Background Renal cell carcinoma (RCC) represents only 2-3% of all cancers. Sunitinib is a standard initial therapy in advanced and metastatic renal cell carcinoma.

Purpose A retrospective review was performed to assess the safety of sunitinib in RCC.

Materials and methods RCC patients undergoing sunitinib treatment and follow-up for at least one month were included. Variables: sex, age, nephrectomy status, histology, risk group, metastatic sites, sunitinib starting dose, % adverse events (AEs) from Common Terminology Criteria for Adverse Events (CTCAE version 4.0), % grade 3-4 AE, % starting dose reduction, % extra week rest period and % colony stimulating factors (CSF) used for toxicity management. Statistical analysis by SPSS 18.0.

Results 19 patients were analysed: 73.7% male, median age 62 years, 94.7% previously nephrectomised (78.9% radical nephrectomy and 15.8% partial nephrectomy), median time to sunitinib treatment 60.5 months. By histology, 79.0% was clear cell carcinomas. Grouped according to their risk (57.9% of patients could be assessed for risk): 15.8% were assessed as favourable, 26.3% intermediate and 15.8% unfavourable. Median metastatic sites were 3, sorted by frequency: lung 68.4%, liver 47.4%, soft tissues 26.3%, bone and pleura 21.1%, brain, skin and heart 10.5%. Starting dose of sunitinib were 68.4% 50 mg/day, 26.3% 37.5 mg/day and 5.3% 25 mg/day administered for four consecutive weeks and followed by a two-week rest period. 100% patients reported at least one AE. The most frequent AEs were asthenia 11.6%, neutropenia or thrombocytopenia 10.7%, hypertension or diarrhoea 9.9%. Grade 3-4 events were neutropenia 4.1%, anaemia 2.5%, bleeding 1.6%, hypertension, hand-foot syndrome or diarrhoea <1.0%. In addition, one case of toxic hepatitis and a cerebral oedema event were reported. Median cycles sunitinib received were 4.3. Toxicity management consisted of dose reduction 38.4%, extra week rest period 57.6%, no patients required CSF as filgrastim or epoetin α.

Conclusions With sunitinib, adverse events such as hematologic toxicity, asthenia, hypertension and gastrointestinal events were common. Toxicity management included dose reduction or additional rest period.