Effects of antibiotics on the anti-tumor efficacy of immune checkpoint inhibitor therapy
Abstract
Purpose Immunotherapy using immune checkpoint inhibitors (ICIs) has shown several benefits over traditional therapies. However, the eligible population remains small. Antibiotic (ATB) use might reduce immunotherapy efficacy by disrupting the gut microbiota. However, in China, ATB effect on ICI therapy efficacy remains unelucidated. We aimed to assess the effects of ATBs on the anti-tumor efficacy of ICIs to provide a reference for clinical use. Methods We included 134 patients with advanced tumors undergoing ICI therapy at Shanghai Jiading District Central Hospital from January 1, 2021, to October 1, 2023. They were divided into Non-ATB and ATB groups based on ATB use within 30 days before and after ICI administration. Moreover, we compared progression-free (PFS) and overall (OS) survival between the groups. Results Median PFS and OS were lower in the ATB than in the Non-ATB group (PFS: 4.0 vs. 5.5 months; OS: 5.4 vs. 6.5 months). Univariate analysis revealed that ATB use significantly affected PFS (hazard ratio [HR] = 2.318, 95% confidence interval [CI] = 1.281-4.194, P = 0.005) and OS (HR = 2.115, 95% CI = 1.161-3.850, P = 0.014). Moreover, multivariate analysis revealed poor PFS (HR = 2.573, 95% CI = 1.373-4.826, P = 0.003) and OS (HR = 2.452, 95% CI = 1.298-4.632, P = 0.006) in patients who received ATBs during ICI therapy. Conclusions ATB use is negatively correlated with ICI therapy efficacy, leading to reduced PFS and OS in patients undergoing such treatment. Owing to the significant impact of ATBs on the human gut microbiome, regulation of the gut microbiome may emerge as a novel therapeutic target that can enhance the clinical activity of ICIs.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
FMT from ICI responders has demonstrated the ability to restore microbial diversity and re-establish antitumor activity.
“However, FMT from ICI responders has demonstrated the ability to restore microbial diversity and re-establish antitumor activity139,141,142.”
From Microbiome meets immunotherapy: unlocking the hidden predictors of immune checkpoint inhibitors (2025) · cites this paper as [139]
The use of antibiotics during ICI treatment is an independent risk factor for poor clinical outcomes, likely due to persistent microbiota diversity loss.
“Conversely, the use of antibiotics during ICI treatment has been confirmed as an independent risk factor for poor clinical outcomes, likely due to persistent microbiota diversity loss139,140.”
From Microbiome meets immunotherapy: unlocking the hidden predictors of immune checkpoint inhibitors (2025) · cites this paper as [139]
Cites
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534 · see citing works
Gut microbiome influences efficacy of PD-1-based immunotherapy against epithelial tumors
Routy, B., Le Chatelier, E., Derosa, L., Duong, C. P. M., Alou, M. T., Daillère, R., Fluckiger, A., Messaoudene, M., Rauber, C., Roberti, M. P., et al. (2018) · Science · doi:10.1126/science.aan3706 · Cited by 5,671 · cited 2× · see citing works
“The gut microbiome is closely related to the efficacy of ICI therapy [20, 21] and is crucial in anti-tumor response.”
Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients
Gopalakrishnan, V., Spencer, C. N., Nezi, L., Reuben, A., Andrews, M. C., Karpinets, T. V., Prieto, P. A., Vicente, D., Hoffman, K., Wei, S. C., et al. (2018) · Science · doi:10.1126/science.aan4236 · Cited by 4,812 · cited 2× · see citing works
“Intestinal microbiota has recently been explored as a predictor of immunotherapy efficacy [17–19].”
Commensal <i>Bifidobacterium</i> promotes antitumor immunity and facilitates anti–PD-L1 efficacy
Sivan, A., Corrales, L., Hubert, N., Williams, J. B., Aquino-Michaels, K., Earley, Z. M., Benyamin, F. W., Man Lei, Y., Jabri, B., Alegre, M.-L., et al. (2015) · Science · doi:10.1126/science.aac4255 · Cited by 3,888 · see citing works
iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics
Seymour, L., Bogaerts, J., Perrone, A., Ford, R., Schwartz, L. H., Mandrekar, S., Lin, N. U., Litière, S., Dancey, J., Chen, A., et al. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30074-8 · Cited by 2,472 · see citing works
Dethlefsen, L., & Relman, D. A. (2011) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1000087107 · Cited by 2,421 · see citing works
Current cancer situation in China: good or bad news from the 2018 Global Cancer Statistics?
Feng, R., Zong, Y., Cao, S., & Xu, R. (2019) · 癌症：英文版 · doi:10.1186/s40880-019-0368-6 · Cited by 1,630 · see citing works
A review of cancer immunotherapy toxicity
Kennedy, L. B., & Salama, A. K. S. (2020) · CA A Cancer Journal for Clinicians · doi:10.3322/caac.21596 · Cited by 1,376 · see citing works
Derosa, L., Hellmann, M. D., Spaziano, M., Halpenny, D., Fidelle, M., Rizvi, H., Long, N., Plodkowski, A. J., Arbour, K. C., Chaft, J. E., et al. (2018) · Annals of Oncology · doi:10.1093/annonc/mdy103 · Cited by 908 · see citing works
Effects of antibiotics on gut microbiota
Lange, K., Buerger, M., Stallmach, A., & Bruns, T. (2016) · Digestive Diseases · doi:10.1159/000443360 · Cited by 607 · see citing works
Sauerbrei, W., Taube, S. E., McShane, L. M., Cavenagh, M. M., & Altman, D. G. (2018) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djy088 · Cited by 489 · see citing works
The effect of antibiotics on the composition of the intestinal microbiota—a systematic review
Zimmermann, P., & Curtis, N. (2019) · Journal of Infection · doi:10.1016/j.jinf.2019.10.008 · Cited by 383 · see citing works
New NCCN Guidelines: Recognition and Management of Immunotherapy-Related Toxicity
Thompson, J. A. (2018) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2018.0047 · Cited by 209 · see citing works
Tinsley, N., Zhou, C., Tan, G., Rack, S., Lorigan, P., Blackhall, F., Krebs, M., Carter, L., Thistlethwaite, F., Graham, D., et al. (2020) · The Oncologist · doi:10.1634/theoncologist.2019-0160 · Cited by 201 · see citing works
Ahmed, J., Kumar, A., Parikh, K., Anwar, A., Knoll, B. M., Puccio, C. A., Chun, H. G., Fanucchi, M. P., & Lim, S. H. (2018) · OncoImmunology · doi:10.1080/2162402x.2018.1507670 · Cited by 173 · see citing works
Kumar, A. R., Devan, A. R., Nair, B., Balachandran, V., & Nath, L. R. (2021) · Molecular Biology Reports · doi:10.1007/s11033-021-06752-9 · Cited by 154 · see citing works
Hayase, E., & Jenq, R. R. (2021) · Genome Medicine · doi:10.1186/s13073-021-00923-w · Cited by 145 · see citing works
New Approaches on Cancer ImmunotherapyPreprint
Cha, J., Chan, L.-C., Song, M. S., & Hung, M. (2019) · Cold Spring Harbor Perspectives in Medicine · doi:10.1101/cshperspect.a036863 · Cited by 129 · see citing works
Impact of prior antibiotic use on the efficacy of nivolumab for non‑small cell lung cancer
Hakozaki, T., Okuma, Y., Omori, M., & Hosomi, Y. (2019) · Oncology Letters · doi:10.3892/ol.2019.9899 · Cited by 116 · see citing works
Turning tumors from cold to inflamed to improve immunotherapy response
Gerard, C. L., Delyon, J., Wicky, A. M., Homicskó, K., Cuendet, M. A., & Michielin, O. A. (2021) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2021.102227 · Cited by 113 · see citing works
Derosa, L., Routy, B., Kroemer, G., & Zitvogel, L. (2018) · OncoImmunology · doi:10.1080/2162402x.2018.1434468 · Cited by 74 · see citing works
Sen, S., Pestana, R. C., Hess, K. R., Viola, G. M., & Subbiah, V. (2018) · Annals of Oncology · doi:10.1093/annonc/mdy453 · Cited by 65 · see citing works
Pederzoli, F., Bandini, M., Raggi, D., Marandino, L., Basile, G., Alfano, M., Colombo, R., Salonia, A., Briganti, A., Andrea Gallina, A., et al. (2021) · European Urology · doi:10.1016/j.eururo.2021.05.018 · Cited by 57 · see citing works
Gaucher, L., Adda, L., Séjourné, A., Joachim, C., CHABY, G., Poulet, C., Liabeuf, S., Gras‐Champel, V., Masmoudi, K., Houessinon, A., et al. (2021) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359211000591 · Cited by 50 · see citing works
Galloway-Peña, J., Jenq, R. R., & Shelburne, S. A. (2017) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-16-3173 · Cited by 32 · see citing works
Long-term survivors with immunotherapy in advanced NSCLC: is ‘cure’ within reach?
Monteverdi, S., Vita, E., Sartori, G., Ferrara, M. G., D’Argento, E., Tortora, G., Milella, M., Bria, E., & Pilotto, S. (2020) · Translational Cancer Research · doi:10.21037/tcr.2019.12.82 · Cited by 8 · see citing works
Eng, L., Sutradhar, R., Niu, Y., Liu, N., Liu, Y., Kaliwal, Y., Powis, M., Liu, G., Peppercorn, J. M., Bedard, P. L., et al. (2021) · Annals of Oncology · doi:10.1016/j.annonc.2021.08.1643 · Cited by 3 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Microbiome meets immunotherapy: unlocking the hidden predictors of immune checkpoint inhibitors
Huang, L., Li, Y., Zhang, C., Jiang, A., Zhu, L., Mou, W., Li, K., Zhang, J., Cui, C., Cui, X., et al. (2025) · npj Biofilms and Microbiomes · doi:10.1038/s41522-025-00819-2 · Cited by 28 · see citing works
“However,FMTfromICIrespondershasdemonstratedthe ability to restore microbial diversity and re-establish antitumor activity 139,141,142 .”
Yin, L., Lv, B., Ge, J., Qi, Y., Xia, J., Ma, S., Wang, Y., Liu, Y., Zhou, D., Cao, J., et al. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1566016 · Cited by 7 · see citing works
Zhai, Z., Ma, S., Shang, S., Liang, X., Yin, S., Lin, H., Ding, R., Jiang, A., Zhang, R., Wu, M., et al. (2026) · The Oncologist · doi:10.1093/oncolo/oyag264
Antibiotics and outcomes of cancer immunotherapy: An updated meta-analysis and clinical applications
Porcari, S., Bolte, L. A., Björk, J. R., Elkrief, A., Derosa, L., Ferrari, M., Pezzullo, A. M., Severino, A., Fusco, W. G., Messaoudene, M., et al. (2026) · Cancer Cell · doi:10.1016/j.ccell.2026.09.012
- Authors
- Nie, F., Guo, J., Pan, J., Guo, Z., Wang, C., Yan, J., & Ma, W.
- Affiliations
- Jiading District Central Hospital (CN)
- Corresponding author
- Yan, Jun
- Ma, WeiNa
- Venue
- Clinical and Translational Oncology
- Published
- 2024-07-24
- Volume
- 27
- Issue
- 2
- Pages
- 790-799
- ISSN
- 1699-048X (ISSN-L)
- 1699-3055
- OpenAlex
- W4400951159
- Cited by
- 4
- References
- 27
- Citations by year
- 2026: 2 · 2025: 2
- FWCI
- 0.68
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Clinical & Translational Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Shanghai Key Specialty Project of Clinical Pharmacy (No.YXZDZK-01)
- the Nature Science Foundation of Jiading District, Shanghai (No. JDKW-2021-0043)
- the University-level research fund of Shanghai University of Medicine &Health Sciences (No.SSF-22-16-001)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Life Sciences › Immunology and Microbiology › Applied Microbiology and Biotechnology › Antibiotic Use and Resistance
- Keywords
- antibiotics, immune checkpoint inhibitors, antitumor efficacy, gut microbiota, immunotherapy, progression-free survival, overall survival, advanced cancer
- MeSH terms
- Gastrointestinal Microbiome, Progression-Free Survival, Immune Checkpoint Inhibitors, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Female, Humans, Immunotherapy, Male, Middle Aged, Neoplasms, Retrospective Studies, Survival Rate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
