ABSTRACT: While there is no generally accepted medical definition of "futile care," many factors may play a role in the delivery of chemotherapy to patients who are unlikely to benefit. In this review, we consider the roles of both the patient and the physician in driving the provision of "futile care" and offer practical steps the oncologist can take to avoid it.
The use of the term ‘futility’ in cancer care has been prompted, in part, by increasing requests from patients for treatments thought to be ineffective as well as costly. The appropriate role of chemotherapy near the end of life is a complex issue. As chemotherapy is increasingly available and better tolerated, its use at life's end involves sophisticated oncologic assessment, a focus on the patient's goals of care, and a balancing of perspectives of the patient and treating oncologist.
A number of factors play a role in the delivery of chemotherapy to patients who are unlikely to benefit. Incentives ranging from the expectation of prolonged survival, symptom improvement, the preservation of hope, or simply not "wanting to give up" all contribute to some degree. In this review we hope to investigate these issues and expand on the role that physicians, patients, and even popular media may play.
What Is 'Futile Care'?
There is no generally accepted medical definition of futile care. If one considers that the goal of medical care is to achieve a benefit above a certain minimal threshold, then futile care could be defined as care that fails to achieve that benefit. The sticking point, then, is not one's definition of futility, but one's definition of benefit. That is why the application of the word "futility" in discussions of medical care is considered ethically hazardous, especially when the values of the physician are incongruous with those of his or her patient.
In addition, the inexact and somewhat unpredictable nature of medicine makes it a precarious endeavor to call a therapy futile unless, as Schneiderman narrowly defines it, "in the last 100 cases a medical treatment has been useless." He goes on to say that "physicians should distinguish between an effect, which is limited to some part of the patient's body, and a benefit, which the patient has the capacity to appreciate." Finally, one of the main reasons the word "futility" became unpopular is that it was perceived to be invoked when a therapy became too costly.
The moral implications of how futility is viewed are equally important as we deal with the emotionally charged issues surrounding the patient for whom further treatment will provide questionable benefit. Notably, the right to refuse a proposed treatment is considered a negative right. This means that if deemed to have decision-making capacity, a patient may refuse any medical care offered. However, a patient is not entitled to any intervention he or she requests that is not deemed medically indicated. In other words, a physician is not obligated to provide futile therapies. This does not mean that a physician should decline to provide requested therapy without a thorough, considered discussion with the patient and his or her family. The specter of futility may signal a turning point in the patient's trajectory at which it is most important to discuss and clarify benefits and burdens as well as goals of care.
The National Comprehensive Cancer Network (NCCN) may define futile care in the patient with metastatic breast cancer as any treatment beyond third-line chemotherapy in the metastatic setting or any treatment with cytotoxic therapy in a woman with an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater (www.NCCN.org). Is there a percentage benefit threshold under which the benefit is generally considered to be futile by patients or providers (eg, a less than 5% chance that therapy will allow patients to be alive at 1 year)? That threshold may depend on whether you are a patient or a payor if the chemotherapy involves expensive biologic agents such as erlotinib (Tarceva) or bevacizumab(Drug information on bevacizumab) (Avastin).
It is critical to understand that people looking death in the eye have a different perspective. Studies from the United States, England, Canada, Japan, Norway, and Italy consistently show that cancer patients generally were willing to undergo aggressive treatment with major side effects for very small chance of benefit—different from what their doctors or nurses would choose. Some American patients with previously treated non–small-cell lung cancer (NSCLC) would accept chemotherapy for a survival benefit as short as 1 week, while others would not, even for a benefit of 2 years (the actual expected benefit was ~3 months). What if the benefit were only to improve quality of life by reducing pain or dyspnea?
The American Society of Clinical Oncology could not decide on a minimal benefit for which chemotherapy was indicated, only that some benefit must be demonstrable in terms of improved survival, quality of life, or symptom control, or lessened toxicity. Consensus panels for supportive cancer care make little distinction between curative treatment and palliative treatment that could extend life, since 6 months of added survival could be as important as an increased rate of cure. Clearly, there are no easy definitions to what exactly patients, providers, and society consider to be futile care.
Chemotherapy at the End of Life
Over 20% of Medicare patients start a new chemotherapy treatment regimen in the 2 weeks before death, and a recent survey documented that the percentage of oncology practices giving chemotherapy within 2 weeks of death ranged from 0% to 34% (C. Desch, personal communication, 2006). Chemotherapy within days of death is unlikely to improve patient survival, produces side effects, precludes entry into most hospices, and typically requires expensive supportive care with erythropoietin(Drug information on erythropoietin)-like drugs and colony-stimulating factors (G-CSF [Neupogen] or GM-CSF [Leukine]). In a retrospective review of patients with incurable NSCLC, chemotherapy was given to 20% of patients within 2 weeks of death and to 43% of patients within 1 month of death. This was time lost for patients to fully take advantage of hospice services.
Palliative chemotherapy regimens have a huge price tag, at a cost of up to $100,000/yr per patient, and even insured patients can be burdened by 20% copayment requirements. The cost of palliative chemotherapy for colorectal cancer could easily be $50,000/yr, not counting supportive care drugs or imaging. Patients with cancer account for about 40% of all Medicare drug costs, totaling an estimated $5.3 billion in 2006, with $1.5 billion for erythropoietin-like drugs alone. Some drugs (oxaliplatin [Eloxatin] for metastatic colon cancer and docetaxel(Drug information on docetaxel) [Taxotere] for metastatic prostate cancer) have acceptable cost-effectiveness ratios. That is, treated patients do gain several weeks or months of life, at a cost less than $100,000 per additional year of life saved—but this is still additional money that must be spent.
How often do patients insist on receiving therapy with full knowledge that treatment is futile, or specifically, will not improve their survival or quality of life? There is little data on specific percentages, but lack of provider-patient communication regarding prognosis, goals of therapy, and benefits of aggressive symptom management (hospice) all play a role in the delivery of futile chemotherapy.
Misalignment of Perceptions
One reason for the delivery of futile chemotherapy may stem from a misalignment of perceptions between providers and patients on the goals, benefits, and side effects of therapy. Poor communication likely plays a significant role in this disconnect. Provider perceptions are often not aligned with patient preferences; for example, patients receiving palliative chemotherapy are often willing to discuss quality-of-life issues with their physicians, but communication regarding these issues is often hampered by discordant expectations as to who (patient vs physician) should initiate such discussions.
In older patients with metastatic colorectal cancer, there is only 26% concordance between a patient's expressed preference for decision control and a provider's perception of the patient's preference. On the other hand, a survey of breast and prostate cancer patients and oncologists demonstrated concordance among patients and providers regarding the amount of fatigue reported by patients (78% and 76%, respectively).
There is even misunderstanding between providers and caregivers on the most important aspects of hospice care. McGorty and Bornstein provide an excellent review of the most common barriers to hospice enrollment (Table 1).
Poor Communication Between Physicians and Patients
Physicians often do not tell patients about their poor prognosis, or they give such a wide range of outcomes that patients choose the most favorable, or are simply unrealistically optimistic about expected length of survival.[26,27] Significant variation exists in how often physicians discuss prognosis and alternatives to chemotherapy, while most patients want more detailed information about their disease. Patients in clinical trials who understand the risks and benefits of therapy and sign informed consent documents may overestimate the chance of success. Other patients may overestimate their prognosis because they confuse the term "response" with "cure."[31,32]
A patient's denial about the terminal nature of their disease is also a significant barrier to a frank discussion about stopping futile therapy and entering hospice. A written plan of communication that clearly defines prognosis, goals of therapy, and treatment options (including hospice) may help to avoid these misunderstandings. Studies consistently show that patients want and use such information. Of 126 terminally ill patients, 98% said they want their oncologist to be realistic. Moreover, patients want oncologists to be truthful and compassionate, and to continue to care for them during the illness.
One-quarter of physicians do not discuss hospice with their terminally ill patients, while the remainder discuss it when they feel patients are ready to accept the option of palliation alone. One paradoxical explanation is that patients do not want to discuss such difficult issues with their oncologist. Of 101 admitted inpatients without advance directives, only 23 wished to discuss the issue with their oncologists; however, 56% of those without advance directives (44/78) supported discussing it with the admitting physician, and not the oncologist. Another explanation is that such discussions are simply too difficult and painful; even clinicians who are well trained and skilled at giving bad news can find it burdensome and emotionally difficult.[25,39]
Unfortunately, families often receive little information from physicians about hospice. In one study, physicians initiated the discussion about hospice only half of the time, whereas patients or families initiated one-third of the discussions. The information that patients and families identified as important in deciding about hospice were the frequency of visits, payment, and practical help such a program provides.