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Articles

Adverse Events Induced by Nivolumab Plus Ipilimumab vs. Nivolumab Monotherapy among Cancer Patients: A Systematic Review and Meta-Analysis

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Pages 777-788 | Received 01 May 2022, Accepted 29 Jul 2022, Published online: 14 Aug 2022

References

  • Zhang Y, Zhang Z. The history and advances in cancer immunotherapy: understanding the characteristics of tumor-infiltrating immune cells and their therapeutic implications. Cell Mol Immunol. 2020;17(8):807–821. doi:10.1038/s41423-020-0488-6.
  • Cramer P, Bresalier RS. Gastrointestinal and hepatic complications of immune checkpoint inhibitors. Curr Gastroenterol Rep. 2017;19(1):3. doi:10.1007/s11894-017-0540-6.
  • Teng F, Meng X, Kong L, Yu J. Progress and challenges of predictive biomarkers of anti PD-1/PD-L1 immunotherapy: A systematic review. Cancer Lett. 2018;414:166–73. doi:10.1016/j.canlet.2017.11.014.
  • Gibney GT, Weiner LM, Atkins MB. Predictive biomarkers for checkpoint inhibitor-based immunotherapy. Lancet Oncol. 2016;17(12):e542–e551. doi:10.1016/S1470-2045(16)30406-5.
  • Long GV, Atkinson V, Lo S, Sandhu S, Guminski AD, Brown MP, et al. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol. 2018;19(5):672–81. doi:10.1016/S1470-2045(18)30139-6.
  • Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, et al. Five-year sSurvival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019;381(16):1535–46. doi:10.1056/NEJMoa1910836.
  • Zamarin D, Burger RA, Sill MW, Powell DJ, Lankes HA, Feldman MD, et al. Randomized phase II trial of nivolumab versus nivolumab and ipilimumab for recurrent or persistent ovarian cancer: an NRG oncology study. J Clin Oncol . 2020;38(16):1814–23. doi:10.1200/JCO.19.02059.
  • Sharma P, Siefker-Radtke A, de Braud F, Basso U, Calvo E, Bono P, et al. Nivolumab alone and with ipilimumab in previously treated metastatic urothelial carcinoma: checkMate 032 nivolumab 1 mg/kg plus ipilimumab 3 mg/kg expansion cohort results. J Clin Oncol. 2019;37(19):1608–16. doi:10.1200/JCO.19.00538.
  • Ready NE, Ott PA, Hellmann MD, Zugazagoitia J, Hann CL, de Braud F, et al. Nivolumab monotherapy and nivolumab plus ipilimumab in recurrent small cell lung cancer: results from the checkmate 032 randomized cohort. J Thorac Oncol. 2020;15(3):426–35. doi:10.1016/j.jtho.2019.10.004.
  • Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim S-W, Carcereny Costa E, et al. Nivolumab plus ipilimumab in advanced non–small-cell lung cancer. N Engl J Med. 2019;381(21):2020–31. doi:10.1056/NEJMoa1910231.
  • Choi J, Lee SY. Clinical characteristics and treatment of immune-related adverse events of immune checkpoint inhibitors. Immune Netw. 2020;20(1):e9. doi:10.4110/in.2020.20.e9.
  • Ascierto PA, Del Vecchio M, Mandalá M, Gogas H, Arance AM, Dalle S, et al. Adjuvant nivolumab versus ipilimumab in resected stage IIIB–C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020;21(11):1465–77. doi:10.1016/S1470-2045(20)30494-0.
  • Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535. doi:10.1136/bmj.b2535.
  • Babineau J. Product review: covidence (systematic review software). J Can Health Libr Assoc. 2014;35(2):68–71. doi:10.5596/c14-016.
  • National Cancer Institute [webpage on the Internet]. Common terminology criteria for adverse events (CTCAE) version 5.0. 2018. 2017:155. [accessed January 10, 2022]. Available from: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.
  • The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials | The BMJ. 2011;343:d5928. [accessed 2022 Jan 10]. Available from:https://www.bmj.com/content/343/bmj.d5928.
  • Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22:719–48. [accessed 2022 Jan 10]. Available from:https://www.scirp.org/(S(lz5mqp453edsnp55rrgjct55))/reference/ReferencesPapers.aspx?ReferenceID=1976498.
  • Deeks JJ, Higgins JPT, Altman DG (editors). Chapter 10: Analysing data and undertaking meta-analyses. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editors. Cochrane handbook for systematic reviews of interventions version 6.3. (updated February 2022). Copenhagen, Denmark: Cochrane Collaboration; 2022. [accessed 2022 Mar 10]. Available from: https://training.cochrane.org/handbook/current/chapter-10.
  • Cochrane-Collaboration. Review manager (version 5.3) [computer software]. Copenhagen, Denmark: The Nordic Cochrane Centre, Cochrane Collaboration; 2014. [accessed 2022 Jan 10]. Available from: https://training.cochrane.org/online-learning/core-software-cochrane-reviews/revman.
  • Gettinger SN, Redman MW, Bazhenova L, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, et al. Nivolumab plus ipilimumab vs. nivolumab for previously treated patients with stage IV squamous cell lung cancer: the lung-MAP S1400I phase 3 randomized clinical trial. JAMA Oncol. 2021;7(9):1368–77. doi:10.1001/jamaoncol.2021.2209.
  • Amaria RN, Reddy SM, Tawbi HA, Davies MA, Ross MI, Glitza IC, et al. Neoadjuvant immune checkpoint blockade in high-risk resectable melanoma. Nat Med. 2018;24(11):1649–54. doi:10.1038/s41591-018-0197-1.
  • Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, et al. CheckMate-032 study: efficacy and safety of nivolumab and nivolumab plus ipilimumab in patients with metastatic esophagogastric cancer. J Clin Oncol. 2018;36(28):2836–44. doi:10.1200/JCO.2017.76.6212.
  • Omuro A, Vlahovic G, Lim M, Sahebjam S, Baehring J, Cloughesy T, et al. Nivolumab with or without ipilimumab in patients with recurrent glioblastoma: results from exploratory phase I cohorts of CheckMate 143. Neuro Oncol. 2018;20(5):674–86. doi:10.1093/neuonc/nox208.
  • Scherpereel A, Mazieres J, Greillier L, Lantuejoul S, Dô P, Bylicki O, et al. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019;20(2):239–53. doi:10.1016/S1470-2045(18)30765-4.
  • Zimmer L, Livingstone E, Hassel JC, Fluck M, Eigentler T, Loquai C, et al. Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020;395(10236):1558–68. doi:10.1016/S0140-6736(20)30417-7.
  • D’Angelo SP, Mahoney MR, Van Tine BA, Atkins J, Milhem MM, Jahagirdar BN, et al. Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials. Lancet Oncol. 2018;19(3):416–26. doi:10.1016/S1470-2045(18)30006-8.
  • Schoenfeld JD, Hanna GJ, Jo VY, Rawal B, Chen YH, Catalano PS, et al. Neoadjuvant nivolumab or nivolumab plus ipilimumab in untreated oral cavity squamous cell carcinoma: a phase 2 open-label randomized clinical trial. JAMA Oncol. 2020;6(10):1563–70. doi:10.1001/jamaoncol.2020.2955.
  • Vanneman M, Dranoff G. Combining immunotherapy and targeted therapies in cancer treatment. Nat Rev Cancer. 2012;12(4):237–51. doi:10.1038/nrc3237.
  • Chen J, Li S, Yao Q, Du N, Fu X, Lou Y, et al. The efficacy and safety of combined immune checkpoint inhibitors (nivolumab plus ipilimumab): a systematic review and meta-analysis. World J Surg Onc. 2020;18(1):150. doi:10.1186/s12957-020-01933-5.
  • Zhou S, Khanal S, Zhang H. Risk of immune-related adverse events associated with ipilimumab-plus-nivolumab and nivolumab therapy in cancer patients. Ther Clin Risk Manag. 2019;15:211–21. doi:10.2147/TCRM.S193338.
  • Abdelhafeez AAM, Shohdy KS, Ibrahim W. Safety of combination immune checkpoint inhibitors compared to monotherapy; a systematic review and meta-analysis. Cancer Invest. 2020;38(3):150–7. doi:10.1080/07357907.2020.1714053.
  • Naidoo J, Wang X, Woo KM, Iyriboz T, Halpenny D, Cunningham J, et al. Pneumonitis in patients treated with anti–programmed death-1/programmed death ligand 1 therapy. J Clin Oncol . 2017;35(7):709–17. doi:10.1200/JCO.2016.68.2005.
  • Rodriguez JL, Hawkins NA, Berkowitz Z, Li C. Factors associated with health-related quality of life among colorectal cancer survivors. Am J Prev Med. 2015;49(5):S518–S527. doi:10.1016/j.amepre.2015.08.007.
  • Marin-Acevedo JA, Kimbrough EO, Lou Y. Next generation of immune checkpoint inhibitors and beyond. J Hematol Oncol. 2021;14(1):45. doi:10.1186/s13045-021-01056-8.

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