Table V.
Randomized controlled trials of prophylactic granulocyte transfusion in non-infected patients.
| Study | N | Indication for GTX |
Stimulation average GTX Dose |
GTX Course | Overall Outcomes | Fungal Outcomes | Adverse Events |
|---|---|---|---|---|---|---|---|
| Clift et al (1978)a | 69 | BMT (HM/AA), ANC < 0.2 × 109/l |
US, 2.22 × 1010 (FL), 1.57 × 1010 (CFC) |
Daily, mean 12.4 (6–25) |
Fewer infections (2/29) in GTX group vs control group (17/40) 21-days post-HSCT |
Fewer deaths from fungal infection in GTX group (0/29) vs controls (2/40) |
NS |
| Schiffer et al (1979)a | 19 | AML ANC < 0.5 × 109/l |
D, 1.15 × 1010 | Alternate days, mean 11 (3- 19) |
No severe infection in GTX group, 3/9 in control group |
3/9 fungal infections in control group |
Fevers, pulmonary reactions alloimmunization |
| Winston et al (1980)a | 38 | BMT (HM/AA), ANC < 0.5 × 109/l |
US, 1.2 × 1010 | Daily, mean 23.4 (13–34) |
No significant difference | 1/19 fungal pneumonia each in GTX and control group |
NS |
| Strauss et al (1981) | 102 | AML ANC < 0.5 × 109/l |
US, 3.4.x 109/m2 | Daily, mean 18.5 (3–28) |
No significant difference | 5/54 IFI (GTX) vs 3/48 (controls) |
Transfusion reactions (72%), pulmonary infiltrates (57%) |
| Winston et al (1981)a | 46 | AML ANC < 0.5 × 109/l |
US, 0.56 × 1010 | Daily, median 24 (7–28) |
No significant difference (p = 0.48) |
1/21 IFI (controls) | 68% had reactions, CMV, pneumonitis |
| Buckner et al (1983)b | 182 | BMT (HM/AA), ANC < 0.2 × 109/l |
NS | Daily, median 13 (2–31) |
No significant difference in infection or mortality at 100 days |
3 IFI (GTX) vs 8 (controls) | Severe pulmonary reaction, CMV, pneumonitis |
| Gomez-Villagran et al (1984) | 35 | AML ANC < 0.5 × 109/l |
D, 1.24 × 1010 | Daily, mean 6.16 (5–11) |
Fewer life-threatening infections (p < 0.01), fewer infectious deaths (p < 0.05) in GTX group vs controls |
No fungal infections in GTX group, 2 oral candidiasis in control group |
Pulmonary (2.3%), febrile (57.1%) and allergic (1.5%) reactions, passive haemolysis |
| Petersen et al (1986)a | 112 | BMT (HM), ANC < 0.2 × 109/l |
NS | Daily, median 12 (6–27) |
No significant difference in 100- day mortality post-HSCT, death from infection |
1/67 IFI (GTX) vs 5/45 (controls) |
7% transfusion reactions, mostly pulmonary |
AA, aplastic anaemia; AML, acute myeloid leukaemia; ANC, absolute neutrophil count; BMT, bone marrow transplantation; CFC, continuous flow centrifugation; CMV, cytomegalovirus; D, dexamethasone; FL, filtration leukapheresis; GTX, granulocyte transfusion; HM, haematological malignancy; HSCT, haematopoietic stem cell transplant; IFI, invasive fungal infection; NS, not specified; US, unstimulated.
a
Patients were eligible to receive therapeutic GTX during the study if they developed infection.
b
Partially randomized: if only one intervention option was available, patients were allocated to that modality.