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Active specific immunotherapy for stage II and stage III human colon cancer : a randomised trial . BACKGROUND Colon cancer is curable by surgery , but cure rate depends on the extent of disease . We investigated whether adjuvant active specific immunotherapy ( ASI ) with an autologous tumour cell-BCG vaccine with surgical resection was more beneficial than resection alone in stage II and III colon cancer . METHODS In a prospective randomised trial , 254 patients with colon cancer were randomly assigned postoperative ASI or no adjuvant treatment . ASI was three weekly vaccinations starting 4 weeks after surgery , with a booster vaccination at 6 months with 10 ( 7 ) irradiated autologous tumour cells . The first vaccinations contained 10 ( 7 ) BCG organisms . We followed up patients for time to recurrence , and recurrence-free and overall survival . Analysis was by intention to treat . FINDINGS The 5.3 year median follow-up ( range 8 months to 8 years 11 months ) showed 44 % ( 95 % CI 7-66 ) risk reduction for recurrence in the recurrence-free period in all patients receiving ASI ( p=0.023 ) . Overall , there were 40 recurrences in the control group and 25 in the ASI group . Analysis by stage showed no significant benefit of ASI in stage III disease . The major impact of ASI was seen in patients with stage II disease , with a significantly longer recurrence-free period ( p=0.011 ) and 61 % ( 18-81 ) risk reduction for recurrences . Recurrence-free survival was significantly longer with ASI ( 42 % risk reduction for recurrence or death [ 0-68 ] , p=0.032 ) and there was a trend towards improved overall survival . INTERPRETATION ASI gave significant clinical benefit in surgically resected patients with stage II colon cancer . ASI has minimal adverse reactions and should be considered in the management of stage II colon cancer .
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Intervention_Pharmacological
Active specific immunotherapy
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Intervention_Pharmacological
active specific immunotherapy
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Intervention_Pharmacological
postoperative ASI
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Intervention_Pharmacological
no adjuvant treatment
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Intervention_Physical
autologous tumour cells
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Intervention_Pharmacological
ASI
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Outcome_Other
ASI
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Outcome_Physical
recurrence-free period
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Outcome_Other
risk reduction for recurrences
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Outcome_Mortality
Recurrence-free survival
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Outcome_Mortality
overall survival
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Participant_Condition
stage II and stage III human colon cancer
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Participant_Sample-size
254