Abstract

ABSTRACT Background Sunitinib is an active agent in the first line treatment of metastatic clear cell kidney cancer, based on the result of a global phase III study. However, complete remission is rarely seen and multiply sequential therapies are used in this patient population. Since options in third line setting are limited, we assessed the clinical activity of sunitinib rechallenge after failure on other therapies. Methods 323 kidney cancer patients were treated with sunitinib from November 2005 to January 2012 in our department. Retrospective data were collected for those 9 patients who we rechallenged with sunitinib failing to at least two previous therapies, including sunitinib. Patient characteristics, objective response based on RECIST criteria and progression-free survival (PFS) were analysed. Tumor assessment was performed every 2nd cycle of sunitinib or every 3 months Results Data of 8 men and 1 woman of median age (at sunitinib challenge 59 years, at sunitinib rechallenge 63 years) with metastatic clear cell cancer of the kidney were analysed. All patients had nephrectomy prior treatment. Initial treatment with sunitinib was associated with a median progression free survival (PFS) of 13,7 months. Objective response was partial remissions (PR) as best response. At the time of re-exposure patients again showed clinical benefit which was associated with a median PFS of 6,8 months and consisted of 1 (11%) PR and 5 (55%) disease stabilizations. PD was seen in 3 (33%) patients. Conclusions In sunitinib-responsive patients, re-challenge with sunitinib has been successful and was well tolerated either after an other TKI or mTOR inhibitor and it seems to be a valid option as a third line treatment. Disclosure All authors have declared no conflicts of interest.

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