PURPOSE: Sorafenib is an oral Raf kinase inhibitor, approved for the treatment of advanced renal cancer. Clinical investigation of the safety and feasibility of sorafenib therapy in patients with impaired renal function was performed in this study. MATERIALS AND METHODS: The protocol was approved by the Human Investigation Committee of Wayne State University. Medical records of patients with metastatic renal cancer at Wayne State University started on sorafenib between November 2005 to January 2007 were reviewed. Patients with a calculated creatinine clearance (CrCl) of 60 mL/min or less (chronic kidney disease stage 3 or greater per Kidney Disease Outcomes Quality Initiative guidelines) were deemed to have renal insufficiency. RESULTS: A total of 32 patients who met the selection criteria were analyzed. Fourteen of 32 (44%) patients had renal insufficiency (range, 32-60 mL/min). Median age was 71 years in patients with CrCl < or = 60 mL/min and 54 years in those with > 60 mL/min. Incidence of diarrhea (57% vs. 33%) and hand-foot syndrome (86% vs. 56%) were higher in the renal-dysfunction group. Dose interruptions and dose reductions were noted in 57% and 43% of patients with renal dysfunction versus 28% and 22% in those without. No significant differences were noted in response rate, progression-free survival or overall survival. CONCLUSION: Renal insufficiency is frequently observed in patients with advanced renal cancer. Sorafenib therapy can be safely delivered in patients with mild and moderate renal dysfunction, and efficacy appears to be maintained.
PURPOSE:Sorafenib is an oral Raf kinase inhibitor, approved for the treatment of advanced renal cancer. Clinical investigation of the safety and feasibility of sorafenib therapy in patients with impaired renal function was performed in this study. MATERIALS AND METHODS: The protocol was approved by the Human Investigation Committee of Wayne State University. Medical records of patients with metastatic renal cancer at Wayne State University started on sorafenib between November 2005 to January 2007 were reviewed. Patients with a calculated creatinine clearance (CrCl) of 60 mL/min or less (chronic kidney disease stage 3 or greater per Kidney Disease Outcomes Quality Initiative guidelines) were deemed to have renal insufficiency. RESULTS: A total of 32 patients who met the selection criteria were analyzed. Fourteen of 32 (44%) patients had renal insufficiency (range, 32-60 mL/min). Median age was 71 years in patients with CrCl < or = 60 mL/min and 54 years in those with > 60 mL/min. Incidence of diarrhea (57% vs. 33%) and hand-foot syndrome (86% vs. 56%) were higher in the renal-dysfunction group. Dose interruptions and dose reductions were noted in 57% and 43% of patients with renal dysfunction versus 28% and 22% in those without. No significant differences were noted in response rate, progression-free survival or overall survival. CONCLUSION:Renal insufficiency is frequently observed in patients with advanced renal cancer. Sorafenib therapy can be safely delivered in patients with mild and moderate renal dysfunction, and efficacy appears to be maintained.
Authors: Mark J Ratain; Tim Eisen; Walter M Stadler; Keith T Flaherty; Stan B Kaye; Gary L Rosner; Martin Gore; Apurva A Desai; Amita Patnaik; Henry Q Xiong; Eric Rowinsky; James L Abbruzzese; Chenghua Xia; Ronit Simantov; Brian Schwartz; Peter J O'Dwyer Journal: J Clin Oncol Date: 2006-04-24 Impact factor: 44.544
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: Said M Moudouni; Amine Lakmichi; Mohammed Tligui; Arach Rafii; Kessile Tchala; Francois Haab; Bernard Gattegno; Philippe Thibault; Jean-Dominique Doublet Journal: BJU Int Date: 2006-08 Impact factor: 5.588
Authors: Andrew S Levey; Kai-Uwe Eckardt; Yusuke Tsukamoto; Adeera Levin; Josef Coresh; Jerome Rossert; Dick De Zeeuw; Thomas H Hostetter; Norbert Lameire; Garabed Eknoyan Journal: Kidney Int Date: 2005-06 Impact factor: 10.612
Authors: S Savaj; V Liakopoulos; S Ghareeb; C Musso; K Sahu; J M Bargman; S I Vas; D G Oreopoulos Journal: Int Urol Nephrol Date: 2003 Impact factor: 2.370
Authors: Robert J Motzer; Jennifer Bacik; Lawrence H Schwartz; Victor Reuter; Paul Russo; Stephanie Marion; Madhu Mazumdar Journal: J Clin Oncol Date: 2004-02-01 Impact factor: 44.544
Authors: Josep M Llovet; Sergio Ricci; Vincenzo Mazzaferro; Philip Hilgard; Edward Gane; Jean-Frédéric Blanc; Andre Cosme de Oliveira; Armando Santoro; Jean-Luc Raoul; Alejandro Forner; Myron Schwartz; Camillo Porta; Stefan Zeuzem; Luigi Bolondi; Tim F Greten; Peter R Galle; Jean-François Seitz; Ivan Borbath; Dieter Häussinger; Tom Giannaris; Minghua Shan; Marius Moscovici; Dimitris Voliotis; Jordi Bruix Journal: N Engl J Med Date: 2008-07-24 Impact factor: 91.245