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Sunitinib
Source: Gastrointestinal Stromal Tumors Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: December 13, 2024 · Captured 2026-09-09.
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In the case of tumor progression (or intolerance to imatinib), data support second-line therapy with either imatinib dose escalation to 800 mg per day (as described above) or sunitinib.[16,21] Sunitinib is given at a dose of 50 mg daily in a 4-weeks-on/2-weeks-off regimen or a daily dose of 37.5 mg.[30] As with imatinib, the response to sunitinib is evaluated with CT, MRI, or 18F-FDG PET, and treatment is usually continued indefinitely in the absence of disease progression or unacceptable toxicity.[3,4,30-36]
Evidence (sunitinib):
An international phase III trial of 312 patients with imatinib-resistant GISTs randomly assigned patients to receive sunitinib or placebo.[30]
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An international phase III trial of 312 patients with imatinib-resistant GISTs randomly assigned patients to receive sunitinib or placebo.[30]
On the basis of radiological assessment, the median time to tumor progression was more than four times as long with sunitinib (27.3 weeks; 95% CI, 16.0–32.1) than with placebo treatment (6.4 weeks; 95% CI, 4.4–10.0) (HR, 0.33; 95% CI, 0.23–0.47; P < .0001).[30][Level of evidence A1]
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An international phase III trial of 312 patients with imatinib-resistant GISTs randomly assigned patients to receive sunitinib or placebo.[30]
OS was similarly better for sunitinib-treated patients (HRdeath, 0.49; 95% CI, 0.29–0.83).[30][Level of evidence A1]
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The response to sunitinib is also influenced by the molecular profile of the GIST. Based on a phase I/II study of 97 patients, the highest clinical benefit rate, PFS benefit, and OS benefit were seen in patients with KIT exon 9 variants, compared with patients with KIT/PDGFRA wild-type or KIT exon 11 variants.[33]
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Fatigue.
Nausea and vomiting.
Anemia.
Neutropenia.
Diarrhea.
Abdominal pain.
Mucositis.
Anorexia.
Skin or hair discoloration.
Proteinuria.
Hypothyroidism (thyroid function monitoring is generally recommended).
Hypertension.
Potential for delayed wound healing (may require holding 3–4 days prior to surgery).
Less frequent toxicities include bleeding, fever, and hand-foot syndrome.[30] Therapy with sunitinib may be cardiotoxic. In a retrospective phase I/II study evaluating the efficacy of sunitinib in patients with imatinib-resistant metastatic GISTs, 8% of patients who received repeated cycles of sunitinib experienced congestive heart failure, while 47% of patients developed hypertension (>150 per 100 mm Hg). Reductions in left ventricular ejection fraction were seen in at least 10% to 28% of patients.[38]
Publication references
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Preserved source evidence · Not medical advice