Febrile Neutropenia
Conditions
Keywords
breast cancer, chemotherapy, PEG-rhG-CSF, prophylactic, febrile neutropenia
Brief summary
This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF in at least two cycles of chemotherapy according to real-world clinical judgement and choice by physicians in local cancer center. Comparing real conditional-FN rate, FN-caused hospitalization rate and antibiotic use rate, direct/indirect medical cost.
Detailed description
The breast cancer patients planning for neo-adjuvant/adjuvant chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) according to NCCN and ASCO guideline are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF according to real-world clinical judgement and choice by physicians in local cancer center for at least two cycles of chemotherapy. The primary outcome is FN rate, the second outcomes are rate of 3-4 grade decrease of ANC, FN-caused hospitalization, FN-caused antibiotic use rate, rate of reduction of chemotherapy dose, delay of chemotherapy, safety and pharmacoeconomics.
Interventions
DRUGPEGCSF first level prophylactic use
6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy
DRUGPEGCSF second level prophylactic use
6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened
Sponsors
Zhejiang Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. provision of informed consent 2. stage I-III, invasive breast cancer 3. accept at least 4 cycles of chemotherapy 4. ECOG score 0-2 5. with medium-high risk of FN according to researchers
Exclusion criteria
1. accepted stem cell or bone marrow transplant 2. undergoing any other clinical trial 3. uncontrolled infection, temperature≥38℃ 4. per-week scheme chemotherapy 5. concurrent with radiotherapy 6. allergic conditions 7. sever organ dysfunction 8. uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FN rate | assessment at 1 month after the last cycle chemotherapy complete | rate of febrile neutropenia during all cycles of chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of 3-4 grade neutropenia | During all cycles of chemotherapy, through study completion, an average of half year | rate of 3-4 grade decrease of ANC |
| FN-caused hospitalization | During all cycles of chemotherapy, through study completion, an average of half year | rate of FN-caused hospitalization |
| FN-caused antibiotic use rate | During all cycles of chemotherapy, through study completion, an average of half year | rate of FN-caused antibiotic use |
| rate of dose reduction | During all cycles of chemotherapy, through study completion, an average of half year | rate of reduction of chemotherapy dose |
Contacts
Backup ContactHaiyan Xu, MD
Primary ContactHongjian Yang, MD
Outcome results
None listed