There is an urgent need for more active agents for the treatment of metastatic renal cell carcinoma (RCC): The 5-year survival rate for metastatic RCC is estimated to be less than ten percent, according to background information in the article. RCC is highly resistant to chemotherapy, and only a limited subset of patients - 20 percent or less - benefit from cytokine therapy, a high-dose interleukin-2 [IL-2] and interferon-alfa. Overall median survival following progression after cytokine therapy is approximately ten to 13 months.
Robert J. Motzer, M.D., of Memorial Sloan-Kettering Cancer Center, New York, and colleagues conducted a multi-centre phase II trial to confirm the anti-tumour efficacy of sunitinib in 106 patients with metastatic clear-cell RCC whose disease was refractory to one prior cytokine therapy. Patients were enrolled between February and November 2004, with follow-up continuing until disease progression, unacceptable toxicity, or withdrawal of consent. Patients received repeated 6-week cycles of sunitinib, 50 mg per day given orally for four consecutive weeks followed by 2 weeks off per treatment cycle.
"The results of this trial confirm that sunitinib given once daily according to a 4 weeks on/2 weeks off schedule has substantial anti-tumour effects against metastatic clear-cell RCC. Of the 105 evaluable patients, 36 patients achieved partial response (34 percent), and a median progression-free survival of 8.3 months as evaluated by the independent third-party core imaging laboratory," the authors write.
"The results of this trial demonstrate the efficacy of sunitinib as a single agent in second-line therapy for patients with cytokine-refractory metastatic clear-cell RCC. The initial observation of anti-tumour activity for sunitinib has been confirmed in a larger trial. Sunitinib as a first-line therapy for metastatic clear-cell RCC is currently being investigated vs. interferon-alfa in a randomised phase 3 study," the researchers conclude.
MEDICA.de; Source: Journal of the American Medical Association