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Annals of Oncology Advance Access published online on November 25, 2005
Annals of Oncology, doi:10.1093/annonc/mdj090
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© 2005 European Society for Medical Oncology
Received September 19, 2005
Revised October 24, 2005
Accepted October 24, 2005

original article

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 1, A. Bhatnagar 2, D. Cunningham 1 *, T. M. Cosgriff 3, P. G. Harper 4, W. Steward 5, J. Bridgewater 6, M. Moore 7, J. Cassidy 8, R. Coleman 9, F. Coxon 10, C. H. Redfern 11, J. J. Jones 12, R. Hawkins 13, D. Northfelt 14, S. Sreedharan 2, F. Valone 2, and J. Carmichael 15

1 Royal Marsden Hospital, Sutton, Surrey, UK
2 Titan Pharmaceuticals, South San Francisco, CA, USA
3 Hematology and Oncology Services, New Orleans, LA, USA
4 Guys Hospital, London, UK
5 Leicester Royal Infirmary, Leicester, UK
6 North Middlesex Hospital, Edmonton, UK
7 Georgia Cancer Research Center, Decatur, GA, USA
8 University of Aberdeen, Aberdeen, UK
9 Weston Park Hospital NHS Trust, Sheffield, UK
10 Newcastle General Hospital, Newcastle-upon-Tyne, UK
11 Sharp Health Care, San Diego, CA, USA
12 Columbus CCOP, Columbus, OH, USA
13 Christie Hospital, Withington, UK
14 University of California, San Diego, CA, USA
15 City Hospital, Nottingham, UK

* To whom correspondence should be addressed.
D. Cunningham, E-mail: david.cunningham{at}icr.ac.uk


  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.

Keywords: anti-idiotype; antibody; carcinoembryonic antigen; response; colorectal.
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