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Title: Sunitinib Showed Better Survival and Response Rates Than Interferon Alfa in Metastatic Renal Cell Carcinoma: Presented at ICACT
URL: http://www.pslgroup.com/dg/21CA56.htm
Doctor's Guide
February 8, 2008


By Shazia Qureshi

PARIS, FRANCE -- February 8, 2008 -- Patients receiving treatment with sunitinib showed significantly better progression-free survival and objective response rates compared with patients on interferon alfa as a first-line treatment for metastatic renal cell carcinoma (mRCC), according to research reported here at the 19th International Congress on Anti-Cancer Treatment (ICACT).

"The benefits of sunitinib treatment extended across all 3 risk groups of patients," said lead investigator Stéphane Oudard, MD, PhD, Professor of Oncology, Hôpital Européen Georges Pompidou, Paris, France, during his presentation on February 5.

In addition, the researchers found that progression-free survival in patients receiving sunitinib was predicted by patients' corrected calcium level in serum, their Eastern Cooperative Oncology Group Performance Status (ECOG PS) score, and the time elapsed from diagnosis of mRCC to the start of treatment.

Dr. Oudard said these results were based on analyses of a previous randomised, phase 3 study in 750 patients with mRCC.

Sunitinib was given at a dose of 50 mg/day in 6-week cycles (4 weeks on treatment, 2 weeks off treatment) to 375 patients for a median of 11.1 months. A second group of 375 patients received interferon alfa 9 MU 3 times per week for a median of 4.1 months.

Results showed that the objective response rate as assessed by an independent central review was 39% (95% confidence interval [CI] 34-44) in patients receiving sunitinib, and 8% (95% CI 6-12) in patients on interferon alfa.

Median progression-free survival was significantly higher in patients receiving sunitinib than in patients receiving interferon alfa (11.2 vs 5.1 months, P <.000001).

Using Memorial Sloan-Kettering Cancer Center risk categories to further assess the survival results, the researchers found that the median progression-free survival remained significantly higher in patients receiving sunitinib than in patients on interferon alfa, whether patients had no risk factors, 1 to 2 risk factors, or 3 or more risk factors,.

Dr. Oudard said that among patients on sunitinib, 3 baseline factors were found to be predictive of longer progression-free survival. These included a patient's corrected calcium level in serum of 10 mg/dL or greater (P =.0084), ECOG PS score 0 (P =.007), and time elapsed from diagnosis of mRCC to the start of treatment no greater than 1 year (P <.001).

"These updated results support the position of sunitinib as the reference standard for first-line treatment of mRCC," concluded Dr. Oudard.


[Presentation title: Updated Results and Further Prognostic Factor Analyses From a Randomised Phase III Trial of Sunitinib vs Interferon alfa as First-Line Treatment for Metastatic Renal Cell Carcinoma. Abstract OR 20]

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