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Clinical Trials in the Elderly — A Concept Comes of Age
Journal Scan
CLINICAL TRIALS IN THE ELDERLY — A CONCEPT COMES OF AGE* Lillian L. Siu, MD
A well-conducted, randomized, controlled trial provides a high level of evidence to guide clinical management. Although this tenet is accepted in all fields of medicine, including oncology, considerable challenges are associated with conducting randomized, controlled trials successfully in special patient populations such as the elderly. When approached, many elderly patients are willing to participate in clinical research, but they may be unaware of opportunities other than those offered by their own physicians. Logistic and financial barriers may further impede the recruitment of older adults for clinical trials. Ready access to information concerning ongoing studies, the development of an appropriate infrastructure to streamline procedures for clinical trials, a reduction in the number of extraneous protocol investigations, and the reimbursement of patients for costs incurred during clinical trials are practical strategies to optimize the number of older patients who participate in them. The performance of clinical trials that have proportionate representation of the elderly would permit the translation of the results to older patients and allow for direct comparisons of results for younger and older patients who have been treated in similar ways. This approach is reasonable for interventions that have favorable therapeutic indexes or if there is preliminary evidence suggesting that the tolerability associated with these interventions is independent of the patient’s age. For instance, many molecularly targeted anticancer agents have toxicity profiles that are acceptable in patients in all age ranges, provided that the patient has adequate organ function and sufficient performance status. In a randomized, controlled trial of an epidermal growth factor receptor inhibitor in patients with advanced non–small-cell lung cancer, more than half of the total accrual included patients 60 years of
Apollo Medicine, Vol. 5, No. 3, September 2008
age or older. There was no difference in the response rate or survival benefit according to age, and the toxic effects of treatment were manageable overall. The findings from this study can be useful in guiding the treatment of older patients with advanced non-small-cell lung cancer. Clinical trials focusing exclusively on the geriatric population, such as the study conducted by Keime-Guibert and colleagues, evaluate therapeutic regimens tailored to meet the specific needs of the older patient. These studies, especially in the randomized, phase 3 setting, can be difficult to conduct and complete, even though the questions being addressed are fundamental and often lead to changes in practice. In the cancer literature, examples of trials that have fulfilled these goals are few and far between. From the societal perspective, the graying of the population has substantial implications for the consumption of drugs and health care. The costs of therapies for cancer, especially in the current era of molecular targeting, are high and escalating. The evaluation of drugs or other interventions should involve patients with demographic characteristics that are representative of other patients with the disease. The prescription of therapies to the elderly on the basis of trial information obtained primarily from younger, more fit patients does not constitute good clinical practice. The collection of evidence-based data ensures that therapies are prescribed to the older patient when they may offer a meaningful gain in survival, quality of life, or both, and avoided in situations in which they may not be beneficial. The conduct of randomized, controlled trials for the treatment of cancer in older patients is no longer a theoretical concept –it is a reality that has come of age. *SOURCE INFORMATION: New England Journal of Medicine, Volume 356:1575-1576, April 12, 2007. From the Division of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, and the Department of Medicine, University of Toronto-both in Toronto.
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CLINICAL TRIALS IN THE ELDERLY — A CONCEPT COMES OF AGE* Lillian L. Siu, MD
A well-conducted, randomized, controlled trial provides a high level of evidence to guide clinical management. Although this tenet is accepted in all fields of medicine, including oncology, considerable challenges are associated with conducting randomized, controlled trials successfully in special patient populations such as the elderly. When approached, many elderly patients are willing to participate in clinical research, but they may be unaware of opportunities other than those offered by their own physicians. Logistic and financial barriers may further impede the recruitment of older adults for clinical trials. Ready access to information concerning ongoing studies, the development of an appropriate infrastructure to streamline procedures for clinical trials, a reduction in the number of extraneous protocol investigations, and the reimbursement of patients for costs incurred during clinical trials are practical strategies to optimize the number of older patients who participate in them. The performance of clinical trials that have proportionate representation of the elderly would permit the translation of the results to older patients and allow for direct comparisons of results for younger and older patients who have been treated in similar ways. This approach is reasonable for interventions that have favorable therapeutic indexes or if there is preliminary evidence suggesting that the tolerability associated with these interventions is independent of the patient’s age. For instance, many molecularly targeted anticancer agents have toxicity profiles that are acceptable in patients in all age ranges, provided that the patient has adequate organ function and sufficient performance status. In a randomized, controlled trial of an epidermal growth factor receptor inhibitor in patients with advanced non–small-cell lung cancer, more than half of the total accrual included patients 60 years of
Apollo Medicine, Vol. 5, No. 3, September 2008
age or older. There was no difference in the response rate or survival benefit according to age, and the toxic effects of treatment were manageable overall. The findings from this study can be useful in guiding the treatment of older patients with advanced non-small-cell lung cancer. Clinical trials focusing exclusively on the geriatric population, such as the study conducted by Keime-Guibert and colleagues, evaluate therapeutic regimens tailored to meet the specific needs of the older patient. These studies, especially in the randomized, phase 3 setting, can be difficult to conduct and complete, even though the questions being addressed are fundamental and often lead to changes in practice. In the cancer literature, examples of trials that have fulfilled these goals are few and far between. From the societal perspective, the graying of the population has substantial implications for the consumption of drugs and health care. The costs of therapies for cancer, especially in the current era of molecular targeting, are high and escalating. The evaluation of drugs or other interventions should involve patients with demographic characteristics that are representative of other patients with the disease. The prescription of therapies to the elderly on the basis of trial information obtained primarily from younger, more fit patients does not constitute good clinical practice. The collection of evidence-based data ensures that therapies are prescribed to the older patient when they may offer a meaningful gain in survival, quality of life, or both, and avoided in situations in which they may not be beneficial. The conduct of randomized, controlled trials for the treatment of cancer in older patients is no longer a theoretical concept –it is a reality that has come of age. *SOURCE INFORMATION: New England Journal of Medicine, Volume 356:1575-1576, April 12, 2007. From the Division of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, and the Department of Medicine, University of Toronto-both in Toronto.
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