This article is more than 5 years old. Information may no longer be current.

Sorafenib demonstrated OS benefit for advanced renal cell carcinoma

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Despite the lack of an OS benefit in a primary intent-to-treat analysis, secondary analysis data demonstrated a significant survival benefit for those patients receiving sorafenib when patients receiving placebo were censored, which the researchers said suggested an important crossover effect.

In 2005, 48% of the patients assigned to placebo in the TARGET trial crossed over to sorafenib based on a data monitoring committee recommendation. Previous preliminary findings from the TARGET trial were published in 2008 and reported in the Nov. 10, 2008 issue of HemOnc Today (p. 20). Findings demonstrated sorafenib (Nexavar, Bayer) treatment improved outcomes in patients with renal cell carcinoma regardless of age.

In the recent phase-3 TARGET trial, the researchers randomly assigned 903 patients to sorafenib or placebo.

OS was 17.8 months for patients assigned to sorafenib compared with 15.2 months in patients assigned to placebo (P=.146). When post-crossover placebo survival data were censored, the OS was 17.8 months in the sorafenib group and 14.3 months in the placebo group (P=.029), according to the researchers.

“Although an OS benefit was not seen on a primary intent-to-treat analysis, results of a secondary OS analysis censoring placebo patients demonstrated a survival advantage for those receiving sorafenib, suggesting an important crossover effect,” the researchers said.

The researchers also examined VEGF levels in these patients, hypothesizing that patients with elevated VEGF levels may yield greater benefit from sorafenib. Baseline VEGF data were available for 712 patients. The researchers found that both the high-VEGF group and the low-VEGF group showed improvement with sorafenib (P<.01), but the high-VEGF group (HR=0.48) showed a trend for deriving greater benefit than the low-VEGF group (HR=0.64).

“The treatment of patients with metastatic renal cell carcinoma continues to evolve, with ongoing and future trials seeking answers on individualizing treatment and optimizing patient outcomes,” Robert J. Motzer, MD, and Ana M. Molina, MD, of Memorial Sloan-Kettering Cancer Center in New York, wrote in an accompanying editorial.

Escudier B. J Clin Oncol. 2009;doi:10.1200/JCO.2008.19.5511.
Motzer RJ, Molina AM. J Clin Oncol. 2009;doi:10.1200/JCO.2009.21.8461.