Speaker: Richard L. Schilsky, M.D., University of Chicago
Co-Chairs: Richard L. Schilsky, M.D., University of Chicago Joel E. Tepper, M.D., University of North Carolina School of Medicine
Clinical research on cancer is often conducted in individuals who are younger than those in whom the targeted malignancy predominates, and older patients in the NCI Cooperative Group clinical trials represent only a narrow subset of older cancer patients undergoing treatment in the United States. Although information on treatment tolerance and efficacy is very much needed for persons in the age groups in which the cancer primarily occurs (the median age range for most major tumors is 70–74 years at initial diagnosis), the unfortunate reality is that older patients tend not to meet clinical trial eligibility criteria and therefore are not referred to such trials. Other health problems and lack of social support (e.g., transportation, caregiver assistance) also preclude the entry of many elderly patients into these studies. Because so few older patients are enrolled in clinical trials, data from existing trials cannot be generalized to the older population as a whole. As one discussant said, "You have to enter older patients on trial to get data on them; if they do not get on trials, you do not get the data, and therefore, we [i.e., the cooperative groups] undoubtedly do have a very biased subset of elderly patients in clinical trials."
Working Group 2 discussed these issues in the context of promoting collaborative and innovative research and clinical and community applications via the NCI-designated cancer centers on behalf of older persons. With their flexible infrastructure for interdisciplinary research, the cancer centers are an ideal setting for integrating aging and cancer research.
Efforts to obtain information on patient tolerance of cancer therapy can be facilitated through the clinical studies of NCI-designated cancer centers. Some cancer centers have a circumscribed catchment area, virtually all have cancer registries, and all comprehensive cancer centers have an integrated research environment that fosters complex interactions to address the "big picture" problem and specific cancer treatment needs of the elderly.
Older patients represent a disproportionately large number of those treated for malignancies. Oncologists need to know how therapies will affect older cancer patients with less than ideal health as well as those with good to excellent health. Most older patients have some type of age-related health condition that could affect the cancer course or cancer treatment trajectories. The time course of absorption, distribution, metabolism, and excretion of drugs from the aged host (i.e., pharmacokinetics); the response of the aged host to the anti-cancer drug (pharmacodynamics); the course of radiation treatment; the surgery recommended; and the tolerance of these treatments could be affected by the following:
An infrastructure is needed to allow appropriate studies to be conducted in the older population. An organized research structure should incorporate the combined professional skills and experience of gerontologists and oncologists, nurses, social support personnel, and other health professionals. Without this infrastructure, conventional centers are unlikely to be able to perform these studies and the studies' applicability to the population as a whole is likely to be unclear. This effort should also provide the educational programs necessary for a successful research program. Many barriers could be overcome by an organized effort involving the cancer centers.
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