Table 5.2GRADE profile: Is primary prophylaxis with G(M)-CSF plus antibiotics more effective than primary prophylaxis with antibiotics at improving outcomes for patients at risk of neutropenic sepsis

Quality assessmentNo of patientsEffectQuality
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsG(M)-CSF+ABXAntibiotics aloneRelative
(95% CI)		Absolute
Febrile neutropenia (quinolone studies) – one trial in patients with solid tumours and one in non-Hodgkin lymphoma
2randomised trialsserious1serious6no serious indirectnessserious2none53/432
(12.3%)		71/410
(17.3%)		RR 0.703
(0.414 to 1.193)		51 fewer per 1000 (from 101 fewer to 33 more)VERY LOW
Mortality from any cause (quinolone studies) – one trial each in patients with solid tumours , non-Hodgkin lymphoma, leukaemia and stem cell transplant
4randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessserious2none25/408
(6.1%)		33/401
(8.2%)		RR 0.817
(0.491 to 1.36)		15 fewer per 1000 (from 42 fewer to 30 more)MODERATE
Infectious mortality (quinolone studies) – one trial each in patients with non-Hodgkin lymphoma, leukaemia and stem cell transplant; two in patients with solid tumours
5randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessserious2none13/498
(2.6%)		29/486
(6%)		RR 0.478
(0.254 to 0.898)		31 fewer per 1000 (from 6 fewer to 45 fewer)MODERATE
Febrile neutropenia (cotrimoxazole studies) – five leukaemia, two non-Hodgkin and two stem cell transplant trials
9randomised trialsserious3no serious inconsistencyno serious indirectnessno serious imprecisionnone349/504
(69.2%)		372/483
(77%)		RR 0.928 (0.86 to 1.002)55 fewer per 1000 (from 108 fewer to 2 more)MODERATE
Mortality from any cause (cotrimoxazole studies) – five leukaemia, two non-Hodgkin and four stem cell transplant trials
11randomised trialsserious4no serious inconsistencyno serious indirectnessserious2none32/706
(4.5%)		29/705
(4.1%)		RR 1.102
(0.685 to 1.773)		4 more per 1000 (from 13 fewer to 32 more)LOW
Infectious mortality (cotrimoxazole studies) – four leukaemia, three non-Hodgkin and two stem cell transplant trials
9randomised trialsserious5no serious inconsistencyno serious indirectnessserious2none7/731
(0.96%)		14/728
(1.9%)		RR 0.6 (0.264 to 1.367)8 fewer per 1000 (from 14 fewer to 7 more)LOW
Length of Hospital stay – not reported
0-----none----
Quality of life - not reported
0-----none----
1

1/2 double blind, 0/2 adequate allocation concealment

2

Low number of events

3

1/9 had adequate allocation concealment, 2/9 double blinding

4

1/11 had adequate allocation concealment, 2/11 double blinding

5

0/9 had adequate allocation concealment, 1/9 was double blind

6

Significant heterogeneity (I2=67%)

From: 5, Reducing the risk of septic complications of anticancer treatment

Cover of Neutropenic Sepsis: Prevention and Management of Neutropenic Sepsis in Cancer Patients
Neutropenic Sepsis: Prevention and Management of Neutropenic Sepsis in Cancer Patients.
NICE Clinical Guidelines, No. 151.
National Collaborating Centre for Cancer (UK).
Copyright © National Collaborating Centre for Cancer, 2012.

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