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Title: Vitespen Shows No Increased Survival in Postoperative Renal Cell Carcinoma Patients
URL: http://www.pslgroup.com/dg/224EB6.htm
Doctor's Guide
July 3, 2008

NEW YORK -- July 3, 2008 -- Patients with renal cell carcinoma who received vitespen postsurgery showed no increased recurrence-free survival (RFS), according to findings published in the July 5 edition of The Lancet.

Christopher Wood, MD, M. D. Anderson Cancer Center, Houston, Texas, and colleagues, investigated the efficacy of vitespen, as adjuvant therapy in a randomised phase 3 trial.

The study enrolled 818 patients who were randomised to receive either vitespen (n = 409) or observation (n = 409) after surgery. Vitespen was given intradermally once a week for 4 weeks, then every 2 weeks until vaccine depletion. A number of patients were excluded from the final analysis as they did not meet postsurgery inclusion criteria. Therefore, analysis was completed on 361 patients in the vitespen group and 367 in the observation group.

Researchers found no significant difference in RFS between the 2 groups. When the subgroup of patients with stage I or II renal cell carcinoma were analysed separately, recurrence events occurred in 15.2% of the patients receiving vitespen compared with 27% in the observation group.

"No difference in recurrence-free survival was seen between patients given vitespen and those who received no treatment after surgery for renal cell carcinoma," the authors wrote.

"A possible improvement in recurrence-free survival in patients with early-stage disease who received vitespen will require further validation."

SOURCE: The Lancet

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