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Title: Dose individualization of sunitinib in metastatic renal cell cancer: toxicity-adjusted dose or therapeutic drug monitoring
Authors: Chan, Matthew M K ;Sabanathan, D.;Zhang, A.;Fox, P.;Coulter, S.;Gebski, V.;Balakrishnar, B.;Liddle, C.;Gurney, H.
Affliation: Central Coast Local Health District
Gosford Hospital
Issue Date: Aug-2017
Source: 80(2):385-393
Journal title: Cancer Chemotherapy & Pharmacology
Department: Medical Oncology
Central Coast Cancer Centre
Abstract: PURPOSE: Dose individualization of sunitinib has been proposed using therapeutic drug monitoring (TDM) or toxicity-adjusted dose (TAD). We prospectively studied aspects of TDM and TAD to inform future trials, namely (1) intrapatient variability (CV) of sunitinib and (2) feasibility of a TAD protocol. METHODS: Sunitinib dose was adjusted to ensure grade 1 or 2 toxicity on 10-20 days of each 42-day cycle. Total trough levels (TTL) C (min) of sunitinib and its active metabolite were measured every 6 weeks. RESULTS: In 45 patients with mRCC, 283 TTL samples were assayed over a median 30 weeks (6-108 weeks). Fifteen patients (33%) had an intrapatient CV of >25% in TTL. Ninety-one percent achieved target toxicity with a final sunitinib dose of 25 mg (18%), 37.5 mg (27%), 50 mg (50%), and 62.5 or 75 mg (7%). TTL C (min) was <50, 50-100, and >100 ng/mL in 7 (15%), 31 (69%), and 7 patients (15.5%), respectively. The median overall survival was 32 months. CONCLUSIONS: Sunitinib level has minimal variability in the majority of patients on stable dose. A subset of patients had a significant intrapatient variation, so we recommend two samples 4 to 6 months apart. TAD is feasible for dosing sunitinib and showed a favourable outcome.
DOI: 10.1007/s00280-017-3362-1
ISSN: 0344-5704
Publicaton type: Journal Article
Keywords: Cancer
Drug Therapy
Appears in Collections:Oncology / Cancer

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