31 juli 2009: Referentielijst met studies toegevoegd onderaan dit artikel.
25 juli 2008: Bron: 1: J Clin Oncol. 2006 Jun 1;24(16):2505-12. Epub 2006 Apr 24.
- Erratum in:
- N Engl J Med. 2007 Jul 12;357(2):203.
- Comment in:
- Eur Urol. 2007 Jul;52(1):279-80.
- N Engl J Med. 2007 Jan 11;356(2):185-7.
- Nat Clin Pract Oncol. 2007 Aug;4(8):456-7.
Sorafenib in advanced clear-cell renal-cell carcinoma.
Department of Medicine, Institut Gustave Roussy, Villejuif, France. email@example.com
BACKGROUND: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of sorafenib, a multikinase inhibitor of tumor-cell proliferation and angiogenesis, in patients with advanced clear-cell renal-cell carcinoma.
METHODS: From November 2003 to March 2005, we randomly assigned 903 patients with renal-cell carcinoma that was resistant to standard therapy to receive either continuous treatment with oral sorafenib (at a dose of 400 mg twice daily) or placebo; 451 patients received sorafenib and 452 received placebo. The primary end point was overall survival. A single planned analysis of progression-free survival in January 2005 showed a statistically significant benefit of sorafenib over placebo. Consequently, crossover was permitted from placebo to sorafenib, beginning in May 2005.
RESULTS: At the January 2005 cutoff, the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group (hazard ratio for disease progression in the sorafenib group, 0.44; 95% confidence interval , 0.35 to 0.55; P<0.01). The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death, as compared with placebo (hazard ratio, 0.72; 95% CI, 0.54 to 0.94; P=0.02), although this benefit was not statistically significant according to the O'Brien-Fleming threshold. Partial responses were reported as the best response in 10% of patients receiving sorafenib and in 2% of those receiving placebo (P<0.001). Diarrhea, rash, fatigue, and hand-foot skin reactions were the most common adverse events associated with sorafenib. Hypertension and cardiac ischemia were rare serious adverse events that were more common in patients receiving sorafenib than in those receiving placebo.
CONCLUSIONS: As compared with placebo, treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed; however, treatment is associated with increased toxic effects. (ClinicalTrials.gov number, NCT00073307 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
PMID: 17215530 [PubMed - indexed for MEDLINE]
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Targeted Drug Boosts Survival Among Liver Cancer Patients
Sorafenib added three months for those with advanced disease, study finds
By Serena Gordon
WEDNESDAY, July 23 (HealthDay News) -- The drug Nexavar can prolong the lives of people with liver cancer by an average of three months, new research shows.
"The results unequivocally showed that sorafenib (Nexavar) increased the survival of patients with a more than 30 percent reduction in the likelihood to die at any time point during follow-up," said study senior author Dr. Jordi Bruix, a senior consultant in the liver unit of the Hospital Clinic of Barcelona.
"These results identify sorafenib as the first agent that is effective in improving survival in patients with this devastating disease," said Bruix. His report is in the July 24 issue of the New England Journal of Medicine.
"Up to now, the patients diagnosed with advanced hepatocellular carcinoma had no effective treatment that could improve their survival. Now, we have an option that is based on oral treatment that is effective if liver function is still preserved," added study author Dr. Josep Maria Llovet, director of research in liver cancer at Mount Sinai School of Medicine in New York City, and a professor at the Barcelona Clinic Liver Cancer (BCLC) Group in Barcelona.
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