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Integrated analysis of concomitant medications and oncological outcomes from PD-1/PD-L1 checkpoint inhibitors in clinical practice
Open accessAbstract
Background: Concomitant medications, such as steroids, proton pump inhibitors (PPI) and antibiotics, might affect clinical outcomes with immune checkpoint inhibitors. Methods: We conducted a multicenter observational retrospective study aimed at evaluating the impact of concomitant medications on clinical outcomes, by weighing their associations with baseline clinical characteristics (including performance status, burden of disease and body mass index) and the underlying causes for their prescription. This analysis included consecutive stage IV patients with cancer, who underwent treatment with single agent antiprogrammed death-1/programmed death ligand-1 (PD-1/PD-L1) with standard doses and schedules at the medical oncology departments of 20 Italian institutions. Each medication taken at the immunotherapy initiation was screened and collected into key categories as follows: corticosteroids, antibiotics, gastric acid suppressants (including proton pump inhibitors - PPIs), statins and other lipid-lowering agents, aspirin, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), ACE inhibitors/Angiotensin II receptor blockers, calcium antagonists, β-blockers, metformin and other oral antidiabetics, opioids. Results: From June 2014 to March 2020, 1012 patients were included in the analysis. Primary tumors were: non-small cell lung cancer (52.2%), melanoma (26%), renal cell carcinoma (18.3%) and others (3.6%). Baseline statins (HR 1.60 (95% CI 1.14 to 2.25), p=0.0064), aspirin (HR 1.47 (95% CI 1.04 to 2.08, p=0.0267) and β-blockers (HR 1.76 (95% CI 1.16 to 2.69), p=0.0080) were confirmed to be independently related to an increased objective response rate. Patients receiving cancer-related steroids (HR 1.72 (95% CI 1.43 to 2.07), p<0.0001), prophylactic systemic antibiotics (HR 1.85 (95% CI 1.23 to 2.78), p=0.0030), prophylactic gastric acid suppressants (HR 1.29 (95% CI 1.09 to 1.53), p=0.0021), PPIs (HR 1.26 (95% CI 1.07 to 1.48), p=0.0050), anticoagulants (HR 1.43 (95% CI: 1.16 to 1.77), p=0.0007) and opioids (HR 1.71 (95% CI 1.28 to 2.28), p=0.0002) were confirmed to have a significantly higher risk of disease progression. Patients receiving cancer-related steroids (HR 2.16 (95% CI 1.76 to 2.65), p<0.0001), prophylactic systemic antibiotics (HR 1.93 (95% CI 1.25 to 2.98), p=0.0030), prophylactic gastric acid suppressants (HR 1.29 (95% CI 1.06 to 1.57), p=0.0091), PPI (HR 1.26 (95% CI 1.04 to 1.52), p=0.0172), anticoagulants (HR 1.45 (95% CI 1.14 to 1.84), p=0.0024) and opioids (HR 1.53 (95% CI 1.11 to 2.11), p=0.0098) were confirmed to have a significantly higher risk of death. Conclusion: We confirmed the association between baseline steroids administered for cancer-related indication, systemic antibiotics, PPIs and worse clinical outcomes with PD-1/PD-L1 checkpoint inhibitors, which can be assumed to have immune-modulating detrimental effects.
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“As previously reported, they also link PPI use with fecal microbiota oralization32 and adverse outcomes in response to anti-PD-1 therapy33.”
From Intestinal microbiota signatures of clinical response and immune-related adverse events in melanoma patients treated with anti-PD-1 (2022) · cites this paper as [33]
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Cancer Neuroscience: From Local Neuro–Immune Microenvironments to Systemic Brain–Body Circuitry
Xie, M., Zhao, Y., Xing, X., Liu, Y., Zhao, J., Yao, M., Tang, J., & Zhao, J. (2026) · MedComm · doi:10.1002/mco2.71025
“Recent retrospective cohort studies and prospective clinical trials have further supported the translational relevance of β -blockade in oncology [ 243, 244 ].”
Proton pump inhibitors and durvalumab in PACIFIC – Authors' reply
Brunetti, L., Derosa, L., & Cortellini, A. (2026) · The Lancet Oncology · doi:10.1016/s1470-2045(26)00475-4
Self-citationOpioids and immunosuppression in patients with cancer
Mercadante, S. (2026) · Supportive Care in Cancer · doi:10.1007/s00520-026-11279-5
“Several retrospective studies have reported that cancer patients receiving ICIs who were also prescribed opioids had significantly worse progression-free survival (PFS) and over-all survival (OS) [8, 9, 16].”
InfluentialRen, X., Xue, L., Wang, Y., & Xiao, J. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1833275
“ICIs stimulate the immune system, thereby enhancing anti-tumor responses (Cortellini et al., 2020).”
Saini, D. K. (2026) · Medicine in Microecology · doi:10.1016/j.medmic.2026.100185
Editorial: Predictive biomarkers to immune checkpoint inhibitors in lung cancer
Russo, A., Rolfo, C. D., & Santarpía, M. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.2011872
Self-citationAntibiotics 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
Metadata
- Authors
- Cortellini, A., Tucci, M., Adamo, V., Stucci, L. S., Russo, A., Tanda, E. T., Spagnolo, F., Rastelli, F., Bisonni, R., Santini, D., Russano, M., Anesi, C., Giusti, R., Filetti, M., Marchetti, P., Botticelli, A., Gelibter, A., Occhipinti, M. A., Marconcini, R., Vitale, M. G., Nicolardi, L., Chiari, R., Bareggi, C., Nigro, O., Tuzi, A., De Tursi, M., Petragnani, N., Pala, L., Bracarda, S., Macrini, S., Inno, A., Zoratto, F., Veltri, E., Di Cocco, B., Mallardo, D., Vitale, M. G., Pinato, D. J., Porzio, G., Ficorella, C., & Ascierto, P. A.
- Affiliations
- University of L'Aquila (IT)
- Istituto Tumori Bari (IT)
- University of Messina (IT)
- University of Bari Aldo Moro (IT)
- Ospedale Policlinico San Martino (IT)
- Medical Oncology, ASUR District Area 4 Fermo, Fermo, Italy
- Università Campus Bio-Medico (IT)
- Azienda Ospedaliera Sant'Andrea (IT)
- Policlinico Umberto I (IT)
- Sapienza University of Rome (IT)
- Azienda Ospedaliera Universitaria Pisana (IT)
- Azienda Ospedaliero-Universitaria di Modena (IT)
- UOC Oncologia Padova Sud, Azienda ULSS 6 Euganea, Padova, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
- Ospedale di Circolo e Fondazione Macchi (IT)
- Department of Medical, Oral and Biotechnological Sciences, Gabriele d'Annunzio University of Chieti and Pescara, Chieti, Italy
- University of Chieti-Pescara (IT)
- European Institute of Oncology (IT)
- Medical Oncology, Azienda Ospedaliera S. Maria, Terni, Italy
- Azienda Ospedaliera S.Maria (IT)
- Ospedale Sacro Cuore Don Calabria (IT)
- Ospedale Santa Maria Goretti (IT)
- Medical Oncology, Santa Maria Goretti Hospital, Latina, Italy
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- Hammersmith Hospital (GB)
- Medical Oncology, St. Salvatore Hospital, L'Aquila, Italy
- Corresponding author
- Cortellini, Alessio
- ORCID
- Cortellini, Alessio
- Tucci, Marco
- Adamo, Vincenzo
- Stucci, Luigia Stefania
- Russo, Alessandro
- Tanda, Enrica Teresa
- Spagnolo, Francesco
- Bisonni, Renato
- Santini, Daniele
- Russano, Marco
- Giusti, Raffaele
- Filetti, Marco
- Marchetti, Paolo
- Botticelli, Andrea
- Gelibter, Alain
- Occhipinti, Mario Alberto
- Marconcini, Riccardo
- Vitale, Maria Giuseppa
- Nicolardi, Linda
- Chiari, Rita
- Nigro, Olga
- Petragnani, Nicola
- Pala, Laura
- Macrini, Serena
- Inno, Alessandro
- Zoratto, Federica
- Veltri, Enzo
- Mallardo, Domenico
- Vitale, Maria Grazia
- Pinato, David James
- Porzio, Giampiero
- Ficorella, Corrado
- Ascierto, Paolo Antonio
- Venue
- Journal for ImmunoTherapy of Cancer
- Publisher
- BMJ
- Published
- 2020-11
- Volume
- 8
- Issue
- 2
- Pages
- e001361
- ISSN
- 2051-1426 (ISSN-L)
- PMC
- PMC7646355
- OpenAlex
- W3097304584
- Cited by
- 275
- References
- 58
- Citations by year
- 2026: 36 · 2025: 46 · 2024: 50 · 2023: 56 · 2022: 50 · 2021: 36 · 2020: 1
- FWCI
- 12.91
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal for ImmunoTherapy of Cancer (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- CINECA IRIS Institutial Research Information System (University of Genoa) (submittedVersion, other-oa)
- CINECA IRIS Institutional Research Information System (University of Bari Aldo Moro) (submittedVersion, cc-by-nc)
- Funders
- Institute for Translational Medicine and Therapeutics
- Wellcome Trust (PS3416)
- Cancer Research UK
- National Institute for Health and Care Research
- Imperial Experimental Cancer Medicine Centre
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Ferroptosis and cancer prognosis
- Health Sciences › Medicine › Oncology › COVID-19 and healthcare impacts
- Keywords
- PD-1/PD-L1 inhibitors, immune checkpoint inhibitors, concomitant medications, drug-drug interactions, corticosteroids, proton pump inhibitors, statins, aspirin, beta-blockers, antibiotics, objective response rate, progression-free survival, overall survival, non-small cell lung cancer, melanoma, renal cell carcinoma, stage IV cancer, immunotherapy safety
- MeSH terms
- Immune Checkpoint Inhibitors, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Retrospective Studies, Young Adult
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