SSG trial: 3 years vs 1 year of adjuvant GLIVEC treatment1

Study objective Determine impact on RFS and 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:
  • Tumour diameter >5 cm and mitotic count >5/50 high-power fields (HPFs)
  • Tumour diameter >10 cm and any mitotic count
  • Tumour of any size with mitotic count >10/50 HPFs
  • Tumours ruptured into the peritoneal cavity
Median follow-up 54 months1
Primary end point RFS, defined as the time from date of randomization to the date of recurrence or death from any cause1
Secondary end points OS, safety2

References: 1. Glivec® (imatinib) summary of product characteristics. West Sussex, UK: Novartis Europharm Limited; 2016. 2. Joensuu H, Eriksson M, Sundby Hall K, et al. One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial. JAMA. 2012;307(12):1265-1272.

At 5-year follow-up, 3 years of adjuvant GLIVEC provided 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.

Recurrence-free survival (RFS): 3 years vs 1 year of adjuvant GLIVEC1

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 (OS): 3 years vs 1 year of adjuvant GLIVEC1

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

View the Scandinavian Sarcoma Group (SSG) study design (3 years vs 1 year of adjuvant GLIVEC treatment)

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

Reference: 1. Glivec® (imatinib) summary of product characteristics. West Sussex, UK: Novartis Europharm Limited; 2016.