| Quality assessment | No of patients | Effect | Quality | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | G(M)-CSF | No G(M)-CSF | Relative (95% CI) | Absolute | |
| Mortality | |||||||||||
| 80 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | no serious imprecision | None | 465/6146 (7.6%) | 472/5913 (8%) | RR 0.95 (0.84 to 1.08) | 4 fewer per 1000 (from 13 fewer to 6 more) | HIGH |
| Mortality (paediatric patients) | |||||||||||
| 7 | randomised trials | serious2 | no serious inconsistency | no serious indirectness | very serious3 | None | 6/301 (2%) | 4/303 (1.3%) | RR 1.46 (0.42 to 5.11) | 6 more per 1000 (from 8 fewer to 54 more) | VERY LOW |
| Mortality (adult patients) | |||||||||||
| 34 | randomised trials | serious4 | no serious inconsistency | no serious indirectness | serious5 | None | 105/1986 (5.3%) | 117/1780 (6.6%) | RR 0.85 (0.66 to 1.11) | 10 fewer per 1000 (from 22 fewer to 7 more) | LOW |
| Mortality (elderly patients) | |||||||||||
| 8 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | no serious imprecision | None | 311/3778 (8.2%) | 317/3586 (8.8%) | RR 1.04 (0.87 to 1.24) | 4 more per 1000 (from 11 fewer to 21 more) | HIGH |
| Mortality (prophylactic antibiotics used) | |||||||||||
| 15 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious5 | None | 51/1045 (4.9%) | 59/1056 (5.6%) | RR 0.92 (0.64 to 1.32) | 4 fewer per 1000 (from 20 fewer to 18 more) | MODERATE |
| Mortality (prophylactic antibiotics not mandated) | |||||||||||
| 66 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | none | 414/5101 (8.1%) | 413/4857 (8.5%) | RR 0.96 (0.84 to 1.09) | 3 fewer per 1000 (from 14 fewer to 8 more) | HIGH |
| Mortality (leukaemia studies) | |||||||||||
| 30 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision5 | None | 263/2725 (9.7%) | 277/2597 (10.7%) | RR 0.95 (0.81 to 1.12) | 5 fewer per 1000 (from 20 fewer to 13 more) | HIGH |
| Mortality (lymphoma or solid tumour studies) | |||||||||||
| 27 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious5 | None | 109/2204 (4.9%) | 113/2155 (5.2%) | RR 0.91 (0.64 to 1.28) | 5 fewer per 1000 (from 19 fewer to 15 more) | MODERATE |
| Mortality (stem cell transplant studies) | |||||||||||
| 21 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious5 | None | 93/1098 (8.5%) | 79/1044 (7.6%) | RR 1.02 (0.77 to 1.34) | 2 more per 1000 (from 17 fewer to 26 more) | MODERATE |
| Mortality (G-CSF studies) | |||||||||||
| 46 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | None | 267/3726 (7.2%) | 265/3531 (7.5%) | RR 0.98 (0.83 to 1.15) | 2 fewer per 1000 (from 13 fewer to 11 more) | HIGH |
| Mortality (GM-CSF studies) | |||||||||||
| 34 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | None | 193/1957 (9.9%) | 193/1917 (10.1%) | RR 0.95 (0.84 to 1.08) | 5 fewer per 1000 (from 16 fewer to 8 more) | HIGH |
| Infection related mortality | |||||||||||
| 67 | randomised trials | no serious risk of bias1,6 | no serious inconsistency | no serious indirectness | serious5,7 | none | 150/4901 (3.1%) | 179/4673 (3.8%) | RR 0.82 (0.66 to 1.02) | 7 fewer per 1000 (from 13 fewer to 1 more) | MODERATE |
| Infection related mortality (prophylactic antibiotics used) | |||||||||||
| 14 | randomised trials | serious8 | no serious inconsistency | no serious indirectness | Serious5 | None | 18/1177 (1.5%) | 42/1181 (3.6%) | RR 0.47 (0.28 to 0.8) | 19 fewer per 1000 (from 7 fewer to 26 fewer) | LOW |
| Infection related mortality (prophylactic antibiotics not mandated) | |||||||||||
| 53 | randomised trials | serious9 | no serious inconsistency | no serious indirectness | no serious imprecision | None | 132/3724 (3.5%) | 137/3492 (3.9%) | RR 0.91 (0.72 to 1.16) | 4 fewer per 1000 (from 11 fewer to 6 more) | MODERATE |
| Febrile neutropenia | |||||||||||
| 49 | randomised trials | serious10 | no serious inconsistency | no serious indirectness | no serious imprecision | None | 1293/4529 (28.5%) | 1649/4470 (36.9%) | RR 0.71 (0.63 to 0.8) | 107 fewer per 1000 (from 74 fewer to 136 fewer) | MODERATE |
| Febrile neutropenia (leukaemia studies) | |||||||||||
| 10 | randomised trials | serious | no serious inconsistency | no serious indirectness | no serious imprecision | None | 389/867 (44.9%) | 339/808 (42%) | RR 0.81 (0.66 to 0.99) | 80 fewer per 1000 (from 4 fewer to 143 fewer) | MODERATE |
| Febrile neutropenia (lymphoma or solid tumour studies) | |||||||||||
| 32 | randomised trials | serious9 | no serious inconsistency | no serious indirectness | no serious imprecision | None | 730/3381 (21.6%) | 1070/3412 (31.4%) | RR 0.64 (0.53 to 0.76) | 113 fewer per 1000 (from 75 fewer to 147 fewer) | MODERATE |
| Febrile neutropenia (stem cell transplant studies) | |||||||||||
| 3 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious5 | none | 135/193 (69.9%) | 127/172 (73.8%) | RR 0.94 (0.74 to 1.2) | 44 fewer per 1000 (from 192 fewer to 148 more) | MODERATE |
| Documented infection | |||||||||||
| 60 | randomised trials | serious9 | no serious inconsistency | no serious indirectness | no serious imprecision | None | 1874/5921 (31.7%) | 2043/5704 (35.8%) | Rate ratio 0.85 (0.79 to 0.92) | 54 fewer per 1000 (from 29 fewer to 75 fewer) | MODERATE |
| Resistance to the antibiotic used for prophylaxis - not reported | |||||||||||
| 0 | - | - | - | - | - | None | - | - | - | - | |
| Length of hospital stay (Better indicated by lower values) | |||||||||||
| 43 | randomised trials | no serious risk of bias11 | no serious inconsistency | serious indirectness12 | no serious imprecision | None | 0 | - | - | Mean difference 2.41 days less with G(M)-CSF (3.13 to 1.7 lower) | MODERATE |
| Quality of life - not reported | |||||||||||
| 0 | - | - | - | - | - | None | - | - | - | - | |
This review included 80 trials: 26/80 trials had adequate allocation concealment and 35/80 had double blinding. Sensitivity analyses according to allocation concealment and double blinding, did not show a significant effect of CSF treatment on mortality, infectious mortality or febrile neutropenia.
None of the 7 paediatric mortality studies had adequate allocation concealment, 2/7 had double blinding
Low number of events
11/34 adult mortality studies had adequate allocation concealment, 15/34 had double blinding.
Low number of events
67 trials reported infection related mortality: 19/67 had adequate allocation concealment and 29/67 had double blinding.
The confidence interval for the pooled estimate spans both no effect and significant benefit.
2/14 trials had adequate allocation concealment, 4/14 double blinding.
Most of the trials did not have adequate allocation concealment or double blinding
Of the studies reporting febrile neutropenia 9/49 had adequate allocation concealment and 15/49 had double blinding.
The quality of studies of duration of hospital stay was not reported.
Hospital discharge criteria in these studies were likely to incorporate neutrophil count and thus influenced by the use of colony stimulating factors.
From: 5, Reducing the risk of septic complications of anticancer treatment
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