Table of Contents
Efficacy and Safety of High-Dose IFN-?2b in Patients With High-Risk Resected Cutaneous Melanoma
Agenda
Stage IIB and III Melanoma are at High Risk of Recurrence
High-Risk Subgroups According to AJCC (2002) Stage Groupings (N = 17,600)
Prognostic Significance of Sentinel Lymph Node Status
ECOG and Intergroup Adjuvant Trials in Stage IIB/III Melanoma
Inclusion Criteria
Comparative Demographics
E1684: Study Design
E1684: Summary of Results Intent-to-Treat Analysis
E1684: Relapse-Free Survival (Eligible Cases) at 6.9 yr Median Follow-up
E1684: Overall Survival (Eligible Cases) at 6.9 yr Median Follow-up
E1684: Conclusions
Impact of Adjuvant IFN Therapy for Melanoma Relative to Other Approved Adjuvant Therapies
Intergroup E1690 Phase III Trial of High or Low Dose IFN-?2b Versus Observation
E1690: Summary of Results Intent-to-Treat Analysis
E1690: Relapse-Free Survival (Eligible Cases)
E1690: Overall Survival (Eligible Cases)
Comparison of E1684 and E1690
Differing Outcome for Observation Arms of E1684 and E1690 (Overall Survival)
Comparison of E1690 and E1684: RFS for Observation Patients with 1 Node+
E1690: Conclusions
Intergroup E1694 Phase III Study of Ganglioside GM2 Vaccine (GMK) Versus High-Dose IFN-?2b
E1694: Summary of Results Intent-to-Treat and Eligible Populations
E1694: Relapse-Free Survival (Eligible Cases)
E1694: Overall Survival (Eligible Cases)
E1694: Subgroup Analysis of RFS by Nodal Involvement (Eligible Cases)
E1694: Summary Conclusions
Relapse-Free Survival Benefit of HDI Hazard Ratio by Number of Nodes Positive
Efficacy Summary of Adjuvant Trials in High-Risk Melanoma
Common Grade 3/4 Adverse Events in Patients Treated With High-Dose IFN-?2b
Safety Summary for High-Dose IFN-?2b
A Updated and Pooled Analysis of ECOG and Intergroup Trials of High-Dose IFN-?2b
Studies Included in Updated and Pooled Analysis
Objectives
Methods
Patient Outcome (N = 1,912)
Patient Characteristics
E1684: Relapse-Free Survival (ITT at 12.6 yr Median Follow-up)
E1684: Overall Survival (ITT at 12.6 yr Median Follow-up)
E1690: Relapse-Free Survival (ITT at 6.6 yr)
E1690: Overall Survival (ITT at 6.6 yr)
E1694: Relapse-Free Survival (ITT at 2.1 years Median Follow-up)
E1694: Overall Survival (ITT at 2.1 years Median Follow-up)
Relapse-Free Survival by Treatment E1684 and E1690 (Pooled)
Overall Survival by Treatment E1684 and E1690 (Pooled)
Proportional Hazards Multivariate Model of Prognostic Factors—Relapse-Free Survival
Proportional Hazards Multivariate Model of Prognostic Factors—Overall Survival
Treatment Effect: Multivariate Cox Model for Relapse-Free Survival (E1684 and E1690)
Treatment Effect: Multivariate Cox Model for Overall Survival (E1684 and E1690)
Conclusions Updated Analysis of Individual Studies
Conclusions Pooled Analysis
Overall Conclusions—Role of HDI
Current ECOG/Intergroup Studies of Adjuvant Therapy
Strategies for Developing New Adjuvant Therapies in Stage IV Disease
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