Randomized phase III study of granulocyte transfusions in neutropenic patients.
Despite antibiotics, antifungals and haematopoietic growth factors, infections remain a major threat to neutropenic patients. To determine the role of granulocyte transfusions (GTs) in anti-infective therapy during neutropenia, GT administration was randomized in 74 adults with haematological or malignant diseases, febrile neutropenia and pulmonary or soft-tissue infiltrates after conventional or high-dose chemotherapy, a majority of them after allo-SCT (n=39). Neutrophil reconstitution was equal in the treatment and control arm. GT toxicity was minimal. The probability of 28-day survival after randomization was >80% in both groups, and no effect of GT on survival until day 100 could be detected in patients with fungal (n=55), bacterial or unknown infection (n=17) and various levels of neutropenia (ANC <500 vs >500 x 10(6)/l). These findings can be attributed primarily to procedural obstacles, such as long delay from randomization to first GT, low cell content and slow sequence of GT, difficulties in randomizing a safe and potentially life-saving treatment in severely endangered individuals, and a large proportion of rapidly recovering patients in both arms. The requirement of another trial in a more specific patient population with daily transfusions of sufficient numbers of granulocytes to support or refute the empirically acknowledged benefits of GT is discussed.
Seidel
M G
MG
St Anna Kinderspital, Kinderspitalgasse, Vienna, Austria.
Peters
C
C
Wacker
A
A
Northoff
H
H
Moog
R
R
Boehme
A
A
Silling
G
G
Grimminger
W
W
Einsele
H
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006098:Granulocytes / Q000637:transplantation*; D006402:Hematologic Diseases / Q000150:complications / Q000628:therapy; D006801:Humans; D007239:Infections / Q000401:mortality / Q000628:therapy; D017708:Leukocyte Transfusion; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000628:therapy; D009503:Neutropenia / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult