Extending Adjuvant GLIVEC

HISTORICAL RISK OF GIST RECURRENCE

In a pre-GLIVEC (imatinib) study, resected GIST patients had a 54% survival rate at 5 years¹

PRE-GLIVEC (IMATINIB) OVERALL DISEASE-SPECIFIC SURVIVAL IN PRIMARY GIST^1,a
^aBased on a subanalysis of patients with primary disease who underwent complete resection (n=80) within a retrospective study of 200 patients with gastrointestinal stromal tumors who were treated at a single institution. Adapted from DeMatteo et al, 2000.¹ PRE-GLIVEC (IMATINIB) OVERALL DISEASE-SPECIFIC SURVIVAL IN PRIMARY GIST^1,a ^aBased on a subanalysis of patients with primary disease who underwent complete resection (n=80) within a retrospective study of 200 patients with gastrointestinal stromal tumors who were treated at a single institution. Adapted from DeMatteo et al, 2000.¹ Today, 3 years of adjuvant GLIVEC provides a substantial and sustained benefit in recurrence-free survival and overall survival at 5 years² SEE THE DATA

PRE-GLIVEC (IMATINIB) OVERALL DISEASE-SPECIFIC SURVIVAL IN PRIMARY GIST^1,a

^aBased on a subanalysis of patients with primary disease who underwent complete resection (n=80) within a retrospective study of 200 patients with gastrointestinal stromal tumors who were treated at a single institution. Adapted from DeMatteo et al, 2000.¹

Today, 3 years of adjuvant GLIVEC provides a substantial and sustained benefit in recurrence-free survival and overall survival at 5 years² SEE THE DATA

GIST=gastrointestinal stromal tumor.

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References

SCANDINAVIAN SARCOMA GROUP (SSG) TRIAL: 3 YEARS VS 1 YEAR OF ADJUVANT GLIVEC TREATMENT¹

Learn about the trial that demonstrated the significant benefit of longer treatment duration with GLIVEC in patients with KIT+ GIST (N=397)¹
Study Objective	Determine impact on recurrence-free survival (RFS) and overall survival (OS) of 3 years vs 1 year of adjuvant GLIVEC treatment in patients at substantial risk of recurrence¹
Study Description	GLIVEC at 400 mg/day for 12 months vs 36 months after surgical resection of primary KIT+ GIST¹
Inclusion Criteria	Resected patients with confirmed KIT+ GIST and one of the following¹: Tumor diameter >5 cm and mitotic count >5/50 high-power fields (HPFs) Tumor diameter >10 cm and any mitotic count Tumor of any size with mitotic count >10/50 HPFs Tumors ruptured into the peritoneal cavity
Median Follow-up	54 months¹
Primary End Point	Recurrence-free survival defined as the time from date of randomization to the date of recurrence or death from any cause¹
Secondary End Points	Overall survival² Safety²

See how 3 years of adjuvant GLIVEC therapy significantly improves recurrence-free survival and overall survival in KIT+ GIST patients at 5 years.¹

GIST=gastrointestinal stromal tumor.

References

AT 5 YEARS, 3 YEARS OF ADJUVANT GLIVEC PROVIDES SIGNIFICANT BENEFIT VS 1 YEAR¹

LONGER RECURRENCE-FREE SURVIVAL¹

At 5 years, 66% of KIT+ GIST patients treated for 3 years were recurrence free vs 48% of those treated for only 1 year.¹

RECURRENCE-FREE SURVIVAL: 3 YEARS VS 1 YEAR OF ADJUVANT GLIVEC^1,a
SSG XVIII/AIO Phase 3 trial: Multicenter, randomized, open-label trial with a median follow-up period of 54 months; GLIVEC 400 mg/day was the dosage for all patients on active therapy.¹ RFS: 3 years vs 1 year of adjuvant therapy1,a SSG XVIII/AIO Phase 3 trial: Multicenter, randomized, open-label trial with a median follow-up period of 54 months; GLIVEC 400 mg/day was the dosage for all patients on active therapy.¹

RECURRENCE-FREE SURVIVAL: 3 YEARS VS 1 YEAR OF ADJUVANT GLIVEC^1,a

SSG XVIII/AIO Phase 3 trial: Multicenter, randomized, open-label trial with a median follow-up period of 54 months; GLIVEC 400 mg/day was the dosage for all patients on active therapy.¹

Longer duration of treatment (>36 months) may delay the onset of further recurrences; however, the impact of this finding on overall survival remains unknown.¹

IMPROVED OVERALL SURVIVAL¹

92% overall survival at 5 years was achieved with 3 years of adjuvant GLIVEC.¹

OVERALL SURVIVAL: 3 YEARS VS 1 YEAR OF ADJUVANT GLIVEC¹
SSG XVIII/AIO Phase 3 trial: Multicenter, randomized, open-label trial with a median follow-up period of 54 months; GLIVEC 400 mg/day was the dosage for all patients on active therapy.¹ OVERALL SURVIVAL: 3 YEARS VS 1 YEAR OF ADJUVANT GLIVEC¹ SSG XVIII/AIO Phase 3 trial: Multicenter, randomized, open-label trial with a median follow-up period of 54 months; GLIVEC 400 mg/day was the dosage for all patients on active therapy.¹

OVERALL SURVIVAL: 3 YEARS VS 1 YEAR OF ADJUVANT GLIVEC¹

SSG XVIII/AIO Phase 3 trial: Multicenter, randomized, open-label trial with a median follow-up period of 54 months; GLIVEC 400 mg/day was the dosage for all patients on active therapy.¹

Twice the number of deaths occurred in the 1-year treatment arm vs the 3-year arm (median follow-up of 54 months)¹

Longer duration of treatment (>36 months) may delay the onset of further recurrences; however, the impact of this finding on overall survival remains unknown.¹

The National Comprehensive Cancer Network (NCCN) guidelines now support the use of adjuvant GLIVEC therapy for up to 36 months in patients with KIT+ GIST³

Learn helpful information about prescribing GLIVEC.

GIST=gastrointestinal stromal tumor.

NCCN=National Comprehensive Cancer Network.

References

Welcome to the GLIVEC Product Website

GLIVEC is approved for use in 116 countries around the world.

GLIVEC Country-Level Websites

GLIVEC International Website

HISTORICAL RISK OF GIST RECURRENCE

In a pre-GLIVEC (imatinib) study, resected GIST patients had a 54% survival rate at 5 years¹

PRE-GLIVEC (IMATINIB) OVERALL DISEASE-SPECIFIC SURVIVAL IN PRIMARY GIST^1,a

Today, 3 years of adjuvant GLIVEC provides a substantial and sustained benefit in recurrence-free survival and overall survival at 5 years² SEE THE DATA

SCANDINAVIAN SARCOMA GROUP (SSG) TRIAL: 3 YEARS VS 1 YEAR OF ADJUVANT GLIVEC TREATMENT¹

AT 5 YEARS, 3 YEARS OF ADJUVANT GLIVEC PROVIDES SIGNIFICANT BENEFIT VS 1 YEAR¹

LONGER RECURRENCE-FREE SURVIVAL¹

RFS: 3 years vs 1 year of adjuvant therapy1,a

IMPROVED OVERALL SURVIVAL¹

OVERALL SURVIVAL: 3 YEARS VS 1 YEAR OF ADJUVANT GLIVEC¹

The National Comprehensive Cancer Network (NCCN) guidelines now support the use of adjuvant GLIVEC therapy for up to 36 months in patients with KIT+ GIST³

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Welcome to the GLIVEC Product Website

GLIVEC is approved for use in 116 countries around the world.

GLIVEC Country-Level Websites

GLIVEC International Website