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document
Treatment of multiple myeloma according to the extension of the disease : a prospective , randomised study comparing a less with a more aggressive cystostatic policy . Cooperative Group of Study and Treatment of Multiple Myeloma . The purpose of the study was to ascertain whether the prognostic significance of staging in multiple myeloma ( MM ) is influenced by the aggressiveness of effective induction treatment and/or by continuing or discontinuing maintenance chemotherapy . Patients with untreated stage I MM ( defined according to Durie and Salmon ) were randomised between being followed without cytostatics until the disease progressed and receiving six courses of melphalan and prednisone ( MP-P ) just after diagnosis ; stage II patients were uniformly treated with MPH-P and stage III patients were randomised between MPH-P and four courses of combination chemotherapy with Peptichemio , vincristine and prednisone ( PTC-VCR-P ) . Within each stage , responsive patients were randomised between receiving additional therapy only until maximal tumour reduction was reached ( plateau phase ) and continuing induction therapy indefinitely until relapse . With resistant , progressive or relapsing disease , patients originally treated with MPH-P for induction received combination chemotherapy and vice versa . The overall first response rate was 43.8 % ( 42.2 % in 206 stage I , II and III patients treated with MPH-P and 48.0 % in 75 stage III patients treated with combination chemotherapy , P = NS ) . Combination chemotherapy was more myelotoxic than MPH-P and , in particular , caused more non-haematological side-effects . Both the less and the more aggressive induction policies gave the same disease control . Progression of disease was statistically similar in stage I patients who were initially left untreated and in t hose who received MPH-P just after diagnosis ; median duration of first response was similar in stage III patients receiving MPH-P and in those on combination chemotherapy . In all stages , discontinuing or continuing maintenance did not alter the median duration of first response . The overall second response rate was 28.5 % ( 34.0 % to MPH-P and 25.3 % to combination chemotherapy , P = NS ) . Median survival was greater than 78 months in stage I , was 46.3 months in stage II and was 24.3 months in stage III patients , still independent of both induction and post-induction policies . In MM , the significance of staging for survival is independent of both the aggressiveness of induction and of continuing or discontinuing maintenance chemotherapy after the maximal tumor reduction has been achieved . Both MPH-P and and the association of PTC , VCR and P are effective in inducing first response and also second response in patients failing on the alternative regimen , but PTC-VCR-P causes more side effects . Thus , the overwhelming majority of patients with MM can safely be given MPH-P as first therapy , and this treatment may be delayed in early diseases .
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Intervention_Pharmacological
aggressive cystostatic
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Intervention_Pharmacological
aggressiveness of effective induction treatment
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Intervention_Physical
followed without cytostatics
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Intervention_Pharmacological
melphalan and prednisone ( MP-P )
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Intervention_Pharmacological
MPH-P
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Intervention_Pharmacological
MPH-P
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Intervention_Pharmacological
combination chemotherapy with Peptichemio , vincristine and prednisone ( PTC-VCR-P )
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Outcome_Mental
overall first response rate
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Outcome_Physical
myelotoxic
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Outcome_Adverse-effects
non-haematological side-effects
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Outcome_Other
disease control
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Outcome_Physical
Progression of disease
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Outcome_Other
duration of first response
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Outcome_Other
median duration of first
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Outcome_Physical
response
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Outcome_Other
overall second response rate
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Outcome_Other
Median
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Outcome_Mortality
survival
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Outcome_Mortality
survival
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Outcome_Other
first response
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Outcome_Other
second response
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Outcome_Adverse-effects
side effects .
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Participant_Condition
Multiple Myeloma
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Participant_Condition
untreated stage I MM