von Delius, Stefan and Eckel, Florian and Wagenpfeil, Stefan and Mayr, Martina and Stock, Konrad and Kullmann, Frank and Obermeier, Florian and Erdmann, Johannes and Schmelz, Renate and Quasthoff, Stefan and Adelsberger, Helmuth and Bredenkamp, Rainer and Schmid, Roland M. and Lersch, Christian (2007) Carbamazepine for prevention of oxaliplatin-related neurotoxicity in patients with advanced colorectal cancer: Final results of a randomised, controlled, multicenter phase II study. INVESTIGATIONAL NEW DRUGS, 25 (2). pp. 173-180. ISSN 0167-6997,
Full text not available from this repository. (Request a copy)Abstract
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. Methods: Chemotherapeutic treatment consisted of oxaliplatin 85 mg/m(2) given biweekly and weekly folinic acid 500 mg/m(2) followed by a 24-h infusion of 5-FU 2000 mg/m(2) (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. 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. 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. 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PERIPHERAL-NERVE HYPEREXCITABILITY; NEUROPATHY; 5-FLUOROURACIL; LEUCOVORIN; ORMAPLATIN; TRIAL; MODEL; ACID; oxaliplatin; neurotoxicity; carbamazepine; randomised clinical trial; colorectal cancer |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 16 Dec 2020 10:30 |
| Last Modified: | 16 Dec 2020 10:30 |
| URI: | https://pred.uni-regensburg.de/id/eprint/32956 |
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