Short summary

Older cancer patients are underrepresented in clinical cancer trials. This group of patients is very heterogenic; many patients have one or more chronic diseases (comorbidity) which are treated with different medications. In this prospective, observational study, we wish to investigate the association of such co-medication on toxicity to and effect of taxane-based chemotherapy in cancer patients above or equal to 70 years. 

Rationale

Approximately 45% of all diagnosed cancer patients in Denmark are aged 70 years or more. Ageing is a heterogeneous process that involves a progressive decline in the functional reserve of multiple organs and systems, increasing susceptibility to stress caused by disease, treatment, and complications to both.

Elderly cancer patients are underrepresented in clinical trials. Furthermore, the senior cancer patients included in clinical trials only represent the fittest part of the population. Therefore, our knowledge of effect and tolerability in elderly cancer patients is very limited. It is irresponsible to transfer study results obtained from a younger, often more healthy population, but unfortunately this is common practice. Therefore, there is a considerable need of clinical research specifically aimed at elucidating specific problems in this population. Elderly with and without comorbidity and polypharmacy should be included.

Elderly cancer patients are at increased risk of polypharmacy (PP), both because of increasing comorbidity with age, and because of the complex treatment of cancer, which often includes multiple antineoplastic agents used together with supportive care agents such as antiemetics, antibiotics and analgesics. In addition to the number of drugs consumed on a daily basis, PP can also be characterised by a potential inappropriate intake of medicine (PIM). The risk of drug-related problems, such as adverse effects and drug-drug interactions have been shown to be linearly associated with the number of drugs consumed on a daily basis. Age-related changes in organ function might significantly impact pharmacokinetics and pharmacodynamics of drugs. Drug-drug interactions could alter the effect of antineoplastic treatment, reducing the effect and/or increasing treatment toxicity.

Based on the current literature, we hypothesize that elderly patients exposed to PP, PIM, or potential Drug Interactions (PDI) will experience

• increased treatment related toxicity.
• reduced efficacy to treatment, mainly due to decreased adherence.
• Reduced overall and disease specific survival.

Description of the cohort

This is a prospective, observational study. Patients aged 70 years or above and about to start a taxane-based chemotherapy regimen are candidates. Patients receiving concomitant chemo-radiation will be excluded.

Data and biological material

Background data:

• patient data
• Disease data
• Treatment data

Exposure data:

• Medications taken on a daily basis

Effect data (toxicity)

• Adverse events to treatment
• Hospital admissions

Collaborating researchers and departments

Department of Geriatric Medicine, Odense University Hospital

• Consultant geriatrician Jens-Ulrich Rosholm