Survival and cancer recurrence after short-course perioperative probiotics in a randomized trial

Abstract

BACKGROUND & AIMSThe long-term impact of perioperative probiotics remains understudied while mounting evidence links microbiome and oncogenesis. Therefore, we analyzed overall survival and cancer recurrence among patients enrolled in a randomized trial of perioperative probiotics. METHODS6-year follow-up of surgical patients participating in a randomized trial evaluating short-course perioperative oral probiotic VSL#3 (n=57) or placebo (n=63). RESULTSStudy groups did not differ in age, preoperative hemoglobin, ASA status, and Charlson comorbidity index. There was a significant difference in preoperative serum albumin (placebo group 4.0±0.1 vs. 3.7±0.1 g/dL in the probiotic group, p=0.030).Thirty-seven deaths (30.8%) have occurred during a median follow-up of 6.2 years. Overall survival stratified on preoperative serum albumin and surgical specialty was similar between groups (p=0.691). Age (aHR=1.081, p=0.001), serum albumin (aHR=0.162, p=0.001), and surgical specialty (aHR=0.304, p<0.001) were the only predictors of overall survival in the multivariate model, while the placebo/probiotic group (aHR=0.808, p=0.726) was not predictive. The progression rate among cancer patients was similar in the probiotic group (30.3%, 10/33) compared to the placebo group (21.2%, 7/33; p=0.398). The progression-free survival was not significantly different (unstratified p=0.270, stratified p=0.317). CONCLUSIONSPerioperative short-course use of VSL#3 probiotics does not influence overall or progression-free survival after complex surgery for visceral malignancy.