2,548
Views
2
CrossRef citations to date
0
Altmetric
Research Article

An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma

ORCID Icon, , ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, , ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, & ORCID Icon show all
Article: 1984059 | Received 28 Jun 2021, Accepted 20 Sep 2021, Published online: 09 Oct 2021

References

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70(1):7–10. doi:10.3322/caac.21590.
  • Atkins MB, Lotze MT, Dutcher JP. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17:2105–2116. doi:10.1200/JCO.1999.17.7.2105.
  • DeSantis CE, Lin CC, Mariotto AB. Cancer treatment and survivorship statistics, 2014. CA Cancer J Clin. 2014;64:252–271. doi:10.3322/caac.21235.
  • Larkin J, Chiarion-Sileni V, Gonzalez R. Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019;381(16):1535–1546. doi:10.1056/NEJMoa1910836.
  • Mier JW, Gallo RC. Purification and some characteristics of human T-cell growth factor from phytohemagglutinin-stimulated lymphocyte-conditioned media. Proc Natl Acad Sci U S A. 1980;77:6134–6138. doi:10.1073/pnas.77.10.6134.
  • Morgan DA, Ruscetti FW, Gallo R. Selective in vitro growth of T lymphocytes from normal human bone marrows. Science. 1976;193(4257):1007–1008. doi:10.1126/science.181845.
  • Rosenberg SA, Lotze MT, Muul LM. Observations on the systemic administration of autologous lymphokine-activated killer cells and recombinant interleukin-2 to patients with metastatic cancer. N Engl J Med. 1985;313:1485–1492. doi:10.1056/NEJM198512053132327.
  • Herzberg B, Fisher DE. Metastatic melanoma and immunotherapy. Clin Immunol. 2016;172:105–110. doi:10.1016/j.clim.2016.07.006.
  • Atkins MB, Kunkel L, Sznol M. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J Sci Am. 2000;6:S11–4.
  • Eggermont AM, Spatz A, Robert C. Cutaneous melanoma. Lancet. 2014;383(9919):816–827. doi:10.1016/S0140-6736(13)60802-8.
  • Fong L, EJ S. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J Clin Oncol. 2008;26:5275–5283. doi:10.1200/JCO.2008.17.8954.
  • FS H, Sj O, DF M. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–723. doi:10.1056/NEJMoa1003466.
  • Maker AV, Phan GQ, Attia P. Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin 2: a phase I/II study. Ann Surg Oncol. 2005;12:1005–1016. doi:10.1245/ASO.2005.03.536.
  • Prieto PA, Yang JC, Sherry RM. CTLA-4 blockade with ipilimumab: long-term follow-up of 177 patients with metastatic melanoma. Clin Cancer Res. 2012;18:2039–2047. doi:10.1158/1078-0432.CCR-11-1823.
  • Jd W, Hoos A, O’Day S. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009;15:7412–7420. doi:10.1158/1078-0432.CCR-09-1624.
  • U.S. Department of Health and Human Services NIoH, National Cancer Institute: Common terminology criteria for adverse events: (CTCAE) v4.03, CTCAE; 2010.
  • SWOG: SWOG Statistical Center website statistical tools.
  • Seymour L, Bogaerts J, Perrone A. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017;18:e143–e152. doi:10.1016/S1470-2045(17)30074-8.
  • Batus M, Waheed S, Ruby C. Optimal management of metastatic melanoma: current strategies and future directions. Am J Clin Dermatol. 2013;14:179–194. doi:10.1007/s40257-013-0025-9.
  • Silk AW, Kaufman HL, Curti B. High-dose ipilimumab and high-dose interleukin-2 for patients with advanced melanoma. Front Oncol. 2019;9:1483. doi:10.3389/fonc.2019.01483.
  • Buchbinder EI, Gunturi A, Perritt J. A retrospective analysis of high-dose interleukin-2 (HD IL-2) following Ipilimumab in metastatic melanoma. J Immunother Cancer. 2016;4:52. doi:10.1186/s40425-016-0155-8.
  • Robert C, Karaszewska B, Schachter J. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015;372:30–39. doi:10.1056/NEJMoa1412690.
  • Sj O, Maio M, Chiarion-Sileni V. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol. 2010;21:1712–1717. doi:10.1093/annonc/mdq013.
  • Weber J, Thompson JA, Hamid O. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res. 2009;15:5591–5598. doi:10.1158/1078-0432.CCR-09-1024.
  • Wolchok JD, Neyns B, Linette G. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010;11:155–164. doi:10.1016/S1470-2045(09)70334-1.
  • ClinicalTrials.gov. Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma. 2020. ls.gov/ct2/show/NCT03033576?term=NCT03033576&draw=2&rank=1