Safety And Activity Of Sunitinib In Elderly Patients (75 Years Or More) With Metastatic Renal Cell Carcinoma: Results Of Retrospective Study In Paoli-Calmettes Cancer Institute In France.

e15506 Background: Actual tolerability of cancer treatment is still poorly documented in elderly patients. Recently some retrospective reviews have been carried out to evaluate tolerability and efficacy of Sunitinib in elderly patients (> 65 years), with metastatic renal cell carcinoma (mRCC) enrolled in clinical trials. Yet data on routine clinical practice are still lacking. Methods: Between January 2009 and May 2012, 17 patients >= 75 years treated with Sunitinib for mRCC were reviewed, to assess toxicity, cause of treatment reduction or discontinuation. Correlation of toxicity with 7 domains comprehensive geriatric assessment (CGA), tumoral response and progression-free survival (PFS) were also analysed. Results: The median age was 79 years, and patients were followed-up until September 2012. The majority of patients were in the MSKCC favourable or intermediate-risk groups. Eleven patients have received Sunitinib in first line. The median dose received was 37.5mg. Grade II-III diarrhea was observed in 6 patients and grade I-II hand-foot syndrome in 9 patients. Treatment was stopped earlier (< 50 days) for 4 pts, due to severe toxicity: hospitalization in intensive care unit, oesophageal ulceration, asthenia and malnutrition. Temporary treatment discontinuation was observed for 3 pts. All patients underwent 7 domains CGA, and were classified according to Balducci scale. Correlation was not found between impairment at CGA with severe toxicity nor with response, but correlation was found between initial dose and treatment discontinuation. Sunitinib at level of 50 mg was associated with early and permanent treatment discontinuation, and initial dose reduction was associated with an acceptable safety profile and long time treatment duration. Response rate was 41.1% for partial response and 41.1% for stable disease. Median PFS was 23.3 months. Conclusions: This is the first retrospective study performed in elderly cancer patients aged over 75 years. There is no evident correlation between CGA impairment and toxicity profile of Sunitinib. Low starting and dose escalation in the absence of severe toxicity could be suggested.