Risk of gastrointestinal complications in cancer patients treated with immune checkpoint inhibitors: A meta-analysis

Immunotherapy

Volumn 7, Issue 11, 2015, Pages 1213-1227

  Abdel Rahman, Omar ^a   Elhalawani, Hesham ^a   Fouad, Mona ^a  

^a AIN SHAMS UNIVERSITY   (Egypt)

Author keywords

colitis; diarrhea; ipilimumab; nivolumab

Indexed keywords

ATEZOLIZUMAB; IPILIMUMAB; NIVOLUMAB; PEMBROLIZUMAB; PIDILIZUMAB; TICILIMUMAB; ANTINEOPLASTIC AGENT; BLOCKING ANTIBODY; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; PROGRAMMED DEATH 1 RECEPTOR;

CANCER CHEMOTHERAPY; CANCER PATIENT; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL TRIAL (TOPIC); COLITIS; DIARRHEA; GASTROINTESTINAL TOXICITY; HUMAN; MELANOMA; META ANALYSIS; NON SMALL CELL LUNG CANCER; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SMALL CELL LUNG CANCER; SOLID TUMOR; SYSTEMATIC REVIEW; VOMITING; ANTAGONISTS AND INHIBITORS; COMPLICATION; DRUG EFFECTS; GASTROINTESTINAL TRACT; IMMUNOLOGY; IMMUNOTHERAPY; NEOPLASMS;

ANTIBODIES, BLOCKING; ANTINEOPLASTIC AGENTS; COLITIS; CTLA-4 ANTIGEN; GASTROINTESTINAL TRACT; HUMANS; IMMUNOTHERAPY; NEOPLASMS; PROGRAMMED CELL DEATH 1 RECEPTOR; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84948171577     PISSN: 1750743X     EISSN: 17507448     Source Type: Journal    
DOI: 10.2217/imt.15.87     Document Type: Review

References (51)

1. Momtaz P, Postow MA. Immunologic checkpoints in cancer therapy: focus on the programmed death-1 (PD-1) receptor pathway. Pharmgenomics Pers. Med. 7, 357 (2014).
2. Abdel-Rahman O. Immune checkpoints aberrations and gastric cancer; assessment of prognostic value and evaluation of therapeutic potentials. Crit. Rev. Oncol. Hematol. doi:10.1016/j.critrevonc.2015.08.015 (2015) (Epub ahead of print).
3. Hodi FS, O'Day SJ, Mcdermott DF et al. Improved survival with ipilimumab in patients with metastatic melanoma. N. Engl. J. Med. 363(8), 711-723 (2010).
4. Robert C, Thomas L, Bondarenko I et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N. Engl. J. Med. 364(26), 2517-2526 (2011).
5. Hamid O, Robert C, Daud A et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N. Engl. J. Med. 369(2), 134-144 (2013).
6. Berger R, Rotem-Yehudar R, Slama G et al. Phase I safety and pharmacokinetic study of CT-011, a humanized antibody interacting with PD-1, in patients with advanced hematologic malignancies. Clin. Cancer Res. 14(10), 3044-3051 (2008).
7. Armand P, Nagler A, Weller EA et al. Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international Phase II trial. J. Clin. Oncol. 31(33), 4199-4206 (2013).
8. 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. 366(26), 2455-2465 (2012).
9. Westin JR, Chu F, Zhang M et al. Safety and activity of pd1 blockade by pidilizumab in combination with rituximab in patients with relapsed follicular lymphoma: a single group, open-label, Phase 2 trial. Lancet Oncol. 15(1), 69-77 (2014).
10. 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. 11(17), 2471-2784 (2015).
11. 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. doi:10.2217/FON.15.222 (2015) (In press).
12. Waterhouse P, Penninger JM, Timms E et al. Lymphoproliferative disorders with early lethality in mice deficient in CTLA-4. Science 270(5238), 985-988 (1995).
13. Tivol EA, Borriello F, Schweitzer AN, Lynch WP, Bluestone JA, Sharpe AH. Loss of CTLA-4 leads to massive lymphoproliferation and fatal multiorgan tissue destruction, revealing a critical negative regulatory role of CTLA-4. Immunity 3(5), 541-547 (1995).
14. Hodi FS, Mihm MC, Soiffer RJ et al. Biologic activity of cytotoxic T lymphocyte-associated antigen 4 antibody blockade in previously vaccinated metastatic melanoma and ovarian carcinoma patients. Proc. Natl Acad. Sci. USA 100(8), 4712-4717 (2003).
15. Johnston R, Lutzky J, Chodhry A, Barkin J. Cytotoxic T-lymphocyte-associated antigen 4 antibody-induced colitis and its management with infliximab. Dig. Dis. Sci. 54(11), 2538-2540 (2009).
16. Lebbe C, O'Day S, Chiarion-Sileni V et al. Analysis of the onset and resolution of immune-related adverse events during treatment with ipilimumab in patients with metastatic melanoma. Presented at: Perspectives in Melanoma XII, Scheveningen, The Hague, The Netherlands, 2-4 October 2008 (Abstract O-015).
17. Cheng R, Cooper A, Kench J et al. Ipilimumabinduced toxicities and the gastroenterologist. J. Gastroenterol. Hepatol. 30(4), 657-666 (2015).
18. Gielisse EA, De Boer NK. Ipilimumab in a patient with known crohn's disease: to give or not to give J. Crohn's Colitis 8(12), 1742-1742 (2014).
19. 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. 11(2), 155-164 (2010).
20. Peggs KS, Quezada SA, Korman AJ, Allison JP. Principles and use of anti-CTLA4 antibody in human cancer immunotherapy. Curr. Opin. Immunol. 18(2), 206-213 (2006).
21. Berman D, Parker S, Chasalow S et al. Potential immune biomarkers of gastrointestinal toxicities and efficacy in patients with advanced melanoma treated with ipilimumab with or without prophylactic budesonide. Presented at: ASCO Annual Meeting Proceedings. IL, USA, 30 May-01 June 2008.
22. Kim KW, Ramaiya NH, Krajewski KM et al. Ipilimumabassociated colitis: CT findings. Am. J. Roentgenol. 200(5), W468-W474 (2013).
23. Lyall A, Vargas HA, Carvajal RD, Ulaner G. Ipilimumabinduced colitis on FDG PET/CT. Clin. Nucl. Med. 37(6), 629-630 (2012).
24. Tarhini A, Laframboise W, Petrosko P, Deamont C, Kirkwood J. Clustered genomic variants specific to patients who develop immune-related colitis after ipilimumab for prediction of toxicity. J. Clin. Oncol. 32, 5s (2014) (suppl; abstr 9024).
25. Merrill SP, Reynolds P, Kalra A, Biehl J, Vandivier RW, Mueller SW. Early administration of infliximab for severe ipilimumab-related diarrhea in a critically ill patient. Ann. Pharmacother. 48(6), 806-810 (2014).
26. Slangen R, Van Den Eertwegh A, Van Bodegraven AA, De Boer NK. Diarrhoea in a patient with metastatic melanoma: Ipilimumab ileocolitis treated with infliximab. World J. Gastrointest. Pharmacol. Ther. 4, 80-82 (2013).
27. Weber JS, Kähler KC, Hauschild A. Management of immune-related adverse events and kinetics of response with ipilimumab. J. Clin. Oncol. 30(21), 2691-2697 (2012).
28. Lin R, Yellin M, Lowy I, Safferman A, Chin K, Ibrahim R. An analysis of the effectiveness of specific guidelines for the management of ipilimumab-mediated diarrhea/colitis: prevention of gastrointestinal perforation and/or colectomy. J. Clin. Oncol. 26(15S), (2008) (suppl; abstr 9063).
29. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the prisma statement. Ann. Intern. Med. 151(4), 264-269 (2009).
30. Dersimonian R, Laird N. Meta-analysis in clinical trials. Control. Clin. Trials 7(3), 177-188 (1986).
31. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 327(7414), 557 (2003).
32. Eggermont AM, Chiarion-Sileni V, Grob J-J et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage iii melanoma (eortc 18071): a randomised, double-blind, Phase 3 trial. Lancet Oncol. 16(5), 522-530 (2015).
33. Lynch TJ, Bondarenko I, Luft A et al. Ipilimumab in combination with paclitaxel and carboplatin as first-line treatment in stage IIIb/IV non-small-cell lung cancer: results from a randomized, double-blind, multicenter Phase II study. J. Clin. Oncol. 30(17), 2046-2054 (2012).
34. Ribas A, Kefford R, Marshall MA et al. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J. Clin. Oncol. 31(5), 616-622 (2013).
35. Robert C, Long GV, Brady B et al. Nivolumab in previously untreated melanoma without BRAF mutation. N. Engl. J. Med. 372(4), 320-330 (2015).
36. Kwon ED, Drake CG, Scher HI et al. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (ca184-043): a multicentre, randomised, double-blind, Phase 3 trial. Lancet Oncol. 15(7), 700-712 (2014).
37. Brahmer J, Reckamp KL, Baas P et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N. Engl. J. Med. 373(2), 123-135 (2015).
38. Weber JS, D'angelo SP, Minor D et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (checkmate 037): a randomised, controlled, open-label, Phase 3 trial. Lancet Oncol. 16(4), 375-384 (2015).
39. Reck M, Bondarenko I, Luft A et al. Ipilimumab in combination with paclitaxel and carboplatin as first-line therapy in extensive-disease-small-cell lung cancer: results from a randomized, double-blind, multicenter Phase 2 trial. Ann. Oncol. 24(1), 75-83 (2013).
40. Intlekofer AM, Thompson CB. At the bench: preclinical rationale for CTLA-4 and PD-1 blockade as cancer immunotherapy. J. Leukoc. Biol. 94(1), 25-39 (2013).
41. Alegre M-L, Noel PJ, Eisfelder BJ et al. Regulation of surface and intracellular expression of CTLA4 on mouse T cells. J. Immunol. 157(11), 4762-4770 (1996).
42. Topalian SL, Hodi FS, Brahmer JR et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N. Engl. J. Med. 366(26), 2443-2454 (2012).
43. Abdel-Rahman O, Fouad M. Risk of selected gastrointestinal toxicities in patients with advanced non-small cell lung cancer receiving erlotinib: a systematic review and metaanalysis. Expert Rev. Anticancer Ther. 15(4), 465-475 (2015).
44. Abdel-Rahman O, Fouad M. Risk of selected gastrointestinal toxicities in breast cancer patients treated with regimens containing lapatinib; a pooled analysis of randomized controlled studies. Expert Rev. Anticancer Ther. 14(10), 1229-1242 (2014).
45. Abdel-Rahman O, Fouad M. Risk of oral and gastrointestinal mucosal injury in patients with solid tumors treated with everolimus, temsirolimus or ridaforolimus: a comparative systematic review and meta-analysis. Expert Rev. Anticancer Ther. 15( 7), 847-858 (2015).
46. Bronstein Y, Ng CS, Hwu P, Hwu W-J. Radiologic manifestations of immune-related adverse events in patients with metastatic melanoma undergoing anti-CTLA-4 antibody therapy. Am. J. Roentgenol. 197(6), W992-W1000 (2011).
47. Yang JC, Hughes M, Kammula U et al. Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis. J. Immunother. (Hagerstown, Md.: 1997) 30(8), 825 (2007).
48. Hendler R, Wu S. Risk of severe diarrhea associated with ipilimumab in cancer patients. J. Clin. Oncol. 32, 5s (2014) (suppl; abstr 9634).
49. Robert C, Schachter J, Long GV et al. Pembrolizumab versus ipilimumab in advanced melanoma. N. Engl. J. Med. 372(26), 2521-2532 (2015).
50. Larkin J, Chiarion-Sileni V, Gonzalez R et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N. Engl. J. Med. 373( 1), 23-34 (2015).
51. Postow MA, Chesney J, Pavlick AC et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N. Engl. J. Med. 372(21), 2006-2017 (2015).