Efficacy
In the initial trial comparing imatinib with placebo, after a median follow-up for surviving patients of 19.7 months (range 0–56.4 months), the estimated 1-year recurrence-free survival was 98% (95% CI 96–100) in the imatinib group versus 83% (78–88) in the placebo group (HR 0.35; CI 95% (0.22–0.53; p<0.0001).r
Recurrence-free survival imatinib versus placebor
© Lancet 2009
There was no difference in overall survival (HR 0.66; CI 95% 0.22-2.03). Five (1%) patients died in the imatinib group, all from causes unrelated to gastrointestinal stromal tumour. Eight (2%) deaths arose in the placebo group, five of which were related to the tumour. Although the trial was not designed to assess patient subsets, analysis of the effect of tumour size showed recurrence-free survival was longer in the imatinib group than in the placebo group in each size category. Size > 3 cm - 6 cm HR 0.23 (CI 95% 0.07-0.79, p=0.011), > 6 cm - <10 cm HR 0.5 (CI 95% 0.25-0.98, p=0.041), > 10 cm HR 0.29 (CI 95% 0.16-0.55).r Quality of life (QOL) data was not collected in the key evidence.
In the SSGXVIII/AIO trial, which had a median follow-up period of 90 months 5-year recurrence-free survival, was significantly higher in the 3-year group (71.1% vs. 52.3%; HR=0.60, 95% CI 0.44-0.81; p<0.001). Additionally, overall survival was also superior in the 3-year group (91.9% vs. 85.3%; HR=0.60, 95% CI 0.37-0.97; p=0.036).r
Overall survival (36 vs 12 months imatinib) : intention-to-treat populationr
© Journal of Clin Oncol 2016