Nivolumab in squamous cell carcinoma of the head and neck

References

• Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136:E359–E386.
   PubMed Web of Science ®Google Scholar
• Gregoire V, Lefebvre JL, Licitra L, et al. Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(Suppl 5):v184–v186.
   PubMed Web of Science ®Google Scholar
• Specenier P, Vermorken JB. Cetuximab: its unique place in head and neck cancer treatment. Biologics. 2013;7:77–90.
   PubMedGoogle Scholar
• Specenier P, Vermorken JB. Advances in the systemic treatment of head and neck cancers. Curr Opin Oncol. 2010;22:200–205.
   PubMed Web of Science ®Google Scholar
• Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008;359:1116–1127.
   PubMed Web of Science ®Google Scholar
• Machiels JP, Haddad RI, Fayette J, et al. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-head & neck 1: an open-label, randomised phase 3 trial. Lancet Oncol. 2015;16:583–594.
   PubMed Web of Science ®Google Scholar
• Machiels JP, Subramanian S, Ruzsa A, et al. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011;12:333–343.
   PubMed Web of Science ®Google Scholar
• Chureemas T, Larbcharoensub N, Juengsamarn J, et al. LNJJLTJCCPTN. Prevalence, pattern, and impact of PD-L1 expression and HPV-status in head and neck squamous cell carcinoma. Ann.Oncol. 2016;27(suppl 6): Abstr 978P.
   Google Scholar
• Brahmer JR, Tykodi SS, Chow LQ, et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012;366:2455–2465.
   PubMed Web of Science ®Google Scholar
• Brahmer JR, Drake CG, Wollner I, et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106 in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010;28:3167–3175.
   PubMed Web of Science ®Google Scholar
• Nishimura H, Nose M, Hiai H, et al. Development of lupus-like autoimmune diseases by disruption of the PD-1 gene encoding an ITIM motif-carrying immunoreceptor. Immunity. 1999;11:141–151.
   PubMed Web of Science ®Google Scholar
• Okazaki T, Honjo T. PD-1 and PD-1 ligands: from discovery to clinical application. Int Immunol. 2007;19:813–824.
   PubMed Web of Science ®Google Scholar
• Dong H, Zhu G, Tamada K, et al. B7-H1, a third member of the B7 family, co-stimulates T-cell proliferation and interleukin-10 secretion. Nat Med. 1999;5:1365–1369.
   PubMed Web of Science ®Google Scholar
• Freeman GJ, Long AJ, Iwai Y, et al. Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med. 2000;192:1027–1034.
   PubMed Web of Science ®Google Scholar
• Latchman Y, Wood CR, Chernova T, et al. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol. 2001;2:261–268.
   PubMed Web of Science ®Google Scholar
• Tseng SY, Otsuji M, Gorski K, et al. B7-DC, a new dendritic cell molecule with potent costimulatory properties for T cells. J Exp Med. 2001;193:839–846.
   PubMed Web of Science ®Google Scholar
• Keir ME, Butte MJ, Freeman GJ, et al. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26:677–704.
   PubMed Web of Science ®Google Scholar
• Dong H, Strome SE, Salomao DR, et al. Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion. Nat Med. 2002;8:793–800.
   PubMed Web of Science ®Google Scholar
• Curiel TJ, Wei S, Dong H, et al. Blockade of B7-H1 improves myeloid dendritic cell-mediated antitumor immunity. Nat Med. 2003;9:562–567.
   PubMed Web of Science ®Google Scholar
• Iwai Y, Ishida M, Tanaka Y, et al. Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade. Proc Natl Acad Sci USA. 2002;99:12293–12297.
   PubMed Web of Science ®Google Scholar
• Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol. 2008;8:467–477.
   PubMed Web of Science ®Google Scholar
• Fife BT, Pauken KE, Eagar TN, et al. Interactions between PD-1 and PD-L1 promote tolerance by blocking the TCR-induced stop signal. Nat Immunol. 2009;10:1185–1192.
   PubMed Web of Science ®Google Scholar
• Brahmer JR, Hammers H, Lipson EJ. Nivolumab: targeting PD-1 to bolster antitumor immunity. Future Oncol. 2015;11:1307–1326.
   PubMed Web of Science ®Google Scholar
• Hino R, Kabashima K, Kato Y, et al. Tumor cell expression of programmed cell death-1 ligand 1 is a prognostic factor for malignant melanoma. Cancer. 2010;116:1757–1766.
   PubMed Web of Science ®Google Scholar
• Taube JM, Klein A, Brahmer JR, et al. Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-PD-1 therapy. Clin Cancer Res. 2014;20:5064–5074.
   PubMed Web of Science ®Google Scholar
• http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003985/WC500189765.pdf. Accessed on 2018 Mar 8
   Google Scholar
• Wong RM, Scotland RR, Lau RL, et al. Programmed death-1 blockade enhances expansion and functional capacity of human melanoma antigen-specific CTLs. Int Immunol. 2007;19:1223–1234.
   PubMed Web of Science ®Google Scholar
• Ferris RL, Jr. BG, Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med. 2016;375:1856–1867.
   PubMed Web of Science ®Google Scholar
• Gillison ML, Blumenschein GR Jr., Fayette J, et al. Nivolumab (Nivo) vs investigator’s choice (IC) for platinum-refractory (PR) recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN; Checkmate 141): outcomes in first-line (1L) R/m patients and updated safety and efficacy. J Clin Oncol. 2017;35(suppl): 6019 (abstract).
   Google Scholar
• Ferris RL, Licitra L, Fayette J, et al. Nivolumab (Nivo) vs investigator’s choice (IC) in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): efficacy and safety in CheckMate 141 by prior cetuximab use. J Clin Oncol. 2017;35(suppl): 6020 (abstract).
   PubMedGoogle Scholar
• Licitra L, Ferris RL, Blumenschein GR Jr., et al. Nivolumab vs investigator’s choice (IC) in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): treatment effect on clinical outcomes by best overall response in checkmate 141. Ann.Oncol. 2017;28(suppl 5): 1055P (abstract).
   Google Scholar
• Concha-Benavente F, Gillison ML, Blumenschein GR, et al. Characterization of potential predictive biomarkers of response to nivolumab in CheckMate 141 in patients with squamous cell carcinoma of the head and neck (SCCHN). J Clin Oncol. 2017;35(suppl): 6050 (abstract).
   Google Scholar
• Haddad R, Blumenschein GR Jr., Fayette J, et al. Treatment beyond progression with nivolumab in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in the phase 3 checkmate 141 study: A biomarker analysis and updated clinical outcomes. Ann.Oncol. 2017;28(suppl 5): 1043O (abstract).
   PubMedGoogle Scholar
• Ferris RL, Gonçalvez A, Baxi SS, et al. An open-label, multicohort, phase 1/2 study in patients with virus-associated cancers (CheckMate 358): safety and efficacy of neoadjuvant nivolumab in squamous cell carcinoma of the head and neck (SCCHN). Ann.Oncol. 2017;28(suppl 5): LBA46 (abstract).
   Google Scholar
• Seiwert TY, Burtness B, Mehra R, et al. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. Lancet Oncol. 2016;17:956–965.
   PubMed Web of Science ®Google Scholar
• Chow LQ, Haddad R, Gupta S, et al. Antitumor activity of pembrolizumab in biomarker-unselected patients with recurrent and/or metastatic head and neck squamous cell carcinoma: results from the phase Ib KEYNOTE-012 expansion cohort. J Clin Oncol. 2016;34:3838–3845.
   PubMed Web of Science ®Google Scholar
• Segal NH, Ou S-HI, Balmanoukian AS, et al. Updated safety and efficacy of durvalumab (MEDI4736), an anti-PD-L 1 antibody, in patients from a squamous cell carcinoma of the head and neck (SCCHN) expansion cohort. Ann.Oncol.. 2016;27(suppl 6): Abstr 949O.
   Google Scholar
• Cohen EE, Harrington K, Le Tourneau C, et al. Pembrolizumab (pembro) vs standard of care (SOC) for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): phase 3 KEYNOTE-040 trial. Ann.Oncol. 2017. 28(suppl 5). LBA45_PR (abstract).
   Google Scholar
• Seiwert TY, Burtness B, Weiss J, et al. Inflamed-phenotype gene expression signatures to predict benefit from the anti-PD-1 antibody pembrolizumab in PD-L1+ head and neck cancer patients. J Clin Oncol. 2015;33(suppl): Abstr 6017.
   Google Scholar
• Mehra R, Seiwert TY, Mahipal A, et al. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): pooled analyses after long-term follow-up in KEYNOTE-012. J Clin Oncol. 2017;34(suppl): Abstr 6012.
   Google Scholar
• Haddad RI, Seiwert TY, Chow LQM, et al. Genomic determinants of response to pembrolizumab in head and neck squamous cell carcinoma (HNSCC). J Clin Oncol. 2017;35(suppl): 6009 (abstract).
   Google Scholar
• Haddad R, Seiwert TY, Pfister DG, et al. Pembrolizumab after progression on platinum and cetuximab in head and neck squamous cell carcinoma (HNSCC): results from KEYNOTE-055. Ann.Oncol. 2016;27(suppl 6): Abstr 957PD.
   Google Scholar
• Hamid O, Bauer TM, Spira A, et al. Epacadostat plus pembrolizumab in patients with SCCHN: preliminary phase I/II results from ECHO-202/KEYNOTE-037. J Clin Oncol. 2017;35suppl: 6010 (abstract).
   Web of Science ®Google Scholar
• https://clinicaltrials.gov/ct2/show/NCT01693562. Accessed on 2018 Mar 8.
   Google Scholar
• Zandberg D, Algazi AP, Jimeno A, et al. Durvalumab for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): preliminary results from a single-arm, phase 2 study. Ann.Oncol. 2017;28(suppl 5): 1042O (abstract).
   Google Scholar
• Bahleda R, Braiteh F, Balmanoukian AS, et al. Long-term safety and clinical outcomes of atezolizumab in head and neck cancer: phase Ia trial results. Ann.Oncol. 2017;28(suppl 5): 1044O (abstract).
   Google Scholar
• Horvath L, Desai J, Sandhu S, et al. Preliminary results from a subset of patients (pts) with advanced head and neck squamous carcinoma (HNSCC) in a dose-escalation and dose-expansion study of BGB-A317, an anti-PD-1 monoclonal antibody. Ann.Oncol. 2017;28(suppl 5): 388P (abstract).
   Google Scholar
• Pai S, Cohen EE, Lin D, et al. RetroSpective cohort stUdy of PD-L1 expression in REcurrent and/or MEtastatic squamous cell carcinoma of the head and neck (SUPREME-HN). Ann.Oncol. 2017;28(suppl 5): 1048PD (abstract).
   Google Scholar
• Stokes M, Wang R, Wildsmith S, et al. Relationship between PD-L1 expression and survival in head and neck squamous cell carcinoma (HNSCC) patients. Ann.Oncol. 2017;28(suppl 5): 1049PD (abstract).
   Google Scholar
• Kutukova S, Beliak N, Manikhas G, et al. The prognostic role of PD-L1 expression in tumor and immune cells in oral cavity squamous cell carcinoma. Ann.Oncol. 2017;28(suppl 5): 1061P (abstract).
   Google Scholar
• Kwon MJ, Hong M, Kang SY. Programmed death ligand-1overexpression is a poor prognostic factor for human papillomavirus-positive tonsillar squamous cell carcinoma. Ann.Oncol. 2017;28(suppl 5). 1060P (abstract).
   Google Scholar
• Wolchok JD, Hoos A, O’Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009;15:7412–7420.
   PubMed Web of Science ®Google Scholar
• Tuma RS. Immunotherapies in clinical trials: do they demand different evaluation tools? J Natl Cancer Inst. 2011;103:780–781.
   PubMedGoogle Scholar
• Saada-Bouzid E, Defaucheux C, Karabajakian A, et al. Tumor’s flare-up and patterns of recurrence in patients (pts) with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with anti-PD1/PD-L1 inhibitors. J Clin Oncol. 2016;34(suppl): Abstr 6075.
   Google Scholar
• Ortega Franco A, Plana M, Brana I, et al. Does hyper-progression exist among head and neck cancer patients treated with immunotherapy?. Ann.Oncol. 2017;28(suppl 5): 1058P (abstract).
   Google Scholar
• Abdel-Rahman O, ElHalawani H, Fouad M. Risk of endocrine complications in cancer patients treated with immune check point inhibitors: a meta-analysis. Future Oncol. 2016;12:413–425.
   PubMed Web of Science ®Google Scholar
• McMillen B, Dhillon MS, Yong-Yow S. A rare case of thyroid storm. BMJ Case Rep. 2016 April 18. published online. DOI:10.1136/bcr-2016-214603
   PubMedGoogle Scholar
• Miyoshi Y, Ogawa O, Oyama Y. Nivolumab, an anti-programmed cell death-1 antibody, induces fulminant Type 1 diabetes. Tohoku J Exp Med. 2016;239:155–158.
   PubMed Web of Science ®Google Scholar
• Narita T, Oiso N, Taketomo Y, et al. Serological aggravation of autoimmune thyroid disease in two cases receiving nivolumab. J Dermatol. 2016;43:210–214.
   PubMed Web of Science ®Google Scholar
• Okamoto M, Okamoto M, Gotoh K, et al. Fulminant Type 1 diabetes mellitus with anti-programmed cell death-1 therapy. J Diabetes Investig. 2016;7:915–918.
   PubMed Web of Science ®Google Scholar
• Okano Y, Satoh T, Horiguchi K, et al. Nivolumab-induced hypophysitis in a patient with advanced malignant melanoma. Endocr J. 2016;63:905–912.
   PubMed Web of Science ®Google Scholar
• Tanaka R, Fujisawa Y, Maruyama H, et al. Nivolumab-induced thyroid dysfunction. Jpn J Clin Oncol. 2016;46:575–579.
   PubMed Web of Science ®Google Scholar
• Teramoto Y, Nakamura Y, Asami Y, et al. Case of type 1 diabetes associated with less-dose nivolumab therapy in a melanoma patient. J Dermatol. 2017;44:605–606.
   PubMed Web of Science ®Google Scholar
• Watanabe S, Kimura H, Takato H, et al. Severe pneumonitis after nivolumab treatment in a patient with melanoma. Allergol Int. 2016;65:487–489.
   PubMed Web of Science ®Google Scholar
• Fujimura T, Kambayashi Y, Furudate S, et al. Isolated adrenocorticotropic hormone deficiency possibly caused by nivolumab in a metastatic melanoma patient. J Dermatol. 2017;44:e13–e14.
   PubMed Web of Science ®Google Scholar
• Narahira A, Yanagi T, Cho KY, et al. Isolated adrenocorticotropic hormone deficiency associated with nivolumab therapy. J Dermatol. 2017;44:e70.
   PubMed Web of Science ®Google Scholar
• Munakata W, Ohashi K, Yamauchi N, et al. Fulminant type I diabetes mellitus associated with nivolumab in a patient with relapsed classical Hodgkin lymphoma. Int J Hematol. 2017;105:383–386.
   PubMed Web of Science ®Google Scholar
• Kahler KC, Hassel JC, Heinzerling L, et al. Management of side effects of immune checkpoint blockade by anti-CTLA-4 and anti-PD-1 antibodies in metastatic melanoma. J Dtsch Dermatol Ges. 2016;14:662–681.
   Web of Science ®Google Scholar
• Spain L, Diem S, Larkin J. Management of toxicities of immune checkpoint inhibitors. Cancer Treat Rev. 2016;44:51–60.
   PubMed Web of Science ®Google Scholar
• Weber JS, Postow M, Lao CD, et al. Management of adverse events following treatment with anti-programmed death-1 agents. Oncologist. 2016;21:1230–1240.
   PubMed Web of Science ®Google Scholar
• Postow MA. Managing immune checkpoint-blocking antibody side effects. Am Soc Clin Oncol Educ Book. 2015;76–83.
   PubMedGoogle Scholar
• Friedman CF, Proverbs-Singh TA, Postow MA. Treatment of the immune-related adverse effects of immune checkpoint inhibitors: a review. JAMA Oncol. 2016;2:1346–1353.
   PubMed Web of Science ®Google Scholar
• O’Kane GM, Labbe C, Doherty MK, et al. Monitoring and management of immune-related adverse events associated with programmed cell death protein-1 axis inhibitors in lung cancer. Oncologist. 2017;22:70–80.
   PubMed Web of Science ®Google Scholar
• Carter CA, Browning R, Oronsky BT, et al. The case of a zebra that was misdiagnosed as a horse: pulmonary tumor thrombotic microangiopathy, a new paraneoplastic syndrome, mimicking PD-1-induced pneumonitis. Case Rep Oncol. 2016;9:68–75.
   PubMed Web of Science ®Google Scholar
• Fujita K, Terashima T, Mio T. Anti-PD1 antibody treatment and the development of acute pulmonary tuberculosis. J Thorac Oncol. 2016;11:2238–2240.
   PubMed Web of Science ®Google Scholar
• Montaudie H, Pradelli J, Passeron T, et al. Pulmonary sarcoid-like granulomatosis induced by nivolumab. Br J Dermatol. 2017;176:1060–1063.
   PubMed Web of Science ®Google Scholar
• Nakashima K, Naito T, Omori S, et al. Organizing pneumonia induced by nivolumab in a patient with metastatic melanoma. J Thorac Oncol. 2016;11:432–433.
   PubMed Web of Science ®Google Scholar
• Sano T, Uhara H, Mikoshiba Y, et al. Nivolumab-induced organizing pneumonia in a melanoma patient. Jpn J Clin Oncol. 2016;46:270–272.
   PubMed Web of Science ®Google Scholar
• Nishino M, Ramaiya NH, Awad MM, et al. PD-1 inhibitor-related pneumonitis in advanced cancer patients: radiographic patterns and clinical course. Clin Cancer Res. 2016;22:6051–6060.
   PubMed Web of Science ®Google Scholar
• Gounant V, Brosseau S, Naltet C, et al. Nivolumab-induced organizing pneumonitis in a patient with lung sarcomatoid carcinoma. Lung Cancer. 2016;99:162–165.
   PubMed Web of Science ®Google Scholar
• Sehgal S, Velcheti V, Mukhopadhyay S, et al. Focal lung infiltrate complicating PD-1 inhibitor use: A new pattern of drug-associated lung toxicity? Respir Med Case Rep. 2016;19:118–120.
   PubMed Web of Science ®Google Scholar
• Nishino M, Giobbie-Hurder A, Hatabu H, et al. Incidence of programmed cell death 1 inhibitor-related pneumonitis in patients with advanced cancer: a systematic review and meta-analysis. JAMA Oncol. 2016;2:1607–1616.
   PubMed Web of Science ®Google Scholar
• Hofmann L, Forschner A, Loquai C, et al. Cutaneous, gastrointestinal, hepatic, endocrine, and renal side-effects of anti-PD-1 therapy. Eur J Cancer. 2016;60:190–209.
   PubMed Web of Science ®Google Scholar
• Zimmer L, Goldinger SM, Hofmann L, et al. Neurological, respiratory, musculoskeletal, cardiac and ocular side-effects of anti-PD-1 therapy. Eur J Cancer. 2016;60:210–225.
   PubMed Web of Science ®Google Scholar
• Kimura T, Fukushima S, Miyashita A, et al. Myasthenic crisis and polymyositis induced by one dose of nivolumab. Cancer Sci. 2016;107:1055–1058.
   PubMed Web of Science ®Google Scholar
• Shirai T, Sano T, Kamijo F, et al. Acetylcholine receptor binding antibody-associated myasthenia gravis and rhabdomyolysis induced by nivolumab in a patient with melanoma. Jpn J Clin Oncol. 2016;46:86–88.
   PubMed Web of Science ®Google Scholar
• Heinzerling L, Ott PA, Hodi FS, et al. Cardiotoxicity associated with CTLA4 and PD1 blocking immunotherapy. J Immunother Cancer. 2016;4:50.
   PubMed Web of Science ®Google Scholar
• Belum VR, Benhuri B, Postow MA, et al. Characterisation and management of dermatologic adverse events to agents targeting the PD-1 receptor. Eur J Cancer. 2016;60:12–25.
   PubMed Web of Science ®Google Scholar
• Hwang SJ, Carlos G, Wakade D, et al. Cutaneous adverse events (AEs) of anti-programmed cell death (PD)-1 therapy in patients with metastatic melanoma: A single-institution cohort. J Am Acad Dermatol. 2016;74:455–461.
   PubMed Web of Science ®Google Scholar
• Abdel-Rahman O, ElHalawani H, Fouad M. Risk of cutaneous toxicities in patients with solid tumors treated with immune checkpoint inhibitors: a meta-analysis. Future Oncol. 2015;11:2471–2484.
   PubMed Web of Science ®Google Scholar
• Kato Y, Otsuka A, Miyachi Y, et al. Exacerbation of psoriasis vulgaris during nivolumab for oral mucosal melanoma. J Eur Acad Dermatol Venereol. 2016;30:e89–e91.
   PubMed Web of Science ®Google Scholar
• Matsumura N, Ohtsuka M, Kikuchi N, et al. Exacerbation of psoriasis during nivolumab therapy for metastatic melanoma. Acta Derm Venereol. 2016;96:259–260.
   PubMed Web of Science ®Google Scholar
• Murata S, Kaneko S, Harada Y, et al. Case of de novo psoriasis possibly triggered by nivolumab. J Dermatol. 2017;44:99–100.
   PubMed Web of Science ®Google Scholar
• Ohtsuka M, Miura T, Mori T, et al. Occurrence of psoriasiform eruption during nivolumab therapy for primary oral mucosal melanoma. JAMA Dermatol. 2015;151:797–799.
   PubMed Web of Science ®Google Scholar
• Law-Ping-Man S, Martin A, Briens E, et al. Psoriasis and psoriatic arthritis induced by nivolumab in a patient with advanced lung cancer. Rheumatology (Oxford). 2016;55:2087–2089.
   PubMed Web of Science ®Google Scholar
• Nonomura Y, Otsuka A, Ohtsuka M, et al. ADAMTSL5 is upregulated in melanoma tissues in patients with idiopathic psoriasis vulgaris induced by nivolumab. J Eur Acad Dermatol Venereol. 2017;31:e100–e101.
   PubMed Web of Science ®Google Scholar
• Schmutz JL. Psoriasis and psoriatic arthritis induced by nivolumab (Opdivo(R)). Ann Dermatol Venereol. 2016;143:881–882.
   PubMed Web of Science ®Google Scholar
• Bonigen J, Raynaud-Donzel C, Hureaux J, et al. Anti-PD1-induced psoriasis. A study of 21 patients. J Eur Acad Dermatol Venereol. 2017;31:e254–e257.
   PubMed Web of Science ®Google Scholar
• Nayar N, Briscoe K, Fernandez PP. Toxic epidermal necrolysis-like reaction with wevere satellite cell necrosis associated with nivolumab in a patient with ipilimumab refractory metastatic melanoma. J Immunother. 2016;39:149–152.
   PubMed Web of Science ®Google Scholar
• Jour G, Glitza IC, Ellis RM, et al. Autoimmune dermatologic toxicities from immune checkpoint blockade with anti-PD-1 antibody therapy: a report on bullous skin eruptions. J Cutan Pathol. 2016;43:688–696.
   PubMed Web of Science ®Google Scholar
• Naidoo J, Schindler K, Querfeld C, et al. Autoimmune bullous skin disorders with immune checkpoint inhibitors targeting PD-1 and PD-L1. Cancer Immunol Res. 2016;4:383–389.
   PubMed Web of Science ®Google Scholar
• Arai T, Harada K, Usui Y, et al. Case of acute anterior uveitis and Vogt-Koyanagi-Harada syndrome-like eruptions induced by nivolumab in a melanoma patient. J Dermatol. 2017;44:975–976.
   PubMed Web of Science ®Google Scholar
• Komori T, Honda T, Irie H, et al. Lichen planus in irradiated skin during nivolumab treatment. Acta Derm Venereol. 2017;97:391–392.
   PubMed Web of Science ®Google Scholar
• Maurice C, Schneider R, Kiehl TR, et al. Subacute CNS demyelination after treatment with nivolumab for melanoma. Cancer Immunol Res. 2015;3:1299–1302.
   PubMed Web of Science ®Google Scholar
• Tanaka R, Maruyama H, Tomidokoro Y, et al. Nivolumab-induced chronic inflammatory demyelinating polyradiculoneuropathy mimicking rapid-onset Guillain-Barre syndrome: a case report. Jpn J Clin Oncol. 2016;46:875–878.
   PubMed Web of Science ®Google Scholar
• Bilen MA, Subudhi SK, Gao J, et al. Acute rhabdomyolysis with severe polymyositis following ipilimumab-nivolumab treatment in a cancer patient with elevated anti-striated muscle antibody. J Immunother Cancer. 2016;4:36.
   PubMed Web of Science ®Google Scholar
• Nesfeder J, Elsensohn AN, Thind M, et al. Pericardial effusion with tamponade physiology induced by nivolumab. Int J Cardiol. 2016;222:613–614.
   PubMed Web of Science ®Google Scholar
• Kushnir I, Wolf I. Nivolumab-induced pericardial tamponade: a case report and discussion. Cardiology. 2017;136:49–51.
   PubMed Web of Science ®Google Scholar
• Semper H, Muehlberg F, Schulz-Menger J, et al. Drug-induced myocarditis after nivolumab treatment in a patient with PDL1- negative squamous cell carcinoma of the lung. Lung Cancer. 2016;99:117–119.
   PubMed Web of Science ®Google Scholar
• Karlin J, Gentzler R, Golen J. Bilateral anterior uveitis associated with nivolumab therapy. Ocul Immunol Inflamm. 2018;26:283–285.
   PubMed Web of Science ®Google Scholar
• Tadokoro T, Keshino E, Makiyama A, et al. Acute lymphocytic myocarditis with anti-PD-1 antibody nivolumab. Circ Heart. 2016;9:e003514.
   PubMed Web of Science ®Google Scholar
• Ikeuchi K, Okuma Y, Tabata T. Immune-related pancreatitis secondary to nivolumab in a patient with recurrent lung adenocarcinoma: a case report. Lung Cancer. 2016;99:148–150.
   PubMed Web of Science ®Google Scholar
• Yanai S, Nakamura S, Matsumoto T. Nivolumab-induced colitis treated by infliximab. Clin Gastroenterol Hepatol. 2017;15:e80–e81.
   PubMed Web of Science ®Google Scholar
• Solomon LR. Thrombocytopenia due to low-dose colchicine therapy: A possible drug interaction with nivolumab and implications for supportive care. Acta Oncol. 2015;54:1235–1237.
   PubMed Web of Science ®Google Scholar
• Kong BY, Micklethwaite KP, Swaminathan S, et al. Autoimmune hemolytic anemia induced by anti-PD-1 therapy in metastatic melanoma. Melanoma Res. 2016;26:202–204.
   PubMed Web of Science ®Google Scholar
• Inadomi K, Kumagai H, Arita S, et al. Bi-cytopenia possibly induced by anti-PD-1 antibody for primary malignant melanoma of the esophagus: a case report. Medicine (Baltimore). 2016;95:e4283.
   PubMed Web of Science ®Google Scholar
• Schwab KS, Heine A, Weimann T, et al. Development of hemolytic anemia in a nivolumab-treated patient with refractory metastatic squamous cell skin cancer and chronic lymphatic leukemia. Case Rep Oncol. 2016;9:373–378.
   PubMed Web of Science ®Google Scholar
• Tardy MP, Gastaud L, Boscagli A, et al. Autoimmune hemolytic anemia after nivolumab treatment in Hodgkin lymphoma responsive to immunosuppressive treatment. a Case Report. Hematol Oncol. 2017;35:875–877.
   PubMed Web of Science ®Google Scholar
• Tabchi S, Weng X, Blais N. Severe agranulocytosis in a patient with metastatic non-small-cell lung cancer treated with nivolumab. Lung Cancer. 2016;99:123–126.
   PubMed Web of Science ®Google Scholar
• Shirali AC, Perazella MA, Gettinger S. Association of acute interstitial nephritis with programmed cell death 1 inhibitor therapy in lung cancer patients. Am J Kidney Dis. 2016;68:287–291.
   PubMed Web of Science ®Google Scholar
• Vandiver JW, Singer Z, Harshberger C. Severe hyponatremia and immune nephritis following an initial infusion of nivolumab. Target Oncol. 2016;11:553–556.
   PubMed Web of Science ®Google Scholar
• Murakami N, Borges TJ, Yamashita M, et al. Severe acute interstitial nephritis after combination immune-checkpoint inhibitor therapy for metastatic melanoma. Clin Kidney J. 2016;9:411–417.
   PubMed Web of Science ®Google Scholar
• Koelzer VH, Rothschild SI, Zihler D, et al. Systemic inflammation in a melanoma patient treated with immune checkpoint inhibitors-an autopsy study. J Immunother Cancer. 2016;4:13.
   PubMed Web of Science ®Google Scholar
• Ma Q, Shilkrut M, Li M, et al. Autoimmune comorbidities in patients with metastatic melanoma: a retrospective analysis of us claims data. BMC Cancer. 2018;18:145.
   PubMed Web of Science ®Google Scholar
• Menzies AM, Johnson DB, Ramanujam S, et al. Anti-PD1 therapy in patients with advanced melanoma and preexisting autoimune disorders or major toxicity with ipilimumab. J Clin.Oncol. 2016;34(suppl): 9515 (abstract).
   PubMedGoogle Scholar
• Maeda O, Yokota K, Atsuta N, et al. Nivolumab for the treatment of malignant melanoma in a patient with pre-existing myasthenia gravis. Nagoya J Med Sci. 2016;78:119–122.
   PubMed Web of Science ®Google Scholar
• Maggiore U, Pascual J. The bad and the good news on cancer immunotherapy: implications for organ transplant recipients. Adv Chronic Kidney Dis. 2016;23:312–316.
   PubMed Web of Science ®Google Scholar
• Spain L, Higgins R, Gopalakrishnan K, et al. Acute renal allograft rejection after immune checkpoint inhibitor therapy for metastatic melanoma. Ann Oncol. 2016;27:1135–1137.
   PubMed Web of Science ®Google Scholar
• Herz S, Hofer T, Papapanagiotou M, et al. Checkpoint inhibitors in chronic kidney failure and an organ transplant recipient. Eur J Cancer. 2016;67:66–72.
   PubMed Web of Science ®Google Scholar
• Carroll K, Ries Tringale K, Zakeri K, et al. Cost-effectiveness of nivolumab for treatment of platinum-resistant recurrent or metastatic squamous cell carcinoma of the head and neck. J Clin Oncol. 2017;35(suppl): 6026 (abstract).
   Google Scholar
• Tartari F, Santoni M, Burattini L, et al. Economic sustainability of anti-PD-1 agents nivolumab and pembrolizumab in cancer patients: recent insights and future challenges. Cancer Treat Rev. 2016;48:20–24.
   PubMed Web of Science ®Google Scholar
• http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf. Accessed on 2018 Mar 8.
   Google Scholar
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf. Accessed on 2018 Mar 8.
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02369874.
   Google Scholar
• Uppaluri R, Zolkind P, Lin T, et al. Immunotherapy with pembrolizumab in surgically resectable head and neck squamous cell carcinoma. J Clin Oncol. 2016;34(suppl): Abstr TPS 6110.
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02741570.
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02551159.
   Google Scholar
• Seiwert TY, Weiss J, Baxi SS, et al. A phase 3, randomized, open-label study of first-line durvalumab (MEDI4736) ± tremelimumab versus standard of care (SoC; EXTREME regimen) in recurrent/metastatic (R/M) SCCHN: KESTREL. J Clin Oncol. 2016;34(suppl): Abstr TPS 6101.
   PubMedGoogle Scholar
• Powell SF, Gitau MM, Sumay CJ, et al. Safety of pembrolizumab with chemoradiation (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). J Clin Oncol. 2017;35(suppl): 6011 (abstract).
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02684253.
   Google Scholar
• Machiels JP, Licitra L, Rischin D, et al. Pembrolizumab plus chemoradiation (CRT) for the treatment of locally advanced head and neck squamous cell carcinoma (LAHNSCC): phase3 KEYNOTE-412 trial. Ann.Oncol. 2017;28(suppl 5): 1105TiP (abstract).
   PubMedGoogle Scholar
• Even C, Texier M, Le Tourneau C, et al. MEDINDUCTION: phase I trial evaluating the safety of durvalumab in combination with Docetaxel, Cisplatin and 5-FU (DCF) in induction for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Ann.Oncol. 2017;28(suppl 5): 1109TiP (abstract).
   PubMedGoogle Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02764593.
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02999087.
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02952586.
   Google Scholar
• Lee NY, Ferris RL, Beck TN, et al. JAVELIN head and neck 100: A phase 3 trial of avelumab in combination with chemoradiotherapy (CRT) vs CRT for 1st-line treatment of locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). J Clin Oncol. 2017;35(Suppl): TPS6093 (abstract).
   Google Scholar
• https://clinicaltrials.gov/ct2/show/NCT02641093. Accessed on 2018 Mar 8.
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02841748.
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02759575.
   Google Scholar
• [cited 2018 Mar 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT02819752.
   Google Scholar
• [cited 2018 Mar 8 . Available from: https://clinicaltrials.gov/ct2/show/NCT03003637.
   Google Scholar