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GERIATRIC ONCOLOGY AND CLINICAL TRIALS
Geriatric Oncology and Clinical Trials
Stuart M. Lichtman, MD
OVERVIEW
The overall aging of the population has resulted in a marked increase in the number of older patients with cancer. These patients have
specific needs that are different from those of the younger population. Cancer clinical trials have included an inadequate number of
older patients, resulting in lack of meaningful data to make evidence-based decisions for this population. As a result, clinicians have
to extrapolate data from younger and healthier patients. There are a number of reasons for this under-representation, including a
design and implementation structure for clinical trials that does not meet the needs of this vulnerable population. Issues that need to
be addressed include alterations in eligibility criteria to make them less restrictive by accounting for multiple comorbidities and prior
malignancy and endpoints specific for older patients, such as quality of life, changes in function, and maintenance of independence.
Other issues specific to the older population include alterations in dose-limiting toxicity, measures of treatment-related toxicity, and
polypharmacy. Phase I trials can be appropriate for older patients but need to be tailored to their needs. Some form of geriatric
assessment needs to be included to help with eligibility, assessment, and stratification. For future clinical trials to be truly meaningful
they need to appropriately assess and incorporate the needs of the majority of the cancer population.
The demographic shift and the resultant increase in the
number of older patients with cancer, which was predicted
by the founders of geriatric oncology (Dr. B.J. Kennedy,
Dr. Rosemary Yancik, and others), has now arrived. It
has long been recognized that the most signifıcant risk factor
for the development of cancer is aging. Cancer and its treatment
can affect the overall life expectancy, as well as the active
life expectancy and function, of older individuals. The
traditional study approach to cancer, with its focus on
younger, healthier patients, has resulted in a lack of highquality
data to adequately guide care for older patients. In
1983, Dr. Yancik organized a symposium sponsored by the
National Cancer Institute and the National Institute on Aging
and published a monograph, “Perspectives on Prevention
and Treatment of Cancer in the Elderly,” highlighting the importance
of research in cancer and aging. 1 In the 1988 American
Society of Clinical Oncology (ASCO) Presidential
Address, Dr. Kennedy encouraged the study of aging and
cancer. 2 He stated, “Our society need not ration how we will
treat our disadvantaged members, but should continue to
seek those preventive and positive measures that can shorten
our later period of morbidity. A very major cancer load will
persist well into the 21st century, even if the attempts at prevention
are eventually a total success. There is a developing
knowledge on aging. Care of the older person needs to be part
of medical education and oncology education. Research will
help attain a desirable quality of life with aging and a reduced
morbidity.”
The goals set forth by Drs. Yancik and Kennedy are yet to
be fully achieved; however, many strides have been made toward
that end. There has been increased recognition of the
importance of the relationship between aging and cancer, as
well as an increase in evidence-based research to guide the
care of older adults with cancer. In addition, this research is
being performed by a growing number of investigators at institutions
across the nation, as well as internationally. The
International Society of Geriatric Oncology, founded in the
year 2000, fosters the mission of developing health professionals
in the fıeld of geriatric oncology to optimize treatment
of older adults with cancer, through education, clinical
practice, and research. The Society’s publication, the Journal
of Geriatric Oncology, is the fırst journal devoted solely to the
fıeld. The Cancer in the Elderly Committee of the Cancer and
Leukemia Group B (now the Alliance for Clinical Trials in
Oncology) has supported furthering research in geriatric oncology
through clinical trials and secondary data analyses.
The Cancer and Aging Research Group has developed an instrument
to predict chemotherapy toxicity, initiated and
supported trials to validate this methodology in different
clinical settings, and, most importantly, mentored junior investigators
in geriatric oncology. The Gynecologic Oncology
Group Elderly Taskforce is supporting the fırst
prospective trial in older women with ovarian cancer and
planning further studies in other diseases and modalities.
The American Society of Clinical Oncology has also fostered
a number of initiatives in geriatric oncology. These
From the Memorial Sloan Kettering Cancer Center, Commack, NY.
Disclosures of potential conflicts of interest are found at the end of this article.
Corresponding author: Stuart M. Lichtman, MD, Memorial Sloan Kettering Cancer Center, 650 Commack Road, Commack, NY 11725; email: lichtmas@mskcc.org.
© 2015 by American Society of Clinical Oncology.
asco.org/edbook | 2015 ASCO EDUCATIONAL BOOK
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