Document Detail

Carbamazepine for prevention of oxaliplatin-related neurotoxicity in patients with advanced colorectal cancer: final results of a randomised, controlled, multicenter phase II study.
MedLine Citation:
PMID:  16983507     Owner:  NLM     Status:  MEDLINE    
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.
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 M Schmid; Christian Lersch
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-09-13
Journal Detail:
Title:  Investigational new drugs     Volume:  25     ISSN:  0167-6997     ISO Abbreviation:  Invest New Drugs     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2006-12-22     Completed Date:  2007-04-02     Revised Date:  2014-07-29    
Medline Journal Info:
Nlm Unique ID:  8309330     Medline TA:  Invest New Drugs     Country:  United States    
Other Details:
Languages:  eng     Pagination:  173-80     Citation Subset:  IM    
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MeSH Terms
Aged, 80 and over
Anticonvulsants / adverse effects,  therapeutic use*
Antineoplastic Agents / adverse effects*,  therapeutic use
Carbamazepine / adverse effects,  therapeutic use*
Colorectal Neoplasms / complications*,  drug therapy
Middle Aged
Neurologic Examination
Neurotoxicity Syndromes / complications*,  drug therapy*
Organoplatinum Compounds / adverse effects*,  therapeutic use
Reg. No./Substance:
0/Anticonvulsants; 0/Antineoplastic Agents; 0/Organoplatinum Compounds; 33CM23913M/Carbamazepine; 63121-00-6/oxaliplatin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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