Omega-3 Poly-Unsaturated Fatty Acids for the Prevention of Severe Neutropenic Enterocolitis in Patients with Acute Myeloid Leukemia

Abstract

Neutropenic enterocolitis is a potentially fatal complication of myeloablative chemotherapy in patients with acute myeloid leukemia. Omega-3 polyunsaturated fatty acids (PUFA) are precursors of potent anti-inflammatory prostaglandins. Our aim was to explore the safety and effectiveness of omega-3 PUFA added to parenteral nutrition in protecting leukemia patients from severe enterocolitis. Fourteen patients with acute myeloid leukemia who received omega-3 PUFA in a Phase II trial were compared with 66 consecutive control patients not getting this intervention. We performed crude and adjusted comparisons, using inverse probability of treatment weighting for adjusted analysis, and blind outcome assessment to minimize assessor bias. Primary outcome was severe enterocolitis (≥Grade 3). The crude odds ratio of Grade 3 colitis or higher was 1.36 (95% CI 0.37 to 4.96, P = 0.64), and the adjusted odds ratio was 0.79 (95% CI 0.35 to 1.78, P = 0.57). There was little evidence to suggest differences between groups in serious adverse events and overall mortality. Our results provide little evidence that addition of omega-3 PUFA is beneficial in this condition. Routine treatment with omega-3 PUFA is currently not warranted.

ACKNOWLEDGMENTS

Johannes Bükki received an unrestricted travel grant (Annual Meeting of the Multinational Association of Supportive Care in Cancer in 2009) by Mundipharma, Switzerland. The authors express their gratitude to all patients who participated, the nursing team of the leukemia unit at the Inselspital (University Hospital of Bern, Switzerland), and to Shu-Fang Hsu Schmitz of the statistics unit at the Swiss cancer research coordinating center, who provided statistical support during the initial Phase II trial. The study drug was kindly provided by FreseniusKabi, Switzerland. The trial has been registered with clinicaltrials.gov (NCT00533078).