Concomitant use of antibiotics and immune checkpoint inhibitors in patients with solid neoplasms: retrospective data from real-world settings

BACKGROUND: The use of antibiotics is known to alter the gut microbiome and it is hypothesised that the use of antibiotics may also alter the response to immune checkpoint inhibitors (ICI). As data is limited from real-world settings, we performed a retrospective audit of patients who received ICI along with concomitant antibiotics. PATIENTS AND METHODS: This study is a retrospective audit of a prospectively collected the database of patients who received ICI for advanced solid tumours in any line between August 2015 and November 2018 at Tata Memorial Hospital, Mumbai, India. Antibiotic use was recorded from 2 weeks before the start of ICI and concomitantly with ICI. All statistical calculations were performed using Statistical Package for the Social Sciences (SPSS) statistical software for windows version 20.0. RESULTS: A total of 155 patients were identified as having received ICI during the study period, out of which 70 (44%) patients received antibiotics. Median PFS in patients who received antibiotics was 1.7 months (95% CI: 1.1–2.3) as against 3.6 months (95% CI: 2.3–4.8) for patients who did not receive antibiotics (p = 0.912). Median OS in the patients who received antibiotics was 3.9 months (95% CI: 1.8–11.4) as compared to 9.2 months (95% CI: 4.2–12.3) who did not receive antibiotics p = 0.053 (HR = 1.023; 95% CI: 1.00–1.04). Among the patients who received antibiotics, median OS for patients who received ≤10 days of antibiotics was 8.8 months (95% CI: 4.2–11.2) while for patients receiving >10 days of antibiotics, it was 2.8 months (95% CI: 1.2–4.4), p = 0.025 (HR = 2.0, 95% CI: 1.1–3.7). Thirty-three (21.2% of total) patients received antibiotics during the window of 2 weeks before the start of ICI to 2 months of starting ICI. Median OS in the patients who received antibiotics in this window was 2.8 months (95% CI: 1.2–4.5) as compared to 9.2 months (95% CI: 5.2–13.1) who did not receive antibiotics p = 0.008 (HR = 1.8; 95%CI: 1.2–3.0). CONCLUSIONS: This study shows that the judicious use of antibiotics is required in patients on ICI or scheduled to be started on ICI.