Phase III trial of 5-fluorouracil and leucovorin plus either 3H1 anti-idiotype monoclonal antibody or placebo in patients with advanced colorectal cancer

G Chong, A Bhatnagar, D Cunningham, T M Cosgriff, P G Harper, W Steward, J Bridgewater, M Moore, Jamie Cassidy, R Coleman, F Coxon, C H Redfern, J J Jones, R Hawkins, D Northfelt, S Sreedharan, F Valone, J Carmichael

    Research output: Contribution to journalArticle

    28 Citations (Scopus)


    Background: The monoclonal antibody 3H1 mimics the external structure of the carcinoembryonic antigen (CEA). It therefore has the potential, via the anti-idiotypic network, to stimulate immune responses to CEA that may benefit colorectal cancer patients.

    Patients and methods: A total of 630 patients with previously untreated metastatic colorectal cancer were randomised in a 2:1 fashion to receive bolus 5-fluorouracil (5-FU) and leucovorin (LV) plus either 3H1 (n = 422) or placebo (n = 208).

    Results: The addition of 3H1 to 5-FU and LV did not result in increased toxicity. Survival for the full intent-to-treat population was 14.7 months for the 3H1 arm and 15.2 months for the placebo arm (P = 0.80). Anti-CEA antibody responses were observed in 70% of patients treated with 3H1. Patients with a negative CEA response had a median survival of 8.3 months (95% CI 7.5-11.0) compared with patients with a strong response: median survival not reached (P < 0.001).

    Conclusion: 3H1 is safe and effectively induces immune responses to CEA. Addition of 3H1 to 5-FU and LV was not shown to improve overall patient outcomes. However, improved survival in patients developing anti-CEA responses to 3H1 are provocative and should be studied in further clinical trials.

    Original languageEnglish
    Pages (from-to)437-442
    Number of pages6
    JournalAnnals of Oncology
    Publication statusPublished - 2006


    • anti-idiotype
    • antibody
    • carcinoembryonic antigen
    • response
    • colorectal
    • MIMICS

    Cite this