passages: 879
passages: document
passages: A pooled analysis of eastern cooperative oncology group and intergroup trials of adjuvant high-dose interferon for melanoma . PURPOSE Nearly 2000 patients with stage IIB and III melanoma have participated in four multicenter , randomized trials , conducted by the Eastern Cooperative Oncology Group and the Intergroup , investigating adjuvant high-dose IFN-alpha 2b therapy . The objectives of this study were to update the analyses of each individual trial and to analyze prognostic factors and treatment effects based on pooled data . EXPERIMENTAL DESIGN Survival and disease status were updated to April 2001 . Analysis of prognostic factors using optimized statistical models was based on data from patients in E1684 , E1690 , E1694 , and E2696 . Analysis of treatment effects versus observation ( Obs ) was based on data from 713 patients randomized to high-dose IFN-alpha 2b ( HDI ) or Obs in Trials E1684 and E1690 . RESULTS Updated analysis of E1684 , E1690 , and E1694 confirmed their original conclusions , now at median follow-up intervals of 2.1-12.6 years . Based on two-sided univariate log-rank analysis of pooled data from E1684 and E1690 ( median follow-up , 7.2 years ) , relapse-free survival ( RFS ) -but not overall survival ( OS ) -was significantly prolonged ( two-sided log-rank P value = 0.006 ) for patients treated with HDI versus Obs . Among all patients , prognostic factors that significantly negatively impacted RFS and OS included ulceration , recurrent disease at entry , enrollment in E1684 , and age > 49 years . Multivariate statistical models adjusting for these factors confirmed the statistically significant RFS benefit of HDI versus Obs but did not demonstrate a significant OS benefit in the pooled populations . CONCLUSIONS In patients with high-risk resected melanoma , HDI is effective adjuvant therapy with strong evidence for improved RFS and evidence for moderate improvement in OS based on two prospective randomized studies but not the pooled analysis . Analyses of predictors of relapse and response are now needed to improve the therapeutic value of this modality .
entities: 880
entities: Intervention_Pharmacological
entities: interferon
entities: 881
entities: Intervention_Pharmacological
entities: IFN-alpha 2b
entities: 882
entities: Intervention_Pharmacological
entities: IFN-alpha 2b ( HDI )
entities: 883
entities: Intervention_Other
entities: Obs
entities: 884
entities: Intervention_Pharmacological
entities: HDI
entities: 885
entities: Intervention_Other
entities: Obs
entities: 886
entities: Intervention_Pharmacological
entities: HDI
entities: 887
entities: Intervention_Other
entities: Obs
entities: 888
entities: Outcome_Mortality
entities: relapse-free survival ( RFS )
entities: 889
entities: Outcome_Mortality
entities: overall survival ( OS )
entities: 890
entities: Outcome_Mortality
entities: RFS
entities: 891
entities: Outcome_Mortality
entities: OS
entities: 892
entities: Outcome_Mortality
entities: RFS
entities: 893
entities: Outcome_Mortality
entities: OS
entities: 894
entities: Participant_Sample-size
entities: Nearly 2000
entities: 895
entities: Participant_Condition
entities: patients with stage IIB and III melanoma
entities: 896
entities: Participant_Condition
entities: patients with high-risk resected melanoma