Efficacy and Safety of High-Dose IFN-?2b in Patients With High-Risk Resected Cutaneous Melanoma

3/8/02


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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 FactorsóRelapse-Free Survival

Proportional Hazards Multivariate Model of Prognostic FactorsóOverall 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 ConclusionsóRole of HDI

Current ECOG/Intergroup Studies of Adjuvant Therapy

Strategies for Developing New Adjuvant Therapies in Stage IV Disease

Author: Judi Manola