Integrated analysis of concomitant medications and oncological outcomes from PD-1/PD-L1 checkpoint inhibitors in clinical practice: Journal for ImmunoTherapy of Cancer

A. Cortellini, M. Tucci, V. Adamo, L.S. Stucci, A. Russo, E.T. Tanda, F. Spagnolo, F. Rastelli, R. Bisonni, D. Santini, M. Russano, C. Anesi, R. Giusti, M. Filetti, P. Marchetti, A. Botticelli, A. Gelibter, M.A. Occhipinti, R. Marconcini, M.G. VitaleL. Nicolardi, R. Chiari, C. Bareggi, O. Nigro, A. Tuzi, M. De Tursi, N. Petragnani, L. Pala, S. Bracarda, S. MacRini, A. Inno, F. Zoratto, E. Veltri, B. DI Cocco, D. Mallardo, D.J. Pinato, G. Porzio, C. Ficorella, P.A. Ascierto

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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
Original languageEnglish
JournalJ. Immunother. Cancer
Issue number2
Publication statusPublished - 2020


  • immunotherapy
  • acetylsalicylic acid
  • antibiotic agent
  • anticoagulant agent
  • antidiabetic agent
  • antilipemic agent
  • atezolizumab
  • beta adrenergic receptor blocking agent
  • calcium channel blocking agent
  • corticosteroid
  • immunosuppressive agent
  • metformin
  • nivolumab
  • nonsteroid antiinflammatory agent
  • nystatin
  • opiate
  • pembrolizumab
  • programmed death 1 ligand 1
  • programmed death 1 receptor
  • proton pump inhibitor
  • serotonin 1 antagonist
  • adult
  • aged
  • Article
  • body mass
  • cancer immunotherapy
  • cancer staging
  • clinical evaluation
  • clinical outcome
  • clinical practice
  • disease burden
  • disease exacerbation
  • drug cost
  • drug efficacy
  • Eastern Cooperative Oncology Group Performance Status
  • female
  • gastritis
  • gastroesophageal reflux
  • human
  • inflammation
  • lung cancer
  • major clinical study
  • male
  • melanoma
  • multicenter study
  • non small cell lung cancer
  • obesity
  • observational study
  • overall survival
  • palliative therapy
  • prescription
  • priority journal
  • progression free survival
  • prophylaxis
  • retrospective study
  • screening test
  • stomach acid
  • tumor associated leukocyte
  • tumor growth
  • tumor-related gene


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