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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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“Although the potential benefit of statins for recurrent/metastatic head and neck cancer treated with anti- PD-1 ICB has not yet been investigated, studies in other cancer types suggest that statins are associated with increased rates of response to ICB [13, 14].”
InfluentialWen, J., Wang, Y., Wang, S., Liang, Y., Ou, Q., Ou, Q., Bao, H., Zhao, K., & Wang, Y. (2025) · Journal of Translational Medicine · doi:10.1186/s12967-025-06467-6 · Cited by 6
“Cortellini et al. demonstrated the immunomodulatory effects of concomitant medications in patients receiving PD-1/ PD-L1 inhibitors across various malignancies [15].”
Li, Y., Jia, X., Liu, M., Zhu, Z., Qiao, H., Jiang, J., Li, M., Xia, W., Xu, L., Zhang, E., et al. (2026) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2025-014360 · Cited by 5
Ma, P., Zhang, Z., Qian, M., Jiang, H., Zhao, Y., Shan, Q., Liu, X., Yao, T., & Guo, J. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241292227 · Cited by 5
The complex interplay of antibiotic use and immune checkpoint inhibition
Wu, L. W., & Moy, R. H. (2025) · The Oncologist · doi:10.1093/oncolo/oyaf010 · Cited by 5
“10,14 Thus, there is a complex interplay of many factors including antibiotic type, timing of antibiotic exposure, and other medications that affect ICI efficacy for patients.”
Ogiwara, T., Kawazoe, H., Egami, S., Hashimoto, H., Saito, Y., Sakiyama, N., Ohe, Y., Yamaguchi, M., Furukawa, T., Hara, A., et al. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.770268 · Cited by 5
“(18) reported that in patients with advanced cancer treated with single-agent ICIs (n = 1012) as a first- and later-line treatment, baseline corticosteroids, PPIs, and antibiotics were associated with worse clinical outcomes.”
BackgroundLuo, Y., Shen, C., Chiang, C., Huang, H.-C., & Chen, Y. (2024) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1269253 · Cited by 5
First-line immunotherapy in non-small cell lung cancer: how to select and where to go
Mogavero, A., Cantale, O., Mollica, V., Anpalakhan, S., Addeo, A., Mountzios, G., Friedlaender, A., Kanesvaran, R., Novello, S., & Banna, G. L. (2023) · Expert Review of Respiratory Medicine · doi:10.1080/17476348.2024.2302356 · Cited by 5
“Steroid and antibiotics (ATB) have been broadly proved to affect clinical outcomes in patients receiving PD-1 blockade, as suggested by Cortellini et al. in a retrospective study of 1,012 patients with different tumors treated with ICIsl [69].”
BackgroundDefining Resistance to Immune Checkpoint Inhibitors in Urothelial Carcinoma: Insights from PURE-01
Clinton, T. N. (2021) · European Urology · doi:10.1016/j.eururo.2021.06.013 · Cited by 5
Bispecific c-Met/PD-1 CAR-T Cells Have Enhanced Therapeutic Effects on Solid Tumor
Yang, H., Zhang, Y., Li, Y., Peng, S., An, R., Du, N., Cao, J., Chu, F., & Min, J. (2025) · Technology in Cancer Research & Treatment · doi:10.1177/15330338251336850 · Cited by 7
“29,30 However, it is not clear whether the c-Met-speci fi c CAR-T secreting PD-1 antibody has a good anti-tumor effect on solid tumors, and whether the killing ef fi ciency and proliferation activity are affected by the expression of c-Met and PD-1.”
Tsuboi, I., Matsukawa, A., Parizi, M. K., Miszczyk, M., Fazekas, T., Schulz, R. J., Laukhtina, E., Kawada, T., Katayama, S., Iwata, T., et al. (2025) · BMC Urology · doi:10.1186/s12894-025-01754-2 · Cited by 4
“Previous retrospective study, investigating the impact of concomitant H2RAs during ICI therapy in patients with lung cancer, melanoma, and renal cell carcinoma, revealed that concomitant use of H2RAs was not associated with OS [40].”
Hata, T., Yamada, T., Gotô, Y., Amano, A., Negi, Y., Watanabe, S., Furuya, N., Oba, T., Ikoma, T., Nakao, A., et al. (2025) · Cancer Research Communications · doi:10.1158/2767-9764.crc-25-0157 · Cited by 4
“Although several studies have reported that PPIs reduce the efficacy of ICI monotherapy, the relationship between ICI–chemotherapy and PPIs remains unclear (34, 48).”
Wang, N., Xu, Y., Yang, G., Chen, H., Wang, X., Fu, J., Li, L., & Pan, X. (2024) · Journal of Hepatocellular Carcinoma · doi:10.2147/jhc.s464033 · Cited by 4
“15 18 The underlying mechanism may involve PPI-induced alterations in the gut microbiota balance.”
BackgroundWu, B., Sun, C. M., Sun, X., & Li, X. (2022) · Medicine · doi:10.1097/md.0000000000030532 · Cited by 4
“Some concomitant drugs may enhance or discount the efficacy of immunotherapy,[4] such as antibiotics[5] and corticosteroids.[6,7] Recently, a body of studies have been conducted to analyze the general impact of proton–pump inhibitors (PPIs) on the efficacy of PD-1/PD-L1 inhibitors.”
BackgroundImmunotherapy Plus Radiotherapy for the Treatment of Sarcomas: Is There a Potential for Synergism?
Wang, J., Ge, H., & Tian, Z. (2023) · OncoTargets and Therapy · doi:10.2147/ott.s410693 · Cited by 4
Impact of opioid analgesics on survival in cancer patients receiving immune checkpoint inhibitors
Kavgacı, G., Güven, D. C., Kaygusuz, Y., Karaca, E., Dızdar, Ö., Kılıçkap, S., Aksoy, S., Erman, M., & Yalçın, Ş. (2024) · Supportive Care in Cancer · doi:10.1007/s00520-024-08681-2 · Cited by 4
“Antibiotics, proton pump inhibitors, and steroids have all been identified as potential influences on the prognosis of patients receiving ICIs [2, 3].”
BackgroundChiang, C., Chang, Y., Wang, S., Chen, Y., See, X. Y., Peng, C., Hsia, Y. P., Chiang, C., Chiang, C., & Peng, C. (2023) · Cancer Medicine · doi:10.1002/cam4.5734 · Cited by 4
Efil, S. C., Celebi, S. N. O., Ozturk, B., Bi̇lgi̇n, B., Hızal, M., Yucel, S., Akıncı, M. B., Dede, D. Ş., Yalçın, B., & Şendur, M. A. N. (2025) · International Journal of Cancer · doi:10.1002/ijc.70169 · Cited by 3
“27 FIGURE 2 Forest plots presenting the association between clinical variables and survival outcomes according to multivariable Cox regression analysis.”
Li, J., Liu, L., Tao, M., Han, Z., Ma, M., Jiang, L., Liu, C., Liu, D., Zhang, P., Zhang, M., et al. (2025) · British Journal of Cancer · doi:10.1038/s41416-025-03289-7 · Cited by 3
Yiu, C. H., Winardi, K., & Lu, C. Y. (2026) · Current Oncology Reports · doi:10.1007/s11912-026-01789-0 · Cited by 3
“Residual confounding by underlying disease characteristics may contribute to the observed associations; for example, patients requiring PPIs may have comorbidities or disease features that independently predict poorer outcomes [42].”
Kennedy, O. J., Glassée, N., Kiciński, M., Blank, C. U., Long, G. V., Atkinson, V. G., Dalle, S., Haydon, A. M., Meshcheryakov, A., Khattak, A., et al. (2024) · European Journal of Cancer · doi:10.1016/j.ejca.2024.113585 · Cited by 3
Self-citationColonese, F., Bulotta, A., Genova, C., Signorelli, D., Bonanno, L., Proto, C., Panel, I. I. N. D., & Cortinovis, D. L. (2024) · Biomedicines · doi:10.3390/biomedicines12122742 · Cited by 4
Cao, X., Wang, Y., Huang, W., Li, P., Guo, C., & Li, Y. (2023) · American Journal of Clinical Oncology · doi:10.1097/coc.0000000000000991 · Cited by 3
Wang, J., Zong, D.-W., Dong, S., Gao, S., Yang, Y., Zhang, P., Wang, X., Yao, W., & Tian, Z. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1185291 · Cited by 3
Precision Immuno-Oncology in NSCLC through Gender Equity Lenses
Marks, J. A., Sridhar, A., Ai, A., Kiel, L., Kaufman, R. A., Abioye, O. F., Mantz, C., & Florez, N. (2024) · Cancers · doi:10.3390/cancers16071413 · Cited by 3
“…responses, hormonal influences, interactions with concurrent medications, and their effects on fertility, sexual health, survivorship, and overall outcomes [95,107]. interactions with concurrent medications, and their effects on fertility, sexual health, survivorship, and overall outcomes [95,107].”
BackgroundBuj, R., Cole, A. R., Danielson, J., Xu, J. P., Hurd, D. E., Kishore, A., Kedziora, K. M., Chen, J., Yang, B., Barras, D., et al. (2025) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2025.02.08.637227 · Cited by 4
Xu, Y., Zhang, L., Huang, Q., Yin, Z., & Zhang, W. (2025) · Medicine · doi:10.1097/md.0000000000040898 · Cited by 2
“29–32] Therefore, a further search for more immunotherapy-related biomarkers is needed to establish a more complete prediction system.”
What should intensivists know about immune checkpoint inhibitors and their side effects?
Aleksandrov, V. Y. Z., Martínez‐Sagasti, F., Moreno, J. P.-S., & Mondéjar, H. H. (2025) · Medicina Intensiva · doi:10.1016/j.medin.2024.502135 · Cited by 2
Long-Term Cardiovascular Toxicity of Immunotherapy: Too Important to Ignore
Camerini, A., Inno, A., Canale, M. L., Oliva, S., Tedeschi, A., Greco, A., Biasio, M. D., Maurea, N., Bisceglia, I., Tarantini, L., et al. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26189100 · Cited by 3
“Moreover, statin use has been associated with an improved objective response to ICIs [57].”
Self-citationSu, P., Tao, Y., Wang, A., & Xiao, Y. (2025) · International Journal of Surgery · doi:10.1097/js9.0000000000004476 · Cited by 3
Miyamoto, I., Shimizu, T., Hanamura, M., Tanaka, R., Kusahana, R., Nomoto, M., Sugaya, K., Nakagawa, Y., & Gon, Y. (2026) · BMC Cancer · doi:10.1186/s12885-026-15646-7 · Cited by 2
“All patients with NSCLC who were receiving PPIs at ICI initiation were classified as the “PPI-exposed group” whereas those not receiving a PPI at that time were classified as the “PPI-unexposed group,” consistent with a previous study [12].”
Isono, T., Furuno, H., Onodera, Y., Maruyama, T., Takeuchi, Y., Kojima, A., Nishida, T., Kobayashi, Y., Ishiguro, T., Takaku, Y., et al. (2024) · Respiratory Investigation · doi:10.1016/j.resinv.2024.08.013 · Cited by 2
The impact of statins on melanoma survival: a systematic review and meta-analysis
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Deng, F., Ye, H., Zhang, P., Xu, J., Li, Y., Sun, M., & Yang, Z. (2024) · Thoracic Cancer · doi:10.1111/1759-7714.15492 · Cited by 2
Riopel, N. D., Chu, Q., Walker, J., & Ye, C. (2022) · Journal of Immunotherapy · doi:10.1097/cji.0000000000000409 · Cited by 2
Nivolumab‐induced acute tubular injury: A case report
Yang, H., Chang, C., & Chen, T. (2023) · Clinical Case Reports · doi:10.1002/ccr3.6991 · Cited by 1
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“Several lines of evidence from the literature support the hypothesis that stress-induced and exogenous GCs cause the subversion of cancer therapy-elicited antineoplastic immune responses and subsequently abolish therapeutic control of tumors [3, 23], paticularly in immunotherapy [5, 6, 24, 25].”
BackgroundMorimoto, K., Yamada, T., Kawachi, H., Tamiya, M., Negi, Y., Gotô, Y., Nakao, A., Shiotsu, S., Tanimura, K., Takeda, T., et al. (2023) · Targeted Oncology · doi:10.1007/s11523-023-01012-1 · Cited by 2
“According to a previous report, corticosteroid administration was defined as prednisone ≥ 10 mg equivalent per day, with a minimum of 24-h dosing within 30 days before first-line treatment initiation (excluding first-line treatment pre-medications) [13].”
BackgroundSekito, T., Bekku, K., Katayama, S., Watanabe, T., Tsuboi, I., Yoshinaga, K., Maruyama, Y., Yamanoi, T., Kawada, T., Tominaga, Y., et al. (2024) · Clinical Genitourinary Cancer · doi:10.1016/j.clgc.2024.102097 · Cited by 2
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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