BERKELEY, CA (UroToday.com) - In this multicenter trial published in the January 11th issue of The New England Journal of Medicine,

750 patients with previously untreated metastatic renal cell cancer were randomized into two groups, Arm A: Sutent 50 mg PO daily on a 4 weeks on, 2 weeks off schedule, and Arm B: Interferon-alfa at a dose of 9 MU given subcutaneously three times weekly. Approximately 80% of patients had presented with lung metastases, with an additional 25% and 30% having liver or bone metastasis, respectively. Treatment was discontinued due to progressive disease in 25% of the Sutent arm and 45% of the interferon arm and because of toxicity in 8% and 13% of patients, respectively.

An objective response (CR or PR) was seen in 31% of patients in the Sutent arm compared with 6% of patients in the interferon arm. Disease progression was observed in 21% of the Sutent arm and 45% of the interferon arm.

Investigator assessment of progression-free survival demonstrated a benefit for Sutent over interferon, with a median time to progression of 11 months compared with 5 months (Hazard ratio 0.416, p < 0.00001). This difference was greatest for patients with tumors of low risk (MSKCC Risk Factor: 0) or intermediate risk (MSKCC Risk factors: 1-2).

The most common toxicities for Sutent were fatigue (51%), diarrhea (53%), nausea (44%), stomatitis (25%), hypertension (24%), and hand-foot syndrome (20%). Grade 3 or 4 toxicities were most commonly seen for hypertension (8%), diarrhea (5%), fatigue (7%), and hand-foot syndrome (5%).

Using the Functional Assessment of Cancer Therapy-General (FACT-G) instrument, patients in the Sutent arm were found to have enhanced quality of life when compared to a baseline sample of cancer patients or the interferon arm. This had not been evaluated in previous studies.

Although patients in the Sutent arm demonstrated a trend towards improved overall survival when compared to the interferon arm (Hazard ratio 0.65, p = 0.0219), the level of significance did not meet the pre-specified level for the study.

While the authors concluded that Sutent should now become the new reference standard as first line therapy for patients with metastatic renal cancer, we await a prospective randomized trial comparing recently introduced targeted therapies (sunitinib, sorafenib, and temsirolimus).

Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA

N Engl J Med.; 356(2):115-24.

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Written by Ricardo Sånchez-Ortiz, MD, a Contributing Editor with UroToday.

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