Journal
TARGETED ONCOLOGY
Volume 10, Issue 3, Pages 429-437Publisher
SPRINGER
DOI: 10.1007/s11523-014-0349-2
Keywords
Sunitinib; SU12662; Metastatic renal cell carcinoma; Toxicities; Therapeutic drug monitoring; Pharmacokineitcs
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Funding
- Singapore Cancer Society
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An attenuated dosing (AD) regimen of 37.5 mg daily in repeated 4 week on, 2 week off cycles has been proposed to ameliorate frequent dose modifications caused by the toxicity observed with the approved dosing regimen of sunitinib for metastatic renal cell carcinoma (mRCC). This study aimed to determine the effect of drug exposure on toxicity and clinical response in patients receiving this regimen. All mRCC patients receiving AD sunitinib were invited to participate. In week 4 of each cycle, toxicity and plasma levels were assessed. Clinical responses were assessed after two cycles. A total of 36 patients were recruited. Patients who manifested a parts per thousand yengrade 2 mucositis (126.46 vs 84.81 ng/mL, p = 0.04) and altered taste (159.91 vs 105.22 ng/mL, p = 0.05) had higher total exposure than those who had grade 1 or no toxicity. Twenty-six patients completed two treatment cycles; four (15 %) had partial responses, 15 (58 %) had a stable disease and 7 (27 %) had progressive disease. No difference in the exposure levels was found among the patients with different clinical outcomes. The AD regimen of sunitinib in Asian mRCC patients provided sufficient drug exposure with a lower incidence of toxicity, with higher drug exposure being observed in patients who experienced toxicity.
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