February 13, 2014
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Sunitinib safe, effective in patients with mRCC, renal insufficiency

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Sunitinib demonstrated encouraging activity and manageable toxicities in patients with metastatic renal cell carcinoma and renal insufficiency, according to study results.

The cohort included 34 Korean patients (median age, 66 years) who received sunitinib (Sutent, Pfizer) as first-line therapy.

The initial dose was 37.5 mg for 12 patients and 50 mg for 22 patients. Thirty-one patients underwent treatment in a 4-weeks-on, 2-weeks-off regimen. One patient received treatment on a 2-weeks-on, 2-weeks-off schedule. Two patients received daily sunitinib.

Ninety percent of patients had an ECOG performance status of 0 or 1.

The median glomerular filtration rate was 46.5 mL/min per 1.73m2 (range, 21.1-59.5).

Overall, eight patients achieved a partial response and 12 patients had stable disease. Median OS was 26.3 months (95% CI, 17.1-35.3) and median PFS was 12.2 months (95% CI, 10.2-13.2).

The most common grade ≥3 adverse events were fatigue, neutropenia and thrombocytopenia.

“Clinicians should not hesitate to treat patients with metastatic renal cell carcinoma with renal insufficiency with sunitinib,” the researchers concluded.

Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.