Clinical Trial Summary
Management of older cancer patients is challenging, due to a lack of good quality evidence to
guide treatment decisions, as well as the wide variability in the level of fitness for
treatment of elderly patients. Oncologists are faced with the challenge of determining the
most suitable treatment for an individual taking into account their comorbidities, competing
causes of death, quality of life and functional reserve.
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the western
world and ranks second among the most frequent malignancies in Europe in both men and women.
The incidence and mortality of CRC strongly increases with age. Approximately 60% of new
cases of CRC and 70% of CRC-related deaths occur in patients aged 65 years and older, with
about 40% of patients aged 75 years or older.
The oncologists' therapeutic decision-making for elderly patients with metastatic colorectal
cancer (mCRC) has been largely debated in the last few years, mainly because of the lack of
trial-based recommendations, due to the underrepresentation of patients more than 65 years
old in clinical trials. As a consequence, therapeutic choices in this setting are frequently
driven by data from retrospective, pooled and meta-analyses. These results do not necessarily
reflect the general population affected with mCRC and are often limited by potential
confounding factors.
It is well recognized that chronological age is not an effective criterion on which to base
therapeutic decisions. Rather, treatment tolerability in an older cancer patient is primarily
related to physiological or biological age, that is the level of fitness, which takes into
account factors such as functional status and comorbidities. Physiological age is better
assessed with a comprehensive geriatric assessment (CGA), a multidisciplinary evaluation
covering domains such as cognitive and mood status, functionality, comorbidities, and
nutrition. These deficits are prevalent in older patients but which may be missed with
routine evaluation.
There is now strong evidence that use of a CGA assessment in a general geriatric patient
population can improve health outcomes. While some form of geriatric assessment have been
recommended by specialist advisory panels for all elderly patients in whom chemotherapy is
considered, evidence of CGA leading to improved outcomes in a geriatric population with
cancer is very limited. CGA for older patients with cancer does appear to provide information
relating to prognosis, likelihood of toxicity from chemotherapy, and has been shown to
influence treatment decisions. However, this approach is time-consuming, leading cancer
specialists to seek an easier screening tool that can separate fit older patients with
cancer, who are able to receive standard cancer treatment, from vulnerable patients that
should subsequently receive a full assessment to guide tailoring of their treatment regimen.
The G8 is a simple 8-items screening tool, developed specifically for older patients with
cancer. This tool, addressed by the clinician, covers multiple domains, focusing on
nutritional status, mobility, neuropsychological problems, medication use, self-rated health
status and age. The G8 demonstrated a good sensitivity in identifying patients with
impairments across multiple domains when a cut-off of 14 points is adopted. Patients with a
score < 14 would be candidate to a CGA. Nevertheless, this cut-off showed poor specificity
and negative predictive value. Furthermore, some evidences suggested that the G8 might be
able to predict survival, while its predictive value for treatment-related toxicities has not
been extensively explored.
While literature data support a promising role for G8 as a simple cost-effective screening
tool in elderly patients, to date its use in clinical practice is not widespread, and only
selected centers with a focus in geriatric oncology routinely perform this assessment to
enhance the baseline evaluation of patients before treatment choice.
The lack of ''real life population'' data makes it difficult to evaluate the role of G8 in
the setting of common practice in an unselected population and to prove its efficacy and
reliability outside selected cases.
Moreover, recent data suggest how a physical performance test, such as Timed Up and Go, could
be a useful indicators of prognosis, functional decline and treatment-related complications.
This study is designed to promote a comprehensive evaluation of elderly patients before
treatment decisions and to prospectively evaluate the association of G8 assessment with
clinical outcome and treatment-related severe toxicity in the real life population of elderly
patients with colorectal cancer in Veneto. Additionally, preliminary data on feasibility and
reliability of Timed Up and Go measurement as prognostic determinant and dynamic marker, will
be collected.
