This protocol addresses patients with metastatic gastrointestinal stromal tumor (GIST) who carry a confirmed KIT or PDGFRA mutation — specifically excluding those with a KIT exon 9 mutation or a PDGFRA D842V mutation. Molecular genotyping is essential in this setting and guides the choice of therapy at each treatment line.
For advanced or metastatic GIST, establishing the precise mutation genotype is a mandatory step before initiating or modifying treatment. The absence of KIT exon 9 and PDGFRA D842V variants defines a distinct clinical sub-population with its own recommended treatment sequence.
DOI: 10.1177/17588359231192388
Genotype is mandatory for treating advanced/metastatic GIST patients (II,A).
Imatinib 400 mg daily is the recommended dose in the first line (I,A).
Standard third- and fourth-line treatments are, respectively, regorafenib 160 mg daily 3/1 (I,A) and ripretinib 150 mg once daily (I,A).
The multikinase inhibitor regorafenib is approved at the doses of 160 mg daily, 3 weeks on, 1 week off, as the third line of treatment based on the results of the phase III GRID trial, exhibiting a PFS of 4.8 months compared with 0.9 in the placebo arm.
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