Adjuvant active specific immunotherapy of stage II and stage III colon cancer with an autologous tumor cell vaccine: first randomized phase III trials show promise

We performed three multi-institutional, prospectively randomized, controlle d clinical trials, assessing the therapeutic effect of post-resection adjuv ant active specific immunotherapy in patients with stage II and stage III c olon cancer. In each study four outcomes were considered: time-to-disease r ecurrence, overall survival intervals, disease-free survival intervals. and recurrence-free survival intervals using the Kaplan-Meir method for genera ting curves and the log-rank test used to compare efficacy distributions. I n addition, a meta-analysis of the three phase III trials was performed sin ce the trials had proven homogeneity. Two main analyses were performed: (1) the intent-to-treat colon cancer patients from all three studies, and (2) analyzable colon cancer patients in all three studies. The conclusion of th ese analyses is that adjuvant active specific immunotherapy provided signif icant clinical benefits in patients with stage II colon cancer and appears to be an important new adjuvant treatment for these patients. (C) 2001 Else vier Science Ltd. All rights reserved.