Haslam A, Prasad V. Estimation of the percentage of US patients with cancer who are eligible for and respond to checkpoint inhibitor immunotherapy drugs. JAMA Netw Open. 2019;2(5):e192535–e192535.

Article  PubMed  PubMed Central  Google Scholar 

Puzanov I, et al. Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group. J Immunother Cancer. 2017;5(1):95–95.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Walunas TL, et al. CTLA-4 can function as a negative regulator of T cell activation. Immunity (Cambridge, Mass.). 1994;1(5):405–413.

Krummel MF, Allison JP. CD28 and CTLA-4 have opposing effects on the response of T cells to stimulation. J Exp Med. 1995;182(2):459–65.

Article  CAS  Google Scholar 

Hodi FS, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711–23.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lebbé C, et al. Evaluation of two dosing regimens for nivolumab in combination with ipilimumab in patients with advanced melanoma: results from the phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019;37(11):867–75.

Article  PubMed Central  Google Scholar 

Alsaab HO, et al. PD-1 and PD-L1 Checkpoint signaling inhibition for cancer immunotherapy: mechanism, combinations, and clinical outcome. Front Pharmacol. 2017;8:561–561.

Article  PubMed  PubMed Central  Google Scholar 

Carter LL, et al. PD-1:PD-L inhibitory pathway affects both CD4+ and CD8+ T cells and is overcome by IL-2. Eur J Immunol. 2002;32(3):634–43.

Article  CAS  PubMed  Google Scholar 

Iwai Y, et al. Cancer immunotherapies targeting the PD-1 signaling pathway. J Biomed Sci. 2017;24(1):26.

Article  PubMed  PubMed Central  Google Scholar 

Robert C, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372(26):2521–32.

Article  CAS  PubMed  Google Scholar 

United States Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE). Version 5.0. 2017. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf.

Wang DY, et al. Fatal toxic effects associated with immune checkpoint inhibitors: a systematic review and meta-analysis. JAMA Oncol. 2018;4(12):1721–8.

Article  PubMed  PubMed Central  Google Scholar 

Inno A, et al. Pathogenesis, clinical manifestations and management of immune checkpoint inhibitors toxicity. Tumori. 2017;103(5):405–21.

Article  CAS  Google Scholar 

Shoushtari AN, et al. Measuring toxic effects and time to treatment failure for nivolumab plus ipilimumab in melanoma. JAMA Oncol. 2018;4(1):98–101.

Article  Google Scholar 

Kanjanapan Y, et al. Delayed immune-related adverse events in assessment for dose-limiting toxicity in early phase immunotherapy trials. Eur J Cancer. 1990;2019(107):1–7.

Google Scholar 

Sibaud V. Dermatologic reactions to immune checkpoint inhibitors: skin toxicities and immunotherapy. Am J Clin Dermatol. 2018;19(3):345–61.

Article  PubMed  Google Scholar 

Ibrahim RA, et al. Ipilimumab safety profile: summary of findings from completed trials in advanced melanoma. J Clin Oncol. 2011;29(15_suppl):8583–8583.

Fredrick TW. et al. Clinical course and impact of immune checkpoint inhibitor colitis resembling microscopic colitis. Crohn's & Colitis 360. 2022;4(2):otac008–otac008.

Beck KE, et al. Enterocolitis in patients with cancer after antibody blockade of cytotoxic T-lymphocyte–associated antigen 4. J Clin Oncol. 2006;24(15):2283–9.

Article  CAS  PubMed  Google Scholar 

Ma C, Armstrong AW. Severe adverse events from the treatment of advanced melanoma: a systematic review of severe side effects associated with ipilimumab, vemurafenib, interferon alfa-2b, dacarbazine and interleukin-2. J Dermatol Treat. 2014;25(5):401–8.

Article  Google Scholar 

Slovin SF, et al. Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study. Ann Oncol. 2013;24(7):1813–21.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ibraheim H, et al. Systematic review with meta-analysis: effectiveness of anti-inflammatory therapy in immune checkpoint inhibitor-induced enterocolitis. Aliment Pharmacol Ther. 2020;52(9):1432–52.

Article  CAS  PubMed  Google Scholar 

Herbst RS, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature (London). 2014;515(7528):563–7.

Article  CAS  PubMed  Google Scholar 

Weber JS, et al. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013;119(9):1675–82.

Article  CAS  PubMed  Google Scholar 

Hamid O, et al. Safety and tumor responses with lambrolizumab (Anti–PD-1) in melanoma. N Engl J Med. 2013;369(2):134–44.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Onuki T, et al. Severe upper gastrointestinal disorders in pembrolizumab‐treated non‐small cell lung cancer patient. Respirol Case Rep. 2018;6(6):e00334–n/a.

Vindum HH, et al. Severe steroid refractory gastritis induced by nivolumab: a case report. World J Gastroenterol: WJG. 2020;26(16):1971–8.

Article  PubMed  PubMed Central  Google Scholar 

Swei E, et al. Proximal gastrointestinal ulcerations: a potential complication of atezolizumab therapy?: 1906. Am J Gastroenterol. 2018;113(Supplement):S1082–S1082.

Article  Google Scholar 

Abu-Sbeih H, et al. Importance of endoscopic and histological evaluation in the management of immune checkpoint inhibitor-induced colitis. J Immunother Cancer. 2018;6(1):95–95.

Article  PubMed Central  Google Scholar 

Geukes Foppen MH, et al. Immune checkpoint inhibition-related colitis: symptoms, endoscopic features, histology and response to management. ESMO open. 2018;3(1):e000278–e000278.

Article  PubMed  PubMed Central  Google Scholar 

Gonzalez RS, et al. PD-1 inhibitor gastroenterocolitis: case series and appraisal of ‘immunomodulatory gastroenterocolitis.’ Histopathology. 2017;70(4):558–67.

Article  Google Scholar 

Hillock NT, et al. Infliximab for ipilimumab-induced colitis: A series of 13 patients. Asia Pac J Clin Oncol. 2017;13(5):e284–90.

Article  Google Scholar 

Marthey L, et al. Cancer immunotherapy with anti-CTLA-4 monoclonal antibodies induces an inflammatory bowel disease. J Crohns Colitis. 2016;10(4):395–401.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Wang Y, et al. Immune-checkpoint inhibitor-induced diarrhea and colitis in patients with advanced malignancies: retrospective review at MD Anderson. J Immunother Cancer. 2018;6(1):37–13.

Article  PubMed  PubMed Central  Google Scholar 

Schadendorf D, et al. Efficacy and safety outcomes in patients with advanced melanoma who discontinued treatment with nivolumab and ipilimumab because of adverse events: a pooled analysis of randomized phase II and III trials. J Clin Oncol. 2017;35(34):3807–14.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Fujikawa M, et al. An autopsy case of immune-related severe colitis due to long-term use of nivolumab in a patient with non-small cell lung cancer. Respir Med Case Rep. 2022;39:101720.

PubMed  Google Scholar 

Wolchok JDD, et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010;11(2):155–64.

Article  CAS  PubMed  Google Scholar 

Robert C, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364(26):2517–26.

Article  CAS  PubMed  Google Scholar 

Smith FO, et al. Risk of bowel perforation in patients receiving interleukin-2 after therapy with anti-CTLA 4 monoclonal antibody. J Immunother (1997). 2007;30(1):130–130.

Larkin J, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373(1):23–34.

Article  PubMed  PubMed Central  Google Scholar 

Wolchok JD, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017;377(14):1345–56.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zhang B, et al. Immune-related adverse events from combination immunotherapy in cancer patients: a comprehensive meta-analysis of randomized controlled trials. Int Immunopharmacol. 2018;63:292–8.

Article  CAS  PubMed  Google Scholar 

Moga C, et al. Development of a quality appraisal tool for case series studies using a modified Delphi technique. 2012.

Mitome N, et al. Clinical, Endoscopic and histologic features of lung cancer patients with programmed cell death protein 1 (PD-1) inhibitor-associated diarrhea and colitis. Haigan. 2018;58:262–70.

Article  Google Scholar 

Abu-Sbeih H, et al. Impact of antibiotic therapy on the development and response to treatment of immune checkpoint inhibitor-mediated diarrhea and colitis. J Immunother Cancer. 2019;7(1):242.

Article  PubMed Central