Toxicity of checkpoint inhibition in advanced RCC: A systematic review

Kidney Cancer

Volumn 1, Issue 2, 2017, Pages 133-141

  Ornstein, Moshe C ^b   Garcia, Jorge A ^a,b  

^a LERNER RESEARCH INSTITUTE   (United States)

^b TAUSSIG CANCER INSTITUTE   (United States)

Author keywords

Checkpoint inhibitors; CTLA 4; Immune related adverse events; Immunotherapy; Kidney carcinoma; PD 1; PD L1; Renal cell carcinoma; Toxicity

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTINEOPLASTIC AGENT; ASPARTATE AMINOTRANSFERASE; CHECKPOINT INHIBITOR; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; IPILIMUMAB; NIVOLUMAB; PROGRAMMED DEATH 1 LIGAND 1; PROGRAMMED DEATH 1 RECEPTOR; UNCLASSIFIED DRUG;

ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER IMMUNOTHERAPY; CANCER INCIDENCE; CANCER PATIENT; CLINICAL TRIAL (TOPIC); DECREASED APPETITE; DIARRHEA; DRY SKIN; EMBASE; FATIGUE; FEVER; HUMAN; HYPOTHYROIDISM; KIDNEY CARCINOMA; KIDNEY METASTASIS; MEDLINE; META ANALYSIS; MONOTHERAPY; NAUSEA; PNEUMONIA; PRACTICE GUIDELINE; PRIORITY JOURNAL; PRURITUS; RASH; RENAL CELL CARCINOMA; SIDE EFFECT; SYSTEMATIC REVIEW;

EID: 85061988861     PISSN: 24684562     EISSN: 24684570     Source Type: Journal    
DOI: 10.3233/KCA-170017     Document Type: Article

References (45)

1. Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol 2008;26:677-704.
2. Peggs KS, Quezada SA, Korman AJ, Allison JP. Principles and use of anti-CTLA4 antibody in human cancer immunotherapy. Curr Opin Immunol 2006;18(2):206-13.
3. Zhang T, Xie J, Arai S, Wang L, Shi X, Shi N, et al. The efficacy and safety of anti-PD-1/PD-L1 antibodies for treatment of advanced or refractory cancers: A meta-analysis. Oncotarget 2016;7(45):73068-79.
4. Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, et al. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med 2015;373(19):1803-13.
5. Herbst RS, Baas P, Kim DW, Felip E, Perez-Gracia JL, Han JY, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): A randomised controlled trial. Lancet 2016;387(10027):1540-50.
6. Cella D, Grunwald V, Nathan P, Doan J, Dastani H, Taylor F, et al. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: A randomised, open-label, phase 3 trial. Lancet Oncol 2016;17(7):994-1003.
7. Costa R, Carneiro BA, Agulnik M, Rademaker AW, Pai SG, Villaflor VM, et al. Toxicity profile of approved anti-PD-1 monoclonal antibodies in solid tumors: A systematic review and meta-analysis of randomized clinical trials. Oncotarget 2017;8(5):8910-20.
8. Escudier BJ, Tannir NM, McDermott DF, Frontera OA, Melichar B, Plimack ER, et al. CheckMate 214: Efficacy and safety of nivolumab + ipilimumab (N+I) v sunitinib (S) for treatment-naïve advanced or metastatic renal cell carcinoma (mRCC), including IMDC risk and PD-L1 expression subgroups. 2017 ESMO Congress:Abstract LBA5.
9. NCT02420821. A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma [IMmo-tion151]. 2017; Available at: https://clinicaltrials.gov/ct2/show/NCT02420821. Accessed September 24, 2017.
10. NCT02684006. A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101). 2017; Available at: https://clinicaltrials.gov/ct2/show/NCT02684006. Accessed September 24, 2017.
11. NCT02811861. Lenvatinib/Everolimus or Lenvatinib/ Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma. 2017; Available at: https://clinicaltrials.gov/ct2/show/NCT02811861. Accessed September 24, 2017.
12. NCT02853331. Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426). 2017; Available at: https://clinicaltrials.gov/ct2/show/NCT02853331. Accessed September 24, 2017.
13. Cappelli LC, Gutierrez AK, Baer AN, Albayda J, Manno RL, Haque U, et al. Inflammatory arthritis and sicca syndrome induced by nivolumab and ipilimumab. Ann Rheum Dis 2017;76(1):43-50.
14. Jung K, Zeng X, Bilusic M. Nivolumab-associated acute glomerulonephritis: A case report and literature review. BMC Nephrol 2016;17(1):188.
15. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1-4053-4-1.
16. McDermott DF, Sosman JA, Sznol M, Massard C, Gordon MS, Hamid O, et al. Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study. J Clin Oncol 2016;34(8):833-42.
17. Hammers HJ, Plimack ER, Infante JR, Rini BI, McDermott DF, Lewis LD, et al. Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016 Study. J Clin Oncol 2017:JCO2016721985.
18. McDermott DF, Drake CG, Sznol M, Choueiri TK, Pow-derly JD, Smith DC, et al. Survival, Durable Response, and Long-Term Safety in Patients With Previously Treated Advanced Renal Cell Carcinoma Receiving Nivolumab. J Clin Oncol 2015;33(18):2013-20.
19. Motzer RJ, Rini BI, McDermott DF, Redman BG, Kuzel TM, Harrison MR, et al. Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial. J Clin Oncol 2015;33(13):1430-7.
20. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012;366(26):2443-54.
21. Fisher RI, Rosenberg SA, Fyfe G. Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma. Cancer J Sci Am 2000;6(Suppl 1):S55-7.
22. Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Ou SS, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol 2008;26(33):5422-8.
23. Mendiratta P, Rini BI, Ornstein MC. Emerging Immunother-apy in Advanced Renal Cell Carcinoma. Urol Oncol 2017;35(12):687-93.
24. Weber JS, Hodi FS, Wolchok JD, Topalian SL, Schadendorf D, Larkin J, et al. Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma. J Clin Oncol 2017;35(7):785-92.
25. Horvat TZ, Adel NG, Dang TO, Momtaz P, Postow MA, Callahan MK, et al. Immune-Related Adverse Events, Need for Systemic Immunosuppression, and Effects on Survival and Time to Treatment Failure in Patients With Melanoma Treated With Ipilimumab at Memorial Sloan Kettering Cancer Center. J Clin Oncol 2015;33(28):3193-8.
26. Bertrand A, Kostine M, Barnetche T, Truchetet ME, Schae-verbeke T. Immune related adverse events associated with anti-CTLA-4 antibodies: Systematic review and meta-analysis. BMC Med 2015;13:211-015-0455-8.
27. Haratani K, Hayashi H, Chiba Y, Kudo K, Yonesaka K, Kato R, et al. Association of Immune-Related Adverse Events With Nivolumab Efficacy in Non-Small-Cell Lung Cancer. JAMA Oncology 2017;Epub ahead of print (September 21 2017): http://jamanetwork.com/journals/jamaoncology/fullarticle/2654556.
28. Hahn AW, Gill DM, Agarwal N, Maughan BL. PD-1 checkpoint inhibition: Toxicities and management. Urol Oncol 2017;35(12):701-707.
29. Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2017;28(suppl 4):iv119-iv142.
30. Friedman CF, Proverbs-Singh TA, Postow MA. Treatment of the Immune-Related Adverse Effects of Immune CheckpointInhibitors:AReview.JAMAOncol2016;2(10): 1346-53.
31. Beck KE, Blansfield JA, Tran KQ, Feldman AL, Hughes MS, Royal RE, 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.
32. Weber JS, Kahler KC, Hauschild A. Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol 2012;30(21):2691-7.
33. Sznol M, Ferrucci PF, Hogg D, Atkins MB, Wolter P, Guidoboni M, et al. Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma. J Clin Oncol 2017:JCO2016721167.
34. Weber JS, Dummer R, de Pril V, Lebbe C, Hodi FS, MDX010-20 Investigators. 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.
35. Pollack MH, Betof A, Dearden H, Rapazzo K, Valentine I, Brohl AS, et al. Safety of resuming anti-PD-1 in patients with immune-related adverse events (irAEs) during combined anti-CTLA-4 and anti-PD1 in metastatic melanoma. Ann Oncol. 2017 Oct 11. doi: 10.1093/annonc/mdx642. [Epub ahead of print]
36. Harmankaya K, Erasim C, Koelblinger C, Ibrahim R, Hoos A, Pehamberger H, et al. Continuous systemic corticosteroids do not affect the ongoing regression of metastatic melanoma for more than two years following ipilimumab therapy. Med Oncol 2011;28(4):1140-4.
37. McKay RR, Martini D, Moreira RB, Hamieh L, Norton C, Mullane A, et al. Outcomes of PD-1/PD-L1 responders who discontinue therapy for immune-related adverse events (irAEs): Results of a cohort of patients (pts) with metastatic renal cell carcinoma (mRCC). J Clin Oncol (Meeting Abstracts) 2017;35:Asbtr467.
38. Atkins MB, Mier JW, Parkinson DR, Gould JA, Berkman EM, Kaplan MM. Hypothyroidism after treatment with interleukin-2 and lymphokine-activated killer cells. N Engl J Med 1988;318(24):1557-63.
39. Phan GQ, Attia P, Steinberg SM, White DE, Rosenberg SA. Factors associated with response to high-dose interleukin-2 in patients with metastatic melanoma. J Clin Oncol 2001;19(15):3477-82.
40. Bouwhuis MG, Ten Hagen TL, Suciu S, Eggermont AM. Autoimmunity and treatment outcome in melanoma. Curr Opin Oncol 2011;23(2):170-6.
41. Downey SG, Klapper JA, Smith FO, Yang JC, Sherry RM, Royal RE, et al. Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res 2007;13(22 Pt 1):6681-8.
42. Yang JC, Hughes M, Kammula U, Royal R, Sherry RM, Topalian SL, et al. Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis. J Immunother 2007;30(8):825-30.
43. Judd J, Zibelman M, Handorf E, O'Neill J, Rama-murthy C, Bentota S, et al. Immune-Related Adverse Events as a Biomarker in Non-Melanoma Patients Treated with Programmed Cell Death 1 Inhibitors. Oncologist 2017;22(10):1232-37.
44. Choueiri TK, Larkin JMG, Oya M, Thistlethwaite F, Mar-tignoni M, Nathan P, et al. First-line avelumab+axitinib therapy in patients pts) with advanced renal cell carcinoma (aRCC): Results from a phase Ib trial. J Clin Oncol (Meeting Abstracts) 2017;35:Abstr4504.
45. Atkins MB, Plimack ER, Puzanov I, Fishman MN, McDermott DF, Cho DC, et al. Axitinib in combination with pembrolizumab in patients (pts) with advanced renal cell carcinoma (aRCC): Preliminary safety and efficacy results. ESMO Congress 2016;Abstr773.