Peripheral blood stem cell mobilization and apheresis: analysis of adverse events in 94 normal donors.
Adverse events were analyzed in 94 normal donors who underwent PBSC harvest with G-CSF. The median dose of G-CSF was 9.7 microg/kg/day (range, 2.0-16.7), and the duration of administration was 4-6 days. Frequent symptoms were bone pain (71%), general fatigue (33%), headache (28%), insomnia (14%), anorexia (11%), nausea and/or vomiting (11%). One donor (1%) developed grade 3 toxicity bone pain (WHO criteria). WBC counts and ANC increased during G-CSF administration. After leukapheresis, three donors (3%) developed grade 3 toxicity neutropenia. Platelet counts decreased after leukapheresis. Three donors (3%) developed grade 3 thrombocytopenia. The means of both ALP and LDH increased approximately 1.9-fold compared with pretreatment levels. In one pediatric donor (1%), ALP was elevated to the grade 3 toxicity level. From multivariate analysis, the incidence of bone pain increased when G-CSF was given at a dose of 8.8 microg/kg/day or more, headaches were frequent in donors younger than 35 years, and the incidence of nausea and/or vomiting was high in female donors. The peak levels of WBC counts and ANC and post-treatment level of LDH increased in correspondence with the escalation of G-CSF dose. All adverse events normalized on follow-up evaluation. In conclusion, although PBSC harvest for normal donors is acceptable, care must be taken for all donors in terms of their sex and age as well as the G-CSF dose. We recommend less than 8.8 microg/kg/day as the G-CSF dose for PBSC mobilization in normal donors.
Murata
M
M
Division of Hematology, Department of Internal Medicine, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.
Harada
M
M
Kato
S
S
Takahashi
S
S
Ogawa
H
H
Okamoto
S
S
Tsuchiya
S
S
Sakamaki
H
H
Akiyama
Y
Y
Kodera
Y
Y
D000293:Adolescent; D000328:Adult; D001781:Blood Component Removal / Q000009:adverse effects*; D001782:Blood Donors; D002648:Child; D005221:Fatigue; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects*; D006261:Headache; D019650:Hematopoietic Stem Cell Mobilization / Q000009:adverse effects*; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009325:Nausea; D009503:Neutropenia; D010146:Pain; D010976:Platelet Count; D007319:Sleep Initiation and Maintenance Disorders; D014839:Vomiting
D016179:Granulocyte Colony-Stimulating Factor