Management of immune checkpoint blockade dysimmune toxicities: A collaborative position paper

Annals of Oncology

Volumn 27, Issue 4, 2016, Pages 559-574

  Champiat, S ^a,b   Lambotte, O ^c,d,e,f   Barreau, E ^c   Belkhir, R ^c   Berdelou, A ^g   Carbonnel, F ^d   Cauquil, C ^c   Chanson, P ^c,d,f   Collins, M ^d   Durrbach, A ^d   Ederhy, S ^h   Feuillet, S ^d,i   Francois H ^d   Lazarovici, J ^g   Le Pavec, J ^d,i   De Martin, E ^j,k   Mateus, C ^g   Michot, J M ^a   Samuel, D ^j,k   Soria, J C ^a,b   Robert, C ^b,g   Eggermont, A ^g   Marabelle, Aurelien ^a,f,g   more..

^a Gustave Roussy ^*  (France)

^b Universite Paris Sud   (France)

^c BICÊTRE HOSPITAL   (France)

^d UNIVERSITÉ PARIS SACLAY   (France)

^e INSTITUT DE RADIOPROTECTION ET DE SÛRETÉ NUCLÉAIRE   (France)

^f INSERM   (France)

^g INSTITUT GUSTAVE ROUSSY   (France)

^h HÔPITAL SAINT ANTOINE   (France)

ⁱ UMR S 999   (United States)

^j Hôpital Universitaire Paul Brousse   (United States)

^k Universite Paris Sud   (France)

more..

Author keywords

Immunotherapy; Medical oncology; Neoplasms; Practice guideline; Toxicity

Indexed keywords

ALLOPURINOL; COTRIMOXAZOLE; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4 ANTIBODY; IMMUNOSUPPRESSIVE AGENT; IPILIMUMAB; METFORMIN; NIVOLUMAB; NONSTEROID ANTIINFLAMMATORY AGENT; PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; SALICYLIC ACID; SILICON DIOXIDE; STEROID; CTLA4 PROTEIN, HUMAN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; MONOCLONAL ANTIBODY; PDCD1 PROTEIN, HUMAN; PROGRAMMED DEATH 1 RECEPTOR;

ABDOMINAL PAIN; AMBULATORY CARE; ANTIBIOTIC PROPHYLAXIS; ARTHRALGIA; CANCER IMMUNOTHERAPY; CANCER INFILTRATION; COMPUTER ASSISTED TOMOGRAPHY; CORTICOSTEROID THERAPY; DECREASED APPETITE; DIARRHEA; DRUG ANTAGONISM; FAMILY HISTORY; FATIGUE; FOURNIER GANGRENE; HEPATITIS B; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOSUPPRESSIVE TREATMENT; IMMUNOTOXICITY; INPATIENT CARE; INTERNIST; LABORATORY TEST; LUPUS VULGARIS; MANAGEMENT; MAXIMUM TOLERATED DOSE; MEDICAL CARE; MEDICAL HISTORY; MINERAL DUST; MONITORING; MULTIPLE SCLEROSIS; NAUSEA; ONCOLOGIST; OPPORTUNISTIC INFECTION; PALLIATIVE THERAPY; PATIENT INFORMATION; PATIENT REFERRAL; PHYSICAL EXAMINATION; PRIORITY JOURNAL; PRURITUS; PULMONARY ASPERGILLUS INFECTION; RASH; REVIEW; RHEUMATOID ARTHRITIS; SYSTEMIC SCLEROSIS; THORAX RADIOGRAPHY; TREATMENT WITHDRAWAL; TUBERCULOSIS; ULCERATIVE COLITIS; VIREMIA; VIRUS HEPATITIS; VOMITING; ADVERSE DRUG REACTION; ADVERSE EFFECTS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE MANAGEMENT; IMMUNOLOGY; IMMUNOTHERAPY; MELANOMA; PATHOLOGY;

ANTIBODIES, MONOCLONAL; CARCINOMA, NON-SMALL-CELL LUNG; CTLA-4 ANTIGEN; DISEASE MANAGEMENT; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; IMMUNOTHERAPY; MELANOMA; PROGRAMMED CELL DEATH 1 RECEPTOR;

EID: 84964573640     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdv623     Document Type: Review

References (88)

1. Antonia SJ, Bendell JC, Taylor MH, et al. Phase I/II study of nivolumab with or without ipilimumab for treatment of recurrent small cell lung cancer (SCLC): CA209-032. ASCO 2015. J Clin Oncol 2015; 33(suppl); abstr 7503.
2. Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med 2015; 150925150201006-11.
3. Plimack ER, Bellmunt J, Gupta S, et al. Pembrolizumab (MK-3475) for advanced urothelial cancer: updated results and biomarker analysis from KEYNOTE-012. ASCO 2015. J Clin Oncol 2015; 33(suppl): abstr 4502.
4. Seiwert TY, Haddad RI, Gupta S, et al. Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): preliminary results from KEYNOTE-012 expansion cohort. ASCO 2015. J Clin Oncol 2015; 33(suppl): abstr LBA6008.
5. Segal NH, Ou AI, Balmanoukian AS, et al. Safety and efficacy of MEDI4736, an anti-PD-L1 antibody, in patients from a squamous cell carcinoma of the head and neck (SCCHN) expansion cohort. ASCO 2015. J Clin Oncol 2015; 33(suppl): abstr 3011.
6. Bang Y, Chung H, Shankaran V, et al. Relationship between PD-L1 expression and clinical outcomes in patients with advanced gastric cancer treated with the anti- PD-1 monoclonal antibody pembrolizumab (MK-3475) in KEYNOTE-012. ASCO 2015. J Clin Oncol 2015; 33(suppl): abstr 4001.
7. El-Khoueiry AB, Melero I, Crocenzi TS, et al. Phase I/II safety and antitumor activity of nivolumab in patients with advanced hepatocellular carcinoma (HCC): CA209 - 040. ASCO 2015. J Clin Oncol 2015; 33(suppl): abstr LBA101.
8. Hamanishi J, Mandai M, Ikeda T, et al. Durable tumor remission in patients with platinum-resistant ovarian cancer receiving nivolumab. ASCO 2015. J Clin Oncol 2015; 33(suppl): abstr 5570.
9. Varga A, Piha-Paul A, Ott PA, et al. Antitumor activity and safety of pembrolizumab in patients (pts) with PD-L1 positive advanced ovarian cancer: interim results from a phase Ib study. ASCO 2015. J Clin Oncol 2015; 33(suppl): abstr 5510.
10. Disis ML, Patel MR, Pant S, et al. Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with previously treated, recurrent or refractory ovarian cancer: a phase Ib, open-label expansion trial. ASCO 2015. J Clin Oncol 2015; 33(suppl): abstr 5509.
11. Emens LA, Braiteh FS, Cassier P, et al. Inhibition of PD-L1 by MPDL3280A leads to clinical activity in patients with metastatic triple-negative breast cancer (TNBC). Presented at: 2015 AACR Annual Meeting; April 18-22; Philadelphia, PA. Abstr 6317.
12. Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med 2015; 372: 2509-2520.
13. Ansell SM, Lesokhin AM, Borrello I, et al. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med 2014; 141206100011003.
14. Moskowitz CH, Ribrag V, Michot JM, et al. PD-1 blockade with the monoclonal antibody pembrolizumab (MK-3475) in patients with classical Hodgkin lymphoma after brentuximab vedotin failure: preliminary results from a phase 1b study (KEYNOTE-013) [abstract]. Blood 2014; 124(21): Abstr 290.
15. 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(23): 7412-7420.
16. Weber JS, Kähler KC, Hauschild A. Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol 2012; 30(21): 2691-2697.
17. Weber JS, Antonia SJ, Topalian SL, et al. Safety profile of nivolumab (NIVO) in patients (pts) with advanced melanoma (MEL): a pooled analysis. J Clin Oncol 2015; 33(suppl): abstr 9018.
18. European Medicines Agency: EMEA/H/C/002213 -PSUSA/00009200/201409- ipilimumab Product information 19/06/2015 Yervoy. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002213/WC500109299.pdf (8 November 2015, date last accessed), August 2015.
19. European Medicines Agency: EMEA/H/C/003985-Nivolumab Product information 19/06/2015 Opdivo. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003985/WC500189765.pdf (8 November 2015, date last accessed), July 2015.
20. European Medicines Agency: EMEA/H/C/003820-Pembrolizumab Product information 17/07/2015 Keytruda. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003820/WC500190990.pdf (8 November 2015, date last accessed), July 2015.
21. Minkis K, Garden BC, Wu S, et al. The risk of rash associated with ipilimumab in patients with cancer: a systematic review of the literature and meta-analysis. J Am Acad Dermatol 2013; 69(3): e121-e128.
22. 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.
23. Cheng R, Cooper A, Kench J, et al. Ipilimumab-induced toxicities and the gastroenterologist. J Gastroenterol Hepatol 2015; 30(4): 657-666.
24. Di Giacomo AM, Danielli R, Guidoboni M, et al. Therapeutic efficacy of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with metastatic melanoma unresponsive to prior systemic treatments: clinical and immunological evidence from three patient cases. Cancer Immunol Immunother 2009; 58(8): 1297-1306.
25. Gentile NM, D'Souza A, Fujii LL, et al. Association between ipilimumab and celiac disease. Mayo Clin Proc 2013; 88(4): 414-417.
26. Ryder M, Callahan M, Postow MA, et al. Endocrine-related adverse events following ipilimumab in patients with advanced melanoma: a comprehensive retrospective review from a single institution. Endocr Relat Cancer 2014; 21(2): 371-381.
27. Albarel F, Gaudy C, Castinetti F, et al. Long-term follow-up of ipilimumab-induced hypophysitis, a common adverse event of the anti-CTLA-4 antibody in melanoma. Eur J Endocrinol 2015; 172(2): 195-204.
28. Gaudy C, Clévy C, Monestier S, et al. Anti-PD1 pembrolizumab can induce exceptional fulminant type 1 diabetes. Diabetes Care 2015; dc151331-2.
29. Barjaktarevic IZ, Qadir N, Suri A, et al. Organizing pneumonia as a side effect of ipilimumab treatment of melanoma. Chest 2013; 143(3): 858-861.
30. Berthod G, Lazor R, Letovanec I, et al. Pulmonary sarcoid-like granulomatosis induced by ipilimumab. J Clin Oncol 2012; 30(17): e156-e159.
31. Thaipisuttikul I, Chapman P, Avila EK. Peripheral neuropathy associated with ipilimumab: a report of 2 cases. J Immunother 2015; 38(2): 77-79.
32. Bot I, Blank CU, Boogerd W, Brandsma D. Neurological immune-related adverse events of ipilimumab. Pract Neurol 2013; 13(4): 278-280.
33. Gaudy-Marqueste C, Monestier S, Franques J, et al. A severe case of ipilimumabinduced Guillain-Barré syndrome revealed by an occlusive enteric neuropathy: a differential diagnosis for ipilimumab-induced colitis. J Immunother 2013; 36(1): 77-78.
34. Abdallah A-O, Herlopian A, Ravilla R, et al. Ipilimumab-induced necrotic myelopathy in a patient with metastatic melanoma: a case report and review of literature. J Oncol Pharm Pract 2015; 1078155215572932.
35. Liao B, Shroff S, Kamiya-Matsuoka C, Tummala S. Atypical neurological complications of ipilimumab therapy in patients with metastatic melanoma. Neuro- Oncol 2014; 16(4): 589-593.
36. Loochtan AI, Nickolich MS, Hobson-Webb LD. Myasthenia gravis associated with ipilimumab and nivolumab in the treatment of small cell lung cancer. Muscle Nerve 2015.
37. Bernardo SG, Moskalenko M, Pan M, et al. Elevated rates of transaminitis during ipilimumab therapy for metastatic melanoma. Melanoma Res 2013; 23(1): 47-54.
38. Kleiner DE, Berman D. Pathologic changes in ipilimumab-related hepatitis in patients with metastatic melanoma. Dig Dis Sci 2012; 57(8): 2233-2240.
39. Forde PM, Rock K, Wilson G, O'Byrne KJ. Ipilimumab-induced immune-related renal failure-a case report. Anticancer Res 2012; 32(10): 4607-4608.
40. Voskens C, Cavallaro A, Erdmann M, et al. Anti-cytotoxic T-cell lymphocyte antigen-4-induced regression of spinal cord metastases in association with renal failure, atypical pneumonia, vision loss, and hearing loss. J Clin Oncol 2012; 30 (33): e356-e357.
41. Thajudeen B, Madhrira M, Bracamonte E, Cranmer LD. Ipilimumab granulomatous interstitial nephritis. Am J Ther 2015; 22: e84-e87.
42. Fadel F, Karoui El K, Knebelmann B. Anti-CTLA4 antibody-induced lupus nephritis. N Engl J Med 2009; 361(2): 211-212.
43. Izzedine H, Gueutin V, Gharbi C, et al. Kidney injuries related to ipilimumab. Invest New Drugs 2014; 32(4): 769-773.
44. Simeone E, Grimaldi AM, Esposito A, et al. Serious haematological toxicity during and after ipilimumab treatment: a case series. J Med Case Rep 2014; 8: 240.
45. Gordon IO, Wade T, Chin K, et al. Immune-mediated red cell aplasia after anti- CTLA-4 immunotherapy for metastatic melanoma. Cancer Immunol Immunother 2009; 58(8): 1351-1353.
46. 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.
47. Ahmad S, Lewis M, Corrie P, Iddawela M. Ipilimumab-induced thrombocytopenia in a patient with metastatic melanoma. J Oncol Pharm Pract 2012; 18(2): 287-292.
48. Kopeckỳ J, Trojanová P, Kubeček O, Kopeckỳ O. Treatment possibilities of ipilimumab-induced thrombocytopenia-case study and literature review. Jpn J Clin Oncol 2015; 45: 381-384.
49. Wei G, Nwakuche U, Cadavid G, et al. Large granular lymphocytosis with severe neutropenia following ipilimumab therapy for metastatic melanoma. Exp Hematol Oncol 2012; 1(1): 3.
50. Akhtari M, Waller EK, Jaye DL, et al. Neutropenia in a patient treated with ipilimumab (anti-CTLA-4 antibody). J Immunother 2009; 32(3): 322-324.
51. Wozniak S, Mackiewicz-Wysocka M, Krokowicz L, et al. Febrile neutropenia in a metastatic melanoma patient treated with ipilimumab-case report. Oncol Res Treat 2015; 38(3): 105-108.
52. du Rusquec P, Saint-Jean M, Brocard A, et al. Ipilimumab-induced autoimmune pancytopenia in a case of metastatic melanoma. J Immunother 2014; 37(6): 348-350.
53. de Velasco G, Bermas B, Choueiri TK. Auto-immune arthropathy and uveitis as complications from PD-1 inhibitor. Arthritis Rheumatol 2015: n/a-n/a.
54. Chan MMK, Kefford RF, Carlino M, et al. Arthritis and tenosynovitis associated with the anti-PD1 antibody pembrolizumab in metastatic melanoma. J Immunother 2015; 38(1): 37-39.
55. Hunter G, Voll C, Robinson CA. Autoimmune inflammatory myopathy after treatment with ipilimumab. Can J Neurol Sci 2009; 36(4): 518-520.
56. Läubli H, Balmelli C, Bossard M, et al. Acute heart failure due to autoimmune myocarditis under pembrolizumab treatment for metastatic melanoma. J Immunother Cancer 2015; 3(1): 11.
57. Geisler BP, Raad RA, Esaian D, et al. Apical ballooning and cardiomyopathy in a melanoma patient treated with ipilimumab: a case of takotsubo-like syndrome. J Immunother Cancer 2015; 3(1): 4.
58. Nallapaneni NN, Mourya R, Bhatt VR, et al. Ipilimumab-induced hypophysitis and uveitis in a patient with metastatic melanoma and a history of ipilimumab-induced skin rash. J Natl Compr Canc Netw 2014; 12(8): 1077-1081.
59. Robinson MR, Chan C-C, Yang JC, et al. Cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma: a new cause of uveitis. J Immunother 2004; 27(6): 478-479.
60. Miserocchi E, Cimminiello C, Mazzola M, et al. New-onset uveitis during CTLA-4 blockade therapy with ipilimumab in metastatic melanoma patient. Can J Ophthal 2015; 50(1): e2-e4.
61. Wong RK, Lee JK, Huang JJ. Bilateral drug (ipilimumab)-induced vitritis, choroiditis, and serous retinal detachments suggestive of vogt-koyanagi-harada syndrome. Retin Cases Brief Rep 2012; 6(4): 423-426.
62. Crosson JN, Laird PW, Debiec M, et al. Vogt-Koyanagi-Harada-like syndrome after CTLA-4 inhibition with ipilimumab for metastatic melanoma. J Immunother 2015; 38(2): 80-84.
63. Manusow JS, Khoja L, Pesin N, et al. Retinal vasculitis and ocular vitreous metastasis following complete response to PD-1 inhibition in a patient with metastatic cutaneous melanoma. J Immunother Cancer 2014; 2(1): 41.
64. Lecouflet M, Verschoore M, Giard C, et al. [Orbital myositis associated with ipilimumab]. Ann Dermatol Venereol 2013; 140(6-7): 448-451.
65. McElnea E, Ní Mhéalóid á, Moran S, et al. Thyroid-like ophthalmopathy in a euthyroid patient receiving ipilimumab. Orbit 2014; 33(6): 424-427.
66. Shelburne SA, Hamill RJ, Rodriguez-Barradas MC, et al. Immune reconstitution inflammatory syndrome: emergence of a unique syndrome during highly active antiretroviral therapy. Medicine (Baltimore) 2002; 81(3): 213-227.
67. Wherry EJ. T cell exhaustion. Nat Immunol 2011; 12(6): 492-499.
68. Xiao X, Chang C. Diagnosis and classification of drug-induced autoimmunity (DIA). J Autoimmun 2014; 48-49(c): 66-72.
69. Bostwick AD, Salama AK, Hanks BA. Rapid complete response of metastatic melanoma in a patient undergoing ipilimumab immunotherapy in the setting of active ulcerative colitis. J Immunother Cancer 2015; 3(1): 19.
70. Pedersen M, Andersen R, Nørgaard P, et al. Successful treatment with ipilimumab and interleukin-2 in two patients with metastatic melanoma and systemic autoimmune disease. Cancer Immunol Immunother 2014; 63(12): 1341-1346.
71. Kyi C, Carvajal RD, Wolchok JD, Postow MA. Ipilimumab in patients with melanoma and autoimmune disease. J Immunother Cancer 2014; 2(1): 35.
72. Chang K, Svabek C, Vazquez-Guillamet C, et al. Targeting the programmed cell death 1: programmed cell death ligand 1 pathway reverses T cell exhaustion in patients with sepsis. Crit Care 2014; 18(1): R3.
73. Kong Y-CM, Flynn JC. Opportunistic autoimmune disorders potentiated by immune-checkpoint inhibitors anti-CTLA-4 and anti-PD-1. Front Immunol 2014; 5: 206.
74. Sharma A, Thompson JA, Repaka A, Mehnert JM. Ipilimumab administration in patients with advanced melanoma and hepatitis B and C. J Clin Oncol 2013; 31 (21): e370-e372.
75. Minter S, Willner I, Shirai K. Ipilimumab-induced hepatitis C viral suppression. J Clin Oncol 2013; 31(19): e307-e308.
76. Sangro B, Gomez-Martin C, de la Mata M, et al. A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C. J Hepatol 2013; 59(1): 81-88.
77. Ravi S, Spencer K, Ruisi M, et al. Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: a multicenter, retrospective case series. J Immunother Cancer 2014; 2(1): 33.
78. Chang C, Gershwin ME. Drugs and autoimmunity-a contemporary review and mechanistic approach. J Autoimmun 2010; 34(3): J266-J275.
79. Wolchok JD, Neyns B, Linette G, 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): 155-164.
80. O'Day SJ, Maio M, Chiarion-Sileni V, et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol 2010; 21(8): 1712-1717.
81. Brahmer JR, Drake CG, Wollner I, et al. Phase I study of single-agent antiprogrammed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol 2010; 2010(19): 3167-3175.
82. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012; 366(26): 2443-2454.
83. Hamid O, Robert C, Daud A, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 2013; 369(2): 134-144.
84. Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet 2014; 384(9948): 1109-1117.
85. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 2015; 150617133829002-13.
86. Larkin J, Chiarion-Sileni V, Gonzalez R et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2015; 373: 23-34.
87. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015; 372(4): 320-330.
88. Kyi C, Hellmann MD, Wolchok JD, et al. Opportunistic infections in patients treated with immunotherapy for cancer. J Immunother Cancer 2014; 2(1): 19.