The beneficial effect of probiotics in the prevention of irinotecan-induced diarrhea in colorectal cancer patients with colostomy: a pooled analysis of two probiotic trials (Probio-SK-003 and Probio-SK-005) led by Slovak Cooperative Oncology Group.

Autor:	Mego M; Faculty of Medicine, Comenius University and National Cancer Institute, Bratislava, Slovakia., Kasperova B; Faculty of Medicine, Comenius University and National Cancer Institute, Bratislava, Slovakia., Chovanec J; Department of Oncology, St. Jacob Hospital, Bardejov, Slovakia., Danis R; Faculty of Medicine, Comenius University, Bratislava, Slovakia., Reckova M; Faculty of Medicine, Comenius University and National Cancer Institute, Bratislava, Slovakia.; Department of Oncology, Regional Cancer Center, Poprad, Slovakia., Bystricky B; Department of Oncology, Faculty Hospital, Trencin, Slovakia., Konkolovsky P; Department of Oncology, Regional Cancer Center, Komarno, Slovakia., Jurisova S; Faculty of Medicine, Comenius University and National Cancer Institute, Bratislava, Slovakia., Porsok S; Faculty of Medicine, Comenius University and National Cancer Institute, Bratislava, Slovakia., Vaclav V; Department of Oncology, University Hospital Milosrdni Bratia, Bratislava, Slovakia., Wagnerova M; Department of Oncology, East Slovakia Comprehensive Cancer Center, Kosice, Slovakia., Stresko M; Department of Oncology, Faculty Hospital, Trnava, Slovakia., Brezinova B; Department of Oncology, Trebisov Hospital, Trebisov, Slovakia., Sutekova D; Department of Oncology, University Hospital Martin, Martin, Slovakia., Ciernikova S; Biomedical Research Center, Cancer Research Institute, Slovak Academy of Sciences, Bratislava, Slovakia., Svetlovska D; Faculty of Medicine, Comenius University and National Cancer Institute, Bratislava, Slovakia., Drgona L; Faculty of Medicine, Comenius University and National Cancer Institute, Bratislava, Slovakia.
Jazyk:	angličtina
Zdroj:	Frontiers in oncology [Front Oncol] 2024 Jul 22; Vol. 14, pp. 1438657. Date of Electronic Publication: 2024 Jul 22 (Print Publication: 2024).
DOI:	10.3389/fonc.2024.1438657
Abstrakt:	Background: Probiotics could decrease irinotecan-induced diarrhea due to the reduction of intestinal beta-d-glucuronidase activity. This study included a combined analysis of two clinical trials aimed to determine the effectiveness of the probiotics in the prophylaxis of irinotecan-induced diarrhea in metastatic colorectal cancer (CRC) patients. Methods: This combined analysis included 46 patients with CRC enrolled in the Probio-SK-003 (NCT01410955) and 233 patients from Probio-SK-005 (NCT02819960) starting a new line of irinotecan-based therapy with identical eligibility criteria. Patients were randomized in a ratio 1:1 to probiotic formulas vs. placebo administered for 12 and 6 weeks, respectively. Due to the different durations of study treatments, only the first 6 weeks of therapy were used for analysis. Results: In total, 279 patients were randomized, including 142 patients in the placebo and 137 participants in the probiotic arm. Administration of probiotics did not significantly reduce the incidence of grade 3/4 diarrhea compared to placebo (placebo 12.7% vs. probiotics 6.6%, p = 0.11). Neither the overall incidence of diarrhea (placebo 48.6% vs. probiotics 41.6%, p = 0.28) nor the incidence of enterocolitis (placebo 4.2% vs. probiotics 0.7%, p = 0.12) was different in the placebo vs. probiotic arm. However, subgroup analysis revealed that patients with a colostomy who received a placebo had a significantly higher incidence of any diarrhea (placebo 51.2% vs. probiotics 25.7%, p = 0.028) and grade 3/4 diarrhea (placebo 14.6% vs. probiotics 0.0%, p = 0.03) compared to the probiotic arm. Conclusions: This combined analysis suggests that probiotics could be beneficial in the prevention of irinotecan-induced diarrhea in colorectal cancer patients with colostomy. Competing Interests: RD is employed by S&D Pharma. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2024 Mego, Kasperova, Chovanec, Danis, Reckova, Bystricky, Konkolovsky, Jurisova, Porsok, Vaclav, Wagnerova, Stresko, Brezinova, Sutekova, Ciernikova, Svetlovska and Drgona.)
Databáze:	MEDLINE
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