Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
von Delius, S; Eckel, F; Wagenpfeil, S; Mayr, M; Stock, K; Kullmann, F; Obermeier, F; Erdmann, J; Schmelz, R; Quasthoff, S; Adelsberger, H; Bredenkamp, R; Schmid, RM; Lersch, C.
Carbamazepine for prevention of oxaliplatin-related neurotoxicity in patients with advanced colorectal cancer: final results of a randomised, controlled, multicenter phase II study.
Invest New Drugs. 2007; 25(2):173-180
Doi: 10.1007/s10637-006-9010-y
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
- Quasthoff Stefan
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- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Aged, 80 and over -
- Anticonvulsants - adverse effects
- Antineoplastic Agents - adverse effects
- Carbamazepine - adverse effects
- Colorectal Neoplasms - complications
- Female - complications
- Humans - complications
- Male - complications
- Middle Aged - complications
- Neurologic Examination - complications
- Neurotoxicity Syndromes - complications
- Organoplatinum Compounds - adverse effects
- Find related publications in this database (Keywords)
- oxaliplatin
- neurotoxicity
- carbamazepine
- randomised clinical trial
- colorectal cancer