[Chemotherapy in patients with colorectal carcinoma: applicability of data from clinical trials for the individual patient].
Randomised, controlled clinical trials provide a valid foundation for evidence-based clinical guidelines. The representativeness of the patient population studied is one major aspect of external validity. With respect to the patient population enrolled in clinical trials studying the effects of chemotherapy in patients with colorectal cancer, older patients are significantly underrepresented, i. e., they represent between 14 and 40 % of the study population, but approximately 70 % of the population concerned. The major reasons for the exclusion of older patients are comorbidities and functional status. Moreover, gender differences in pharmacokinetics and therapeutic effects of 5-fluorouracil are usually not considered. Although individualisation of therapy by means of pharmacogenetics and pharmacogenomics may offer promising options, to date these methods are still not in routine use for colorectal cancer patients. Due to a lack of information about the relevant populations from randomised controlled trials, data from registries and observational trials are necessary to complement our knowledge.
Thürmann
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PA
Philipp Klee-Institut für Klinische Pharmakologie, HELIOS Klinikum Wuppertal. petra.thuermann@helios-kliniken.de
D000367:Age Factors; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D015897:Comorbidity; D019317:Evidence-Based Medicine / Q000706:statistics & numerical data*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000517:prevention & control; D009367:Neoplasm Staging; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D015983:Selection Bias; D012737:Sex Factors; D016019:Survival Analysis
D000970:Antineoplastic Agents; D005472:Fluorouracil