Real‐world experience of the feasibility and tolerability of the 2/1 dosing schedule with sunitinib in the treatment of patients with advanced renal cell carcinoma in Australia

Real‐world experience of the feasibility and tolerability of the 2/1 dosing schedule with... 1INTRODUCTIONThe orally administered multitargeted tyrosine kinase inhibitor sunitinib is a standard first‐line treatment for metastatic renal cell carcinoma (mRCC). The dose and schedule approved by the Australian Therapeutic Goods Administration (TGA) and funded by the Pharmaceutical Benefits Scheme is a 6‐week dosing cycle comprising sunitinib 50 mg/day for 4 weeks, followed by a 2‐week rest period (Schedule 4/2), and repeated until disease progression. However, phase III and ‘real‐world’ data indicate that this schedule can result in adverse events necessitating dose reductions or delays in up to 50% of patients and discontinuation of therapy in a further 10–20% of patients. Maintaining dose intensity and target plasma concentrations of sunitinib is essential for optimal clinical outcomes in patients with mRCC. The challenge, therefore, is to minimize toxicity while maintaining sunitinib systemic exposure intensity and maximizing treatment adherence and overall time on treatment.Alternative sunitinib dosing regimens have been studied in patients with mRCC with the goal of providing a better safety profile than the 4/2 schedule. Continuous daily dosing with sunitinib 37.5 mg daily has been investigated in two prospective single‐arm phase II studies. Overall response rate was 20% in 107 cytokine pretreated patients and 35% in 119 treatment naïve patients. Median progression‐free survival was 8.2 and 9.0 months. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Asia-Pacific Journal of Clinical Oncology Wiley

Real‐world experience of the feasibility and tolerability of the 2/1 dosing schedule with sunitinib in the treatment of patients with advanced renal cell carcinoma in Australia

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Publisher
Wiley Subscription Services, Inc., A Wiley Company
Copyright
Copyright © 2018 John Wiley & Sons Australia, Ltd
ISSN
1743-7555
eISSN
1743-7563
D.O.I.
10.1111/ajco.12686
Publisher site
See Article on Publisher Site

Abstract

1INTRODUCTIONThe orally administered multitargeted tyrosine kinase inhibitor sunitinib is a standard first‐line treatment for metastatic renal cell carcinoma (mRCC). The dose and schedule approved by the Australian Therapeutic Goods Administration (TGA) and funded by the Pharmaceutical Benefits Scheme is a 6‐week dosing cycle comprising sunitinib 50 mg/day for 4 weeks, followed by a 2‐week rest period (Schedule 4/2), and repeated until disease progression. However, phase III and ‘real‐world’ data indicate that this schedule can result in adverse events necessitating dose reductions or delays in up to 50% of patients and discontinuation of therapy in a further 10–20% of patients. Maintaining dose intensity and target plasma concentrations of sunitinib is essential for optimal clinical outcomes in patients with mRCC. The challenge, therefore, is to minimize toxicity while maintaining sunitinib systemic exposure intensity and maximizing treatment adherence and overall time on treatment.Alternative sunitinib dosing regimens have been studied in patients with mRCC with the goal of providing a better safety profile than the 4/2 schedule. Continuous daily dosing with sunitinib 37.5 mg daily has been investigated in two prospective single‐arm phase II studies. Overall response rate was 20% in 107 cytokine pretreated patients and 35% in 119 treatment naïve patients. Median progression‐free survival was 8.2 and 9.0 months.

Journal

Asia-Pacific Journal of Clinical OncologyWiley

Published: Jan 1, 2018

Keywords: ; ; ;

References

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