Tolerability, response and outcome of high-risk neuroblastoma patients treated with long-term infusion of anti-GD₂ antibody ch14.18/CHO

References

• Cheung NK, Dyer MA. Neuroblastoma: developmental biology, cancer genomics and immunotherapy. Nat Rev Cancer. 2013;13(6):397–411. PMID:23702928
   PubMed Web of Science ®Google Scholar
• Simon T, Hero B, Faldum A, Handgretinger R, Schrappe M, Klingebiel T, Berthold F. Long term outcome of high-risk neuroblastoma patients after immunotherapy with antibody ch14.18 or oral metronomic chemotherapy. BMC Cancer. 2011;11:21. PMID:21244693
   PubMed Web of Science ®Google Scholar
• Yu AL, Gilman AL, Ozkaynak MF, London WB, Kreissman SG, Chen HX, Smith M, Anderson B, Villablanca JG, Matthay KK, et al. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010;363(14):1324–1334.
   PubMed Web of Science ®Google Scholar
• Zeng Y, Fest S, Kunert R, Katinger H, Pistoia V, Michon J, Lewis G, Ladenstein R, Lode HN. Anti-neuroblastoma effect of ch14.18 antibody produced in CHO cells is mediated by NK-cells in mice. Mol Immunol. 2005;42(11):1311–1319.
   PubMed Web of Science ®Google Scholar
• Ladenstein R, Weixler S, Baykan B, Bleeke M, Kunert R, Katinger D, Pribill I, Glander P, Bauer S, Pistoia V, et al. Ch14.18 antibody produced in CHO cells in relapsed or refractory Stage 4 neuroblastoma patients: a SIOPEN Phase 1 study. MAbs. 2013;5(5):801–809.
   PubMed Web of Science ®Google Scholar
• Cheung NK, Lazarus H, Miraldi FD, Abramowsky CR, Kallick S, Saarinen UM, Spitzer T, Strandjord SE, Coccia PF, Berger NA. Ganglioside GD2 specific monoclonal antibody 3F8: a phase I study in patients with neuroblastoma and malignant melanoma. J Clin Oncol. 1987;5(9):1430–1440. PMID:3625258
   PubMed Web of Science ®Google Scholar
• Yu AL, Uttenreuther-Fischer MM, Huang CS, Tsui CC, Gillies SD, Reisfeld RA, Kung FH. Phase I trial of a human-mouse chimeric anti-disialoganglioside monoclonal antibody ch14.18 in patients with refractory neuroblastoma and osteosarcoma. J Clin Oncol. 1998;16(6):2169–2180. PMID:9626218
   PubMed Web of Science ®Google Scholar
• Handgretinger R, Anderson K, Lang P, Dopfer R, Klingebiel T, Schrappe M, Reuland P, Gillies SD, Reisfeld RA, Neithammer D. A phase I study of human/mouse chimeric antiganglioside GD2 antibody ch14.18 in patients with neuroblastoma. Eur J Cancer. 1995;31A(2):261–267. PMID:7718335
   PubMed Web of Science ®Google Scholar
• Xiao WH, Yu AL, Sorkin LS. Electrophysiological characteristics of primary afferent fibers after systemic administration of anti-GD2 ganglioside antibody. Pain. 1997;69(1–2):145–151. PMID:9060025
   PubMed Web of Science ®Google Scholar
• Navid F, Sondel PM, Barfield R, Shulkin BL, Kaufman RA, Allay JA, Gan J, Hutson P, Seo S, Kim K, et al. Phase I trial of a novel anti-GD2 monoclonal antibody, Hu14.18K322A, designed to decrease toxicity in children with refractory or recurrent neuroblastoma. J Clin Oncol. 2014;32(14):1445–1452. doi:10.1200/JCO.2013.50.4423. PMID:24711551
   PubMed Web of Science ®Google Scholar
• Moreno L, Rubie H, Varo A, Le Deley MC, Amoroso L, Chevance A, Garaventa A, Gambart M, Bautista F, Valteau-Couanet D, et al. Outcome of children with relapsed or refractory neuroblastoma: A meta-analysis of ITCC/SIOPEN European phase II clinical trials. Pediatr Blood Cancer. 2017;64(1):25–31. doi:10.1002/pbc.26192. PMID:27555472
   PubMed Web of Science ®Google Scholar
• Sorkin LS, Otto M, Baldwin WM, III, Vail E, Gillies SD, Handgretinger R, Barfield RC, Ming Yu H, Yu AL. Anti-GD(2) with an FC point mutation reduces complement fixation and decreases antibody-induced allodynia. Pain. 2010;149(1):135–142. doi:10.1016/j.pain.2010.01.024. PMID:20171010
   PubMed Web of Science ®Google Scholar
• Siebert N, Eger C, Seidel D, Juttner M, Zumpe M, Wegner D, Kietz S, Ehlert K, Veal GJ, Siegmund W, et al. Pharmacokinetics and pharmacodynamics of ch14.18/CHO in relapsed/refractory high-risk neuroblastoma patients treated by long-term infusion in combination with IL-2. MAbs. 2016;8(3):604–616. doi:10.1080/19420862.2015.1130196. PMID:26785755
   PubMed Web of Science ®Google Scholar
• London WB, Bagatell R, Weigel B, Fox E, van Ryn C, Naranjo A, et al. Historical gold standard for time-to-progression (TTP) and progression-free survival (PFS) from relapsed/refractory neuroblastoma modern era (2002–2014) patients. J Clin Oncol. 2014;32(5s):5–6. PMID:24190110
   PubMedGoogle Scholar
• Cohn SL, Pearson AD, London WB, Monclair T, Ambros PF, Brodeur GM, Faldum A, Hero B, Iehara T, Machin D, et al. The International Neuroblastoma Risk Group (INRG) classification system: an INRG task force report. J Clin Oncol. 2009;27(2):289–297. doi:10.1200/JCO.2008.16.6785. PMID:19047291
   PubMed Web of Science ®Google Scholar
• Buttner W, Breitkopf L, Miele B, Finke W. [Initial results of the reliability and validity of a German-language scale for the quantitative measurement of postoperative pain in young children]. Anaesthesist. 1990;39(11):593–602. PMID:2288408
   PubMed Web of Science ®Google Scholar
• Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974;2(5920):656–659. doi:10.1136/bmj.2.5920.656. PMID:4835444
   PubMed Web of Science ®Google Scholar
• Zernikow B, Hechler T. Pain therapy in children and adolescents. Dtsch Arztebl Int. 2008;105(28–29):511–521. PMID:19626208
   PubMed Web of Science ®Google Scholar
• Wilson GA, Doyle E. Validation of three paediatric pain scores for use by parents. Anaesthesia. 1996;51(11):1005–1007. doi:10.1111/j.1365-2044.1996.tb14991.x. PMID:8943588
   PubMed Web of Science ®Google Scholar
• Mehes G, Luegmayr A, Hattinger CM, Lorch T, Ambros IM, Gadner H, Ambros PF. Automatic detection and genetic profiling of disseminated neuroblastoma cells. Med Pediatr Oncol. 2001;36(1):205–209. doi:10.1002/1096-911X(20010101)36:1%3c205::AID-MPO1050%3e3.0.CO;2-G. PMID:11464886
   PubMedGoogle Scholar
• Garaventa A, Parodi S, De BB, Dau D, Manzitti C, Conte M, Casale F, Viscardi E, Bianchi M, D'Angelo P, et al. Outcome of children with neuroblastoma after progression or relapse. A retrospective study of the Italian neuroblastoma registry. Eur J Cancer. 2009;45(16):2835–2842. doi:10.1016/j.ejca.2009.06.010. PMID:19616426
   PubMed Web of Science ®Google Scholar