gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

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Association of CPT-11 pharmacokinetics and non-hematological toxicity in patients with advanced gastrointestinal cancer and influence of age

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  • corresponding author presenting/speaker Ute Merkel - Institut für Klinische Pharmakologie, Universitätsklinikum Jena, Deutschland
  • Katrin Farker - Institut für Klinische Pharmakologie, Universitätsklinikum Jena
  • Mandy Rückert - Institut für Klinische Pharmakologie, Universitätsklinikum Jena
  • Ulrich Wedding - Klinik für Innere Medizin II, Universitätsklinikum Jena
  • Marion Hippius - Institut für Klinische Pharmakologie, Universitätsklinikum Jena
  • Klaus Höffken - Klinik für Innere Medizin II, Universitätsklinikum Jena
  • Annemarie Hoffmann - Institut für Klinische Pharmakologie, Universitätsklinikum Jena

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPE220

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dkk2006/06dkk330.shtml

Published: March 20, 2006

© 2006 Merkel et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Objective: In patients with advanced gastrointestinal cancer, we investigated the association of non-haematological toxicities and the age of patients as well as pharmacokinetic parameters of irinotecan.

Methods: All patients received a chronomodulated infusional regimen consisting of irinotecan , 5-fluorouracil and folinic acid. Non-hematological toxicities (nausea, vomiting, mucositis/stomatitis, diarrhoea, fever, infection, mood alteration, motor neuropathy, sensory neuropathy and general condition) were monitored. The toxicities were evaluated according to NCI-CTCAE version 3.0 and the grading of the general condition was performed according to the performance status (WHO). For the evaluation of the pharmacokinetics of irinotecan blood sampling was performed up to 48 h from the end of infusion. Plasma concentrations of irinotecan were assayed using HPLC with fluorescence detection.

Results: Twenty-eight patients (17 men and 11 women, 27 colorectal cancer) were involved in this investigation. The age of the patients ranged between 38 and 79 years. Observed toxicity was moderate. Grade 4 toxicities of general conditions and mucositis/stomatitis occurred in 14% and 3% of the patients. Grade 3 diarrhoea, a characteristic non-hematological side effect of irinotecan therapy, experienced 18% of the patients. We did not find any association between the age and non-hematological toxicities. Considerable variability in the pharmacokinetic parameters of irinotecan was observed. The age of the patients was not significantly related to any of the studied kinetic parameters and had no effect on the observed variability. Cmax, AUC as well as CL were associated with severity of diarrhoea, nausea and mood alteration.

Conclusion: Our results show that non-hematological toxicities correlated with the pharmacokinetics of irinotecan. That means patients with higher irinotecan systemic exposures had more serious toxicities of diarrhoea, nausea and mood alteration. The findings suggest that age is not a predictor of irinotecan pharmacokinetics. In addition elderly patients have not experienced qualitative and/or quantitative altered non-hematological toxicities after chronomodulated chemotherapy of irinotecan, 5-FU and FS.

This project is supported by German Cancer Aid (grant AZ-70-2445-Hö3).