Palliative imatinib treatment has dramatically improved survival in patients with malignant gastrointestinal stromal tumours, particularly in patients with tumours harbouring activating KIT mutations. To evaluate the effectiveness of adjuvant imatinib after radical surgery, a consecutive series of patients with high-risk tumours (n ¼ 23) was compared with historic controls (n ¼ 48) who were treated with surgery alone. The mean follow-up period was over 3 years in both groups. Only 1 out of 23 patients (4%) in the adjuvant treatment group developed recurrent disease compared to 32 out of 48 patients (67%) in the control group. This preliminary study indicates that 1 year of adjuvant treatment with imatinib dramatically improves recurrence-free survival. Confirmation of these findings awaits the results of ongoing randomised studies. The survival of patients with metastatic and inoperable malignant gastrointestinal stromal tumours (GIST), particularly those whose tumours have KIT exon 11 mutations, has improved dramatically since the introduction of imatinib mesylate into treatment protocols (Verweij et al, 2004). The role of adjuvant imatinib treatment in GIST, however, is unclear and is currently being investigated in ongoing trials. Four such studies, including patients have undergone radical (R0) surgery, are currently being conducted with different inclusion criteria in terms of malignant potential according to the consensus grading system of Fletcher et al (2002). ACOSOG Z9000 addresses treatment with imatinib (400 mg day À1 p.o.(orally)) for 1 year in patients with high-risk GIST with no control arm, while ACOSOG Z9001 compares imatinib treatment with placebo in patients with tumours X3 cm (low, intermediate, and high-risk tumours). EORTC 62024 is designed for patients with intermediate-and high-risk GIST treated with imatinib (400 mg day À1 p.o.(orally)) vs placebo for 2 years. Finally, SSG XVIII includes high-risk GIST treated with imatinib (400 mg day À1 p.o.(orally)) for either 1 or 3 years. The purpose of this study was to report our experience with adjuvant imatinib, while awaiting the results of ongoing multicentre trials. Our study consists of a single-centre, consecutive pilot series of 23 patients with high-risk GIST who have been treated with adjuvant imatinib (400 mg day À1 ) for 1 year after R0 resection. These cases are compared with historical controls from a previous population-based series (Nilsson et al, 2005;Bumming et al, 2006) with matched risk scores with respect to tumour size and maximal proliferative activity with Ki67 antibodies.
MATERIALS AND METHODSThe pilot adjuvant imatinib study group consisted of 23 consecutive patients (11 women and 12 men; mean age 56 years, range 21 -82 years) with high-risk GIST diagnosed between February 2001 and June 2005. The mean tumour size was 9.4 cm (s.d. ¼ 7.7, range 2 -35 cm), and the mean Ki67 max% (maximum percentage of cells positive with Ki67 immunostains) was 7.0 (s.d. 5.0, range 2 -10%). These patients received adjuvant imatinib (400 mg day...