Safety And Efficacy Of Sunitinib In An Expanded-Access Trial Of Metastatic Renal Cell Carcinoma (mRCC)

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 13 Apr 2008 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

UroToday.com - Sunitinib malate is an oral, multi-targeted tyrosine kinase inhibitor with direct anti-tumor and anti-angiogenic activities, internationally approved for the first-line treatment of advanced RCC. This international, open-label trial was undertaken to provide sunitinib to patients with advanced RCC who might benefit from therapy, but who had no access to the drug prior to regulatory approval in their countries.

Eligibility criteria were minimal: pts >18 yrs of age with histologically confirmed mRCC received oral sunitinib 50 mg/day for 4 weeks followed by 2 weeks off treatment (4/2 schedule).

4,217 patients had received treatment. Data are currently available on 3,997 pts (median age, 59). Baseline demographics included 522 pts (13%) with ECOG performance status (PS) ≥2; 542 pts (14%) with non-clear cell histology; 298 pts (8%) with brain metastases; and 229 pts (6%) with prior anti-angiogenic treatment. Median duration of treatment was 6.5 months (mo) (0.0 - 23.6). Dose reductions occurred in 42.0% of pts, and discontinuations due to adverse events (AEs) in 5.6% of pts. The most common treatment-related AEs were diarrhea (27.8% grade 1/2, 3.2% grade 3/4), nausea (23.8% grade 1/2, 1.6% grade 3/4) and fatigue (20.3% grade 1/2, 5.8% grade 3/4). The incidence of grade 3/4 treatment-related diarrhea, nausea and fatigue in pts with brain metastases was 1.7%, 1.7% and 6.0%, respectively. The corresponding incidence in patients with PS ≥2 was 2.9%, 2.1% and 5.0%, respectively. In pts with prior cytokine treatment (n=2,727), the estimated median progression-free survival (PFS) was 9.6 mo. Among the group with prior cytokine therapy, PFS was longer in pts in MSKCC favorable vs. intermediate vs. poor prognostic criteria subgroups (13.5 vs. 8.4 vs. 4.8 mo). ORR in pts with ECOG PS ≥2, non-clear cell histology and brain metastases was 4.6%, 6.1% and 7.4%, respectively. Median overall survival has not been reached.

The safety profile of sunitinib in this international expanded-access trial was similar to that reported in the pivotal phase II and III clinical trials. Data are now available on specific subgroups of pts such as those with brain metastases, non-clear cell histology or PS ≥2 that have been under-represented in previous trials.

Presented by: S. Oudard, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

Reported by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to: www.urotoday.com

Copyright © 2008 - UroToday