10238
document
Combined therapy in the treatment of primary mediastinal B-cell lymphoma : conventional versus escalated chemotherapy . Treatment of patients with primary mediastinal B-cell lymphoma ( PMBCL ) remains controversial . We started a controlled clinical trial to evaluate the efficacy and toxicity of a conventional versus more intensive regimen of combined chemotherapy followed by radiotherapy to the mediastinum with the mantle technique . From 1989 to 1997 , 68 patients diagnosed with previously untreated PMBCL , aged 18-65 years and negative for immunodeficiency virus test , were considered candidates to receive either conventional chemotherapy with CEOP-Bleo ( cyclophosphamide 750 mg/m ( 2 ) , vincristine 1.4 mg/m ( 2 ) , prednisone 40 mg/m ( 2 ) , epirubicin 70 mg/m ( 2 ) , and bleomycin 10 mg/m ( 2 ) ) or mega CEOP-Bleo ( cyclophosphamide 1000 mg/m ( 2 ) , epirubicin 120 mg/m ( 2 ) , vincristine , prednisone , and bleomycin at the same doses ) every 21 days for six cycles , followed by radiotherapy to the mediastinum with the mantle technique ( 35-45 Gy , mean 38 Gy ) . Complete response ( CR ) rates were not statistically different : 64 % [ 95 percent confidence interval ( CI ) : 58 percent to 70 percent ] for conventional arm vs 81 percent ( 95 CI : 77-86 percent ) in the intensive group ( p=0.2 ) . However , failure-free survival ( FFS ) and overall survival ( OS ) had statistical differences . At 5 years , actuarial FFS for patients treated with conventional chemotherapy was 51 percent ( 95 percent CI : 44-59 percent ) compared to 70 percent ( 95 percent CI : 65-76 percent ) in the intensive arm ( p > 0.01 ) . OS rates were also different : 54 percent ( 95 percent CI : 48-57 percent ) vs 70 percent ( 95 percent CI : 65-76 percent ) , respectively ( p < 0.01 ) . Toxicity was mild and no therapy-related deaths were observed . At a median follow-up of 7.3 years , no second neoplasia or acute leukemia has been observed . The international prognostic index was not useful to define clinical risk in this selected group of patients . Multivariate analysis identified pleural and pericardial effusion and chemotherapy regimen as prognostic factors influencing FFS and OS . We feel that patients with PMBCL should be treated with more intensive , but not myeloablative chemotherapy , followed by adjuvant radiotherapy to achieve an improvement in outcome in this setting of patients . Patients with pleural or pericardial effusion are considered at high risk for failure with the actual programs of treatment and probably will be considered for experimental therapeutic approaches .
10239
Intervention_Control
conventional chemotherapy with CEOP-Bleo ( cyclophosphamide 750 mg/m ( 2 ) , vincristine 1.4 mg/m ( 2 ) , prednisone 40 mg/m ( 2 ) , epirubicin 70 mg/m ( 2 ) , and bleomycin 10 mg/m ( 2 ) )
10240
Intervention_Pharmacological
mega CEOP-Bleo ( cyclophosphamide 1000 mg/m ( 2 ) , epirubicin 120 mg/m ( 2 ) , vincristine , prednisone , and bleomycin at the same doses )
10241
Intervention_Physical
radiotherapy to the mediastinum with the mantle technique ( 35-45 Gy , mean 38 Gy ) .
10242
Outcome_Other
efficacy and toxicity
10243
Outcome_Other
Complete response ( CR ) rates
10244
Outcome_Other
confidence interval ( CI ) :
10245
Outcome_Mortality
failure-free survival ( FFS ) and overall survival ( OS ) had statistical differences .
10246
Outcome_Mortality
actuarial FFS
10247
Outcome_Mortality
OS rates
10248
Outcome_Adverse-effects
Toxicity
10249
Outcome_Mortality
therapy-related deaths
10250
Outcome_Physical
neoplasia or acute leukemia
10251
Outcome_Physical
The international prognostic index
10252
Outcome_Mortality
FFS and OS .
10253
Participant_Condition
primary mediastinal B-cell lymphoma
10254
Participant_Condition
patients with primary mediastinal B-cell lymphoma ( PMBCL )