Neoplasma Vol.52, p.159-164, 2005
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| Title: Prevention of febrile neutropenia in cancer patients by probiotic
strain Enterococcus faecium M-74. Pilot study phase I
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| Author: M., MEGO
; L., EBRINGER
; L., DRGONA
; J., MARDIAK
; J., TRUPL
; R., GREKSAK
; I., NEMOVA
; E., ORAVCOVA
; V., ZAJAC
; I., KOZA
; |
|
Abstract: Febrile neutropenia (FN) remains a potentially life-threatening
complication of anticancer chemotherapy. Bacterial translocation
via intestinal mucosa is a significant mechanism of FN
development. Competitive inhibition of bowel colonization by
pathogenic microorganisms by lactic acid bacteria could be a
useful prevention of FN. The aim of the study was the evaluation
of dose and safety of probiotic strain Enterococcus faecium M-74
enriched with organic selenium in patients with solid and
hematological malignancies. Eleven (9M/2F) patients were included
in the study. In the first phase six patients with germ cell
tumors treated by chemotherapy were included. They received
prophylaxis by nonpathogenic strain E. faecium M-74 during 2
cycles of chemotherapy. The planned daily dose was 6x109 bacteria.
Regarding the insufficient colonization of the gut, the dose was
further increased up to 18x109 tid. After safety evaluation, five
patients were included with relapse of acute leukemia. In patients
with germ cell cancer, severe neutropenia G3/4 was noted in 10 of
12 cycles of chemotherapy. The febrile episode was not observed in
any of the patients. The gut colonization by enterococci reaches
106 CFU/g stool. In 5 patients with acute leukemia during 127 days
of severe neutropenia 12 febrile episodes occurred. There was not
noted any febrile episode or infection provoked by the tested
strain. Tolerance of therapy was excellent without significant
undesirable effects. Optimal dose was assessed and safety of
probiotic strain was evaluated in neutropenic patients with solid,
or hematological malignancies. Based on these results we plan
phase II study to evaluate the effectiveness of this strain in FN
prophylaxis.
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| Keywords: febrile neutropenia, probiotics, infection prevention, safety
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| Year: 2005, Volume: 52, Issue: |
Page From: 159, Page To: 164 |
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