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The Challenges of Treating Cancer in Older Patients
The challenges of trials include ageist attitudes, personal beliefs, Older patients are significantly under-represented in cancer clinical
elderly beliefs, end-points of trials, practicality, feasibility, funding and trials. Age is a significant barrier to recruitment; only one-quarter to
publication related to the elderly. To provide evidence-based literature one-third of potentially eligible older patients are enrolled into trials.
28
on the evaluation and management of elderly patients with cancer, Most of the trial protocols limit the eligibility to participate on the basis
clinical trials are needed to guide medical professionals in their of age, with the cut-off being between 65 and 70 years of age. This
decisions. This was recognised in 1989 when the US Food and Drug automatically excludes many patients on chronological age alone,
Administration (FDA) issued a recommendation that elderly patients without evaluating their health performance. The heterogeneity of this
should not be excluded from clinical trials.
4,22
group of patients indicates the need to develop objective patient
performance evaluation methods.
5,28
Despite this, the under-representation of elderly patients in cancer
treatment trials is a persistent problem that is a result of scant elderly Screening tests may become more accurate in older individuals
specific trials and unfair inclusion criteria favourable for younger because of the increased prevalence of cancer, but may be less
beneficial as a result of more limited patient life expectancy. With
more limited life expectancy, the effect of treatment on quality of life
is paramount. Reliable assessment of quality of life is essential for
Omission of primary surgery in
interpreting clinical trials in older individuals. Today’s older patient is
unselected elderly women with much healthier and more active than in previous years. There is clearly
operable breast cancer who were fit for
a healthy subgroup of the elderly who can benefit from standard
therapy. Because of the exclusion of patients with pre-existing diseases
the procedure resulted in an increased
from clinical trials, few data are available on which to base optimal
rate of progression, therapeutic
cancer treatment.
29,30
Current evidence suggests that the health of the
oldest-old is improving and that interventions can still be successful
intervention and mortality.
even in more advanced age groups.
31
Omission of primary surgery in unselected elderly women with
patients. Without developing new trials designated especially for the operable breast cancer who were fit for the procedure resulted in an
elderly and improving their inclusion in the existing studies, it is increased rate of progression, therapeutic intervention and mortality.
32
difficult to determine how this population should be treated. The reasons for not recommending surgery were protocol exclusion
criteria affecting the elderly, many patient factors, treating clinician
Fewer than 3% of newly diagnosed adult cancer patients participate in factors, lack of knowledge base and unfounded fear of adverse
clinical trials, with the rate of elderly enrolment reaching only treatment outcome. In a recent study by O’Connell et al.,
33
among the
25%.
23–26
The European Organisation for Research and Treatment of
Cancer (EORTC) conducted an analysis of European trials in which
22% of the patients were aged 65 years or older and 8% were aged
The reasons for not recommending
70 years and older. The EORTC investigators, as well as others,
advocate that the elderly should be candidates for all phases of clinical surgery were protocol exclusion criteria
trials and that they should not be excluded on the basis of age.
affecting the elderly, many patient
There seems to be a need for a more comprehensive tool of pre-
factors, treating clinician factors, lack of
treatment assessment so that the potential problems in treating elderly
knowledge base and unfounded fear
patients can be predicted and avoided. Because ageing is the result of
highly individualised processes, an assessment should be made of each
of adverse treatment outcome.
patient to adequately plan therapy.
6
If we consider the low numbers of
clinical trials dedicated to the elderly, and especially surgical trials, the
effectiveness of these studies in the development of unique therapies many reasons cited for not receiving cancer-directed surgery, “not
for this group of patients seems to be very limited. It is important to recommended” achieved statistical significance. Rates of refusing
identify the barriers to patient participation in clinical trials in order to surgery were <13.1% and contraindicated in <21.5%. Age was
reduce the disparity in the care of elderly cancer patients. a strong predictor, beginning at 75–79 years, for which there was a
steady increase in odds of surgery not being recommended. Hazard
A literature review was undertaken to identify the barriers that impede analyses showed that patients with all types of tumour who received
the accrual of this vulnerable population into clinical trials and to cancer-directed surgery had a decreased hazard of dying.
33
determine what specific strategies are needed to improve the
representation of older patients in research studies. The perceptions of Clinician attitude and knowledge of the available ongoing clinical trials
physicians, protocol eligibility criteria with restrictions on co-morbid is the second most frequent factor related to patient enrolment.
34
conditions and functional status to optimise treatment tolerability are Often, doctors do not check the current trials in order to find suitable
the most important reasons resulting in the exclusion of older patients. treatments for elderly patients, resulting in very low inclusion. In
Other barriers include the lack of social support and the need for extra addition, older patients are not included mainly because of their age
time and resources to enrol these patients.
27
and associated higher rate of co-morbidities, leading to clinician
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