BACKGROUND: The monoclonal antibody 3H1 mimics the external structure of the @entity10580 ( @entity10580 ). It therefore has the potential, via the anti-idiotypic network, to stimulate immune responses to @entity10580 that may benefit @entity14 @entity1 . @entity1 AND METHODS: A total of 630 @entity1 with previously untreated metastatic @entity14 were randomised in a 2:1 fashion to receive bolus @entity1487 ( @entity1487 ) and @entity4181 (LV) plus either 3H1 (n = 422) or placebo (n = 208). RESULTS: The addition of 3H1 to @entity1487 and LV did not result in increased @entity137 . 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- @entity10580 antibody responses were observed in 70% of @entity1 treated with 3H1. @entity1 with a negative @entity10580 response had a median survival of 8.3 months (95% CI 7.5-11.0) compared with @entity1 with a strong response: median survival not reached (P <0.001). CONCLUSION: 3H1 is safe and effectively induces immune responses to @entity10580 . Addition of 3H1 to @entity1487 and LV was not shown to improve overall @entity1 outcomes. However, improved survival in patients developing anti- @entity10580 responses to 3H1 are provocative and should be studied in further clinical trials.

Phase III trial of @entity1487 and XXXX plus either 3H1 anti-idiotype monoclonal antibody or placebo in @entity1 with advanced @entity14 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PATIENTS'] @entity4181 :: ('MESH:D002955', 'Chemical') :: ['leucovorin'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity10580 :: ('1048', 'Gene') :: ['CEA', 'carcinoembryonic antigen'] @entity14 :: ('MESH:D015179', 'Disease') :: ['colorectal cancer'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5-FU', '5-fluorouracil']
@entity4181 :: (MESH:D002955,Chemical) :: ['leucovorin']
