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Clin Genitourin Cancer. 2015 Aug;13(4):350-358. doi: 10.1016/j.clgc.2015.01.007. Epub 2015 Jan 21.

Assessment of Sunitinib-Induced Toxicities and Clinical Outcomes Based on Therapeutic Drug Monitoring of Sunitinib for Patients With Renal Cell Carcinoma.

Author information

1
Department of Pharmacy, Shiga University of Medical Science Hospital, Shiga, Japan.
2
Department of Pharmacy, Shiga Medical Center for Adults, Shiga, Japan.
3
Department of Urology, Shiga University of Medical Science Hospital, Shiga, Japan.
4
Department of Urology, Shiga Medical Center for Adults, Shiga, Japan.
5
Department of Pharmacy, Shiga University of Medical Science Hospital, Shiga, Japan. Electronic address: teradat@belle.shiga-med.ac.jp.

Abstract

BACKGROUND:

Sunitinib has been approved for the treatment of metastatic renal cell carcinoma (RCC). Sunitinib pharmacokinetics shows a large interpatient variability.

PATIENTS AND METHODS:

A retrospective, observational clinical study of 21 patients with RCC was performed. Sunitinib was administered for 4 weeks of a 6-week cycle for the first cycle. We evaluated the association of sunitinib-induced toxicities and clinical outcomes with the trough total sunitinib concentration in a steady state during the first cycle.

RESULTS:

The median total sunitinib concentration was 91.8 ng/mL (range, 49.8-205 ng/mL). There was an association between total sunitinib concentration and the severity of thrombocytopenia, anorexia, and fatigue. Patients with ≥ 100 ng/mL total sunitinib (n = 8), compared with patients with < 100 ng/mL (n = 13), had a greater incidence of Grade ≥ 3 toxicities (6 patients [75.0%] vs. 3 patients [23.1%]). Patients with < 100 ng/mL total sunitinib had significantly longer time to treatment failure (TTF) and progression-free survival (PFS) time than patients with ≥ 100 ng/mL (median TTF, 590 vs. 71 days; P = .04; median PFS, 748 vs. 238 days; P = .02).

CONCLUSION:

Results of this study suggest that therapeutic drug monitoring of sunitinib could be useful for avoiding severe toxicities. Dose reduction might be needed, especially when the total sunitinib concentration is ≥ 100 ng/mL, to avoid unnecessary early discontinuation of treatment.

KEYWORDS:

Individualized pharmacotherpy; Kidney cancer; Pharmacokinetics; Tolerability; Tyrosine kinase inhibitor

PMID:
25701374
DOI:
10.1016/j.clgc.2015.01.007
[Indexed for MEDLINE]

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