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Title: Phase III trial of 5-fluorouracil and leucovorin plus either 3H1 anti-idiotype monoclonal antibody or placebo in patients with advanced colorectal cancer
Authors: Chong, G.
Cunningham, D.
Bhatnagar, A.
Sreedharan, S.
Valone, F.
Cosgriff, T. M.
Harper, P. G.
Steward, W.
Bridgewater, J.
Moore, M.
Cassidy, J.
Coleman, R.
Coxon, F.
Redfern, C. H.
Jones, J. J.
Hawkins, R.
Northfelt, D.
Carmichael, J.
First Published: Mar-2006
Citation: Annals of Oncology, 2006, 17 (3), pp. 437-442
Abstract: 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.
DOI Link: 10.1093/annonc/mdj090
ISSN: 0923-7534
eISSN: 1569-8041
Type: Journal Article
Appears in Collections:Published Articles, Dept. of Cancer Studies and Molecular Medicine

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