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2 Prepared Presentations and Discussion
Pages 3-91

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From page 3...
... Older cancer patients continue to be underrepresented in clinical trials. Hospice care is covered by the Centers for Medicare and Medicaid Services (CMS)
From page 4...
... They are often living with complications of treatments that at the time were much more radical and much more toxic than procedures of today. Some final thoughts as we begin our discussion: I think the older cancer patient provides an opportunity for us to think of all the issues that we face in cancer care, including quality of care, access to care, survivorship concerns, and end of life.
From page 5...
... In Figure 2-1, the proportion of cancers in all sites in the 65 and older population is 56 percent; for many individual tumors, the proportions rise much higher. TABLE 2-1 Median Age of Cancer Patients at Diagnosis, 2000–2003 Male Female Cancer Site Median Age Number Median Age Number Breast 67 1,720 61 212,920 Colon 71 49,220 75 57,460 Corpus uteri -- -- 63 41,200 Leukemia 66 20,000 68 15,070 Lung 70 92,700 71 81,770 NHL*
From page 6...
... NHL = non-Hodgkin's lymphoma. SOURCE: Adapted by Yancik from NCI SEER Program Data, 2000–2003.
From page 7...
... FIGURE 2-3 All-site cancer incidence rates by age and sex, 2000-2003. SOURCE: Adapted by Yancik from NCI SEER Program Data 2000–2003.
From page 8...
... FIGURE 2-5 Male deaths for lung, prostate, and colorectal cancer by age, 2000. SOURCE: Adapted by Yancik from NCI SEER Program Data, 2000–2003.
From page 9...
... life expectancy is almost twice as high as it was in 1900. This is very important.
From page 10...
... The presence of comorbidities and cancer in older patients was mentioned earlier. The remainder of this presentation features data on female breast cancer which, after lung cancer, is the second highest cause of U.S.
From page 11...
... . To briefly describe this sample of new breast cancer patients, 73 percent were diagnosed with stage I or II disease, 10 percent with stage III or TABLE 2-3 Cause of Death in Breast Cancer Sample 55–64 65–74 75–84 85+ Total Breast cancer 48 (75.0)
From page 12...
... Breast cancer is presented as an example; other cancers in the context of comorbidity must be integrated. It is not known which diseases and other age-related health conditions are present at the time of a cancer diagnosis and to what extent the concomitant conditions compete for care and treatment, nor is there much information on how to treat cancer in the presence of pre-existing chronic conditions.
From page 13...
... So we are stuck with the 65 and older definition, but we always have to qualify it. I should mention that, in the breast cancer study's case, the 55 to 64 interval was added as a comparison group, because this malignancy's incidence tends to rapidly increase in the postmenopausal years.
From page 14...
... Speaking from a cancer care perspective, focusing on the second part of the title given to me, "implications for medical oncology," is very important. What workforce will be in place to care for older patients with cancer and concurrent health problems?
From page 15...
... Mortality from hip fracture is so much higher than from breast cancer in late life, but we will not give treatments that help hip fracture if they might affect breast cancer risk. We need to rethink how we balance our treatment decisions and perhaps even the way we do clinical trials in light of the biology and natural history of some kinds of cancer in older people.
From page 16...
... I want to emphasize the issues raised about the setting of care for older people, in particular home care support. Within the last month, I finished a study that followed 100 lung cancer patients in my cancer center.
From page 17...
... Aging is marked by increased heterogeneity across organ function, comorbidities, functional status, life experiences, and support systems, among others. There is a decreased ability to maintain homeostasis due to decreased functional reserves and impaired compensatory mechanisms.
From page 18...
... 2-4 lists the declining functional status with age in a group of older cancer patients in New Mexico. The important thing to note is the increasing challenges focused primarily in the oldest-old in bathing, transfers, toileting, dressing, and other activities related to mobility.
From page 19...
... Having said this, what do doctors say that they do? In a survey of over 2,000 primary care physicians who responded to scenarios about women ages 70, 80, or 90 at three levels of comorbidity and disability, 31 percent were somewhat or very likely to offer a mammographic screening to a frail, 90-year-old woman with a median life expectancy of 1.8 years, and 79 percent were somewhat or very likely to offer screening to a healthy 80year-old woman with a median life expectancy of 13 years (Heflin et al., 2006)
From page 20...
... However, people with cancer over age 65 are substantially underrepresented in clinical trials to define these problems and in general. This is particularly true of breast cancer patients: women age 65 or older make up 49 percent of the population with breast cancer, but only 9 percent of those participating in breast cancer clinical trials (Hutchins et al., 1999)
From page 21...
... Table 2-5 displays results from a study of 1,859 women 65 and older, with 20 percent in the 80 and older group, who presented with stage I or stage II breast cancer between 1990 and 1994. Although the data show some effects by comorbidities and risk of recurrence (tumor characteristics)
From page 22...
... . Even though there are no clinical trials that have been designed to look at what is recommended for surveillance for older breast cancer patients or for breast cancer patients in general, data from our studies indicate that guideline surveillance is not only associated with a 0.66-fold decrease in the odds of mortality (95 percent confidence interval [CI]
From page 23...
... Considering the declines with increasing comorbidity within age groups, but also how amazingly long the average future life is, can be useful when assessing older cancer patients. It is also important to estimate the probability of future life expectancy for the individual as that estimate may deviate from the averages shown in Figure 2-10.
From page 24...
... We have much more to learn, and our care systems need to be redesigned to facilitate appropriate assessment and care coordination among primary care providers and cancer specialists for this burgeoning population, particularly its vulnerable subcomponents, of cancer patients.
From page 25...
... That is a very important goal, but it may mean the elimination of distracting influences. Can we perform clinical trials that are aligned with the goals of treatment -- sometimes it might be eradication of the tumor or a cure -- but couldn't we also do trials that examine which of several dosage-adjustment protocols or agent choices give the longest independent functioning or something to that effect?
From page 26...
... It may be hormonal therapies in both breast and prostate cancer. These patients often have localized disease, and for them we do not necessarily need more clinical trials.
From page 27...
... One might find maybe a sub-subgroup that you can just treat with endocrine therapy with lumpectomy, but, by and large, they all need radiation, and there have been some targeted trials looking at older women. We are talking about management strategies where for many tumors, such as prostate cancer and colon cancer, there have been good overviews of the clinical trials data in elderly people who did participate, and they do tolerate adjuvant therapy.
From page 28...
... We have a very at-risk population here, because of comorbidity, because of different handling of drugs, and because of the likelihood of polypharmacy. And so, even if we look at physiological rather than chronological age in terms of their eligibility for clinical trials, because of these factors many elderly people will be automatically excluded.
From page 29...
... In the past, the Food and Drug Administration (FDA) demanded that there be uniformity in all of the patients in clinical trials for ease in analyzing the data, even though we know that the drugs were going to be prescribed for people who were anything but the ideal persons in the trials.
From page 30...
... Dr. Khleif: We have taken a number of steps, such as geriatric oncology and committees or consortia for older cancer patients, and now I am wondering if there are options beside clinical trials specifically for older persons?
From page 31...
... Vulnerability to disability with cancer and cancer treatment is affected by functional status prior to treatment. Our understanding of disability in the older cancer patient is strongly affected by the current approach to obtaining evidence.
From page 32...
... scores, patients were compared with national norms for ages 55–64 immediately before a cancer diagnosis and at 6 to 8 weeks after diagnosis. The data confirm that older cancer patients referred for cancer care are a select group.
From page 33...
... We should also be able to monitor recovery of function and persistent disability in the cancer survivor. Such a measure must be sensitive to small but important change and also feasible with proxy respondents, since the more disabled cancer patients are less likely to respond for themselves.
From page 34...
... In a recent study, I applied concepts about active life expectancy to the way we look at older patient's experience with cancer and cancer treatment. I used simple measures of number of days spent in bed and number of days unable to get out of the house as an alternative way to describe the cancer treatment experience.
From page 35...
... We do not have consensus on how to detect neuropathy or when to alter treatment because of it, but it is an emerging important issue. A recent study of peripheral neuropathy in ovarian cancer patients in remission after initial chemotherapy (carboplatin and paclitaxel)
From page 36...
... For example, functional status end points could be assessed in prostate cancer patients on androgen blockage who are assessed in a clinical trial of agents that reduce loss of muscle
From page 37...
... If we are causing these problems, we should track and intervene in combined ways. I hope, as we move toward keeping cancer patients alive longer and dealing with cancers that seem to smolder for a long time, that we think of disability as an important element for treatment consequences.
From page 38...
... However, we know that we are dealing with many chronic diseases -- diabetes or heart failure or cancer -- where patients may want to maintain their function rather than to decline. My concerns are how do we change the rehabilitation community, which does not like to deal with these patient populations, and how do we change reimbursement policy so that maintenance of function, keeping somebody independently functioning at home and deferring an assisted-living situation, can be an accepted goal?
From page 39...
... We can be proud that the Oncology Nursing Society has stepped forward for many vulnerable populations, and I certainly think that older people are one of these vulnerable populations. We did so for the needs of cancer survivors, and we wrote our first position paper on cancer in elderly people in 1992 and did a second edit of that paper as a joint position statement in concert with the Geriatric Oncology Consortium in 2004 (Oncology Nursing Society and Geriatric Oncology Consortium, 2004)
From page 40...
... We tell a patient that she has a very curable breast malignancy, but all she can remember is that her husband had cancer and was dead in 6 weeks. We can not assume that the older patient can make the distinction between acute leukemia and early stage breast cancer.
From page 41...
... Cognitive dysfunction is one of the biggest deterrents to sending older cancer patients home and expecting a family to keep them at home. Much of these patients' delirium is caused by things that either we do to them or a metabolic problem.
From page 42...
... The hovering nature of many of these family caregivers can be absolutely all consuming. Although we often think that, by virtue of being old, there are not as many people in a person's social support network, it may be just the opposite.
From page 43...
... To continue with the breast cancer example and adherence, so many decisions on the use of tamoxifen as an adjuvant treatment or for prevention of breast cancer are based on extensive clinical trial data. But how do we know those women took the agent as instructed?
From page 44...
... Exclusion of elderly people from clinical trials not only limits the evidence base on best treatments for our patients, but it also means we lack toxicity data, its prevalence, and optimal management. Also, comorbidities may confound symptom recognition.
From page 45...
... Geriatric oncology and cancer survivorship share the feature that they are latecomers. The majority of people who survive cancer are elderly, and when we look at what kinds of cancers they had, a history of three primary solid tumors, breast, prostate, and colorectal, make up the majority.
From page 46...
... We need to acknowledge and incorporate some of the advances that are possible with the sophisticated technical support that is in development. In summary, those of us that work primarily with adult cancer patients do not think of ourselves as geriatric oncology nurses, but, in essence, we are.
From page 47...
... Also, under Dr. Hyman Muss they have looked at first-line therapy for older women with metastatic breast cancer.
From page 48...
... We do not think about cancer caregiving in terms of years, but if you examine caregiving from the initial diagnosis through therapy, potential progression, possible recurrence, and then perhaps even a second cancer or palliative care or end-of-life care, patients are involved with cancer a very long time. And when we have a second cancer or a late recurrence, family members tell us that they are already involved 4.6 years, on average.
From page 49...
... . Comorbidities add complexity to this population of cancer patients, and some of them even have more than one cancer.
From page 50...
... I recently heard a story that illustrates some of these problems. An elderly woman had breast cancer surgery.
From page 51...
... What are the factors affecting caregiver distress? The research includes gender, relationship (adult children versus spouse)
From page 52...
... These things are problems for family members of cancer patients. We have talked about geriatric syndromes such as falls, incontinence, and delirium, and I gave the example of the hip fracture.
From page 53...
... Often the formal home care referrals reviewed in our medical record audits are not consistent with patient need at discharge or later. Social support can also be lacking.
From page 54...
... We have many breast cancer studies. We have a fair number of prostate cancer caregiving studies.
From page 55...
... We have, in our studies, certain family members that use the emergency room as a security blanket every time something happens, rather than problem solve. There are few formal home care studies that examine cancer patients.
From page 56...
... For example, we have in our church a woman treated for breast cancer, and her husband needs to go on hospice for prostate cancer. This has resulted in a controversy as to whether he can use hospice because his wife is not going to be available enough to provide the care.
From page 57...
... What other kinds of things could we look at, and what could be outcomes? We need to think about variation in skills, because what works when a person is requiring a great deal of emotional support from a family member is different than when they are at end of life or in palliative care.
From page 58...
... Dr. Given: We have not been to Henry Ford or Kaiser, but we approached the Blue Cross Insurance plans in Michigan, and they said they did not have enough cancer patients in any one location, and the difficulty of their systems communicating with one another would make it difficult to gather information on time, place, and cost of various services.
From page 59...
... There is, as well, an IOM study, Approaching Death: Improving Care at the End of Life, that examines palliative care as a generic issue across all diseases, including cancers, and serves as a model with a set of recommendations, which also have been addressed only in part. And, lastly, there are some really terrific books out there.
From page 60...
... However, they need also to consider a good symptom assessment scale, information about the patient's shared decision-making process, where patients stand on advance directives, and goals of care. This is an opportunity where palliative care and geriatrics can come together, al
From page 61...
... In the care of the cancer patient we should build into the algorithm in Figure 2-12 that patients, depending on their needs, will receive palliative care. This is different than supportive care, which, in the cancer literature, is about treating symptoms caused by chemotherapy; it is about blood products.
From page 62...
... In the United States, the SEER data do not tell us the patients' place of death, how long they were there, or the quality of care. But the British do have some data, and what they are seeing over time in the older cancer patients is an increasing return to hospital for treatment and for care at the end-of-life (close to 50 percent of deaths at ages 65–94 in 1999)
From page 63...
... According to data from the Brown Medical School website (http://www.chcr.brown.edu/dying/MAPADALL.htm) examining formal advance directives in populations in nursing homes (which are, with hospitals, one of the two most common sites of death for cancer patients over age 75)
From page 64...
... This number has not changed, no matter what recommendations we have made. When research or career development funding for geriatrics is compared with funding for palliative care, the huge majority is for geriatrics.
From page 65...
... With this kind of information, we probably could create prediction models for cancer. For example, we have data to show that activities of daily living also are stable and then decline rapidly as death approaches for cancer patients compared to congestive heart failure, stroke, COPD, or diabetes.
From page 66...
... About 41.2 percent of nursing home residents who have pain on their first assessment experience moderate daily pain or excruciating pain on their second assessment. This is persistent pain in cancer patients in nursing homes, and statistics on pain in nursing home patients vary considerably across the United States.
From page 67...
... The cancer patients are more than twice as likely (45 percent versus 17 percent) as the national average to have advance directives, suggesting that they have been more thoughtful and focused on these issues.
From page 68...
... . The majority of patients over age 65 (48 percent of whom were cancer patients)
From page 69...
... There clearly are disparities in the access to hospice care, knowledge about hospice care, and the decision making about these issues for the African American population, where it has been best studied, and some data suggest similarities in the Hispanic population. As for a research agenda, Goldstein and Morrison, noting that the evidence base for palliative care in older people is sparse, suggested major areas that should be addressed, including establishing the prevalence of symptoms in patients with chronic disease; evaluating the association between treatment of symptoms and outcomes; increasing the evidence base for treatment of symptoms; understanding psychological well-being, spiritual well-being, and quality of life of patients, elucidating and alleviating sources of caregiver burden; reevaluating service delivery; adapting research methodologies specifically for geriatric palliative care; and increasing the number of geriatricians trained as investigators in palliative care research (Goldstein and Morrison, 2005)
From page 70...
... I think the regulations that control the nursing homes interfere with good care of cancer patients. That is the problem.
From page 71...
... The ultimate goal of economic study is to come up with policy recommendations through rigorous analysis of available evidence. Today, I will review the literature on the following four areas: the economic burden of cancer; the economics of cancer prevention in the elderly population; the economics of cancer treatment in the elderly population;
From page 72...
... . Total medical costs of cancer account for five percent of total healthcare expenditures in the nation, but in terms of Medicare expenditures, where the burden is concentrated, cancer patients account for about 10 percent of total costs.
From page 73...
... The finding that low-income elderly cancer patients spent about 27 percent of their annual income on medical costs, compared with only seven percent in the higher-income individuals is disturbing because it implies a much higher financial burden of cancer for a low-income elderly family (Langa et al., 2004)
From page 74...
... That is already very close to $2,250 where the coverage gap starts, and we know that in the elderly population outpatient drug costs will be a great deal higher. That means that it is possible that elderly cancer patients will reach the donut hole much earlier than most other elderly patients.
From page 75...
... However, even when Medicare covers screening thus removing the economic barrier, low rates of screening may persist in certain populations. For example, mammography screening benefits started in 1991, but a study of the rate of breast cancer screening before and after Medicare coverage found very little increase in utilization.
From page 76...
... Most studies also use a casecontrol approach so that they can attribute costs to cancer rather than cite total costs, and studies also combine survival information to try to look at the long-term care costs of cancer patients. Most studies do not consider structural changes, which means that assessments of long-term costs do not consider possible innovations that might lead to better outcomes in the future.
From page 77...
... These earlier data show that elderly cancer patients were treated less aggressively than younger cancer patients, especially in the terminal care phase. More recent studies, using data from the 1990s, have found increasing use of chemotherapy in the 65 and over population; one study found that use of adjuvant chemotherapy increased from 7.4 percent in 1991 to 16.3 percent in 1999 (Giordano et al., 2006)
From page 78...
... Medicare data from 1996–1999 show that hospice care costs $27,917 in the last year of life of cancer patients compared with costs of $29,905 for cancer patients who are not in hospice, so early studies concluded that hospice may be cost neutral or cost saving for Medicare (Campbell et al.,
From page 79...
... Many of the complications, such as lymphedema, pain, fatigue, and depression, are likely to be even more prevalent in the elderly population, either because of the biology of aging or, for example, because some breast cancer patients treated 20 years ago with more radical surgery are now accumulating in the older survivor populations. So those patients are in the system now, but we just do not know how costly they are to the system.
From page 80...
... The greater prevalence of comorbidities in the elderly cancer population might also increase the caregivers' burden. And the unequal financial burden for high- versus low-income cancer families might also apply to the informal caregiver population, as we know that poor families are less likely to use any kind of formal care for cancer patients because they can not afford to.
From page 81...
... We also need to reevaluate the disease burden and the cost-effectiveness of treatment to account for the unique physiologic characteristics of the elderly cancer population. We need to assess the effects of Medicare Part D and the Medicare Modernization Act on practice patterns, costs, and the disparities in financial burdens between high- and low-income cancer families.
From page 82...
... public database of all funded projects for cancer in the older population yielded 19 relevant projects: 12 were investigator initiated, either RO1s, R21s, or the small RO3s; five were K mechanisms, specifically focused on developing a career in working with the older population, and two in the U mechanism, which were not cooperative groups but cooperative agreements. And there were seven different foci of these projects: four of them were focused on novel treatment or dosing schedules unique to the older population; four on prevention and screening, of which two were really comparing screening in cancer patients for cancer versus noncancer patients and screening for hypertension, diabetes, and so on.
From page 83...
... Social support that would encourage enrollment of the elderly cancer population in trials is a problem. Finally, what we know about referral patterns to cancer centers, as well as what we have learned about cancer within Medicare, suggests barriers to access to clinical trials.
From page 84...
... The programs of the institute include biology TABLE 2-9 NIA Priority Areas for Integration of Aging/Cancer Research • Age-related factors in development of tumors in older persons • Time and its importance in developing cancer in a person's life span • Aggressive tumor behavior in the aged patient • Pharmacology of aging and cancer -- antitumor drug alterations • Prognostic indicators for patient evaluation and workup • Comorbidity, previous illness, and disabilities in older cancer patients • Occurrence of multiple primary tumors in the elderly • Cancer survivorship -- need long-term data on older cancer survivors • Access issues for older patients, their families, and physicians • Use generic age-related issues as in breast and prostate program announcements (PAs) SOURCE: Yancik, 1997b.
From page 85...
... ; aging, race, and ethnicity in prostate cancer; aging women and breast cancer; NCI clinical trials cooperative groups; studies on older patients; aging and risk factors for multiple primary tumors; cancer pharmacology and treatment in older patients; bioimaging techniques for early prostate cancer; long-term survivors research initiatives; interdisciplinary studies in genetic epidemiology of cancer; late medical effects of cancer treatment in older women; and diagnostic cancer imaging and radiation therapy in older patients. These have been issued as program announcements or requests for applications.
From page 86...
... The NIA and the NCI held a large workshop to explore the role of NCI-designated cancer centers for integrating aging and cancer research in 2001. We convened plenary sessions and seven working groups for 2 1/2 days.
From page 87...
... We have been trying to get the CMS to perform a chronic disease, cancerlike demonstration project, and I think that some coordinated effort from a variety of organizations might, in fact, help that to come about. In the targeted research area, although this is not elderly research, we have set aside $500,000 for pilot projects for palliative care research.
From page 88...
... A recent Agency for Healthcare Research and Quality (AHRQ) report noted the great increase in lumpectomies for treatment of breast cancer.
From page 89...
... Now there is some psychosocial support, but we really could be conveying better educational messages, and I think that is what we need to think about doing. Dr Ferrell: The American Cancer Society could make a great contribution by creating a "preparing to care for someone you love with cancer" program, where family members could come in and learn about caring throughout the whole trajectory of cancer care.
From page 90...
... At the end of November, the National Partners for Comprehensive Cancer Control are convening to talk about phase 4 of the leadership institutes and state plan implementation that begins in early 2007, and I made a number of notes today on things that ought to be considered. I will carry the message back about some of the issues you put on the table today.
From page 91...
... Only about five percent of older breast cancer patients with early-stage disease are African American, and this sort of thing makes the numbers problematic for studies in one geographic location. So you need to have integrated health systems or take advantage of SEER-Medicare data.


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