Amphotericin B lipid soluble formulations versus amphotericin B in cancer patients with neutropenia (Cochrane Review)

A substantive amendment to this systematic review was last made on 03 April 2000. Cochrane reviews are regularly checked and updated if necessary.

Background: Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever.

Objectives: To compare the effect and adverse effects of lipid soluble formulations of amphotericin B with conventional amphotericin B in cancer patients with neutropenia.

Search strategy: MEDLINE and Cochrane Library; date of last search Nov. 2001. Unpublished trials from conference proceedings and contact to industry.

Selection criteria: Randomised trials comparing lipid soluble formulations of amphotericin B with conventional amphotericin B.

Data collection and analysis: Data on mortality, invasive fungal infection, nephrotoxicity, serum creatinine and dropouts were extracted by both authors independently.

Main results: AmBisome vs conventional amphotericin B (3 trials, 1149 patients): At the doses used, AmBisome tended to be more effective than conventional amphotericin B for invasive fungal infection (relative risk 0.63, 95% confidence interval (CI) 0.39 to 1.01, P=0.053) whereas there was no significant difference in mortality (relative risk 0.74, 95% CI 0.52 to 1.07). AmBisome decreased significantly the incidence of nephrotoxicity, defined as a 100% increase in serum creatinine (relative risk 0.51, 95% CI 0.40 to 0.64). Amphotericin B in Intralipid vs conventional amphotericin B (6 trials, 379 patients): There were no significant differences in clinical effect whereas the patients treated with the lipid soluble formulation experienced significantly less nephrotoxicity (relative risk 0.44, 95% CI 0.24 to 0.81) and smaller increases in serum creatinine (weighted mean difference 19 µmol/l, 95% CI 5 to 34 µmol/l). Amphotericin B colloidal dispersion (ABCD) vs conventional amphotericin B (2 trials, 262 patients): There were no significant differences in clinical effect whereas the patients treated with ABCD experienced significantly less nephrotoxicity (relative risk 0.35, 95% CI 0.23 to 0.53).

Reviewers' conclusions: The studies we reviewed indicate that some lipid soluble formulations of amphotericin B may be better drugs than conventional amphotericin B, but their high cost prohibit routine use in most settings. Furthermore, it is not clear whether there are any advantages of these formulations if conventional amphotericin B is administered under optimal circumstances. There is a need for large trials comparing lipid formulations of amphotericin B with conventional amphotericin B given in the same dose and with routine premedication for prevention of infusion-related toxicity and supplementation with potassium and magnesium for prevention of nephrotoxicity.

Citation: Johansen HK, Gøtzsche PC. Amphotericin B lipid soluble formulations versus amphotericin B in cancer patients with neutropenia (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford: Update Software.

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