If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Cediranib Demonstrates Safe, Well Tolerated Antitumour Activity in Patients With Advanced Renal Cell Carcinoma: Presented at EMUC By Chris Berrie BARCELONA, Spain -- December 1, 2009 -- Cediranib is safe and well tolerated, and shows significant antitumour activity compared with placebo in patients with advanced renal cell carcinoma (RCC), according to research presented at the 2nd European Multidisciplinary Meeting on Urological Cancers (EMUC). Principal investigator Peter Mulders, MD, PhD, University Medical Centre St Radboud, Nijmegen, Netherlands, led a randomised, double-blind, parallel-group, phase 2 study to compare safety and efficacy of cediranib versus placebo in patients with advanced RCC. He presented the results here on November 29. The entry criteria included metastatic or recurrent clear-cell RCC/adenocarcinoma, with a World Health Organization performance status (WHO PS) of 0 to 2. Individuals were excluded who had received previous anti-vascular endothelial growth factor therapy, more than 1 previous immunotherapy, or prior chemotherapy (except 5-fluorouracil with immunotherapy). Seventy-one patients were initially randomised 1:3 to placebo (n = 18; male, 83%) or cediranib 45 mg (n = 53; male 75%). “After 12 weeks,” Dr. Mulders explained, “the study treatment was unblinded and, in the case where placebo showed progression, there was crossover to the cediranib treatment.” Baseline characteristics across these treatment groups were well balanced, with patients mainly under the age of 75 years (95% vs 96%), with a WHO PS of 0/1 (95% vs 97%), and a clear-cell histology (83% vs 91%), with about 50% having undergone immunotherapy/hormonal therapy, and almost all following surgery (89% vs 92%). The primary objective was efficacy of cediranib as determined by changes from baseline in tumour size to 12 weeks of therapy. Secondary objectives included response rate and duration according to the Response Evaluation Criteria in Solid Tumours criteria, progression-free survival (PFS), and safety and tolerability. After the 12 weeks of treatment, cediranib showed significant benefit over placebo for change in tumour size: -20% versus +19% (P < .0001). With a response rate (all partial responders) of 34% and 47% with stable disease, the overall disease control rate was 81%. For median PFS, cediranib showed significant prolongation over placebo (12.1 vs 2.8 months; hazard ratio [HR], 0.45; 90% confidence interval [CI], 0.26-0.76; P = .017). In an exploratory analysis, where this was also corrected for confounding effects of patient crossover from placebo to cediranib, the HR was 0.14 (90% CI, 0.06-0.30; P < .0001). The most frequently reported adverse events with cediranib were all-grade diarrhoea (88%), fatigue (66%), hypertension (61%), and dysphonia (63%). Of note, 87% of patients treated with cediranib at some point during the study had a dose reduction or treatment pause. Dr. Mulders noted that the overall mean daily dose of cediranib, therefore, was approximately 30 mg. EMUC was jointly organised by the European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), and the European Society for Therapeutic Radiology and Oncology (ESTRO). [Presentation title: Cediranib (Recentin) in Patients With Advanced Renal Cell Carcinoma (RCC): Final Results of a Phase II Randomised Study. Oral Abstract O6]
|
