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 (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-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 [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.
1. von Gruenigen VE, Daly BJ: Futility: Clinical decisions at the end-of-life in women with ovarian cancer. Gynecol Oncol 97:638-644, 2005.
2. Temel JS, Jackson VA, Billings JA, et al: Phase II study: Integrated palliative care in newly diagnosed advanced non-small-cell lung cancer patients. J Clin Oncol 25:2377-2382, 2007.
3. von Gruenigen VE, Daly BJ: Futility: Clinical decisions at the end-of-life in women with ovarian cancer. Gynecol Oncol 97:638-644, 2005.
4. Schneiderman LJ, Jecker N: Futility in practice. Arch Intern Med 153:437-441, 1993.
5. Youngner SJ: Who defines futility? JAMA 260:2094-2095, 1988.
6. Federal Patient Self Determination Act 42 USC Â§1395 cc(a), 1990.
7. Tomlinson T, Michalski AJ, Pentz RD, et al: Futile care in oncology: When to stop trying. Lancet Oncol 2:759-764, 2001.
8. Lantos JD, Singer PA, Walker RM, et al: The illusion of futility in clinical practice. Am J Med 87:81-84, 1989.
9. Jonsen AR, Siegler M, Winslade WJ: Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine, 5th ed. New York, 2002.
10. Matsuyama R, Reddy SN, Smith TJ: Why do patients choose chemotherapy near the end of life? A review of the perspective of those facing death from cancer. J Clin Oncol 24:1-7, 2006.
11. Silvestri G, Pritchard R, Welch HG: Preferences for chemotherapy in patients with advanced non-small cell lung cancer: Descriptive study based on scripted interviews. BMJ 317:771-775, 1998.
12. American Society of Clinical Oncology Outcomes Working Group: Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol 14:671-679, 1996.
13. Smith T, Khatcheressian J, Lyman G, et al: 2006 ASCO recommendations for the use of white blood cell growth factors. J Clin Onc 24:1-19, 2006.
14. Earle CC, Neville BA, Landrum MB, et al: Trends in the aggressiveness of cancer care near the end of life. J Clin Oncol 22:315-321, 2004.
15. Murillo JR Jr, Koeller J: Chemotherapy given near the end of life by community oncologists for advanced non-small cell lung cancer. Oncologist 11:1095-1099, 2006.
16. Schrag D: The price tag on progress—chemotherapy for colorectal cancer. N Engl J Med 351:317-319, 2004.
17. Meropol NJ, Schulman KA: Cost of cancer care: Issues and implications. J Clin Oncol 25:180-186, 2007.
18. Hillner BE, Schrag D, Sargent DJ, et al: Cost-effectiveness projections of oxaliplatin and infusional fluorouracil versus irinotecan and bolus fluorouracil in first-line therapy for metastatic colorectal carcinoma. Cancer 104:1871-1884, 2005.
19. Collins R, Fenwick E, Trowman R, et al: A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer. Health Technol Assess 11(2):iii-iv, xv-xviii, 1-179, 2007.
20. Detmar SB, Aaronson NK, Wever LD, et al: How are you feeling? Who wants to know? Patients' and oncologists' preferences for discussing health-related quality-of-life issues. J Clin Oncol 18:3295-3301, 2000.
21. Elkin EB, Lee S, Casper ES, et al: Treatment decision-making preferences in older patients with metastatic colorectal cancer (abstract 8519). J Clin Oncol 24(18S):472s, 2006.
22. Vogelzang NJ, Breitbart W, Cella D, et al: Patient, caregiver, and oncologist perceptions of cancer-related fatigue: Results of a tripart assssment survey. The Fatigue Coalition. Semin Hematol 34(3 suppl 2):4-12, 1997.
23. Gochman DS, Bonham GS: Physicians and the hospice decision: Awareness, discussion, reasons and satisfaction. Hosp J 4:25-53, 1988.
24. McGorty EK, Bornstein BH: Barriers to physicians' decisions to discuss hospice: Insights gained from the United States hospice model.J Eval Clin Pract 9:363-372, 2003.
25. Helft PR: Necessary collusion: Prognostic communication with advanced cancer patients. J Clin Oncol 23:3146-3150, 2005.
26. Chow E, Harth T, Hruby G, et al: How accurate are physicians' clinical predictions of survival and the available prognostic tools in estimating survival times in terminally ill cancer patients? A systematic review. Clin Oncol (R Coll Radiol) 13:209-218, 2001.
27. Viganò A, Dorgan M, Bruera E, et al: The relative accuracy of the clinical estimation of the duration of life for patients with end of life cancer.Cancer 86:170-176, 1999.
28. Gattellari M, Voigt KJ, Butow PN, et al: When the treatment goal is not cure: Are cancer patients equipped to make informed decisions? J Clin Oncol 20:503-513, 2002.
29. Hagerty RG, Butow PN, Ellis PA, et al: Cancer patient preferences for communication of prognosis in the metastatic setting. J Clin Oncol 22:1721-1730, 2004.
30. Meropol NJ, Weinfurt KP, Burnett CB, et al: Perceptions of patients and physicians regarding phase I cancer clinical trials: Implications for physician-patient communication. J Clin Oncol 21:2589-2596, 2003.
31. Weeks JC, Cook EF, O'Day SJ, et al: Relationship between cancer patients' predictions of prognosis and their treatment preferences.JAMA 279:1709-1714, 1998.
32. Doyle C, Crump M, Pintilie M, et al: Does palliative chemotherapy palliate? Evaluation of expectations, outcomes, and costs in women receiving chemotherapy for advanced ovarian cancer. J Clin Oncol 19:1266-1274, 2001.
33. Zimmermann C: Death denial: obstacle or instrument for palliative care? An analysis of clinical literature. Sociol Health Illn 29:297-314, 2007.
34. Smith TJ: Tell it like it is. J Clin Oncol 21(9S):12s-16s, 2003.
35. Hagerty RG, Butow PN, Ellis PM, et al: Communicating with realism and hope: Incurable cancer patients' views on the disclosure of prognosis. J Clin Oncol 23:1278-1288, 2005.
36. Kirk P, Kirk I, Kristjanson LJ: What do patients receiving palliative care for cancer and their families want to be told? A Canadian and Australian qualitative study. BMJ 328:1343-1347, 2004.
37. McGorty EK, Bornstein BH: Barriers to physicians' decisions to discuss hospice: Insights gained from the United States hospice model. J Eval Clin Pract 9:363-372, 2003.
38. Lamont EB, Siegler M: Paradoxes in cancer patients' advance care planning. J Palliat Med 3:27-35, 2000.
39. Smith TJ: The art of oncology: When the tumor is not the target. Tell it like it is. J Clin Oncol 18:3441-3445, 2000.
40. Casarett D, Crowley R, Stevenson C, et al: Making difficult decisions about hospice enrollment: What do patients and families want to know? J Am Geriatr Soc 53:249-254, 2005.
41. Casarett DJ, Crowley RL, Hirschman KB: How should clinicians describe hospice to patients and families? J Am Geriatr Soc 52:1924-1928, 2004.
42. Pfister DG, Johnson DH, Azzoli CG, et al: American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: Update 2003. J Clin Oncol 22:330-353, 2004.
43. Shepherd FA, Dancey J, Ramlau R, et al: Prospective randomized trial of docetaxel versus best supportive care in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18:2095-2103, 2000.
44. Dancey J, Shepherd FA, Gralla RJ, et al: Quality of life assessment of second-line docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: Results of a prospective, randomized phase III trial. Lung Cancer 43:83-194, 2004.
45. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al: Erlotinib in previously treated non-small-cell lung cancer (National Cancer Institute of Canada Clinical Trials Group). N Engl J Med 353:123-132, 2005.
46. Goldberg RM, Rothenberg ML, Van Cutsem E, et al: The continuum of care: A paradigm for the management of metastatic colorectal cancer. Oncologist 12:38-50, 2007.
47. Tannock IF, de Wit R, Berry WR, et al, for TAX 327 Investigators: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004.
48. Wright AA, Katz IT: Letting go of the rope—aggressive treatment, hospice care, and open access. N Engl J Med 357:324-327, 2007.
49. Pitorak EF, Armour M, Sivec HD: Project Safe Conduct integrates palliative goals into comprehensive cancer care: An interview with Elizabeth Ford Pitorak and Meri Armour. Innovations in End-of-Life Care 4(4), 2002.
50. Finn J, Pienta K, Parzuchowski J, et al: Palliative care project: Bridging active treatment and hospice for terminal cancer (abstract 1452). Proc Am Soc Clin Oncol 21:364a, 2002.
51. Whelan TM, O'Brien MA, Villasis-Keever M, et al: Impact of cancer-related decision aids. Evidence report/technology assessment no. 46. (Prepared by McMaster University under Contract No. 290-97-0017.) AHRQ publication no. 02-E004. Rockville, Md; Agency for Healthcare Research and Quality; July 2002.
52. Peele PB, Siminoff LA, Xu Y, et al: Decreased use of adjuvant breast cancer therapy in a randomized controlled trial of a decision aid with individualized risk information. Med Decis Making 25:301-307, 2005.
53. National Cancer Institute: Treatment options for recurrent non-small cell lung cancer. Available at www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/Patient/page6. Accessed May 20, 2008.
54. Lung Cancer Alliance: Lung cancer facts. Available at www.lungcanceralliance.org/facing/facts.html. Accessed May 20, 2008.
55. Fintor L: Direct-to-consumer marketing: How has it fared? J Natl Cancer Inst 94:329-331, 2002.
56. Report to Congressional Requesters: Prescription drugs: Improvement needed in FDA's oversight of direct-to-consumer adverstising. Report GAO-07-54, US Government Accountability Office, p 13. Washington, DC, 2006.
57. Viale PH, Sanchez Yamamoto D: The attitudes and beliefs of oncology nurse practitioners regarding direct-to-consumer advertising of prescription medications. Oncol Nurs Forum 31:777-783, 2004.
58. Abel GA, Lee SJ, Weeks JC: Direct-to-consumer advertising in oncology: A content analysis of print media. J Clin Oncol 25:1267-1271, 2007.
59. Abel GA, Penson RT, Joffe S, et al: Direct-to-consumer advertising in oncology.Oncologist 11:217-226, 2006.
60. Quill TE, Williamson PR: Healthy approaches to physician stress. Arch Intern Med 150:1857-1861, 1990.
61. Meier DE, Back AL, Morrison S: The inner life of physicians and care of the seriously ill. JAMA 286:3007-3014, 2001.
62. Baile WF, Lenzi R, Parker PA, et al: Oncologists' attitudes toward and practices in giving bad news: An exploratory study. J Clin Oncol 20:2189-2196, 2002.
63. National Hospice and Palliative Care Organization website. Available at www.nhpco.org. Accessed May 28, 2008.
64. Christakis NA, Iwashyna TJ: The health impact of health care on families: A matched cohort study of hospice use by decedents and mortality outcomes in surviving, widowed spouses. Soc Sci Med 57:465-475, 2003.
65. Schockett ER, Teno JM, Miller SC, et al: Late referral to hospice and bereaved family member perception of quality of end-of-life care. J Pain Symptom Manage 30:400-407, 2005.
66. Teno JM, Shu JE, Casarett D, et al: Timing of referral to hospice and quality of care: Length of stay and bereaved family members' perceptions of the timing of hospice referral. J Pain Symptom Manage 34:120-125, 2007.
67. Rabow MW, Schanche K, Petersen J, et al: Patient perceptions of an outpatient palliative care intervention: â€œIt had been on my mind before, but I did not know how to start talking about death..." J Pain Symptom Manage 26:1010-1015, 2003.
68. Brickner L, Scannell K, Marquet S, et al: Barriers to hospice care and referrals: Survey of physicians' knowledge, attitudes and perceptions in a health maintenance organization. J Palliat Med 7:411-418, 2004.
69. Casarett DJ, Quill TE: "I'm not ready for hospice": Strategies for timely and effective hospice discussions. Ann Intern Med 146:443-449, 2007.
70. Wright AA, Katz IT: Letting go of the rope—aggressive treatment, hospice care, and open access. N Engl J Med 357:324-327, 2007.
71. Weeks JC, Cook EF, O'Day S J, et al: Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA 279:1709-1714, 1998.
72. Smith T, Swisher K: Telling the truth about terminal cancer. JAMA 279:1746-1748, 1998.
73. Hagerty RG, Butow PN, Ellis PM, et al: Communicating with realism and hope: Incurable cancer patients' views on the disclosure of prognosis. J Clin Oncol 23:1278-1288, 2005
74. Tobias JS, Souhami RL: Fully informed consent can be needlessly cruel. BMJ 307:1199-1201, 1993.
75. Fallowfield L: Participation of patients in decisions about treatment for cancer. BMJ 323:1144, 2001.
76. Emanuel LL, Ferris FD, von Gunten CF, et al: EPEC-O: Education in Palliative and End of Life Care for Oncology. The EPEC Project, Chicago, 2005.
77. Creagan ET: Burnout and balance: How to go the distance in the 21st century. Cancer Control 11:266-268, 2004.
78. Back A: Patient-physician communication in oncology: What does the evidence show? Oncology (Williston Park) 20:67-74, 2006.
79. Rabinowitz T, Peirson R: "Nothing is wrong, doctor": Understanding and managing denial in patients with cancer. Cancer Invest 24:68-76, 2006.
80. Neff P, Lyckholm L, Smith T: Truth or consequences: What to do when the patient doesn't want to know. J Clin Oncol 20:3035-3037, 2002.
81. Fallowfield L, Lipkin M, Hall A: Teaching senior oncologists communication skills: Results from phase I of a comprehensive longitudinal program in the United Kingdom. J Clin Oncol 16:1961-1968, 1998.