A Cochrane review [Abstract] 1 included 2 studies with a total of 195 subjects. One study included 40 breast cancer patients receiving high-dose chemotherapy and compared granulocyte colony-stimulating factors (G-CSF) to antibiotics. Another study evaluated 155 patients with small-cell lung cancer receiving granulocyte-macrophage colony-stimulating factors (GM-CSF) or antibiotics.
For the study comparing G-CSF to antibiotics, there was no difference in infection-related mortality (zero events in each arm) or in frequency of febrile neutropenia (RR 1.22, 95% CI 0.53 to 2.84). All cause mortality, microbiologically or clinically documented infections, severe infections, quality of life, and adverse events were not reported.
There was no difference in median survival time in the study comparing GM-CSF and antibiotics. There was no difference in toxic deaths (RR 1.32, 95% CI 0.30 to 5.69), severe infections (28% vs 18%, RR 1.55, 95% CI 0.86 to 2.80), non-haematological toxicities like diarrhoea, stomatitis, infections, neurologic, respiratory, or cardiac adverse events between GM-CSF and antibiotics. Grade III and IV thrombopenia occurred significantly more frequently in the GM-CSF arm compared to the antibiotics arm (60.8% vs 28.9%, RR 2.10, 95% CI 1.41 to 3.12). Neither infection-related mortality, incidence of febrile neutropenia, nor quality of life were reported in this study.
Comment: The quality of evidence is downgraded by study limitations (unclear allocation concealment, lack of blinding, and failure to adhere to the intention-to-treat principle), and by imprecise results (few patients and outcome events).
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