neutropenia

Intervention / Treatment
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* Drug: PEG-rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Before the start of the study, all patients have been fully understood the research and the must sign the informed consent Aged 13 years or older accept at least 4 cycles of chemotherapy ECOG PS 0-2 expected survival time ≥ 3 months with -high risk of FN according to researchers Exclusion Criteria: accepted stem cell or bone marrow transplant undergoing any other clinical trial uncontrolled infection, temperature≥38℃ per-week scheme chemotherapy severe and uncontrolled diabetes People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products Suspected or confirmed drug use, drug abuse, alcoholics Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation Severe heart, kidney, liver and other important organs chronic diseases Pregnancy or lactation in women or women with gestation detection positive before the first time using drug Patients who have fertility but are unwilling to receive contraception or partners are not willing to accept contraceptives The investigator believes that the patient's condition is not suitable for this clinical study.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEG-rhG-CSF primary prophylaxis<br>Patients receiving chemotherapy who have a overall FN risk >=20% receive PEG-rhG-CSF for primary prophylaxis | Drug: PEG-rhG-CSF<br>* All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles<br>|
| PEG-rhG-CSF secondary prophylaxis<br>Patients receiving chemotherapy who had FN or dose-limited neutropenia receive PEG-rhG-CSF for secondary prophylaxis | Drug: PEG-rhG-CSF<br>* All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of FN rate | FN was defined as fever >=38.3°C orally (>=38.0°C for a duration over 2h) or axillary temperature >=38.1°C (>=37.8°C for a duration over 2h) and ANC < 0.5 X 10*9/L | through study completion, an average of 2 year | 
| Proportion of patients completing chemotherapy on schedule | proportion of patients completing chemotherapy on schedule | through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 3-4 grade of neutropenia | the second outcomes are the incidence of 3-4 grade of neutropenia | through study completion, an average of 2 year | 
| FN-related hospitalization and antibiotic use | FN-related hospitalization and antibiotic use | through study completion, an average of 2 year |