Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia

CSPC Pharmaceutical Group

Status: Unknown

Conditions: Chemotherapy-induced Neutropenia; Myelosuppression

Treatments: Drug: PEG-rhG-CSF

Study type: Observational

Funder types: Industry

Identifiers

NCT03846414

CSPC-JYL-RWS-07

Details and patient eligibility

About

The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients' age≥18 years old, male or female
2. Diagnosis of non-myeloid malignant solid tumors
3. Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
4. Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
5. The investigator believes that patients can benefit from this study

Exclusion criteria

1. Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
2. Pregnant or lactating women and women who plan to be pregnant during clinical observation
3. Other patients that the doctor believe not suitable for inclusion

Trial design

1,500 participants in 2 patient groups

PEG-rhG-CSF group

Description:

This group comprised 1000 patients who received a single subcutaneous injection of PEG-rhG-CSF 24 hours after the end of chemotherapy for each chemotherapy cycle. The dose of PEG-rhG-CSF is determined by the patients' body weight, patients with body weight ≥45 kg is given to PEG-rhG-CSF 6 mg each time, patients\<45 kg is given to PEG-rhG-CSF 3 mg each time.

Treatment:

Drug: PEG-rhG-CSF

rhG-CSF group

Description:

This group comprised 500 patients who received rhG-CSF 5 μg/kg/day by subcutaneous injection 24 hours after the end of chemotherapy or the appearance of CIN until the ANC was ≥2.0x109/L for each chemotherapy cycle.