Patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round are randomly assigned to either the control or experimental arm. Patients in the control arm continue pegfilgrastim injection on day 1 while patients in the experimental arm will receive pegfilgrastim injection on day 3 to see if changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy could reduce the incidence of neutropenia
The use of pegfilgrastim, which has a long-lasting effect in the human body, after myelosuppressive chemotherapy for solid tumors, including breast cancer, and blood cancers has led to a decrease in the incidence of neutropenia, including febrile neutropenia, and a reduction in medical costs by shortening hospitalization periods related to side effects of chemotherapy. During the early stages of drug development, there was controversy over the timing of pegfilgrastim administration, and attempts were made to administer it at various times, from the day of chemotherapy to the day of neutropenia began. However, based on several studies, it is now known that patients who receive pegfilgrastim on the day of chemotherapy or after 4 days of chemotherapy have a higher incidence of febrile neutropenia. Therefore, administering pegfilgrastim on day 1-3 after chemotherapy is ideal, but in reality, it is often difficult for patients to visit the hospital multiple times after chemotherapy, so many patients are discharged after receiving pegfilgrastim on day 1. The FDA and National Comprehensive Cancer Network (NCCN) guidelines also recommend administration on day 1. It is known that patients who experience neutropenia after the first round of chemotherapy are more likely to experience it again in subsequent rounds. The investigators aimed to see whether changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy for patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round can reduce the incidence of neutropenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
long-acting granulocyte-colony stimulating factor
Good Gang-An Hospital
Busan, South Korea
RECRUITINGIncidence rate of severe neutropenia Incidence rate of severe neutropenia
The incidence rates of Grade 4 neutropenia (ANC \< 500 respectively)
Time frame: cycle 2-5 (21 days for each cycle), 105 days
Duration of severe neutropenia
number of consecutive days ANC lower than 500
Time frame: cycle 2-5 (21 days for each cycle), 105 days
Incidence rate of febrile neutropenia
Severe neutropenia with fever. Fever is defined as below * 37.5℃ single axillary temperature * 38.0℃ single ear probe temperature * 38.3℃ single oral temperature * 38.0℃ oral temperature over 1 hour in the absence of an obvious cause
Time frame: cycle 2-5 (21 days for each cycle), 105 days
Incidence rate of neutropenia related death
Death related chemotherapy induced neutropenia sepsis
Time frame: 1 year
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