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Final report of a randomized controlled study with streptococcal preparation OK-432 as a supplementary immunopotentiator for laryngeal cancer . We conducted a randomized controlled study of streptococcal preparation OK-432 on 120 newly identified cases of laryngeal squamous cell carcinoma who were registered at 10 participating institutions between November 1984 and October 1989 . The patients were divided into two groups : those in early stages ( stage I or II ) and those in advanced stages ( stage III or IV ) ; these groups were further subdivided into an immunotherapy group ( receiving OK-432 ) and a control group ( who did not receive OK-432 ) . The usefulness of OK-432 was studied using the sealed envelope method . The basic therapy for all cases was radiotherapy and , when required , surgery . As adjuvant therapy , 5Fu or derivatives were administered to all cases from the beginning of the treatment period to one year after the basic therapy , with the exception of cases in whom side effects were serious enough to contraindicate use of the drug . The target administration period was 5 years . Of the initial 120 cases , 11 cases were disqualified ( 3 cases of double cancer and 8 of incomplete primary therapy ) and the remaining 109 were used for evaluation . The 5-year survival rate and the 5-year recurrence-free rate were 76 % and 84 % , respectively , in the immunized groups ( both the early and advanced groups ) , whereas the same rates for the control groups were 78 % and 75 % . There was a tendency for the immunized groups to enjoy a slightly longer recurrence-free period . Over a 24-month observation period the immunized group always had higher levels of peripheral leukocytes and peripheral lymphocytes ; this difference was significant for the first 21 months . Inhibition of bone marrow function is sometimes observed with radiotherapy . It is hoped that , if this inhibition can be mitigated , it will be possible to assist the compromised immune system and maintain a certain level of immune performance which will prevent recurrence and improve survival rate . In the present study we observed a tendency of the lower recurrence rate in the immunized group , and we hypothesize that OK-432 is effective in extending the recurrence-free period .
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Intervention_Pharmacological
OK-432
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Intervention_Pharmacological
OK-432
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Intervention_Pharmacological
OK-432
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Intervention_Control
control
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Intervention_Pharmacological
OK-432
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Intervention_Pharmacological
OK-432
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Outcome_Mental
5-year survival rate and the 5-year recurrence-free rate
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Outcome_Mental
slightly longer recurrence-free period
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Outcome_Physical
levels of peripheral leukocytes and peripheral lymphocytes
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Outcome_Physical
Inhibition of bone marrow function
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Outcome_Physical
certain level of immune performance
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Outcome_Mortality
improve survival rate