Objective: To explore the tolerability and safety of sorafenib for patients with advanced renal cell carcinoma.
Methods: Among 63 cases of advanced renal cell carcinoma, there were 45 males and 18 females with a median age of 57 years. And 48 patients had recurrence or metastasis after nephrectomy. And cytokine therapy was offered for 36 of them before recurrence or metastasis. Postoperative recurrence or metastasis occurred <1 year (n = 11) and ≥ 1 year (n = 37). And 15 cases of primary non-resectable renal lesions received biopsy. The pathological types were clear cell carcinoma (n = 49) and papillary carcinoma (n = 14). The pre-dosing Karnofsky performance scores were all ≥ 70 points. Sorafenib was used as a first-line single drug at 400 mg twice daily until disease progression or an onset of intolerable adverse reactions.
Results: Follow-ups ended in February 2013. The median follow-up period was 20 (6-42) months. Twenty-four patients died. The outcomes were complete remission (n = 2), partial remission (n = 8), stable disease (n = 30) and disease progression (n = 23). The overall objective response rate was 15.9% (10/63) and disease control rate 63.5% (40/63) . Hand-foot skin reaction (70.0%), alopecia (62.5%), rash (52.5%), diarrhea (37.5%), loss of appetite (32.5%) and fatigue (27.5%) were noted. Most adverse reactions occurred at 2-4 weeks and subsided after symptomatic measures. And medication was not disrupted.
Conclusion: Sorafenib has a high disease control rate for advanced renal cell carcinoma. And its adverse reactions are generally mild and similar to those reported in the literature. It has excellent profiles of tolerability and safety.