We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Carbamazepine for prevention of oxaliplatin-related neurotoxicity in patients with advanced colorectal cancer: Final results of a randomised, controlled, multicenter phase II study.
- Authors
Stefan von Delius; Florian Eckel; Stefan Wagenpfeil; Martina Mayr; Konrad Stock; Frank Kullmann; Florian Obermeier; Johannes Erdmann; Renate Schmelz; Stefan Quasthoff; Helmuth Adelsberger; Rainer Bredenkamp; Roland Schmid; Christian Lersch
- Abstract
<div class="abstract"><a name="abs1"/><span class="abstractheading">Summary??</span>Background:Oxaliplatin-induced neurotoxicity is a growing, relevant clinical problem. In this study we evaluated the efficacy and safety of carbamazepine for prevention of oxaliplatin-associated neuropathy in patients with advanced colorectal cancer.<div class="abstractpara"><div class="">Methods:Chemotherapeutic treatment consisted of oxaliplatin 85?mg/m2given biweekly and weekly folinic acid 500?mg/m2followed by a 24-h infusion of 5-FU 2000?mg/m2(FUFOX). One cycle consisted of six consecutive weeks of treatment followed by two weeks of rest (=Treatment B). For Treatment A carbamazepine was added in a dosage for targeted plasma levels of 4?6?mg/L.</div></div><div class="abstractpara"><div class="">Neurotoxicity was regularly assessed using a specific scale. Moreover, an evaluation of chronic sensory symptoms and a neurologic examination including tests for vibrational sense, strength and deep tendon reflexes were added creating a peripheral neuropathy (PNP) score.</div></div><div class="abstractpara"><div class="">Results:The prospectively defined adequate number of patients needed to provide power for the primary outcome could not be achieved. 19 patients were assigned to Treatment A and 17 to Treatment B. At baseline, the distribution of all clinicopathologic variables was comparable between the two groups. Overall response rates were 16% and 24% and overall survival 15.1 months and 17.4 months for Treatment A and Treatment B, respectively. Between Treatment A and Treatment B there were no major differences when considering worst neurotoxicity during the study period (p=0.46). Grade 3/4 neurotoxicity occured in 4 patients with Treatment A vs. 6 patients with Treatment B. There were no major differences between both groups in each category of the PNP score.</div></div><div class="abstractpara"><div class="">Conclusions:Based on the small number of patients and low statistical power of our study definite conclusions regarding efficacy and safety of carbamazepine for prevention of oxaliplatin-associated neuropathy in patients with advanced colorectal cancer cannot be drawn.</div></div></div>
- Publication
Investigational New Drugs, 2007, Vol 25, Issue 2, p173
- ISSN
0167-6997
- Publication type
Academic Journal
- DOI
10.1007/s10637-006-9010-y