Immune checkpoint inhibitor use in patients with end-stage kidney disease: an analysis of reported cases and literature review

CKJ: Clinical Kidney Journal - Tập 14 Số 9 - Trang 2012-2022 - 2021
Abhijat Kitchlu1, Kenar D. Jhaveri2, Ben Sprangers3,4, Motoko Yanagita5, Rimda Wanchoo2
1Department of Medicine, Division of Nephrology, University Health Network, University of Toronto, Toronto, ON, Canada
2Division of Kidney Diseases and Hypertension, Donald and Barbara Zucker School of Medicine, Northwell Health, Great Neck, NY, USA
3Department of Microbiology, Immunology and Transplantation, Laboratory of Molecular Immunology, Rega Institute, KU Leuven, Leuven, Belgium
4Division of Nephrology, University Hospitals Leuven, Leuven, Belgium
5Department of Nephrology, Graduate School of Medicine, Kyoto University, Kyoto, Japan

Tóm tắt

Abstract Immune checkpoint inhibitors (ICIs), immunomodulatory antibodies that are used to enhance the immune system, have substantially improved the prognosis of patients with advanced malignancy. As the use of ICI therapy becomes increasingly widespread across different types of cancer, their use in patients receiving dialysis is likely to increase. In this review we summarize the current literature on the use of ICIs in end-stage kidney disease (ESKD) patients and provide aggregate data from reported cases and series. Based on available pharmacological information, ICIs require no dosing adjustment in ESKD patients. Analysis of the reported cases in the literature demonstrates a similar incidence of immune-related adverse events in patients with ESKD receiving dialysis as compared with the general population (49%). Severe reactions graded as 3 and 4 have been seen in 15 patients (16%). As such, it is important that these patients are monitored very closely for immune-related adverse events; however, the risk of these adverse events should not preclude patients on dialysis from receiving these therapies. Cancer remission (complete and partial) was seen in close to 30% of patients, stable disease was seen in 28% and progression of disease in ∼36%. One-third of the patients died. Urothelial and renal cell cancer represented approximately half of all treated cancers and accounted for ∼50% of all deaths reported. Additional data in the dialysis population with the use of ICIs and involvement in prospective studies are needed to better assess outcomes, particularly within specific cancer types.

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Tài liệu tham khảo

Centanni, 2019, Clinical pharmacokinetics and pharmacodynamics of immune checkpoint inhibitors, Clin Pharmacokinet, 58, 835, 10.1007/s40262-019-00748-2

Lipson, 2016, Tumor regression and allograft rejection after administration of anti-PD-1, N Engl J Med, 374, 896, 10.1056/NEJMc1509268

Boils, 2016, Use of the PD-1 pathway inhibitor nivolumab in a renal transplant patient with malignancy, Am J Transplant, 16, 2496, 10.1111/ajt.13786

Hirsch, 399

Strohbehn, 2020, Safety and efficacy of immune checkpoint inhibitors in patients on dialysis: a retrospective case series, Am J Kidney Dis, 76, 299, 10.1053/j.ajkd.2020.02.451

Cheun, 2019, Safety and efficacy of immune checkpoint inhibitors for end-stage renal disease patients undergoing dialysis: a retrospective case series and literature review, Invest New Drugs, 37, 579, 10.1007/s10637-018-0673-y

Ryman, 2017, Pharmacokinetics of monoclonal antibodies, CPT Pharmacometrics Syst Pharmacol, 6, 576, 10.1002/psp4.12224

Wang, 2008, Monoclonal antibody pharmacokinetics and pharmacodynamics, Clin Pharmacol Ther, 84, 548, 10.1038/clpt.2008.170

Keizer, 2010, Clinical pharmacokinetics of therapeutic monoclonal antibodies, Clin Pharm, 49, 493, 10.2165/11531280-000000000-00000

Counsilman, 2015, Pharmacokinetics of rituximab in a pediatric patient with therapy-resistant nephrotic syndrome, Pediatr Nephrol, 30, 1367, 10.1007/s00467-015-3120-8

MacFarlane, 2014, PD-1 expression on peripheral blood cells increases with stage in renal cell carcinoma patients and is rapidly reduced after surgical tumor resection, Cancer Immunol Res, 2, 320, 10.1158/2326-6066.CIR-13-0133

Glassman, 2014, Mechanistic considerations for the use of monoclonal antibodies for cancer therapy, Cancer Biol Med, 11, 20

Waki, 2014, PD-1 expression on peripheral blood T-cell subsets correlates with prognosis in non-small cell lung cancer, Cancer Sci, 105, 1229, 10.1111/cas.12502

Kim, 2007, Kinetics of FcRn-mediated recycling of IgG and albumin in human: pathophysiology and therapeutic implications using a simplified mechanism-based model, Clin Immunol, 122, 146, 10.1016/j.clim.2006.09.001

Billiet, 2016, A genetic variation in the neonatal Fc-receptor affects anti-TNF drug concentrations in inflammatory bowel disease, Am J Gastroenterol, 111, 1438, 10.1038/ajg.2016.306

Sachs, 2006, A variable number of tandem repeats polymorphism influences the transcriptional activity of the neonatal Fc receptor α-chain promoter, Immunology, 119, 83, 10.1111/j.1365-2567.2006.02408.x

Feng, 2014, Model-based clinical pharmacology profiling of ipilimumab in patients with advanced melanoma: clinical pharmacology profiling of ipilimumab in advanced melanoma, Br J Clin Pharmacol, 78, 106, 10.1111/bcp.12323

Stroh, 2017, Clinical pharmacokinetics and pharmacodynamics of atezolizumab in metastatic urothelial carcinoma, Clin Pharmacol Ther, 102, 305, 10.1002/cpt.587

Zhao, 2017, Assessment of nivolumab benefit–risk profile of a 240-mg flat dose relative to a 3-mg/kg dosing regimen in patients with advanced tumors, Ann Oncol, 28, 2002, 10.1093/annonc/mdx235

Chitty, 2020, Kidney transplantation in patients with multiple myeloma: narrative analysis and review of the last 2 decades, Nephrol Dial Transplant, 10.1093/ndt/gfaa361

Vitale, 2019, Immunotherapy in dialysis-dependent cancer patients: our experience in patients with metastatic renal cell carcinoma and a review of the literature, Clin Genitourin Cancer, 17, e903, 10.1016/j.clgc.2019.06.009

Tan, 2021, Acute renal transplant rejection following nivolumab therapy for metastatic melanoma, BMJ Case Rep, 14, e238037, 10.1136/bcr-2020-238037

Tachibana, 2019, Safety and efficacy of nivolumab in patients with metastatic renal cell carcinoma and end-stage renal disease at 2 centers, Clin Genitourin Cancer, 17, e772, 10.1016/j.clgc.2019.04.004

Tabei, 2017, Successful treatment of metastatic clear cell carcinoma with nivolumab in a patient receiving dialysis treatment, Int J Urol, 24, 708, 10.1111/iju.13420

Parisi, 2019, Safe administration of anti-PD-L1 atezolizumab in a patient with metastatic urothelial cell carcinoma and end-stage renal disease on dialysis, Case Rep Oncol Med, 2019, 3452762

Osmán-García, 2020, Outcomes and safety of biweekly and monthly nivolumab in patients with metastatic renal cell carcinoma and dialysis: three case reports and literature review, Urol Int, 104, 323, 10.1159/000504515

Osa, 2019, Monitoring antibody binding to T cells in a pembrolizumab-treated patient with lung adenocarcinoma on hemodialysis, Thorac Cancer, 10, 2183, 10.1111/1759-7714.13197

Ong, 2016, Antitumor activity of nivolumab on hemodialysis after renal allograft rejection, J Immunother Cancer, 4, 64, 10.1186/s40425-016-0171-8

Mroue, 2021, Exploring the knowledge gap of immune checkpoint inhibitors in chronic renal failure: a systematic review of the literature, Critic Rev Oncol Hematol, 157, 103169, 10.1016/j.critrevonc.2020.103169

Morinaga, 2019, Longer control of nivolumab in metastatic renal cell carcinoma patients with end-stage kidney disease on dialysis, Case Rep Oncol, 12, 608, 10.1159/000501768

Mejia, 2021, Immune checkpoint inhibitor therapy-associated graft intolerance syndrome in a failed kidney transplant recipient, Am J Transplant, 21, 1322, 10.1111/ajt.16326

Lipson, 2020, Kidney retransplantation after anti-programmed cell death-1 (PD-1)-related allograft rejection, Am J Transplant, 20, 2264, 10.1111/ajt.15856

Kuo, 2020, Safety and efficacy of immune checkpoint inhibitors for patients with metastatic urothelial carcinoma and end-stage renal disease: experiences from real-world practice, Front Oncol, 10, 584834, 10.3389/fonc.2020.584834

Klajer, 2020, Targeted and immune therapies among patients with metastatic renal carcinoma undergoing hemodialysis: a systematic review, Semin Oncol, 47, 103, 10.1053/j.seminoncol.2020.05.001

Jain, 2020, Evaluation of checkpoint inhibitors in cancer patients with end-stage renal disease on hemodialysis: case series and review of the literature, J Immunother, 43, 244, 10.1097/CJI.0000000000000327

Iwaki, 2021, Safe administration of ipilimumab plus nivolumab to a dialysis patient with renal cell carcinoma, IJU Case Rep, 4, 32, 10.1002/iju5.12231

Ishizuka, 2018, Successful treatment by pembrolizumab in a patient with end-stage renal disease with advanced non-small cell lung cancer and high PD-L1 expression, Respir Investig, 56, 361, 10.1016/j.resinv.2018.03.005

Fernandez-Diaz, 2019, Are patients in haemodialysis good candidates for immunotherapy treatment?, Melan Res, 29, 553, 10.1097/CMR.0000000000000616

Chang, 2016, Safety and efficacy of pembrolizumab in a patient with advanced melanoma on haemodialysis, BMJ Case Rep, 2016, bcr2016216426, 10.1136/bcr-2016-216426

Cavalcante, 2015, Ipilimumab was safe and effective in two patients with metastatic melanoma and end-stage renal disease, Cancer Manag Res, 7, 47, 10.2147/CMAR.S73389

Carlo, 2016, Response to nivolumab in a patient with metastatic clear cell renal cell carcinoma and end-stage renal disease on dialysis, Eur Urol, 70, 1082, 10.1016/j.eururo.2016.05.040

Boyle, 2017, Donor-derived metastatic melanoma and checkpoint inhibition, Transplant Proc, 49, 1551, 10.1016/j.transproceed.2017.06.007

Venkatachalam, 2019, Poor outcomes with the use of checkpoint inhibitors in kidney transplant recipients, Transplantation, 104, 1041, 10.1097/TP.0000000000002914

Alhamad, 2016, Checkpoint inhibitors in kidney transplant recipients and the potential risk of rejection, Am J Transplant, 16, 1332, 10.1111/ajt.13711

Akturk, 2018, PD-1 inhibitor immune-related adverse events in patients with preexisting endocrine autoimmunity, J Clin Endocrinol Metab, 103, 3589, 10.1210/jc.2018-01430

Murakami, 2021, A multi-center study on safety and efficacy of immune checkpoint inhibitors in cancer patients with kidney transplant, Kidney Int, 100, 196, 10.1016/j.kint.2020.12.015

Ito, 2019, Complete response to nivolumab for metastatic renal cell carcinoma on hemodialysis patients; a case report, Urol Case Rep, 28, 101048, 10.1016/j.eucr.2019.101048

Spain, 2016, Acute renal allograft rejection after immune checkpoint inhibitor therapy for metastatic melanoma, Ann Oncol, 27, 1135, 10.1093/annonc/mdw130

Duni, 2021, Acute kidney transplant rejection after administration of nivolumab in a dialysis patient with a failed graft, Kidney Int Rep, 6, 1459, 10.1016/j.ekir.2021.02.039

Haslam, 2019, Estimation of the percentage of US patients with cancer who are eligible for and respond to checkpoint inhibitor immunotherapy drugs, JAMA Netw Open, 2, e192535, 10.1001/jamanetworkopen.2019.2535

Butler, 2015, Cancer incidence among US Medicare ESRD patients receiving hemodialysis, 1996–2009, Am J Kidney Dis, 65, 763, 10.1053/j.ajkd.2014.12.013

Maisonneuve, 1999, Cancer in patients on dialysis for end-stage renal disease: an international collaborative study, Lancet, 354, 93, 10.1016/S0140-6736(99)06154-1

Kitchlu, 2018, Representation of patients with chronic kidney disease in trials of cancer therapy, JAMA, 319, 2437, 10.1001/jama.2018.7260

Jose, 2016, Renal allograft failure after ipilimumab therapy for metastatic melanoma: a case report and review of the literature, Transplant Proc, 48, 3137, 10.1016/j.transproceed.2016.07.019

Ansari, 2018, Efficacy of Nivolumab in a patient with metastatic renal cell carcinoma and end-stage renal disease on dialysis: case report and literature review, Case Reports in Immunology, 10.1155/2018/1623957

Ramos-Casals, 2020, Immune-related adverse events of checkpoint inhibitors, Nat Rev Dis Primers, 6, 38, 10.1038/s41572-020-0160-6

Indini, 2019, Immune-related adverse events correlate with improved survival in patients undergoing anti-PD1 immunotherapy for metastatic melanoma, J Cancer Res Clin Oncol, 145, 511, 10.1007/s00432-018-2819-x

Grangeon, 2019, Association between immune-related adverse events and efficacy of immune checkpoint inhibitors in non-small-cell lung cancer, Clin Lung Cancer, 20, 201, 10.1016/j.cllc.2018.10.002

Postow, 2018, Immune-related adverse events associated with immune checkpoint blockade, N Engl J Med, 378, 158, 10.1056/NEJMra1703481

Zhang, 2019, Cardiotoxicity of immune checkpoint inhibitors, Curr Treat Options Cardiovasc Med, 21, 32, 10.1007/s11936-019-0731-6

Cuzzubbo, 2017, Neurological adverse events associated with immune checkpoint inhibitors: review of the literature, Eur J Cancer, 73, 1, 10.1016/j.ejca.2016.12.001

Daste, 2017, Immune checkpoint inhibitors and elderly people: a review, Eur J Cancer, 82, 155, 10.1016/j.ejca.2017.05.044

Sui, 2018, Risk of hematologic toxicities with programmed cell death-1 inhibitors in cancer patients: a meta-analysis of current studies, Drug Des Devel Ther, 12, 1645, 10.2147/DDDT.S167077

Brahmer, 2018, Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American Society of Clinical Oncology clinical practice guideline, J Clin Oncol, 36, 1714, 10.1200/JCO.2017.77.6385

Haanen, 2017, Management of toxicities from immunotherapy: ESMO clinical practice guidelines for diagnosis, treatment and follow-up, Ann Oncol, 28, iv119, 10.1093/annonc/mdx225

Petrescu, 2010, Tuberculin skin test, interferon-gamma assay, and T cells subpopulations in hemodialysis patients, J Renal Nutr, 20, S109, 10.1053/j.jrn.2010.06.011

Chiu, 2018, A comprehensive characterization of aggravated aging-related changes in T lymphocytes and monocytes in end-stage renal disease: the iESRD study, Immun Ageing, 15, 27, 10.1186/s12979-018-0131-x

Barnett, 2017, Preserved renal-allograft function and the PD-1 pathway inhibitor nivolumab, N Engl J Med, 376, 191, 10.1056/NEJMc1614298

Lavacchi, 2020, Immune checkpoint inhibitors in the treatment of renal cancer: current state and future perspective, Int J Mol Sci, 21, 4691, 10.3390/ijms21134691

Herrscher, 2020, Immune checkpoint inhibitors in melanoma in the metastatic, neoadjuvant, and adjuvant setting, Curr Opin Oncol, 32, 106, 10.1097/CCO.0000000000000610

Massarelli, 2014, Immunotherapy in lung cancer, Trans Lung Cancer Res, 3, 53

La, 2020, Real-world outcomes for patients treated with immune checkpoint inhibitors in the veterans affairs system, JCO Clin Cancer Inform, 4, 918, 10.1200/CCI.20.00084

Fiala, 2020, Immune-related adverse effects and outcome of patients with cancer treated with immune checkpoint inhibitors, Anticancer Res, 40, 1219, 10.21873/anticanres.14063

Pang, 2020, Long-term prognosis in patients with end-stage renal disease after coronary artery bypass grafting, J Thorac Dis, 12, 6722, 10.21037/jtd-20-2046

Gilbertson, 2019, Excess deaths attributable to influenza-like illness in the ESRD population, J Am Soc Nephrol, 30, 346, 10.1681/ASN.2018060581

Ng, 2020, Outcomes of patients with end-stage kidney disease hospitalized with COVID-19, Kidney Int, 98, 1530, 10.1016/j.kint.2020.07.030

Naylor, 2019, Mortality in incident maintenance dialysis patients versus incident solid organ cancer patients: a population-based cohort, Am J Kidney Dis, 73, 765, 10.1053/j.ajkd.2018.12.011

Yanik, 2016, Variation in cancer incidence among patients with ESRD during kidney function and nonfunction intervals, J Am Soc Nephrol, 27, 1495, 10.1681/ASN.2015040373

Chan, 2016, Cancer incidence and mortality in chronic dialysis population: a multicenter cohort study, Am J Neuroradiol, 43, 153

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CKJ: Clinical Kidney Journal

Tập 14 Số 9

2012-2022

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