Annino, L., Chierichini, A., Anaclerico, B., Finolezzi, E., Norata, M., Cortese, S., . . . Girmenia, C. (2013). Prospective phase II single-center study of the safety of a single very high dose of liposomal amphotericin B for antifungal prophylaxis in patients with acute myeloid leukemia. Antimicrobial Agents and Chemotherapy, 57, 2596–2602.

To evaluate the feasibility and tolerability of prophylactic administration of a single, very high dose of liposomal amphotericin B (L-AmB) in adult patients newly diagnosed with acute myeloid leukemia (AML) and undergoing induction chemotherapy

The study was a pilot, phase II, single-center trial. The L-AmB was used to evaluate its efficacy and the level of toxicity. The study enrolled patients with AML undergoing first remission induction chemotherapy from January 2004–January 2011.

• N = 48      
• AGE = 32–78 years
• MALES: 61.7%
• KEY DISEASE CHARACTERISTICS: Induction chemotherapy; type of AML; toxicity level

• SITE: Not stated/unknown   
• SETTING TYPE: Inpatient   
• LOCATION: Not specific

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Palliative care

• Phase II, single-center trial

• Common toxicity criteria (CTC)
• Pharmacokinetic study

Overall, 18 of the 48 (37.5 %) patients experienced at least one adverse effect (all CTC grade) after the first or second L-AmB, and only six of them (12.5%) reported CTC grade 3 adverse events related to L-AmB administration.

The study demonstrates the feasibility and safety of a single, very high dose of L-AmB as antifungal prophylaxis in patients with AML undergoing induction chemotherapy.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Measurement validity/reliability questionable

This study basically determines the use of L-AmB to be used safely in patients with AML undergoing induction chemotherapy and does not have enough specification related to nursing.