Abstract 1466P
Background
To evaluate the effects of JK5G postbiotics on regulating the imbalanced gut microbiota and its impacts on the efficacy and incidence rate of immune-related adverse events (irAEs) in non-small-cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICIs).
Methods
We conducted a randomized, controlled trial in China and included non-squamous or squamous NSCLC patients without EGFR, ROS1, and ALK alteration, stage IIIb-IV. Patients were randomly (1:1) divided into two groups to receive four cycles of programmed cell death-1 (PD-1) plus chemotherapy plus placebo (control group) or to receive PD-1 plus chemotherapy plus JK5G postbiotics (JK5G group). The primary endpoint were adverse effects, quality of life (QoL), 16S DNA sequencing of gut microbiota, blood inflammatory cytokines, and lymphocyte subsets. This study was registered at www.chictr.org.cn (ChiCTR2200064690).
Results
60 patients were enrolled. The JK5G group had better QoL and nutritional levels, as well as lower depression symptoms than the control group (all p < 0.05). The JK5G group had a lower incidence of anemia (55.56% vs. 11.11%, p = 0.012), decreased lymphocyte count (33.33% vs. 0%, p = 0.019), decreased appetite (55.56% vs. 16.67%, p = 0.035), nausea (55.56% vs. 11.11%, p = 0.012), and asthenia (50.00% vs. 11.11%, p = 0.034) than the control group. Moreover, JK5G attenuated intestinal flora imbalance, accompanied by increased Faecalibacterium, Ruminococcaceae, and fecal butyrate concentration. Furthermore, JK5G administration significantly decreased the pro-inflammatory markers, including TNF-α, IL-2, and C-reactive protein (CRP) (p < 0.05). Significant increases in CD3+CD4+ T cells and CD4/CD8 ratio were observed in the peripheral blood of JK5G group patients (p < 0.05).
Conclusions
Our current findings indicated that JK5G postbiotics may attenuated irAEs, enhanced the QoL and nutrition levels in advanced NSCLC patients who received ICIs. JK5G postbiotics could improve the gut microbiota structures and accompanied with the ameliorate of tumor microenvironment and inflammation.
Clinical trial identification
ChiCTR2200064690.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1368P - LUMINATE 102: A real-world study on biomarker testing rates among patients with non-small cell lung cancer (NSCLC) across lines of therapy
Presenter: Charu Aggarwal
Session: Poster session 20
1369P - BrigAlec study: Focus on alectinib efficacy after brigatinib exposure in BrigALK2 study (GFPC 02-2019)
Presenter: Renaud Descourt
Session: Poster session 20
1370P - Efficacy and safety of ensartinib in ALK-positive non-small cell lung cancer patients with brain metastases: A multicenter, open-label, single-arm, phase II study
Presenter: Jianhua Chang
Session: Poster session 20
1371P - First-line alectinib vs. brigatinib in advanced metastatic NSCLC with ALK rearrangement: Real-world data
Presenter: Young Kyung Jeon
Session: Poster session 20
1372P - Repotrectinib in patients (pts) with NTRK fusion-positive (NTRK+) advanced solid tumors, including NSCLC: Update from the phase I/II TRIDENT-1 trial
Presenter: Ben Solomon
Session: Poster session 20
1373P - Efficacy and safety of taletrectinib in patients (Pts) with ROS1+ non-small cell lung cancer (NSCLC): Interim analysis of global TRUST-II study
Presenter: Maurice Pérol
Session: Poster session 20
1374P - Survival and therapy analysis of small-scale ROS1-mutant non-small cell lung cancer (NSCLC) patients
Presenter: Moritz Glaser
Session: Poster session 20
1375P - Beamion Lung 1, an ongoing phase Ia/Ib trial of the HER2 TKI, BI 1810631 in patients (pts) with advanced solid tumors with HER2 aberrations: Latest data
Presenter: Frans Opdam
Session: Poster session 20
1377P - Differential impact of EGFR exon 20 insertion location on tyrosine kinase inhibitor sensitivity
Presenter: Xiuning Le
Session: Poster session 20
1378P - Efficacy and safety of tunlametinib (HL-085) combined with vemurafenib in patients with advanced BRAF V600-mutated solid tumors: A multicenter, phase I study
Presenter: Yuan-Kai Shi
Session: Poster session 20