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document
Long-term follow-up of a randomized trial of fludarabine-mitoxantrone , compared with cyclophosphamide , doxorubicin , vindesine , prednisone ( CHVP ) , as first-line treatment of elderly patients with advanced , low-grade non-Hodgkin 's lymphoma before the era of monoclonal antibodies . BACKGROUND This randomized study compared the efficacy and safety of fludarabine-mitoxantrone ( FM ) with mini-CHVP ( cyclophosphamide , doxorubicin , vindesine , prednisone ) in elderly patients with advanced , low-grade non-Hodgkin 's lymphoma . PATIENTS AND METHODS End points were remission rates [ overall response ( OR ) and complete response ( CR ) ] , failure-free survival ( FFS ) , survival and toxicity . One hundred and fifty-five patients were randomized , 144 were evaluable for safety and 142 for response . Each treatment arm was given as six monthly cycles , followed by three bimonthly cycles . FM comprised fludarabine ( 20 mg/m ( 2 ) i.v . ) , days 1-5 , plus mitoxantrone ( 10 mg/m ( 2 ) i.v . ) , day 1 . CHVP cycles comprised cyclophosphamide ( 750 mg/m ( 2 ) i.v . infusion ) , doxorubicin ( 25 mg/m ( 2 ) i.v . ) and vindesine ( 3 mg/m ( 2 ) i.v . ) on day 1 , and prednisone ( 50 mg/m ( 2 ) ) on days 1-5 . RESULTS FM therapy resulted in superior remission rates ( OR 81 % versus 64 % , CR 49 % versus 17 % ; P = 0.0004 ) . Median FFS for FM patients was 36 months , compared with 19 months for CHVP patients , and has not yet been reached for early CR patients at 53 months . Treatment arm was the major risk factor influencing survival . Both treatments were well tolerated , with only few infectious complications . CONCLUSION FM was more effective than CHVP in achieving OR and CR , and favorably affected the outcome .
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Intervention_Pharmacological
fludarabine-mitoxantrone
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Intervention_Pharmacological
cyclophosphamide , doxorubicin , vindesine , prednisone ( CHVP )
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Intervention_Pharmacological
fludarabine-mitoxantrone ( FM )
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Intervention_Pharmacological
mini-CHVP
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Intervention_Pharmacological
cyclophosphamide
20462
Intervention_Pharmacological
doxorubicin
20463
Intervention_Pharmacological
vindesine
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Intervention_Pharmacological
prednisone
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Intervention_Pharmacological
fludarabine
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Intervention_Pharmacological
mitoxantrone
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
doxorubicin
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Intervention_Pharmacological
vindesine
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Intervention_Pharmacological
prednisone
20471
Intervention_Pharmacological
FM
20472
Intervention_Pharmacological
FM
20473
Intervention_Pharmacological
FM
20474
Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Physical
remission rates [
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Outcome_Other
overall response ( OR )
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Outcome_Physical
and
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Outcome_Other
complete response ( CR )
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Outcome_Mortality
failure-free survival ( FFS )
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Outcome_Mortality
survival
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Outcome_Adverse-effects
toxicity
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Outcome_Other
remission rates
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Outcome_Mortality
Median FFS
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Outcome_Mortality
survival
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Outcome_Mental
tolerated
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Outcome_Adverse-effects
infectious complications
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Outcome_Other
effective
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Outcome_Other
OR
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Outcome_Other
CR
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Participant_Condition
elderly patients with advanced , low-grade non-Hodgkin 's lymphoma before the era of monoclonal antibodies .
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Participant_Condition
elderly patients with advanced , low-grade non-Hodgkin 's lymphoma .