Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Peptide Vaccine for Prevention of Recurrent Colorectal Adenoma.

Clinical cancer research : an official journal of the American Association for Cancer Research 2023 May 01

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To assess whether MUC1 peptide vaccine produces an immune response and prevents subsequent colon adenoma formation. Multicenter, double-blind, placebo-controlled randomized trial in individuals age 40 to 70 with diagnosis of an advanced adenoma ≤1 year from randomization. Vaccine was administered at 0, 2, and 10 weeks with a booster injection at week 53. Adenoma recurrence was assessed ≥1 year from randomization. The primary endpoint was vaccine immunogenicity at 12 weeks defined by anti-MUC1 ratio ≥2.0. Fifty-three participants received the MUC1 vaccine and 50 placebo. Thirteen of 52 (25%) MUC1 vaccine recipients had a ≥2-fold increase in MUC1 IgG (range, 2.9-17.3) at week 12 versus 0/50 placebo recipients (one-sided Fisher exact P < 0.0001). Of 13 responders at week 12, 11 (84.6%) responded to a booster injection at week 52 with a ≥2-fold increase in MUC1 IgG measured at week 55. Recurrent adenoma was observed in 31 of 47 (66.0%) in the placebo group versus 27 of 48 (56.3%) in the MUC1 group [adjusted relative risk (aRR), 0.83; 95% confidence interval (CI), 0.60-1.14; P = 0.25]. Adenoma recurrence occurred in 3/11 (27.3%) immune responders at week 12 and week 55 (aRR, 0.41; 95% CI, 0.15-1.11; P = 0.08 compared with placebo). There was no difference in serious adverse events. An immune response was observed only in vaccine recipients. Adenoma recurrence was not different than placebo, but a 38% absolute reduction in adenoma recurrence compared with placebo was observed in participants who had an immune response at week 12 and with the booster injection. ©2023 American Association for Cancer Research.

Citation

Robert E Schoen, Lisa A Boardman, Marcia Cruz-Correa, Ajay Bansal, David Kastenberg, Chin Hur, Lynda Dzubinski, Sharon F Kaufman, Luz M Rodriguez, Ellen Richmond, Asad Umar, Eva Szabo, Andres Salazar, John McKolanis, Pamela Beatty, Reetesh K Pai, Aatur D Singhi, Camille M Jacqueline, Riyue Bao, Brenda Diergaarde, Ryan P McMurray, Carrie Strand, Nathan R Foster, David M Zahrieh, Paul J Limburg, Olivera J Finn. Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Peptide Vaccine for Prevention of Recurrent Colorectal Adenoma. Clinical cancer research : an official journal of the American Association for Cancer Research. 2023 May 01;29(9):1678-1688