Abstract
15568 Background: Sorafenib, an oral multi-kinase inhibitor, prolonged progression free survival (PFS) of MRC patients (pts) in second line when compared to placebo in a phase III trial (Escudier at al ECCO 2005). Grade 3/4 adverse events (AE) were reported in 12% of pts. Here we present sorafenib’s efficacy and safety in a less selected cohort of pts enrolled in the Bayer Expanded Access Program at PMH. Methods: Pts with MRC received Sorafenib 400 mg bid continuously until disease progression (PD) and/or clinical deterioration..Tumor response was measured by RECIST criteria. AE were graded by NCI common toxicity criteria. Summary statistics and logistic regression were used to describe the results. Results: From Nov 2005 to Aug 2006, 58 pts were enrolled: median age was 59 years (range 14–86), 47 (81%) were male, 48 (83%) had clear cell histology and 46 (79%) received Sorafenib in first line. None received prior kinase-inhibitors. Using the Motzer Prognostic Index, 29 pts (50%) were low risk, 21 (36%) intermediate and 8 (14%) poor risk. Grade 3/4 AE occurred in 37 pts (64%, 95% CI 50–76%): 15 (26%) pts had skin rash, 10 (17%) hand-foot syndrome, 4 (7%) hypertension, 4 (7%) fatigue, and 4 (7%) diarrhea. Thirty-six (62%) pts required dose reductions and/or treatment interruptions, most due to skin reactions and hand-foot syndrome. Median follow-up was 9 months (IQR range 2–11), the median PFS was 7.5 months (IQR range 5.4–11.3), and the best responses among 56 evaluable pts were: 10 (17%) confirmed partial responses (median duration: 6 months, range 4–11), 14 (24%) stable diseases for = 6 months and 10 (18%) early progression. Pts with bony mets progressed earlier than pts without bony mets. Abnormal creatinine clearance, age, performance status, line of treatment and presence of significant comorbid conditions were not associated with grade 3/4 AE in univariate analysis. Conclusions: Sorafenib is effective in a ”real world”, less selected patient population with MRC but leads to more toxicity than described previously. [Table: see text]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
