Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumours
Imatinib produced responses in more than half of patients with advanced gastrointestinal stromal tumours, a cancer that had been completely resistant to chemotherapy, and turned a lethal disease into a chronic one.
Overview
Phase 2 trial of 147 patients with unresectable or metastatic KIT-positive gastrointestinal stromal tumour randomised to imatinib 400 or 600 mg daily.
Partial response occurred in 53.7 percent and stable disease in 27.9 percent, with only 13.6 percent early progression; oedema, nausea, diarrhoea and myalgia were common but serious toxicity was uncommon. Long-term follow-up showed median survival of about five years.
- Partial response 53.7 percent; stable disease 27.9 percent.
- No significant difference between 400 and 600 mg doses.
Imatinib is the standard first-line treatment for advanced GIST and the model for kinase-targeted therapy in solid tumours.
- Randomised between doses only, without a control arm.
- Response assessment by size criteria underestimates benefit (Choi criteria came later).
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