Gastrointestinal stromal tumour (GIST) is a tumour of the digestive tract that, in some patients, has a high chance of coming back after surgery. In this study, patients at high risk of the tumour returning after surgery took imatinib tablets for either one year or three years. Taking it for three years meant patients stayed free of the disease for longer and lived longer. However, more patients in the three-year group stopped treatment for reasons other than the disease coming back.
KIT-positive; adults
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Imatinib | 400 mg | Oral, with food and a large glass of water | Once daily |
In the high-risk population of the second trial, 3 years of treatment is recommended; the optimal duration is not known.
On the page “Imatinib (Gleevec)” · Standard dosing: GIST, DFSP and other uses (FDA label)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Imatinib 400 mg per day, orally, for 12 months; treatment started within 12 weeks after surgery.
Imatinib 400 mg per day, orally, for 36 months; treatment started within 12 weeks after surgery.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with KIT-positive gastrointestinal stromal tumour (GIST) that had been surgically removed and who had a high estimated risk of recurrence according to the modified consensus criteria of the US National Institutes of Health (NIH). Patients were enrolled between February 2004 and September 2008. The diagnosis of GIST was confirmed on central pathology review in 382 of 397 patients (96%) in the intention-to-treat (ITT) population. A KIT or PDGFRA mutation was detected in 333 of 366 testable tumours (91%).
Primary endpoint: recurrence-free survival (RFS). Secondary endpoints: overall survival and treatment safety.
Imatinib was generally well tolerated, but 12.6% of patients in the 12-month group and 25.8% of patients in the 36-month group stopped imatinib for a reason other than GIST recurrence. Further adverse-event details (including grade 3 and higher events) are not reported in the abstract and are available in the full text of the paper.
On the basis of this trial, in patients with GIST at high risk of recurrence after surgery, 36 months of adjuvant imatinib improved recurrence-free survival and overall survival compared with 12 months. This finding supports extending the duration of adjuvant treatment in this high-risk group. The status of this recommendation in current clinical guidelines and drug approvals should be checked separately, as the abstract does not address them.
The study was open-label, without blinding. The higher rate of discontinuation for reasons other than recurrence in the 36-month group reflects the tolerability burden of longer treatment. Median follow-up was 54 months. The evidence applies only to patients at high risk of recurrence according to the modified NIH criteria. Other limitations should be checked in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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