Intracutaneous and intravesical immunotherapy with keyhole limpet hemocyanin compared with intravesical mitomycin in patients with non-muscle-invasive bladder cancer: results from a prospective randomized phase III trial

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Rianne J M LammersJ Alfred Witjes

Abstract

Despite current treatment after transurethral resection of a bladder tumor, recurrences and progression remain a problem. Keyhole limpet hemocyanin (KLH) was beneficial in earlier studies. In this study, safety and efficacy of KLH were compared with that of mitomycin (MM). Patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) without carcinoma in situ were enrolled in a randomized phase III trial. In all, 283 patients were randomly assigned for 16 adjuvant intravesical instillations with KLH after preimmunization, and 270 patients were randomly assigned for 11 adjuvant intravesical instillations with MM. Primary outcome measurement was recurrence-free survival (RFS). Secondary outcome measurements were progression-free survival, adverse events (AEs), and the effect of delayed-type hypersensitivity (DTH) response on clinical outcome. There were significantly more pT1 tumors in the MM group (P = .01). In a log-rank test, univariate and multivariate Cox regression analysis, KLH was less effective than MM regarding RFS (all P < .001). Progression was uncommon (n = 20). In univariate Cox regression analyses, KLH tended to prevent progression more effectively than MM, but in multivariate Cox regression ...Continue Reading

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Citations

Feb 4, 2014·Developmental and Comparative Immunology·Christopher J Coates, Jacqueline Nairn
Oct 31, 2013·Expert Review of Anticancer Therapy·Anna V van LingenJ Alfred Witjes
Aug 21, 2013·Expert Opinion on Biological Therapy·Anna V van Lingen, J Alfred Witjes
May 17, 2014·British Journal of Clinical Pharmacology·Ashwin SwaminathanAnthony J McMichael
Mar 12, 2015·Current Treatment Options in Oncology·Philip L HoAshish M Kamat
Mar 2, 2017·Nature Reviews. Urology·Ashish M KamatJ Alfred Witjes
Oct 17, 2017·Expert Opinion on Pharmacotherapy·Francisco Caramés Masana, Theo M de Reijke
Jan 9, 2013·Nature Reviews. Urology·Aidan P Noon, James W F Catto
May 18, 2020·International Immunopharmacology·Emiliya StoyanovaAndrey Tchorbanov
Apr 23, 2021·Expert Review of Anticancer Therapy·Eddy Lilly, Khalil El Gharib

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