Baseline characteristics for modified intention-to-treat subjects (N = 97)
| . | Treatment arm . | P* . | |
|---|---|---|---|
| Control, n = 49 . | Granulocytes, n = 48 . | ||
| Age, y | 46.9 + 20.2 | 54.9 + 17.1 | .04 |
| <18, n (%) | 6 (12) | 4 (8) | .24 |
| 18-64, n (%) | 33 (67) | 27 (56) | |
| >65, n (%) | 10 (20) | 17 (35) | |
| Male sex, n (%) | 27 (55) | 28 (58) | .84 |
| Race, n (%) | .18 | ||
| White | 31(63) | 37 (77) | |
| Asian | 4 (8) | 1 (2) | |
| Black/African American | 1 (2) | 3 (6) | |
| Other/unknown | 13 (27) | 7 (15) | |
| ANC at randomization, cells/μL | 43 ± 88 | 59 ± 100 | .38 |
| Cause of neutropenia, n (%) | .83 | ||
| HSC transplantation | 8 (16) | 8 (17) | |
| Chemotherapy | 36 (73) | 37 (77) | |
| Other | 5 (10) | 3 (6) | |
| Underlying disorder, n (%) | .73 | ||
| Acute lymphocytic leukemia | 6 (12) | 6 (13) | |
| Acute nonlymphocytic leukemia | 31 (63) | 32 (67) | |
| Chronic myelogenous leukemia | 2 (4) | 0 (0) | |
| Chronic lymphocytic leukemia | 1 (2) | 0 (0) | |
| Non-Hodgkin lymphoma | 3 (6) | 4 (8) | |
| Myelodysplasia | 1 (2) | 2 (4) | |
| Myeloma | 1 (2) | 0 (0) | |
| Aplastic anemia | 2 (4) | 0 (0) | |
| Other malignancy | 0 (0) | 1 (2) | |
| Other | 2 (4) | 3 (6) | |
| Infection at enrollment, n (%) | .48† | ||
| Proven fungal | 15 (31) | 11 (23) | |
| Bloodstream | |||
| Candida | 6 (12) | 3 (6) | |
| Zygomycetes | 1 (2) | 0 (0) | |
| Mold not specified | 1 (2) | 0 (0) | |
| Pulmonary | |||
| Aspergillus | 1 (2) | 2 (4) | |
| Zygomycetes | 1 (2) | 0 (0) | |
| Facial/sinus | |||
| Aspergillus | 0 (0) | 2 (4) | |
| Zygomycetes | 0 (0) | 1 (2) | |
| Skin/soft tissue | |||
| Aspergillus | 1 (2) | 1 (2) | |
| Fusarium | 0 (0) | 1 (2) | |
| Disseminated | |||
| Candida | 1 (2) | 2 (4) | |
| Fusarium | 1 (2) | 0 (0) | |
| Other | |||
| Aspergillus | 1 (2) | 0 (0) | |
| Mold not specified | 1 (2) | 0 (0) | |
| Probable/presumptive pulmonary fungal | 9 (18) | 11 (23) | |
| Typhlitis | 2 (4) | 5 (10) | |
| Invasive bacterial | 13 (27) | 8 (17) | |
| Bacteremia alone | 10 (20) | 13 (27) | |
| Signs/symptoms | |||
| Fever | 46 (94) | 41 (85) | .20 |
| Pulmonary Sx/signs, n (%) | 30 (61) | 30 (63) | >.99 |
| Dyspnea, n (%) | 10 (20) | 10 (21) | >.99 |
| Respiratory rate, per min | 23.4 ± 6.1 | 20.6 ± 4.6 | .03 |
| FIO2 | 0.42 ± .23 | 0.40 ± .24 | .76 |
| Arterial O2 saturation, % | 96.0 ± 3.5 | 95.4 ± 5.5 | .83 |
| Ventilator, n (%) | 10 (20) | 9 (19) | >.99 |
| Nasal/sinus Sx/signs, n (%) | 4 (8) | 9 (19) | .15 |
| CNS Sx/signs, n (%) | 11 (22) | 7 (15) | .31 |
| Skin nodules/papules, n (%) | 5 (10) | 7 (15) | .76 |
| Zubrod score,‡ >2, n (%) | 34 (69) | 36 (75) | .65 |
| . | Treatment arm . | P* . | |
|---|---|---|---|
| Control, n = 49 . | Granulocytes, n = 48 . | ||
| Age, y | 46.9 + 20.2 | 54.9 + 17.1 | .04 |
| <18, n (%) | 6 (12) | 4 (8) | .24 |
| 18-64, n (%) | 33 (67) | 27 (56) | |
| >65, n (%) | 10 (20) | 17 (35) | |
| Male sex, n (%) | 27 (55) | 28 (58) | .84 |
| Race, n (%) | .18 | ||
| White | 31(63) | 37 (77) | |
| Asian | 4 (8) | 1 (2) | |
| Black/African American | 1 (2) | 3 (6) | |
| Other/unknown | 13 (27) | 7 (15) | |
| ANC at randomization, cells/μL | 43 ± 88 | 59 ± 100 | .38 |
| Cause of neutropenia, n (%) | .83 | ||
| HSC transplantation | 8 (16) | 8 (17) | |
| Chemotherapy | 36 (73) | 37 (77) | |
| Other | 5 (10) | 3 (6) | |
| Underlying disorder, n (%) | .73 | ||
| Acute lymphocytic leukemia | 6 (12) | 6 (13) | |
| Acute nonlymphocytic leukemia | 31 (63) | 32 (67) | |
| Chronic myelogenous leukemia | 2 (4) | 0 (0) | |
| Chronic lymphocytic leukemia | 1 (2) | 0 (0) | |
| Non-Hodgkin lymphoma | 3 (6) | 4 (8) | |
| Myelodysplasia | 1 (2) | 2 (4) | |
| Myeloma | 1 (2) | 0 (0) | |
| Aplastic anemia | 2 (4) | 0 (0) | |
| Other malignancy | 0 (0) | 1 (2) | |
| Other | 2 (4) | 3 (6) | |
| Infection at enrollment, n (%) | .48† | ||
| Proven fungal | 15 (31) | 11 (23) | |
| Bloodstream | |||
| Candida | 6 (12) | 3 (6) | |
| Zygomycetes | 1 (2) | 0 (0) | |
| Mold not specified | 1 (2) | 0 (0) | |
| Pulmonary | |||
| Aspergillus | 1 (2) | 2 (4) | |
| Zygomycetes | 1 (2) | 0 (0) | |
| Facial/sinus | |||
| Aspergillus | 0 (0) | 2 (4) | |
| Zygomycetes | 0 (0) | 1 (2) | |
| Skin/soft tissue | |||
| Aspergillus | 1 (2) | 1 (2) | |
| Fusarium | 0 (0) | 1 (2) | |
| Disseminated | |||
| Candida | 1 (2) | 2 (4) | |
| Fusarium | 1 (2) | 0 (0) | |
| Other | |||
| Aspergillus | 1 (2) | 0 (0) | |
| Mold not specified | 1 (2) | 0 (0) | |
| Probable/presumptive pulmonary fungal | 9 (18) | 11 (23) | |
| Typhlitis | 2 (4) | 5 (10) | |
| Invasive bacterial | 13 (27) | 8 (17) | |
| Bacteremia alone | 10 (20) | 13 (27) | |
| Signs/symptoms | |||
| Fever | 46 (94) | 41 (85) | .20 |
| Pulmonary Sx/signs, n (%) | 30 (61) | 30 (63) | >.99 |
| Dyspnea, n (%) | 10 (20) | 10 (21) | >.99 |
| Respiratory rate, per min | 23.4 ± 6.1 | 20.6 ± 4.6 | .03 |
| FIO2 | 0.42 ± .23 | 0.40 ± .24 | .76 |
| Arterial O2 saturation, % | 96.0 ± 3.5 | 95.4 ± 5.5 | .83 |
| Ventilator, n (%) | 10 (20) | 9 (19) | >.99 |
| Nasal/sinus Sx/signs, n (%) | 4 (8) | 9 (19) | .15 |
| CNS Sx/signs, n (%) | 11 (22) | 7 (15) | .31 |
| Skin nodules/papules, n (%) | 5 (10) | 7 (15) | .76 |
| Zubrod score,‡ >2, n (%) | 34 (69) | 36 (75) | .65 |
Continuous variables are displayed as mean ± standard deviation, and categorical variables are displayed as n (%).
CNS, central nervous system; HSC, hematopoietic stem cell; Sx, symptoms.
P values: Fisher exact test for categorical variables and Kruskal-Wallis test for continuous variables.
P value for 5 infection groups: proven fungal, probable/presumptive pulmonary fungal, typhlitis, invasive bacterial, bacteremia alone.
Zubrod score defined as: 0, asymptomatic; 1, symptomatic, fully ambulatory; 2, symptomatic, in bed <50% of the day but not bedridden; 3, symptomatic, in bed >50% of the day but not bedridden; 4, bedridden; 5, death.