The Pharmaceutical Journal
Vol 276 No 7405 p713
17 June 2006

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First-line use of sunitinib improves survival for patients with metastatic renal cell carcinoma

Sunitinib, a new therapy for metastatic renal cell carcinoma, almost doubles progression-free survival compared with interferon-alfa when used as a first-line treatment.

Data from a Pfizer-sponsored trial were presented at the American Society of Clinical Oncology meeting held in Atlanta, Georgia, earlier this month and coincide with publication of a study using sunitinib as a second-line treatment (JAMA 2006;295:2516).

The trial presented at ASCO involved 750 patients with advanced clear cell carcinoma, which accounts for around 90 per cent of all renal cell cancers. No patients had previously received chemotherapy, although most had undergone surgery.

Half received sunitinib, given orally once daily for four weeks followed by a two-week treatment break. The other half were given standard therapy — interferon-alfa in six week cycles of 9 million units given subcutaneously three times weekly.

Presenting the results, Robert Motzer, of Memorial-Sloan-Kettering Cancer Centre, New York, said that although interferon-alfa is one of the standard first-line treatments for advanced kidney cancer, only about 11 per cent of patients respond to it. Interleukin-2 is another therapy that has been studied for this condition but only about 14 per cent of patients respond and it is hardly used at all outside the US, he added.

The primary end point of the first-line treatment trial was progression-free survival, which was 47.3 weeks for the sunitinib group compared with 24.9 weeks for the interferon-alfa group (P<0.000001). Response rates were 24.8 per cent for sunitinib and 4.9 per cent for interferon-alfa (P<0.000001).

Dr Motzer said: “I believe this means sunitinib will now become the new standard of care for advanced renal cell cancer, and it’s important to remember that this study was carried out in all-comers with a range of prognoses.”

The study published in JAMA involved 106 patients with metastatic clear-cell carcinoma that had progressed despite previous cytokine therapy. Sunitinib was given as repeated six-week cycles (50mg daily for four weeks followed by a two-week treatment break) and resulted in 36 patients having a partial response (34 per cent, 95 per cent confidence interval, 25–44 per cent). Median progression-free survival was 8.3 months (CI 7.8–14.5 months).

The Committee for Medicinal Products for Human Use endorsed sunitinib last month, giving a positive opinion for its use in the treatment of advanced and/or metastatic renal cell carcinoma and unresectable and/or metastatic malignant gastrointestinal stromal tumour.

The drug is a multitargeted tyrosine kinase inhibitor that specifically inhibits vascular endothelial growth factor receptor and platelet-derived growth factor receptor.