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Research and Reviews for the Practicing Oncologist
Guiding Patients Facing Decisions about “Futile” Chemotherapy
Volume 9, Issue 5, September-October 2011, Pages 184-187
| doi:10.1016/j.suponc.2011.04.001 |
| Permissions & Reprints |
How We Do It
Received 4 April 2011; Accepted 16 December 2011. Available online 24 September 2011.
Case Presentation
Ms. G is a 71-year-old woman with metastatic gastric adenocarcinoma recently diagnosed after an extensive surgical resection for a small bowel obstruction (SBO). She was admitted from the surgery clinic with intractable nausea and vomiting. An abdominal computerized tomographic (CT) scan revealed a partial SBO and peritoneal carcinomatosis. Given her recent surgery, the extent of her disease, and high likelihood of recurrent SBO, the surgical team decided that Ms. G was no longer a surgical candidate. When her symptoms did not improve with conservative measures, both oncology and palliative medicine were consulted to assist with symptom management and goals of care. The oncology team stated that Ms. G was still a chemotherapy candidate and suggested that she attend her new patient evaluation in oncology clinic the following week. The palliative medicine team then met with the patient to discuss management options and her preferences for care. The palliative care team explained ways to control her nausea and vomiting without using a nasogastric tube, and the patient agreed to transfer to their service for symptom management. The palliative team explained that her cancer was incurable but that chemotherapy options existed to help control her disease and possibly prolong her life. They also explained that the chemotherapy has side effects and that the patient would need to decide if she wanted to undergo treatment and accept potential side effects for the possibility of prolonging her life by weeks to months and improving her symptoms. As an alternative, she was told that she could focus solely on symptom control with medications and allow her disease to take its natural course. Ms. G was asked to think about how she wanted to spend the time she had left. Prior to discharge, as her symptoms improved, Ms. G was evaluated by another oncologist, who, after consulting the expert gastrointestinal cancer team, explained to her that the current chemotherapy options available for metastatic gastric cancer were rarely, if ever, successful at reversing malignant obstruction. With this information, the patient decided to be discharged home with hospice and spend time with her family. She died peacefully at her home approximately two weeks later.
Article Outline
- Futile Is as Futile Does
- Palliative Care: It's Not Just Giving Up on People
- Oncology: Palliative Care Is Giving Up
- Take-Home Messages
- Acknowledgments
- References
Futile Is as Futile Does
When deciding whether or not chemotherapy is “futile,” the concept of medical futility must be explored.[1] Though it remains difficult to adequately define, the qualitative and quantitative descriptions offered by Schneiderman et al[2] are widely used. Qualitatively, futile treatment “merely preserves permanent unconsciousness or cannot end dependence on intensive medical care.” More precisely, it is a medical treatment “that in the last 100 cases … has been useless.”[2] A useful, albeit imprecise, definition of futile chemotherapy is that in which the burdens and risks outweigh the benefits. As an example, studies on chemotherapy for advanced non-small-cell lung cancer (NSCLC) have shown that patients with poor performance status or chemotherapy-unresponsive disease receive little benefit in terms of response rates and survival. [3] and [4] A retrospective analysis by Massarelli et al3 showed dismal response rates for third- and fourth-line NSCLC chemotherapy of 2.3% and 0%, respectively. Additionally, an observational study by Zietemann and Duell[4] showed that 40% and 50% of patients receiving second- and third-line chemotherapy for NSCLC die during or soon after treatment, respectively, and that over 20% receive chemotherapy within 14 days of death. Neither study commented on quality of life experienced by patients. However, a recent study by Temel et al[5] demonstrated that NSCLC patients receiving concurrent palliative care and standard oncologic care had better quality of life and even longer survival than patients receiving only standard oncologic care, despite being less likely to receive aggressive end-of-life care. Though limited to patients with NSCLC, these studies illustrate that chemotherapy in advanced cancer is often futile, especially when less aggressive care can improve quality of life as well as survival.
Addressing the futility of chemotherapy with patients is challenging for most oncologists. Although defining treatments as “futile” is suitable in the medical literature, it is a word that may carry negative connotations, such as hopelessness or abandonment, to patients. A more descriptive and less negative term, “nonbeneficial,” may be used when discussing futile chemotherapy with patients. The point when chemotherapy becomes nonbeneficial, and thus futile, is different for each patient and might even change over time. Addressing the patient's definition of nonbeneficial chemotherapy regularly during treatment ensures that the patient's goals are clear and allows the oncologist to direct conversation toward alternative options, such as palliative and hospice care, when chemotherapy cannot provide the benefits sought by the patient. This can be as simple as asking the patient, “Do you think the chemotherapy is giving you enough benefit to continue?”
Palliative Care: It's Not Just Giving Up on People
Both the physician and the patient face several decisions when considering whether or not to pursue chemotherapy for advanced cancer. First of all, the patient must decide how much information he or she wants from the oncologist. If the patient is the decision maker, he or she must choose to accept chemotherapy that is palliative, not curative. After a frank discussion about the anticipated outcomes and symptoms associated with chemotherapy, the patient must consider whether he or she can accept the burden of treatment for the potential of prolonging life by days, weeks, or months. On the other hand, the oncologist must decide if chemotherapy should even be offered, based on patient performance status, known therapeutic outcomes, and patient values and goals. The oncologist can reassure patients that the best available data show that patients who use hospice for even one day actually live longer than those who do not.[6] Once informed about what palliative care and hospice offer, the patient may determine whether or not alternatives to chemotherapy are more favorable. If the patient qualifies for clinical trials, he or she must decide to accept treatment with uncertain outcome. When reflecting upon such difficult issues, both the patient and oncologist should involve others to help guide decision making. Oncologists can consult trusted colleagues for their expertise and to ensure that they are using the best information available. Patients should involve loved ones whom they trust to help make decisions in their best interest. Table 1 provides key questions that the oncologist faces when making these decisions and how to approach them.
| Table 1: Questions to discuss with the patient when chemotherapy may be futile | ||
| Question | Leading prompts | Comment |
| What is the patient’s current understanding of the disease? | How much do you know about your cancer at this point?
How much do you want to know? | Be sure the patient is ready to discuss this issue and that you have enough time for discussion.
Ask if there are others who should receive this information simultaneously, afterwards, or instead of the patient. |
| What are the patient’s goals? | Knowing that we can’t cure your cancer, what are your goals, wishes, or hopes for the future? | Treatment decisions may be impacted greatly by a patient’s personal goals (e.g. patient wants to live to child’s graduation, or patient wants to be as comfortable as possible) |
| If chemotherapy is an option and the patient is interested, is he/she aware of potential risks and benefits? | Although everyone responds differently, these are the likely side effects and outcomes of this treatment… | Be specific in terms of likelihood of response, type of response (palliation instead of cure, extent of life prolongation expected, symptom relief, etc.) and how likely it is that treatment will help achieve patient’s goals.
Discuss potential symptom burden from treatment in detail.
Patient needs to be able to make informed decision about risks vs. benefits involved in potential treatment. |
| If the patient declines chemotherapy, treatment is not indicated, or treatment fails, what other options are available? | Let’s talk about options to make sure that you are comfortable and enjoy the highest quality of life possible in the time that you have left. | Focus on pain and symptom management. Discuss hospice options (home vs. inpatient) and make referrals when appropriate.
Stress that you will continue your relationship with the patient (possibly as their hospice provider) and that you will ensure that their symptoms are managed, either directly or through hospice nurses. |
As an alternative to addressing the above issues with the patient independently, oncologists may involve a palliative care specialist to facilitate this conversation.[7] Particularly in cases where the oncologist decides that chemotherapy is no longer a viable option, it may be easier, from both the patient and the provider perspectives, for the palliative care specialist to have this discussion. In a recent survey of patients on our oncology ward, the great majority did not want to discuss advance directives (ADs) with their oncologist—these patients thought ADs were important and should be discussed but were more comfortable discussing them with the admitting provider than the oncologist.[8] Patients may feel that they are disappointing their oncologist by being unable to take further treatment or by admitting that treatment has failed them. Similarly, oncologists might view having this discussion as an admission of their failure as a provider. The palliative care specialist, on the other hand, has no responsibility for chemotherapy and possibly no prior relationship with the patient, thus alleviating this type of emotional association between provider and patient. Furthermore, the conversation about nonbeneficial chemotherapy provides a segue for the palliative care provider to discuss with patients what he or she does best: establishing goals of care, managing symptoms, and maintaining comfort. For the palliative care specialist, providing symptom management and the best possible quality of life for patients are the fundamental goals. Death is generally not viewed with a sense of failure when palliation is the focus of care.
Oncology: Palliative Care Is Giving Up
We still hear from oncologists like ourselves the dreaded words “What do you want me to do, give up on the patient?” or, to the patient, “What, are you giving up? I thought you'd keep fighting!” We would argue that current best practices include knowing when the risks and harms of chemotherapy outweigh any potential chance of benefit. Physicians and patients should follow current National Comprehensive Cancer Network (NCCN) guidelines for solid tumors such as breast9 and lung10 cancer and stop chemotherapy when the chance of success is minimal. If the doctor cannot describe a specific, substantial benefit that outweighs the toxicity, he or she should not recommend it.[11] And all the relevant guidelines call for considering a switch to nonchemotherapy palliative care when the patient's performance status is Eastern Cooperative Oncology Group (ECOG) ≥3, defined as “3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.”[12] Such a simple threshold could dramatically reduce the use of chemotherapy at the end of life and lessen downstream toxicities.
Oncologists can implement several strategies to help facilitate the transition from aggressive care to comfort care (Table 2). For patients with incurable cancer, oncologists can hold early discussions about palliative and hospice options that will need to be implemented when chemotherapy is no longer able to control their disease. This discussion introduces palliative medicine as part of the care plan for incurable disease and allows the patient to anticipate such a transition. Oncologists can also provide reassurance that they will continue to be involved in their patient's care and to support them, even if the patient does not undergo further chemotherapy. There are at least four studies that show equal[13] or better[6] survival, smoother transitions to hospice when death is inevitable, less intensive end-of-life care, and superior patient and family outcomes with concurrent palliative care. [14] and [15] By helping patients establish legal documents, such as ADs and power of attorney, oncologists and palliative care specialists can alleviate some of the stress related to the end of life and make the transition to comfort care easier. Finally, oncologists can review guidelines such as those from the NCCN and American Society of Clinical Oncology, which call for a switch to palliative care when the cancer has grown on three regimens or the patient's ECOG performance status is three or above. [11] and [12]
| Table 2: Things that help ONCOLOGISTS and their patients | ||
| Item | How it helps | Comments |
| Early discussion of palliative and hospice care when chemotherapy may no longer help. | Hospice (and eventual death) will not come as a complete surprise. | “We will do our best to help you with this cancer, but at some point there may not be any treatments known to help….” “Remember the conversation we had when we first met?...” |
| Reassurance that the oncologist will not abandon the patient if concurrent care is given. | This major fear may keep oncology patients at the same practice they have known for years – it is familiar – when they would be better served by transition. | There are now at least 4 randomized trials showing that most patients will accept concurrent palliative care if offered, and that outcomes are equal or better, at less cost.6,13,14,15 |
| Legal documents such as Advance Medical Directives, Durable Medical Power of Attorney | Reinforces the seriousness and “now” aspect of care. | These are readily available in all states at no cost. They are not the final word on how to live one’s remaining time, but will get the conversation started. |
| Best nationally recognized information showing that further chemotherapy will not help due to 3 prior failures, or is not indicated due to poor performance status.9,10 | The oncologist can point to the right page and say “The best national guidelines call for a switch away from chemo…because it will do no good and will cause harmful side effects.” | Readily accessed from the Internet. |
| Use decision aids, similar to Adjuvant!. | Increases the amount of truthful information given, even when the news is bad, and helps with transition points. | An increasing number of these are available[i],[ii],[iii],[iv] and will soon be offered as smart phone applications (aps). |
Communication tools, such as the National Cancer Institute's Oncotalk and EPEC-O, are useful for oncologists seeking to further enhance their communication skills.
Take-Home Messages
Guiding patients in making decisions about nonbeneficial, or futile, chemotherapy presents a challenge for many oncologists as well as their patients and families. Though futility is difficult to define, oncologists and their patients can decide through regular, open discussion if the burdens of chemotherapy outweigh the benefits and whether or not chemotherapy can achieve the reasonable benefits desired by the patient. “Your cancer is advancing despite our best efforts to keep it from growing. Let's talk about what options we have at this point and see what will work best for you.” To make such decisions, oncologists must obtain the most current information and convey it to patients (or their designated decision makers) as clearly as possible. “Based on the latest evidence, there is a 20% chance that the cancer will shrink or stay the same size with this treatment and an 80% chance that it will continue to grow despite treatment.” Both oncologists and their patients should involve those whom they trust to help with decision making. In cases where chemotherapy is nonbeneficial, oncologists may prefer to involve palliative and hospice care specialists to discuss the transition to comfort care with the patient. “At this time, I do not have any treatments that are likely to help you live longer or more comfortably, but I want to make sure that we get the most out of the rest of your life. I have asked a palliative care specialist to help us make this possible.” In order to ease the transition from aggressive or curative care to comfort care, oncologists can employ approaches such as early discussion of palliative and hospice care, assuring the patient of continued involvement in their care, and helping patients with ADs. These approaches not only benefit patients and their families but also strengthen the relationship between the oncologist and the patients and their families.
Acknowledgments
This research was supported by grants GO8 LM0095259 from the National Library of Medicine and R01CA116227-01 (both to T. J. S.) from the National Cancer Institute.
References [PubMed ID in brackets]
1 P.R. Helft, M. Siegler and J. Lantos, The rise and fall of the medical futility movement, . N Engl J Med, 343 (2000), pp. 293–296 [10911014].
2 L.J. Schneiderman, N.S. Jecker and A.R. Jonsen, Medical futility: its meaning and ethical implications, . Ann Intern Med, 112 (1990), pp. 949–954 [2187394].
3 E. Massarelli, F. Andre, D.D. Liu, J.J. Lee, M. Wolf, A. Fandi, J. Ochs, T. Le Chevalier, F. Fossella and R.S. Herbst, A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer, . Lung Cancer, 39 1 (2003), pp. 55–61 [12499095].
4 V. Zietemann and T. Duell, Every-day clinical practice in patients with advanced non-small-cell lung cancer, . Lung Cancer, 68 2 (2010), pp. 273–277 [19632737].
5 J.S. Temel, J.A. Greer, A. Muzikansky, E.R. Gallagher, S. Admane, V.A. Jackson, C.M. Dahlin, C.D. Blinderman, J. Jacobsen, W.F. Pirl, J.A. Billings and T.J. Lynch, Early palliative care for patients with metastatic non-small-cell lung cancer, . N Engl J Med, 363 (2010), pp. 733–742 [20818875].
6 S.R. Connor, B. Pyenson, K. Fitch, C. Spence and K. Iwasaki, Comparing hospice and nonhospice patient survival among patients who die within a three-year window. J Pain Symptom Manage, 33 3 (2007), pp. 238–246.
7 S.E. Harrington and T.J. Smith, The role of chemotherapy at the end of life: “when is enough, enough?”. JAMA, 299 22 (2008), pp. 2667–2678.
8 L. Dow, R. Matsuyama, L. Kuhn, L. Lyckholm, E.B. Lamont and T.J. Smith, Paradoxes in advance care planning. J Clin Oncol, 28 2 (2010), pp. 299–304.
9 NCCN Breast Cancer Clinical Practice Guidelines Panel, R.W. Carlson, D.C. Allred, B.O. Anderson, H.J. Burstein, W.B. Carter, S.B. Edge, J.K. Erban, W.B. Farrar, L.J. Goldstein, W.J. Gradishar, D.F. Hayes, C.A. Hudis, M. Jahanzeb, K. Kiel, B.M. Ljung, P.K. Marcom, I.A. Mayer, B. McCormick, L.M. Nabell, L.J. Pierce, E.C. Reed, M.L. Smith, G. Somlo, R.L. Theriault, N.S. Topham, J.H. Ward, E.P. Winer and A.C. Wolff, Breast cancer. J Natl Compr Canc Netw, 7 2 (2009), pp. 122–192.
10 NCCN Non-Small Cell Lung Cancer Panel Members, D.S. Ettinger, W. Akerley, G. Bepler, M.G. Blum, A. Chang, R.T. Cheney, L.R. Chirieac, T.A. D'Amico, T.L. Demmy, A.K. Ganti, R. Govindan, F.W. Grannis, T. Jahan, M. Jahanzeb, D.H. Johnson, A. Kessinger, R. Komaki, F.M. Kong, M.G. Kris, L.M. Krug, Q.T. Le, I.T. Lennes, R. Martins, J. O'Malley, R.U. Osarogiagbon, G.A. Otterson, J.D. Patel, K.M. Pisters, K. Reckamp, G.J. Riely, E. Rohren, G.R. Simon, S.J. Swanson, D.E. Wood and S.C. Yang, Non-small cell lung cancer. J Natl Compr Canc Netw, 8 7 (2010), pp. 740–801.
11 American Society of Clinical Oncology Outcomes Working Group, Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol, 14 (1996), pp. 671–679.
12 Eastern Cooperative Oncology Group, ECOG Performance Status, http://ecog.dfci.harvard.edu/general/perf_stat.html Accessed November 30, 2010.
13 J. Finn, K. Pienta and J. Parzuchowski, Bridging cancer treatment and hospice care. Proc Am Soc Clin Oncol, 21 (2002), p. 1452.
14 G. Gade, I. Venohr, D. Conner, K. McGrady, J. Beane, R.H. Richardson, M.P. Williams, M. Liberson, M. Blum and R. Della Penna, Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med, 11 2 (2008), pp. 180–190.
Copyright © 2011 Elsevier Inc. All rights reserved.
Volume 9, Issue 5, September-October 2011, Pages 184-187
| doi:10.1016/j.suponc.2011.04.001 |
| Permissions & Reprints |
How We Do It
Received 4 April 2011; Accepted 16 December 2011. Available online 24 September 2011.
Case Presentation
Ms. G is a 71-year-old woman with metastatic gastric adenocarcinoma recently diagnosed after an extensive surgical resection for a small bowel obstruction (SBO). She was admitted from the surgery clinic with intractable nausea and vomiting. An abdominal computerized tomographic (CT) scan revealed a partial SBO and peritoneal carcinomatosis. Given her recent surgery, the extent of her disease, and high likelihood of recurrent SBO, the surgical team decided that Ms. G was no longer a surgical candidate. When her symptoms did not improve with conservative measures, both oncology and palliative medicine were consulted to assist with symptom management and goals of care. The oncology team stated that Ms. G was still a chemotherapy candidate and suggested that she attend her new patient evaluation in oncology clinic the following week. The palliative medicine team then met with the patient to discuss management options and her preferences for care. The palliative care team explained ways to control her nausea and vomiting without using a nasogastric tube, and the patient agreed to transfer to their service for symptom management. The palliative team explained that her cancer was incurable but that chemotherapy options existed to help control her disease and possibly prolong her life. They also explained that the chemotherapy has side effects and that the patient would need to decide if she wanted to undergo treatment and accept potential side effects for the possibility of prolonging her life by weeks to months and improving her symptoms. As an alternative, she was told that she could focus solely on symptom control with medications and allow her disease to take its natural course. Ms. G was asked to think about how she wanted to spend the time she had left. Prior to discharge, as her symptoms improved, Ms. G was evaluated by another oncologist, who, after consulting the expert gastrointestinal cancer team, explained to her that the current chemotherapy options available for metastatic gastric cancer were rarely, if ever, successful at reversing malignant obstruction. With this information, the patient decided to be discharged home with hospice and spend time with her family. She died peacefully at her home approximately two weeks later.
Article Outline
- Futile Is as Futile Does
- Palliative Care: It's Not Just Giving Up on People
- Oncology: Palliative Care Is Giving Up
- Take-Home Messages
- Acknowledgments
- References
Futile Is as Futile Does
When deciding whether or not chemotherapy is “futile,” the concept of medical futility must be explored.[1] Though it remains difficult to adequately define, the qualitative and quantitative descriptions offered by Schneiderman et al[2] are widely used. Qualitatively, futile treatment “merely preserves permanent unconsciousness or cannot end dependence on intensive medical care.” More precisely, it is a medical treatment “that in the last 100 cases … has been useless.”[2] A useful, albeit imprecise, definition of futile chemotherapy is that in which the burdens and risks outweigh the benefits. As an example, studies on chemotherapy for advanced non-small-cell lung cancer (NSCLC) have shown that patients with poor performance status or chemotherapy-unresponsive disease receive little benefit in terms of response rates and survival. [3] and [4] A retrospective analysis by Massarelli et al3 showed dismal response rates for third- and fourth-line NSCLC chemotherapy of 2.3% and 0%, respectively. Additionally, an observational study by Zietemann and Duell[4] showed that 40% and 50% of patients receiving second- and third-line chemotherapy for NSCLC die during or soon after treatment, respectively, and that over 20% receive chemotherapy within 14 days of death. Neither study commented on quality of life experienced by patients. However, a recent study by Temel et al[5] demonstrated that NSCLC patients receiving concurrent palliative care and standard oncologic care had better quality of life and even longer survival than patients receiving only standard oncologic care, despite being less likely to receive aggressive end-of-life care. Though limited to patients with NSCLC, these studies illustrate that chemotherapy in advanced cancer is often futile, especially when less aggressive care can improve quality of life as well as survival.
Addressing the futility of chemotherapy with patients is challenging for most oncologists. Although defining treatments as “futile” is suitable in the medical literature, it is a word that may carry negative connotations, such as hopelessness or abandonment, to patients. A more descriptive and less negative term, “nonbeneficial,” may be used when discussing futile chemotherapy with patients. The point when chemotherapy becomes nonbeneficial, and thus futile, is different for each patient and might even change over time. Addressing the patient's definition of nonbeneficial chemotherapy regularly during treatment ensures that the patient's goals are clear and allows the oncologist to direct conversation toward alternative options, such as palliative and hospice care, when chemotherapy cannot provide the benefits sought by the patient. This can be as simple as asking the patient, “Do you think the chemotherapy is giving you enough benefit to continue?”
Palliative Care: It's Not Just Giving Up on People
Both the physician and the patient face several decisions when considering whether or not to pursue chemotherapy for advanced cancer. First of all, the patient must decide how much information he or she wants from the oncologist. If the patient is the decision maker, he or she must choose to accept chemotherapy that is palliative, not curative. After a frank discussion about the anticipated outcomes and symptoms associated with chemotherapy, the patient must consider whether he or she can accept the burden of treatment for the potential of prolonging life by days, weeks, or months. On the other hand, the oncologist must decide if chemotherapy should even be offered, based on patient performance status, known therapeutic outcomes, and patient values and goals. The oncologist can reassure patients that the best available data show that patients who use hospice for even one day actually live longer than those who do not.[6] Once informed about what palliative care and hospice offer, the patient may determine whether or not alternatives to chemotherapy are more favorable. If the patient qualifies for clinical trials, he or she must decide to accept treatment with uncertain outcome. When reflecting upon such difficult issues, both the patient and oncologist should involve others to help guide decision making. Oncologists can consult trusted colleagues for their expertise and to ensure that they are using the best information available. Patients should involve loved ones whom they trust to help make decisions in their best interest. Table 1 provides key questions that the oncologist faces when making these decisions and how to approach them.
| Table 1: Questions to discuss with the patient when chemotherapy may be futile | ||
| Question | Leading prompts | Comment |
| What is the patient’s current understanding of the disease? | How much do you know about your cancer at this point?
How much do you want to know? | Be sure the patient is ready to discuss this issue and that you have enough time for discussion.
Ask if there are others who should receive this information simultaneously, afterwards, or instead of the patient. |
| What are the patient’s goals? | Knowing that we can’t cure your cancer, what are your goals, wishes, or hopes for the future? | Treatment decisions may be impacted greatly by a patient’s personal goals (e.g. patient wants to live to child’s graduation, or patient wants to be as comfortable as possible) |
| If chemotherapy is an option and the patient is interested, is he/she aware of potential risks and benefits? | Although everyone responds differently, these are the likely side effects and outcomes of this treatment… | Be specific in terms of likelihood of response, type of response (palliation instead of cure, extent of life prolongation expected, symptom relief, etc.) and how likely it is that treatment will help achieve patient’s goals.
Discuss potential symptom burden from treatment in detail.
Patient needs to be able to make informed decision about risks vs. benefits involved in potential treatment. |
| If the patient declines chemotherapy, treatment is not indicated, or treatment fails, what other options are available? | Let’s talk about options to make sure that you are comfortable and enjoy the highest quality of life possible in the time that you have left. | Focus on pain and symptom management. Discuss hospice options (home vs. inpatient) and make referrals when appropriate.
Stress that you will continue your relationship with the patient (possibly as their hospice provider) and that you will ensure that their symptoms are managed, either directly or through hospice nurses. |
As an alternative to addressing the above issues with the patient independently, oncologists may involve a palliative care specialist to facilitate this conversation.[7] Particularly in cases where the oncologist decides that chemotherapy is no longer a viable option, it may be easier, from both the patient and the provider perspectives, for the palliative care specialist to have this discussion. In a recent survey of patients on our oncology ward, the great majority did not want to discuss advance directives (ADs) with their oncologist—these patients thought ADs were important and should be discussed but were more comfortable discussing them with the admitting provider than the oncologist.[8] Patients may feel that they are disappointing their oncologist by being unable to take further treatment or by admitting that treatment has failed them. Similarly, oncologists might view having this discussion as an admission of their failure as a provider. The palliative care specialist, on the other hand, has no responsibility for chemotherapy and possibly no prior relationship with the patient, thus alleviating this type of emotional association between provider and patient. Furthermore, the conversation about nonbeneficial chemotherapy provides a segue for the palliative care provider to discuss with patients what he or she does best: establishing goals of care, managing symptoms, and maintaining comfort. For the palliative care specialist, providing symptom management and the best possible quality of life for patients are the fundamental goals. Death is generally not viewed with a sense of failure when palliation is the focus of care.
Oncology: Palliative Care Is Giving Up
We still hear from oncologists like ourselves the dreaded words “What do you want me to do, give up on the patient?” or, to the patient, “What, are you giving up? I thought you'd keep fighting!” We would argue that current best practices include knowing when the risks and harms of chemotherapy outweigh any potential chance of benefit. Physicians and patients should follow current National Comprehensive Cancer Network (NCCN) guidelines for solid tumors such as breast9 and lung10 cancer and stop chemotherapy when the chance of success is minimal. If the doctor cannot describe a specific, substantial benefit that outweighs the toxicity, he or she should not recommend it.[11] And all the relevant guidelines call for considering a switch to nonchemotherapy palliative care when the patient's performance status is Eastern Cooperative Oncology Group (ECOG) ≥3, defined as “3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.”[12] Such a simple threshold could dramatically reduce the use of chemotherapy at the end of life and lessen downstream toxicities.
Oncologists can implement several strategies to help facilitate the transition from aggressive care to comfort care (Table 2). For patients with incurable cancer, oncologists can hold early discussions about palliative and hospice options that will need to be implemented when chemotherapy is no longer able to control their disease. This discussion introduces palliative medicine as part of the care plan for incurable disease and allows the patient to anticipate such a transition. Oncologists can also provide reassurance that they will continue to be involved in their patient's care and to support them, even if the patient does not undergo further chemotherapy. There are at least four studies that show equal[13] or better[6] survival, smoother transitions to hospice when death is inevitable, less intensive end-of-life care, and superior patient and family outcomes with concurrent palliative care. [14] and [15] By helping patients establish legal documents, such as ADs and power of attorney, oncologists and palliative care specialists can alleviate some of the stress related to the end of life and make the transition to comfort care easier. Finally, oncologists can review guidelines such as those from the NCCN and American Society of Clinical Oncology, which call for a switch to palliative care when the cancer has grown on three regimens or the patient's ECOG performance status is three or above. [11] and [12]
| Table 2: Things that help ONCOLOGISTS and their patients | ||
| Item | How it helps | Comments |
| Early discussion of palliative and hospice care when chemotherapy may no longer help. | Hospice (and eventual death) will not come as a complete surprise. | “We will do our best to help you with this cancer, but at some point there may not be any treatments known to help….” “Remember the conversation we had when we first met?...” |
| Reassurance that the oncologist will not abandon the patient if concurrent care is given. | This major fear may keep oncology patients at the same practice they have known for years – it is familiar – when they would be better served by transition. | There are now at least 4 randomized trials showing that most patients will accept concurrent palliative care if offered, and that outcomes are equal or better, at less cost.6,13,14,15 |
| Legal documents such as Advance Medical Directives, Durable Medical Power of Attorney | Reinforces the seriousness and “now” aspect of care. | These are readily available in all states at no cost. They are not the final word on how to live one’s remaining time, but will get the conversation started. |
| Best nationally recognized information showing that further chemotherapy will not help due to 3 prior failures, or is not indicated due to poor performance status.9,10 | The oncologist can point to the right page and say “The best national guidelines call for a switch away from chemo…because it will do no good and will cause harmful side effects.” | Readily accessed from the Internet. |
| Use decision aids, similar to Adjuvant!. | Increases the amount of truthful information given, even when the news is bad, and helps with transition points. | An increasing number of these are available[i],[ii],[iii],[iv] and will soon be offered as smart phone applications (aps). |
Communication tools, such as the National Cancer Institute's Oncotalk and EPEC-O, are useful for oncologists seeking to further enhance their communication skills.
Take-Home Messages
Guiding patients in making decisions about nonbeneficial, or futile, chemotherapy presents a challenge for many oncologists as well as their patients and families. Though futility is difficult to define, oncologists and their patients can decide through regular, open discussion if the burdens of chemotherapy outweigh the benefits and whether or not chemotherapy can achieve the reasonable benefits desired by the patient. “Your cancer is advancing despite our best efforts to keep it from growing. Let's talk about what options we have at this point and see what will work best for you.” To make such decisions, oncologists must obtain the most current information and convey it to patients (or their designated decision makers) as clearly as possible. “Based on the latest evidence, there is a 20% chance that the cancer will shrink or stay the same size with this treatment and an 80% chance that it will continue to grow despite treatment.” Both oncologists and their patients should involve those whom they trust to help with decision making. In cases where chemotherapy is nonbeneficial, oncologists may prefer to involve palliative and hospice care specialists to discuss the transition to comfort care with the patient. “At this time, I do not have any treatments that are likely to help you live longer or more comfortably, but I want to make sure that we get the most out of the rest of your life. I have asked a palliative care specialist to help us make this possible.” In order to ease the transition from aggressive or curative care to comfort care, oncologists can employ approaches such as early discussion of palliative and hospice care, assuring the patient of continued involvement in their care, and helping patients with ADs. These approaches not only benefit patients and their families but also strengthen the relationship between the oncologist and the patients and their families.
Acknowledgments
This research was supported by grants GO8 LM0095259 from the National Library of Medicine and R01CA116227-01 (both to T. J. S.) from the National Cancer Institute.
References [PubMed ID in brackets]
1 P.R. Helft, M. Siegler and J. Lantos, The rise and fall of the medical futility movement, . N Engl J Med, 343 (2000), pp. 293–296 [10911014].
2 L.J. Schneiderman, N.S. Jecker and A.R. Jonsen, Medical futility: its meaning and ethical implications, . Ann Intern Med, 112 (1990), pp. 949–954 [2187394].
3 E. Massarelli, F. Andre, D.D. Liu, J.J. Lee, M. Wolf, A. Fandi, J. Ochs, T. Le Chevalier, F. Fossella and R.S. Herbst, A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer, . Lung Cancer, 39 1 (2003), pp. 55–61 [12499095].
4 V. Zietemann and T. Duell, Every-day clinical practice in patients with advanced non-small-cell lung cancer, . Lung Cancer, 68 2 (2010), pp. 273–277 [19632737].
5 J.S. Temel, J.A. Greer, A. Muzikansky, E.R. Gallagher, S. Admane, V.A. Jackson, C.M. Dahlin, C.D. Blinderman, J. Jacobsen, W.F. Pirl, J.A. Billings and T.J. Lynch, Early palliative care for patients with metastatic non-small-cell lung cancer, . N Engl J Med, 363 (2010), pp. 733–742 [20818875].
6 S.R. Connor, B. Pyenson, K. Fitch, C. Spence and K. Iwasaki, Comparing hospice and nonhospice patient survival among patients who die within a three-year window. J Pain Symptom Manage, 33 3 (2007), pp. 238–246.
7 S.E. Harrington and T.J. Smith, The role of chemotherapy at the end of life: “when is enough, enough?”. JAMA, 299 22 (2008), pp. 2667–2678.
8 L. Dow, R. Matsuyama, L. Kuhn, L. Lyckholm, E.B. Lamont and T.J. Smith, Paradoxes in advance care planning. J Clin Oncol, 28 2 (2010), pp. 299–304.
9 NCCN Breast Cancer Clinical Practice Guidelines Panel, R.W. Carlson, D.C. Allred, B.O. Anderson, H.J. Burstein, W.B. Carter, S.B. Edge, J.K. Erban, W.B. Farrar, L.J. Goldstein, W.J. Gradishar, D.F. Hayes, C.A. Hudis, M. Jahanzeb, K. Kiel, B.M. Ljung, P.K. Marcom, I.A. Mayer, B. McCormick, L.M. Nabell, L.J. Pierce, E.C. Reed, M.L. Smith, G. Somlo, R.L. Theriault, N.S. Topham, J.H. Ward, E.P. Winer and A.C. Wolff, Breast cancer. J Natl Compr Canc Netw, 7 2 (2009), pp. 122–192.
10 NCCN Non-Small Cell Lung Cancer Panel Members, D.S. Ettinger, W. Akerley, G. Bepler, M.G. Blum, A. Chang, R.T. Cheney, L.R. Chirieac, T.A. D'Amico, T.L. Demmy, A.K. Ganti, R. Govindan, F.W. Grannis, T. Jahan, M. Jahanzeb, D.H. Johnson, A. Kessinger, R. Komaki, F.M. Kong, M.G. Kris, L.M. Krug, Q.T. Le, I.T. Lennes, R. Martins, J. O'Malley, R.U. Osarogiagbon, G.A. Otterson, J.D. Patel, K.M. Pisters, K. Reckamp, G.J. Riely, E. Rohren, G.R. Simon, S.J. Swanson, D.E. Wood and S.C. Yang, Non-small cell lung cancer. J Natl Compr Canc Netw, 8 7 (2010), pp. 740–801.
11 American Society of Clinical Oncology Outcomes Working Group, Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol, 14 (1996), pp. 671–679.
12 Eastern Cooperative Oncology Group, ECOG Performance Status, http://ecog.dfci.harvard.edu/general/perf_stat.html Accessed November 30, 2010.
13 J. Finn, K. Pienta and J. Parzuchowski, Bridging cancer treatment and hospice care. Proc Am Soc Clin Oncol, 21 (2002), p. 1452.
14 G. Gade, I. Venohr, D. Conner, K. McGrady, J. Beane, R.H. Richardson, M.P. Williams, M. Liberson, M. Blum and R. Della Penna, Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med, 11 2 (2008), pp. 180–190.
Copyright © 2011 Elsevier Inc. All rights reserved.
Volume 9, Issue 5, September-October 2011, Pages 184-187
| doi:10.1016/j.suponc.2011.04.001 |
| Permissions & Reprints |
How We Do It
Received 4 April 2011; Accepted 16 December 2011. Available online 24 September 2011.
Case Presentation
Ms. G is a 71-year-old woman with metastatic gastric adenocarcinoma recently diagnosed after an extensive surgical resection for a small bowel obstruction (SBO). She was admitted from the surgery clinic with intractable nausea and vomiting. An abdominal computerized tomographic (CT) scan revealed a partial SBO and peritoneal carcinomatosis. Given her recent surgery, the extent of her disease, and high likelihood of recurrent SBO, the surgical team decided that Ms. G was no longer a surgical candidate. When her symptoms did not improve with conservative measures, both oncology and palliative medicine were consulted to assist with symptom management and goals of care. The oncology team stated that Ms. G was still a chemotherapy candidate and suggested that she attend her new patient evaluation in oncology clinic the following week. The palliative medicine team then met with the patient to discuss management options and her preferences for care. The palliative care team explained ways to control her nausea and vomiting without using a nasogastric tube, and the patient agreed to transfer to their service for symptom management. The palliative team explained that her cancer was incurable but that chemotherapy options existed to help control her disease and possibly prolong her life. They also explained that the chemotherapy has side effects and that the patient would need to decide if she wanted to undergo treatment and accept potential side effects for the possibility of prolonging her life by weeks to months and improving her symptoms. As an alternative, she was told that she could focus solely on symptom control with medications and allow her disease to take its natural course. Ms. G was asked to think about how she wanted to spend the time she had left. Prior to discharge, as her symptoms improved, Ms. G was evaluated by another oncologist, who, after consulting the expert gastrointestinal cancer team, explained to her that the current chemotherapy options available for metastatic gastric cancer were rarely, if ever, successful at reversing malignant obstruction. With this information, the patient decided to be discharged home with hospice and spend time with her family. She died peacefully at her home approximately two weeks later.
Article Outline
- Futile Is as Futile Does
- Palliative Care: It's Not Just Giving Up on People
- Oncology: Palliative Care Is Giving Up
- Take-Home Messages
- Acknowledgments
- References
Futile Is as Futile Does
When deciding whether or not chemotherapy is “futile,” the concept of medical futility must be explored.[1] Though it remains difficult to adequately define, the qualitative and quantitative descriptions offered by Schneiderman et al[2] are widely used. Qualitatively, futile treatment “merely preserves permanent unconsciousness or cannot end dependence on intensive medical care.” More precisely, it is a medical treatment “that in the last 100 cases … has been useless.”[2] A useful, albeit imprecise, definition of futile chemotherapy is that in which the burdens and risks outweigh the benefits. As an example, studies on chemotherapy for advanced non-small-cell lung cancer (NSCLC) have shown that patients with poor performance status or chemotherapy-unresponsive disease receive little benefit in terms of response rates and survival. [3] and [4] A retrospective analysis by Massarelli et al3 showed dismal response rates for third- and fourth-line NSCLC chemotherapy of 2.3% and 0%, respectively. Additionally, an observational study by Zietemann and Duell[4] showed that 40% and 50% of patients receiving second- and third-line chemotherapy for NSCLC die during or soon after treatment, respectively, and that over 20% receive chemotherapy within 14 days of death. Neither study commented on quality of life experienced by patients. However, a recent study by Temel et al[5] demonstrated that NSCLC patients receiving concurrent palliative care and standard oncologic care had better quality of life and even longer survival than patients receiving only standard oncologic care, despite being less likely to receive aggressive end-of-life care. Though limited to patients with NSCLC, these studies illustrate that chemotherapy in advanced cancer is often futile, especially when less aggressive care can improve quality of life as well as survival.
Addressing the futility of chemotherapy with patients is challenging for most oncologists. Although defining treatments as “futile” is suitable in the medical literature, it is a word that may carry negative connotations, such as hopelessness or abandonment, to patients. A more descriptive and less negative term, “nonbeneficial,” may be used when discussing futile chemotherapy with patients. The point when chemotherapy becomes nonbeneficial, and thus futile, is different for each patient and might even change over time. Addressing the patient's definition of nonbeneficial chemotherapy regularly during treatment ensures that the patient's goals are clear and allows the oncologist to direct conversation toward alternative options, such as palliative and hospice care, when chemotherapy cannot provide the benefits sought by the patient. This can be as simple as asking the patient, “Do you think the chemotherapy is giving you enough benefit to continue?”
Palliative Care: It's Not Just Giving Up on People
Both the physician and the patient face several decisions when considering whether or not to pursue chemotherapy for advanced cancer. First of all, the patient must decide how much information he or she wants from the oncologist. If the patient is the decision maker, he or she must choose to accept chemotherapy that is palliative, not curative. After a frank discussion about the anticipated outcomes and symptoms associated with chemotherapy, the patient must consider whether he or she can accept the burden of treatment for the potential of prolonging life by days, weeks, or months. On the other hand, the oncologist must decide if chemotherapy should even be offered, based on patient performance status, known therapeutic outcomes, and patient values and goals. The oncologist can reassure patients that the best available data show that patients who use hospice for even one day actually live longer than those who do not.[6] Once informed about what palliative care and hospice offer, the patient may determine whether or not alternatives to chemotherapy are more favorable. If the patient qualifies for clinical trials, he or she must decide to accept treatment with uncertain outcome. When reflecting upon such difficult issues, both the patient and oncologist should involve others to help guide decision making. Oncologists can consult trusted colleagues for their expertise and to ensure that they are using the best information available. Patients should involve loved ones whom they trust to help make decisions in their best interest. Table 1 provides key questions that the oncologist faces when making these decisions and how to approach them.
| Table 1: Questions to discuss with the patient when chemotherapy may be futile | ||
| Question | Leading prompts | Comment |
| What is the patient’s current understanding of the disease? | How much do you know about your cancer at this point?
How much do you want to know? | Be sure the patient is ready to discuss this issue and that you have enough time for discussion.
Ask if there are others who should receive this information simultaneously, afterwards, or instead of the patient. |
| What are the patient’s goals? | Knowing that we can’t cure your cancer, what are your goals, wishes, or hopes for the future? | Treatment decisions may be impacted greatly by a patient’s personal goals (e.g. patient wants to live to child’s graduation, or patient wants to be as comfortable as possible) |
| If chemotherapy is an option and the patient is interested, is he/she aware of potential risks and benefits? | Although everyone responds differently, these are the likely side effects and outcomes of this treatment… | Be specific in terms of likelihood of response, type of response (palliation instead of cure, extent of life prolongation expected, symptom relief, etc.) and how likely it is that treatment will help achieve patient’s goals.
Discuss potential symptom burden from treatment in detail.
Patient needs to be able to make informed decision about risks vs. benefits involved in potential treatment. |
| If the patient declines chemotherapy, treatment is not indicated, or treatment fails, what other options are available? | Let’s talk about options to make sure that you are comfortable and enjoy the highest quality of life possible in the time that you have left. | Focus on pain and symptom management. Discuss hospice options (home vs. inpatient) and make referrals when appropriate.
Stress that you will continue your relationship with the patient (possibly as their hospice provider) and that you will ensure that their symptoms are managed, either directly or through hospice nurses. |
As an alternative to addressing the above issues with the patient independently, oncologists may involve a palliative care specialist to facilitate this conversation.[7] Particularly in cases where the oncologist decides that chemotherapy is no longer a viable option, it may be easier, from both the patient and the provider perspectives, for the palliative care specialist to have this discussion. In a recent survey of patients on our oncology ward, the great majority did not want to discuss advance directives (ADs) with their oncologist—these patients thought ADs were important and should be discussed but were more comfortable discussing them with the admitting provider than the oncologist.[8] Patients may feel that they are disappointing their oncologist by being unable to take further treatment or by admitting that treatment has failed them. Similarly, oncologists might view having this discussion as an admission of their failure as a provider. The palliative care specialist, on the other hand, has no responsibility for chemotherapy and possibly no prior relationship with the patient, thus alleviating this type of emotional association between provider and patient. Furthermore, the conversation about nonbeneficial chemotherapy provides a segue for the palliative care provider to discuss with patients what he or she does best: establishing goals of care, managing symptoms, and maintaining comfort. For the palliative care specialist, providing symptom management and the best possible quality of life for patients are the fundamental goals. Death is generally not viewed with a sense of failure when palliation is the focus of care.
Oncology: Palliative Care Is Giving Up
We still hear from oncologists like ourselves the dreaded words “What do you want me to do, give up on the patient?” or, to the patient, “What, are you giving up? I thought you'd keep fighting!” We would argue that current best practices include knowing when the risks and harms of chemotherapy outweigh any potential chance of benefit. Physicians and patients should follow current National Comprehensive Cancer Network (NCCN) guidelines for solid tumors such as breast9 and lung10 cancer and stop chemotherapy when the chance of success is minimal. If the doctor cannot describe a specific, substantial benefit that outweighs the toxicity, he or she should not recommend it.[11] And all the relevant guidelines call for considering a switch to nonchemotherapy palliative care when the patient's performance status is Eastern Cooperative Oncology Group (ECOG) ≥3, defined as “3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.”[12] Such a simple threshold could dramatically reduce the use of chemotherapy at the end of life and lessen downstream toxicities.
Oncologists can implement several strategies to help facilitate the transition from aggressive care to comfort care (Table 2). For patients with incurable cancer, oncologists can hold early discussions about palliative and hospice options that will need to be implemented when chemotherapy is no longer able to control their disease. This discussion introduces palliative medicine as part of the care plan for incurable disease and allows the patient to anticipate such a transition. Oncologists can also provide reassurance that they will continue to be involved in their patient's care and to support them, even if the patient does not undergo further chemotherapy. There are at least four studies that show equal[13] or better[6] survival, smoother transitions to hospice when death is inevitable, less intensive end-of-life care, and superior patient and family outcomes with concurrent palliative care. [14] and [15] By helping patients establish legal documents, such as ADs and power of attorney, oncologists and palliative care specialists can alleviate some of the stress related to the end of life and make the transition to comfort care easier. Finally, oncologists can review guidelines such as those from the NCCN and American Society of Clinical Oncology, which call for a switch to palliative care when the cancer has grown on three regimens or the patient's ECOG performance status is three or above. [11] and [12]
| Table 2: Things that help ONCOLOGISTS and their patients | ||
| Item | How it helps | Comments |
| Early discussion of palliative and hospice care when chemotherapy may no longer help. | Hospice (and eventual death) will not come as a complete surprise. | “We will do our best to help you with this cancer, but at some point there may not be any treatments known to help….” “Remember the conversation we had when we first met?...” |
| Reassurance that the oncologist will not abandon the patient if concurrent care is given. | This major fear may keep oncology patients at the same practice they have known for years – it is familiar – when they would be better served by transition. | There are now at least 4 randomized trials showing that most patients will accept concurrent palliative care if offered, and that outcomes are equal or better, at less cost.6,13,14,15 |
| Legal documents such as Advance Medical Directives, Durable Medical Power of Attorney | Reinforces the seriousness and “now” aspect of care. | These are readily available in all states at no cost. They are not the final word on how to live one’s remaining time, but will get the conversation started. |
| Best nationally recognized information showing that further chemotherapy will not help due to 3 prior failures, or is not indicated due to poor performance status.9,10 | The oncologist can point to the right page and say “The best national guidelines call for a switch away from chemo…because it will do no good and will cause harmful side effects.” | Readily accessed from the Internet. |
| Use decision aids, similar to Adjuvant!. | Increases the amount of truthful information given, even when the news is bad, and helps with transition points. | An increasing number of these are available[i],[ii],[iii],[iv] and will soon be offered as smart phone applications (aps). |
Communication tools, such as the National Cancer Institute's Oncotalk and EPEC-O, are useful for oncologists seeking to further enhance their communication skills.
Take-Home Messages
Guiding patients in making decisions about nonbeneficial, or futile, chemotherapy presents a challenge for many oncologists as well as their patients and families. Though futility is difficult to define, oncologists and their patients can decide through regular, open discussion if the burdens of chemotherapy outweigh the benefits and whether or not chemotherapy can achieve the reasonable benefits desired by the patient. “Your cancer is advancing despite our best efforts to keep it from growing. Let's talk about what options we have at this point and see what will work best for you.” To make such decisions, oncologists must obtain the most current information and convey it to patients (or their designated decision makers) as clearly as possible. “Based on the latest evidence, there is a 20% chance that the cancer will shrink or stay the same size with this treatment and an 80% chance that it will continue to grow despite treatment.” Both oncologists and their patients should involve those whom they trust to help with decision making. In cases where chemotherapy is nonbeneficial, oncologists may prefer to involve palliative and hospice care specialists to discuss the transition to comfort care with the patient. “At this time, I do not have any treatments that are likely to help you live longer or more comfortably, but I want to make sure that we get the most out of the rest of your life. I have asked a palliative care specialist to help us make this possible.” In order to ease the transition from aggressive or curative care to comfort care, oncologists can employ approaches such as early discussion of palliative and hospice care, assuring the patient of continued involvement in their care, and helping patients with ADs. These approaches not only benefit patients and their families but also strengthen the relationship between the oncologist and the patients and their families.
Acknowledgments
This research was supported by grants GO8 LM0095259 from the National Library of Medicine and R01CA116227-01 (both to T. J. S.) from the National Cancer Institute.
References [PubMed ID in brackets]
1 P.R. Helft, M. Siegler and J. Lantos, The rise and fall of the medical futility movement, . N Engl J Med, 343 (2000), pp. 293–296 [10911014].
2 L.J. Schneiderman, N.S. Jecker and A.R. Jonsen, Medical futility: its meaning and ethical implications, . Ann Intern Med, 112 (1990), pp. 949–954 [2187394].
3 E. Massarelli, F. Andre, D.D. Liu, J.J. Lee, M. Wolf, A. Fandi, J. Ochs, T. Le Chevalier, F. Fossella and R.S. Herbst, A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer, . Lung Cancer, 39 1 (2003), pp. 55–61 [12499095].
4 V. Zietemann and T. Duell, Every-day clinical practice in patients with advanced non-small-cell lung cancer, . Lung Cancer, 68 2 (2010), pp. 273–277 [19632737].
5 J.S. Temel, J.A. Greer, A. Muzikansky, E.R. Gallagher, S. Admane, V.A. Jackson, C.M. Dahlin, C.D. Blinderman, J. Jacobsen, W.F. Pirl, J.A. Billings and T.J. Lynch, Early palliative care for patients with metastatic non-small-cell lung cancer, . N Engl J Med, 363 (2010), pp. 733–742 [20818875].
6 S.R. Connor, B. Pyenson, K. Fitch, C. Spence and K. Iwasaki, Comparing hospice and nonhospice patient survival among patients who die within a three-year window. J Pain Symptom Manage, 33 3 (2007), pp. 238–246.
7 S.E. Harrington and T.J. Smith, The role of chemotherapy at the end of life: “when is enough, enough?”. JAMA, 299 22 (2008), pp. 2667–2678.
8 L. Dow, R. Matsuyama, L. Kuhn, L. Lyckholm, E.B. Lamont and T.J. Smith, Paradoxes in advance care planning. J Clin Oncol, 28 2 (2010), pp. 299–304.
9 NCCN Breast Cancer Clinical Practice Guidelines Panel, R.W. Carlson, D.C. Allred, B.O. Anderson, H.J. Burstein, W.B. Carter, S.B. Edge, J.K. Erban, W.B. Farrar, L.J. Goldstein, W.J. Gradishar, D.F. Hayes, C.A. Hudis, M. Jahanzeb, K. Kiel, B.M. Ljung, P.K. Marcom, I.A. Mayer, B. McCormick, L.M. Nabell, L.J. Pierce, E.C. Reed, M.L. Smith, G. Somlo, R.L. Theriault, N.S. Topham, J.H. Ward, E.P. Winer and A.C. Wolff, Breast cancer. J Natl Compr Canc Netw, 7 2 (2009), pp. 122–192.
10 NCCN Non-Small Cell Lung Cancer Panel Members, D.S. Ettinger, W. Akerley, G. Bepler, M.G. Blum, A. Chang, R.T. Cheney, L.R. Chirieac, T.A. D'Amico, T.L. Demmy, A.K. Ganti, R. Govindan, F.W. Grannis, T. Jahan, M. Jahanzeb, D.H. Johnson, A. Kessinger, R. Komaki, F.M. Kong, M.G. Kris, L.M. Krug, Q.T. Le, I.T. Lennes, R. Martins, J. O'Malley, R.U. Osarogiagbon, G.A. Otterson, J.D. Patel, K.M. Pisters, K. Reckamp, G.J. Riely, E. Rohren, G.R. Simon, S.J. Swanson, D.E. Wood and S.C. Yang, Non-small cell lung cancer. J Natl Compr Canc Netw, 8 7 (2010), pp. 740–801.
11 American Society of Clinical Oncology Outcomes Working Group, Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol, 14 (1996), pp. 671–679.
12 Eastern Cooperative Oncology Group, ECOG Performance Status, http://ecog.dfci.harvard.edu/general/perf_stat.html Accessed November 30, 2010.
13 J. Finn, K. Pienta and J. Parzuchowski, Bridging cancer treatment and hospice care. Proc Am Soc Clin Oncol, 21 (2002), p. 1452.
14 G. Gade, I. Venohr, D. Conner, K. McGrady, J. Beane, R.H. Richardson, M.P. Williams, M. Liberson, M. Blum and R. Della Penna, Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med, 11 2 (2008), pp. 180–190.
Copyright © 2011 Elsevier Inc. All rights reserved.
Understanding Bereavement: What Every Oncology Practitioner Should Know
The Journal of Supportive Oncology
| doi:10.1016/j.suponc.2011.04.007 |
| Permissions & Reprints |
Review
Abstract
Death and dying are ever-present in the practice of oncology. Oncology clinic staff regularly encounter terminally ill patients and grieving family members and, therefore, are well positioned to identify and intervene on behalf of those at risk for extreme psychological distress. It is important for oncology providers to understand grief, the factors that heighten the risk for maladjustment to the loss, and how best to ease the emotional pain and suffering of bereaved family members. This article highlights models of grief that examine early relationships, relationships at the time of the loss, cognitive processes, and cultural practices. We also discuss special circumstances of grief such as the loss of a child or parent and grief in young adults. Risk factors for severe grief reactions, specifically prolonged grief disorder, are examined, as are the efficacy of various interventions, including staff support, psychodynamic therapy, cognitive-behavioral therapy, interpersonal therapy, group therapy, and Internet interventions. Overall, the literature on treatment for grief has demonstrated mixed results, but some therapies have shown promise in treating particularly distressed families and individuals. We discuss the clinical significance of grief and the importance of recognizing the unique factors which contribute to individuals' abilities to cope with loss.
*For a PDF of the full article and accompanying viewpoints by Noreen Carrington and Charles F. von Gunten and Judith Lacey, click on the links to the left of this introduction.
The Journal of Supportive Oncology
| doi:10.1016/j.suponc.2011.04.007 |
| Permissions & Reprints |
Review
Abstract
Death and dying are ever-present in the practice of oncology. Oncology clinic staff regularly encounter terminally ill patients and grieving family members and, therefore, are well positioned to identify and intervene on behalf of those at risk for extreme psychological distress. It is important for oncology providers to understand grief, the factors that heighten the risk for maladjustment to the loss, and how best to ease the emotional pain and suffering of bereaved family members. This article highlights models of grief that examine early relationships, relationships at the time of the loss, cognitive processes, and cultural practices. We also discuss special circumstances of grief such as the loss of a child or parent and grief in young adults. Risk factors for severe grief reactions, specifically prolonged grief disorder, are examined, as are the efficacy of various interventions, including staff support, psychodynamic therapy, cognitive-behavioral therapy, interpersonal therapy, group therapy, and Internet interventions. Overall, the literature on treatment for grief has demonstrated mixed results, but some therapies have shown promise in treating particularly distressed families and individuals. We discuss the clinical significance of grief and the importance of recognizing the unique factors which contribute to individuals' abilities to cope with loss.
*For a PDF of the full article and accompanying viewpoints by Noreen Carrington and Charles F. von Gunten and Judith Lacey, click on the links to the left of this introduction.
The Journal of Supportive Oncology
| doi:10.1016/j.suponc.2011.04.007 |
| Permissions & Reprints |
Review
Abstract
Death and dying are ever-present in the practice of oncology. Oncology clinic staff regularly encounter terminally ill patients and grieving family members and, therefore, are well positioned to identify and intervene on behalf of those at risk for extreme psychological distress. It is important for oncology providers to understand grief, the factors that heighten the risk for maladjustment to the loss, and how best to ease the emotional pain and suffering of bereaved family members. This article highlights models of grief that examine early relationships, relationships at the time of the loss, cognitive processes, and cultural practices. We also discuss special circumstances of grief such as the loss of a child or parent and grief in young adults. Risk factors for severe grief reactions, specifically prolonged grief disorder, are examined, as are the efficacy of various interventions, including staff support, psychodynamic therapy, cognitive-behavioral therapy, interpersonal therapy, group therapy, and Internet interventions. Overall, the literature on treatment for grief has demonstrated mixed results, but some therapies have shown promise in treating particularly distressed families and individuals. We discuss the clinical significance of grief and the importance of recognizing the unique factors which contribute to individuals' abilities to cope with loss.
*For a PDF of the full article and accompanying viewpoints by Noreen Carrington and Charles F. von Gunten and Judith Lacey, click on the links to the left of this introduction.
Animal Models of Mucositis: Implications for Therapy
Journal of Supportive Oncology
| doi:10.1016/j.suponc.2011.04.009 |
| Permissions & Reprints |
Review
Joanne M. Bowen PhD, Rachel J. Gibson PhD, Dorothy M.K. Keefe MD, FRACP
Received 28 February 2011; Accepted 25 April 2011. Available online 24 September 2011.
Abstract
Alimentary mucositis is a major acute complication in the clinical setting, occurring in a large percentage of patients undergoing cytotoxic therapy. One of the major problems with alimentary mucositis is that the underlying mechanisms behind its development are not entirely understood, which makes it extremely difficult to develop effective interventions. Animal models provide a critical source of knowledge when sampling from patients is unavailable or interventions are yet to be fully tested. This review focuses on the animal models used to increase our understanding of the mechanisms of mucositis and translate new antimucotoxic agents into clinical trials.Correspondence to: Joanne M. Bowen, PhD, School of Medical Sciences, University of Adelaide, North Terrace, Adelaide, South Australia 5005; telephone: +61-8-83131374; fax: +61-8-8303 4408; email [email protected]
Volume 9, Issue 5, September-October 2011, Pages 161-168
Journal of Supportive Oncology
| doi:10.1016/j.suponc.2011.04.009 |
| Permissions & Reprints |
Review
Joanne M. Bowen PhD, Rachel J. Gibson PhD, Dorothy M.K. Keefe MD, FRACP
Received 28 February 2011; Accepted 25 April 2011. Available online 24 September 2011.
Abstract
Alimentary mucositis is a major acute complication in the clinical setting, occurring in a large percentage of patients undergoing cytotoxic therapy. One of the major problems with alimentary mucositis is that the underlying mechanisms behind its development are not entirely understood, which makes it extremely difficult to develop effective interventions. Animal models provide a critical source of knowledge when sampling from patients is unavailable or interventions are yet to be fully tested. This review focuses on the animal models used to increase our understanding of the mechanisms of mucositis and translate new antimucotoxic agents into clinical trials.Correspondence to: Joanne M. Bowen, PhD, School of Medical Sciences, University of Adelaide, North Terrace, Adelaide, South Australia 5005; telephone: +61-8-83131374; fax: +61-8-8303 4408; email [email protected]
Volume 9, Issue 5, September-October 2011, Pages 161-168
Journal of Supportive Oncology
| doi:10.1016/j.suponc.2011.04.009 |
| Permissions & Reprints |
Review
Joanne M. Bowen PhD, Rachel J. Gibson PhD, Dorothy M.K. Keefe MD, FRACP
Received 28 February 2011; Accepted 25 April 2011. Available online 24 September 2011.
Abstract
Alimentary mucositis is a major acute complication in the clinical setting, occurring in a large percentage of patients undergoing cytotoxic therapy. One of the major problems with alimentary mucositis is that the underlying mechanisms behind its development are not entirely understood, which makes it extremely difficult to develop effective interventions. Animal models provide a critical source of knowledge when sampling from patients is unavailable or interventions are yet to be fully tested. This review focuses on the animal models used to increase our understanding of the mechanisms of mucositis and translate new antimucotoxic agents into clinical trials.Correspondence to: Joanne M. Bowen, PhD, School of Medical Sciences, University of Adelaide, North Terrace, Adelaide, South Australia 5005; telephone: +61-8-83131374; fax: +61-8-8303 4408; email [email protected]
Volume 9, Issue 5, September-October 2011, Pages 161-168
Commentary: Depression Stymies Care in Latina Breast Cancer Survivors
Depression emerged as a significant barrier to secondary cancer screening in Latina survivors of breast cancer in a thought-provoking study released Sept. 19 at the American Association of Cancer Research Conference on the Science of Cancer Health Disparities in Washington.
The cross-sectional study explored adherence to recommended screening guidelines for ovarian and colorectal cancer among 117 Latina breast cancer survivors. Not surprisingly, but disturbingly, adherence was low among this very-high-risk group. Nearly 60% (69 of 117) failed to receive standard screening for either disease.
One would hope that these high-risk women knew, based on their prior treatment, how to negotiate financial and logistical barriers to care. It would seem likely that they formed relationships with health care professionals. Certainly, it would be expected that they learned that early detection saves lives; perhaps, it had already saved theirs.
So what happened? How did the prevention message fail to reach women who had already directly faced the reality of a cancer diagnosis, and survived?
One sobering possibility lies in the fact that nearly a third of Latinas in the study met the criteria for depression, according to scores for the simple but comprehensive CES-D (Center for Epidemiologic Studies) screening tool.
The self-administered questionnaire assesses mood "("I felt that I could not shake off the blues, even with help from family or friends"; "I [did not] feel hopeful about the future"), somatic symptoms ("I did not feel like eating; my appetite was poor"), behavior ("I talked less than usual"), and self-concept ("I thought my life had been a failure").
Depression was associated with poor rates of ovarian screening, along with language barriers, unemployment, worries about the cost of screening, and the lack of a family history of cancer.
Poor rates of colorectal cancer screening were associated with being unmarried.
In online video interview from a 2010 AACR breast cancer meeting, the current study’s primary investigator, Amelie G. Ramirez, Dr. P.H., spoke of challenging issues surrounding Latina access to cancer prevention and care, driven by cultural as well as socioeconomic issues.
Sheer terror of cancer, she explained, wields a powerful influence over portions of the Latina community.
"When they hear the word cancer, it’s very fearful for them. It almost shuts down all ... communication," said Dr. Ramirez, director of the Institute for Health Promotion Research and professor of epidemiology and biostatistics at the University of Texas, San Antonio.
Depression, too, casts a dark, silent cloud over the Latino community.
In a 2009 study, University of California, Los Angeles, researchers identified a strong link between self-perceived stigma and secrecy surrounding depressive symptoms, less likelihood of taking antidepressants, and – importantly with regard to the current screening study – more missed medical appointments among Latinos.
Taken together, these studies and observations begin to paint a picture of the type of woman whose life might be reflected in the numbers in Dr. Ramirez’s study. She is poor and unemployed; she struggles with English. She survived a disease that is unspeakably terrifying in her community and perhaps in her family as well. She may be unmarried.
And now, with bills and scars still reminding her of the trauma, a new, equally unmentionable burden shadows her days. She sleeps restlessly and cannot eat; she is quiet and withdrawn; she cannot shake off the blues. She feels that her life has been a failure.
Assuming the best possible scenario, a card arrives in the mail, reminding her that she is due for cancer screening: an annual pelvic exam, perhaps, or a colonoscopy.
Is it any wonder she fails to comply?
Dr. Freed is a clinical psychologist in Santa Barbara, Calif., and a medical journalist. She has no relevant financial disclosures.
Depression emerged as a significant barrier to secondary cancer screening in Latina survivors of breast cancer in a thought-provoking study released Sept. 19 at the American Association of Cancer Research Conference on the Science of Cancer Health Disparities in Washington.
The cross-sectional study explored adherence to recommended screening guidelines for ovarian and colorectal cancer among 117 Latina breast cancer survivors. Not surprisingly, but disturbingly, adherence was low among this very-high-risk group. Nearly 60% (69 of 117) failed to receive standard screening for either disease.
One would hope that these high-risk women knew, based on their prior treatment, how to negotiate financial and logistical barriers to care. It would seem likely that they formed relationships with health care professionals. Certainly, it would be expected that they learned that early detection saves lives; perhaps, it had already saved theirs.
So what happened? How did the prevention message fail to reach women who had already directly faced the reality of a cancer diagnosis, and survived?
One sobering possibility lies in the fact that nearly a third of Latinas in the study met the criteria for depression, according to scores for the simple but comprehensive CES-D (Center for Epidemiologic Studies) screening tool.
The self-administered questionnaire assesses mood "("I felt that I could not shake off the blues, even with help from family or friends"; "I [did not] feel hopeful about the future"), somatic symptoms ("I did not feel like eating; my appetite was poor"), behavior ("I talked less than usual"), and self-concept ("I thought my life had been a failure").
Depression was associated with poor rates of ovarian screening, along with language barriers, unemployment, worries about the cost of screening, and the lack of a family history of cancer.
Poor rates of colorectal cancer screening were associated with being unmarried.
In online video interview from a 2010 AACR breast cancer meeting, the current study’s primary investigator, Amelie G. Ramirez, Dr. P.H., spoke of challenging issues surrounding Latina access to cancer prevention and care, driven by cultural as well as socioeconomic issues.
Sheer terror of cancer, she explained, wields a powerful influence over portions of the Latina community.
"When they hear the word cancer, it’s very fearful for them. It almost shuts down all ... communication," said Dr. Ramirez, director of the Institute for Health Promotion Research and professor of epidemiology and biostatistics at the University of Texas, San Antonio.
Depression, too, casts a dark, silent cloud over the Latino community.
In a 2009 study, University of California, Los Angeles, researchers identified a strong link between self-perceived stigma and secrecy surrounding depressive symptoms, less likelihood of taking antidepressants, and – importantly with regard to the current screening study – more missed medical appointments among Latinos.
Taken together, these studies and observations begin to paint a picture of the type of woman whose life might be reflected in the numbers in Dr. Ramirez’s study. She is poor and unemployed; she struggles with English. She survived a disease that is unspeakably terrifying in her community and perhaps in her family as well. She may be unmarried.
And now, with bills and scars still reminding her of the trauma, a new, equally unmentionable burden shadows her days. She sleeps restlessly and cannot eat; she is quiet and withdrawn; she cannot shake off the blues. She feels that her life has been a failure.
Assuming the best possible scenario, a card arrives in the mail, reminding her that she is due for cancer screening: an annual pelvic exam, perhaps, or a colonoscopy.
Is it any wonder she fails to comply?
Dr. Freed is a clinical psychologist in Santa Barbara, Calif., and a medical journalist. She has no relevant financial disclosures.
Depression emerged as a significant barrier to secondary cancer screening in Latina survivors of breast cancer in a thought-provoking study released Sept. 19 at the American Association of Cancer Research Conference on the Science of Cancer Health Disparities in Washington.
The cross-sectional study explored adherence to recommended screening guidelines for ovarian and colorectal cancer among 117 Latina breast cancer survivors. Not surprisingly, but disturbingly, adherence was low among this very-high-risk group. Nearly 60% (69 of 117) failed to receive standard screening for either disease.
One would hope that these high-risk women knew, based on their prior treatment, how to negotiate financial and logistical barriers to care. It would seem likely that they formed relationships with health care professionals. Certainly, it would be expected that they learned that early detection saves lives; perhaps, it had already saved theirs.
So what happened? How did the prevention message fail to reach women who had already directly faced the reality of a cancer diagnosis, and survived?
One sobering possibility lies in the fact that nearly a third of Latinas in the study met the criteria for depression, according to scores for the simple but comprehensive CES-D (Center for Epidemiologic Studies) screening tool.
The self-administered questionnaire assesses mood "("I felt that I could not shake off the blues, even with help from family or friends"; "I [did not] feel hopeful about the future"), somatic symptoms ("I did not feel like eating; my appetite was poor"), behavior ("I talked less than usual"), and self-concept ("I thought my life had been a failure").
Depression was associated with poor rates of ovarian screening, along with language barriers, unemployment, worries about the cost of screening, and the lack of a family history of cancer.
Poor rates of colorectal cancer screening were associated with being unmarried.
In online video interview from a 2010 AACR breast cancer meeting, the current study’s primary investigator, Amelie G. Ramirez, Dr. P.H., spoke of challenging issues surrounding Latina access to cancer prevention and care, driven by cultural as well as socioeconomic issues.
Sheer terror of cancer, she explained, wields a powerful influence over portions of the Latina community.
"When they hear the word cancer, it’s very fearful for them. It almost shuts down all ... communication," said Dr. Ramirez, director of the Institute for Health Promotion Research and professor of epidemiology and biostatistics at the University of Texas, San Antonio.
Depression, too, casts a dark, silent cloud over the Latino community.
In a 2009 study, University of California, Los Angeles, researchers identified a strong link between self-perceived stigma and secrecy surrounding depressive symptoms, less likelihood of taking antidepressants, and – importantly with regard to the current screening study – more missed medical appointments among Latinos.
Taken together, these studies and observations begin to paint a picture of the type of woman whose life might be reflected in the numbers in Dr. Ramirez’s study. She is poor and unemployed; she struggles with English. She survived a disease that is unspeakably terrifying in her community and perhaps in her family as well. She may be unmarried.
And now, with bills and scars still reminding her of the trauma, a new, equally unmentionable burden shadows her days. She sleeps restlessly and cannot eat; she is quiet and withdrawn; she cannot shake off the blues. She feels that her life has been a failure.
Assuming the best possible scenario, a card arrives in the mail, reminding her that she is due for cancer screening: an annual pelvic exam, perhaps, or a colonoscopy.
Is it any wonder she fails to comply?
Dr. Freed is a clinical psychologist in Santa Barbara, Calif., and a medical journalist. She has no relevant financial disclosures.
Molecular tumor profile: another consideration for postmastectomy radiotherapy
I enjoyed the review article by Dr. Jeannie Shen (Community Oncology, December 2010), both for her succinct summary of the indications for postmastectomy plastic surgical reconstruction and the optimal timing of the procedure. Her salient presentation contained some of the most contemporary indications for postmastectomy radiotherapy (PMRT).
Along with the points Dr. Shen mentioned as indicators for PMRT— tumor size, regional nodal involvement, presence of lymphovascular space invasion, and patient youth—I would add estrogen receptor-negative disease as another tumor factor to consider for adjuvant radiotherapy. Many series, including some of those referenced by Dr. Shen and the American Society of Clinical Oncology in the composition of its recommendations, have demonstrated that estrogen receptor-negative status represents an independent risk factor for locoregionally recurrent disease after mastectomy and that the risk is significantly reduced by PMRT.1–7 ...
* For a PDF of the full article, click in the link to the left of this introduction.
I enjoyed the review article by Dr. Jeannie Shen (Community Oncology, December 2010), both for her succinct summary of the indications for postmastectomy plastic surgical reconstruction and the optimal timing of the procedure. Her salient presentation contained some of the most contemporary indications for postmastectomy radiotherapy (PMRT).
Along with the points Dr. Shen mentioned as indicators for PMRT— tumor size, regional nodal involvement, presence of lymphovascular space invasion, and patient youth—I would add estrogen receptor-negative disease as another tumor factor to consider for adjuvant radiotherapy. Many series, including some of those referenced by Dr. Shen and the American Society of Clinical Oncology in the composition of its recommendations, have demonstrated that estrogen receptor-negative status represents an independent risk factor for locoregionally recurrent disease after mastectomy and that the risk is significantly reduced by PMRT.1–7 ...
* For a PDF of the full article, click in the link to the left of this introduction.
I enjoyed the review article by Dr. Jeannie Shen (Community Oncology, December 2010), both for her succinct summary of the indications for postmastectomy plastic surgical reconstruction and the optimal timing of the procedure. Her salient presentation contained some of the most contemporary indications for postmastectomy radiotherapy (PMRT).
Along with the points Dr. Shen mentioned as indicators for PMRT— tumor size, regional nodal involvement, presence of lymphovascular space invasion, and patient youth—I would add estrogen receptor-negative disease as another tumor factor to consider for adjuvant radiotherapy. Many series, including some of those referenced by Dr. Shen and the American Society of Clinical Oncology in the composition of its recommendations, have demonstrated that estrogen receptor-negative status represents an independent risk factor for locoregionally recurrent disease after mastectomy and that the risk is significantly reduced by PMRT.1–7 ...
* For a PDF of the full article, click in the link to the left of this introduction.
Medicare Shared Savings Program ignores oncology—but value-based reimbursement is on the way
The Medicare Shared Savings Program (MSSP) will likely be a nonevent for oncology. Initially, many expected that the accountable care organization (ACO) framework implemented through the 2010 Patient Protection and Affordable Care Act’s MSSP would speed up changes that were already in progress, such as intensifying shifts toward hospital employment of oncologists, creating integrated delivery systems in geographic areas, and requiring oncologists either to form their own ACOs or figure out how to plug into established ACOs. Those expectations were quashed, however, after the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the MSSP (see sidebar), and would-be participants realized how burdensome and proscriptive it would be to implement the program. More important for oncology, under the proposed rule, it seems that the CMS does not intend for the shared savings program to tackle cost-effectiveness in the oncology setting for the following reasons:
- Oncologist-managed patients are not considered in the MSSP and would not be assigned to an ACO (see sidebar);
- Even if oncologist-managed patients were to be included in the MSSP, they would still likely be excluded by the outlier threshold because their treatment and management costs are so high;
- Even if the rules were to be changed to count oncologist-managed patients who exceed the proposed outlier threshold, the CMS approach of inflating historic spending to set future targets would not allow for a dynamic standard of care in oncology, with the new, costly therapies that are likely to emerge over any 3-year window.
The upshot is that the MSSP provides no incentive for oncologist participation in ACOs, and oncologist participation under a system that bases future targets on historic spending would likely result in missed targets and shared loss payments back to the CMS. With the expected rapid growth of the cancer patient population and the high relative costs to Medicare, it is likely that the CMS will consider targeted approaches to value-based reimbursement in oncology outside of the MSSP. Community oncology practices would be better served by preparing for a targeted oncology approach with private payers and the CMS rather than through the one-size-fits-few MSSP....
* For a PDF of the full article, click in the link to the left of this introduction.
The Medicare Shared Savings Program (MSSP) will likely be a nonevent for oncology. Initially, many expected that the accountable care organization (ACO) framework implemented through the 2010 Patient Protection and Affordable Care Act’s MSSP would speed up changes that were already in progress, such as intensifying shifts toward hospital employment of oncologists, creating integrated delivery systems in geographic areas, and requiring oncologists either to form their own ACOs or figure out how to plug into established ACOs. Those expectations were quashed, however, after the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the MSSP (see sidebar), and would-be participants realized how burdensome and proscriptive it would be to implement the program. More important for oncology, under the proposed rule, it seems that the CMS does not intend for the shared savings program to tackle cost-effectiveness in the oncology setting for the following reasons:
- Oncologist-managed patients are not considered in the MSSP and would not be assigned to an ACO (see sidebar);
- Even if oncologist-managed patients were to be included in the MSSP, they would still likely be excluded by the outlier threshold because their treatment and management costs are so high;
- Even if the rules were to be changed to count oncologist-managed patients who exceed the proposed outlier threshold, the CMS approach of inflating historic spending to set future targets would not allow for a dynamic standard of care in oncology, with the new, costly therapies that are likely to emerge over any 3-year window.
The upshot is that the MSSP provides no incentive for oncologist participation in ACOs, and oncologist participation under a system that bases future targets on historic spending would likely result in missed targets and shared loss payments back to the CMS. With the expected rapid growth of the cancer patient population and the high relative costs to Medicare, it is likely that the CMS will consider targeted approaches to value-based reimbursement in oncology outside of the MSSP. Community oncology practices would be better served by preparing for a targeted oncology approach with private payers and the CMS rather than through the one-size-fits-few MSSP....
* For a PDF of the full article, click in the link to the left of this introduction.
The Medicare Shared Savings Program (MSSP) will likely be a nonevent for oncology. Initially, many expected that the accountable care organization (ACO) framework implemented through the 2010 Patient Protection and Affordable Care Act’s MSSP would speed up changes that were already in progress, such as intensifying shifts toward hospital employment of oncologists, creating integrated delivery systems in geographic areas, and requiring oncologists either to form their own ACOs or figure out how to plug into established ACOs. Those expectations were quashed, however, after the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the MSSP (see sidebar), and would-be participants realized how burdensome and proscriptive it would be to implement the program. More important for oncology, under the proposed rule, it seems that the CMS does not intend for the shared savings program to tackle cost-effectiveness in the oncology setting for the following reasons:
- Oncologist-managed patients are not considered in the MSSP and would not be assigned to an ACO (see sidebar);
- Even if oncologist-managed patients were to be included in the MSSP, they would still likely be excluded by the outlier threshold because their treatment and management costs are so high;
- Even if the rules were to be changed to count oncologist-managed patients who exceed the proposed outlier threshold, the CMS approach of inflating historic spending to set future targets would not allow for a dynamic standard of care in oncology, with the new, costly therapies that are likely to emerge over any 3-year window.
The upshot is that the MSSP provides no incentive for oncologist participation in ACOs, and oncologist participation under a system that bases future targets on historic spending would likely result in missed targets and shared loss payments back to the CMS. With the expected rapid growth of the cancer patient population and the high relative costs to Medicare, it is likely that the CMS will consider targeted approaches to value-based reimbursement in oncology outside of the MSSP. Community oncology practices would be better served by preparing for a targeted oncology approach with private payers and the CMS rather than through the one-size-fits-few MSSP....
* For a PDF of the full article, click in the link to the left of this introduction.
CASE LETTER Mandibular fracture in a patient treated with long-term antiangiogenic therapy and previous bisphosphonate exposure
Bisphosponate-related osteonecrosis of the jaw (ONJ) has been reported in the literature since 2003,1,2 with more than 90% of the events attributed to treatment with bisphosphonate agents, such as zoledronic acid (Zometa) and pamidronate, which are used to treat hypercalcemia of malignancy and to reduce the risk of skeletal-related events due to bone metastases.3– 5 Patients with ONJ generally present with exposed necrotic bone that does not heal for 6–8 weeks, often leading to significant morbidity. The pathogenic mechanism for osteonecrosis is unclear, but, in addition to inhibiting bone resorption, preclinical data have demonstrated thrombotic microangiopathy and potent inhibition of angiogenesis,6 which may lead to avascular necrosis and poor wound healing after dental procedures.
Angiogenesis is a critical step in tumor growth, and agents that block neovascularization by targeting vascular endothelial growth factor (VEGF) or its receptor (VEGFR) have been used successfully for a variety of solid tumors. Bevacizumab (Avastin) is a monoclonal antibody that inhibits angiogenesis by binding to VEGF,7 and sorafenib (Nexavar) is a multiple-kinase inhibitor that inhibits several intracellular and cell-surface kinases, including VEGFR.8 Osteonecrosis of the jaw or femoral heads has been increasingly recognized in patients treated with antiangiogenic therapies, even without concurrent bisphosphonate use.9–12 Previous data on combining bisphosphonates with antiangiogenic agents are conflicting, with some reports indicating a similar risk of ONJ compared with the use of bisphosphonates alone13,14 and others showing significantly higher rates (18% vs 1% with bisphosphonates alone).15.16
In this paper, we describe the case of a patient with metastatic prostate cancer and a history of ONJ from use of zoledronic acid who developed a mandibular fracture while he was off zoledronic acid for 15 months but undergoing treatment with paclitaxel and bevacizumab plus sorafenib on a clinical trial. The case may help explain the temporal relationship between therapy and the occurrence of jaw fracture, as well as the link between ONJ and the risk of fractures with sequential use of bisphosphonates and antiangiogenic agents. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Bisphosponate-related osteonecrosis of the jaw (ONJ) has been reported in the literature since 2003,1,2 with more than 90% of the events attributed to treatment with bisphosphonate agents, such as zoledronic acid (Zometa) and pamidronate, which are used to treat hypercalcemia of malignancy and to reduce the risk of skeletal-related events due to bone metastases.3– 5 Patients with ONJ generally present with exposed necrotic bone that does not heal for 6–8 weeks, often leading to significant morbidity. The pathogenic mechanism for osteonecrosis is unclear, but, in addition to inhibiting bone resorption, preclinical data have demonstrated thrombotic microangiopathy and potent inhibition of angiogenesis,6 which may lead to avascular necrosis and poor wound healing after dental procedures.
Angiogenesis is a critical step in tumor growth, and agents that block neovascularization by targeting vascular endothelial growth factor (VEGF) or its receptor (VEGFR) have been used successfully for a variety of solid tumors. Bevacizumab (Avastin) is a monoclonal antibody that inhibits angiogenesis by binding to VEGF,7 and sorafenib (Nexavar) is a multiple-kinase inhibitor that inhibits several intracellular and cell-surface kinases, including VEGFR.8 Osteonecrosis of the jaw or femoral heads has been increasingly recognized in patients treated with antiangiogenic therapies, even without concurrent bisphosphonate use.9–12 Previous data on combining bisphosphonates with antiangiogenic agents are conflicting, with some reports indicating a similar risk of ONJ compared with the use of bisphosphonates alone13,14 and others showing significantly higher rates (18% vs 1% with bisphosphonates alone).15.16
In this paper, we describe the case of a patient with metastatic prostate cancer and a history of ONJ from use of zoledronic acid who developed a mandibular fracture while he was off zoledronic acid for 15 months but undergoing treatment with paclitaxel and bevacizumab plus sorafenib on a clinical trial. The case may help explain the temporal relationship between therapy and the occurrence of jaw fracture, as well as the link between ONJ and the risk of fractures with sequential use of bisphosphonates and antiangiogenic agents. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Bisphosponate-related osteonecrosis of the jaw (ONJ) has been reported in the literature since 2003,1,2 with more than 90% of the events attributed to treatment with bisphosphonate agents, such as zoledronic acid (Zometa) and pamidronate, which are used to treat hypercalcemia of malignancy and to reduce the risk of skeletal-related events due to bone metastases.3– 5 Patients with ONJ generally present with exposed necrotic bone that does not heal for 6–8 weeks, often leading to significant morbidity. The pathogenic mechanism for osteonecrosis is unclear, but, in addition to inhibiting bone resorption, preclinical data have demonstrated thrombotic microangiopathy and potent inhibition of angiogenesis,6 which may lead to avascular necrosis and poor wound healing after dental procedures.
Angiogenesis is a critical step in tumor growth, and agents that block neovascularization by targeting vascular endothelial growth factor (VEGF) or its receptor (VEGFR) have been used successfully for a variety of solid tumors. Bevacizumab (Avastin) is a monoclonal antibody that inhibits angiogenesis by binding to VEGF,7 and sorafenib (Nexavar) is a multiple-kinase inhibitor that inhibits several intracellular and cell-surface kinases, including VEGFR.8 Osteonecrosis of the jaw or femoral heads has been increasingly recognized in patients treated with antiangiogenic therapies, even without concurrent bisphosphonate use.9–12 Previous data on combining bisphosphonates with antiangiogenic agents are conflicting, with some reports indicating a similar risk of ONJ compared with the use of bisphosphonates alone13,14 and others showing significantly higher rates (18% vs 1% with bisphosphonates alone).15.16
In this paper, we describe the case of a patient with metastatic prostate cancer and a history of ONJ from use of zoledronic acid who developed a mandibular fracture while he was off zoledronic acid for 15 months but undergoing treatment with paclitaxel and bevacizumab plus sorafenib on a clinical trial. The case may help explain the temporal relationship between therapy and the occurrence of jaw fracture, as well as the link between ONJ and the risk of fractures with sequential use of bisphosphonates and antiangiogenic agents. ...
* For a PDF of the full article, click in the link to the left of this introduction.
The wearable external cardiac defibrillator for cancer patients at risk for sudden cardiac death
Implantable cardioverter defibrillators (ICDs) are indicated for primary prevention of sudden cardiac death (SCD) in patients with reduced left ventricular function (an ejection fraction of ≤ 35%). ICD therapy is also recommended for secondary prevention of SCD in patients with a life-threatening cardiac arrhythmia, including aborted sudden cardiac death. Contraindications to ICD therapy are life expectancy ≤ 1 year, incessant arrhythmia, significant psychiatric illness, syncope without evidence of inducible ventricular arrhythmia or structural heart disease, ventricular arrhythmia amenable to catheter ablation, ventricular arrhythmia due to a reversible cause, and primary prevention of SCD in patients ineligible for cardiac transplantation or cardiac resynchronization therapy.1 In addition, relative contraindications to ICD therapy include the need for radiation therapy to the thorax, high risk for infection, and high risk for deep venous thrombosis.
A subset of patients with cancer is at risk for SCD due to a variety of cardiac causes, including chemotherapy-induced cardiomyopathy or druginduced long QT syndrome. These patients may benefit from ICD placement. However, the aforementioned relative contraindications for permanent defibrillator implantation often coexist in patients with cancer. Moreover, an individual with acute malignancy may have other contraindications for permanent defibrillator implantation, including the potential reversibility of cardiomyopathy or arrhythmia or an unclear prognosis for 1-year survival. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Implantable cardioverter defibrillators (ICDs) are indicated for primary prevention of sudden cardiac death (SCD) in patients with reduced left ventricular function (an ejection fraction of ≤ 35%). ICD therapy is also recommended for secondary prevention of SCD in patients with a life-threatening cardiac arrhythmia, including aborted sudden cardiac death. Contraindications to ICD therapy are life expectancy ≤ 1 year, incessant arrhythmia, significant psychiatric illness, syncope without evidence of inducible ventricular arrhythmia or structural heart disease, ventricular arrhythmia amenable to catheter ablation, ventricular arrhythmia due to a reversible cause, and primary prevention of SCD in patients ineligible for cardiac transplantation or cardiac resynchronization therapy.1 In addition, relative contraindications to ICD therapy include the need for radiation therapy to the thorax, high risk for infection, and high risk for deep venous thrombosis.
A subset of patients with cancer is at risk for SCD due to a variety of cardiac causes, including chemotherapy-induced cardiomyopathy or druginduced long QT syndrome. These patients may benefit from ICD placement. However, the aforementioned relative contraindications for permanent defibrillator implantation often coexist in patients with cancer. Moreover, an individual with acute malignancy may have other contraindications for permanent defibrillator implantation, including the potential reversibility of cardiomyopathy or arrhythmia or an unclear prognosis for 1-year survival. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Implantable cardioverter defibrillators (ICDs) are indicated for primary prevention of sudden cardiac death (SCD) in patients with reduced left ventricular function (an ejection fraction of ≤ 35%). ICD therapy is also recommended for secondary prevention of SCD in patients with a life-threatening cardiac arrhythmia, including aborted sudden cardiac death. Contraindications to ICD therapy are life expectancy ≤ 1 year, incessant arrhythmia, significant psychiatric illness, syncope without evidence of inducible ventricular arrhythmia or structural heart disease, ventricular arrhythmia amenable to catheter ablation, ventricular arrhythmia due to a reversible cause, and primary prevention of SCD in patients ineligible for cardiac transplantation or cardiac resynchronization therapy.1 In addition, relative contraindications to ICD therapy include the need for radiation therapy to the thorax, high risk for infection, and high risk for deep venous thrombosis.
A subset of patients with cancer is at risk for SCD due to a variety of cardiac causes, including chemotherapy-induced cardiomyopathy or druginduced long QT syndrome. These patients may benefit from ICD placement. However, the aforementioned relative contraindications for permanent defibrillator implantation often coexist in patients with cancer. Moreover, an individual with acute malignancy may have other contraindications for permanent defibrillator implantation, including the potential reversibility of cardiomyopathy or arrhythmia or an unclear prognosis for 1-year survival. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Personalized medicine: myth to reality
Ever since the International Human GenomeSequencing Consortium unveiled its “working draft” of the human genome sequence in 2000, the scientific community has eagerly discussed and speculated on the potential of genomic medicine. Patients, clinicians, and scientists were—and still are—excited about the possibilities of targeted therapies such as imatinib (Gleevec) for chronic myeloid leukemias and gastrointestinal stromal tumors and trastuzumab (Herceptin) for HER2/neu-positive breast cancer. There has been significant progress in the development of these and other targeted therapies, and they remain part of an intriguing and promising work in progress. However, for patients with lung cancer and melanoma, both of which are highly refractory diseases, the therapeutic choices other than chemotherapy have been limited and the commensurate outcomes discouraging.
In the early 2000s, we were excited about targeted therapies such as gefitinib (Iressa), which blocks epidermal growth factor receptor (EGFR)- tyrosine kinase activity in non-small cell lung cancer (NSCLC), but its clinical benefit was still limited. We have since gained a better understanding of lung cancer as a molecularly heterogeneous disease and have adjusted our approach to its treatment, based on new data showing that all lung cancer patients cannot be treated with the same drug regimen and achieve the same outcomes. With those insights, the implications of targeted therapies came into sharper focus in 2004 with the US Food and Drug Administration (FDA) approval of erlotinib (Tarceva) for the 10%–15% of patients with NSCLC (adenocarcinoma) who have the EGFR gene mutation. At around the same time, scientists identified BRAF gene mutations in about 40%– 60% of patients with melanoma, and the quest for therapies for that disease was redirected to the cellular level as well. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Ever since the International Human GenomeSequencing Consortium unveiled its “working draft” of the human genome sequence in 2000, the scientific community has eagerly discussed and speculated on the potential of genomic medicine. Patients, clinicians, and scientists were—and still are—excited about the possibilities of targeted therapies such as imatinib (Gleevec) for chronic myeloid leukemias and gastrointestinal stromal tumors and trastuzumab (Herceptin) for HER2/neu-positive breast cancer. There has been significant progress in the development of these and other targeted therapies, and they remain part of an intriguing and promising work in progress. However, for patients with lung cancer and melanoma, both of which are highly refractory diseases, the therapeutic choices other than chemotherapy have been limited and the commensurate outcomes discouraging.
In the early 2000s, we were excited about targeted therapies such as gefitinib (Iressa), which blocks epidermal growth factor receptor (EGFR)- tyrosine kinase activity in non-small cell lung cancer (NSCLC), but its clinical benefit was still limited. We have since gained a better understanding of lung cancer as a molecularly heterogeneous disease and have adjusted our approach to its treatment, based on new data showing that all lung cancer patients cannot be treated with the same drug regimen and achieve the same outcomes. With those insights, the implications of targeted therapies came into sharper focus in 2004 with the US Food and Drug Administration (FDA) approval of erlotinib (Tarceva) for the 10%–15% of patients with NSCLC (adenocarcinoma) who have the EGFR gene mutation. At around the same time, scientists identified BRAF gene mutations in about 40%– 60% of patients with melanoma, and the quest for therapies for that disease was redirected to the cellular level as well. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Ever since the International Human GenomeSequencing Consortium unveiled its “working draft” of the human genome sequence in 2000, the scientific community has eagerly discussed and speculated on the potential of genomic medicine. Patients, clinicians, and scientists were—and still are—excited about the possibilities of targeted therapies such as imatinib (Gleevec) for chronic myeloid leukemias and gastrointestinal stromal tumors and trastuzumab (Herceptin) for HER2/neu-positive breast cancer. There has been significant progress in the development of these and other targeted therapies, and they remain part of an intriguing and promising work in progress. However, for patients with lung cancer and melanoma, both of which are highly refractory diseases, the therapeutic choices other than chemotherapy have been limited and the commensurate outcomes discouraging.
In the early 2000s, we were excited about targeted therapies such as gefitinib (Iressa), which blocks epidermal growth factor receptor (EGFR)- tyrosine kinase activity in non-small cell lung cancer (NSCLC), but its clinical benefit was still limited. We have since gained a better understanding of lung cancer as a molecularly heterogeneous disease and have adjusted our approach to its treatment, based on new data showing that all lung cancer patients cannot be treated with the same drug regimen and achieve the same outcomes. With those insights, the implications of targeted therapies came into sharper focus in 2004 with the US Food and Drug Administration (FDA) approval of erlotinib (Tarceva) for the 10%–15% of patients with NSCLC (adenocarcinoma) who have the EGFR gene mutation. At around the same time, scientists identified BRAF gene mutations in about 40%– 60% of patients with melanoma, and the quest for therapies for that disease was redirected to the cellular level as well. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Quality care is a team effort
Everyone in community oncology practice has a role to play in the delivery of quality care. If you are looking to implement a quality program, each member of the practice, patients included, should be involved in the planning, implementing, reporting, and revising processes. Once those processes are in place, the practice can set up partnerships with payers based on standardized measures, costs, and outcomes, with appropriate payments.
Click on the PDF icon at the top of this introduction to read the full article.
Everyone in community oncology practice has a role to play in the delivery of quality care. If you are looking to implement a quality program, each member of the practice, patients included, should be involved in the planning, implementing, reporting, and revising processes. Once those processes are in place, the practice can set up partnerships with payers based on standardized measures, costs, and outcomes, with appropriate payments.
Click on the PDF icon at the top of this introduction to read the full article.
Everyone in community oncology practice has a role to play in the delivery of quality care. If you are looking to implement a quality program, each member of the practice, patients included, should be involved in the planning, implementing, reporting, and revising processes. Once those processes are in place, the practice can set up partnerships with payers based on standardized measures, costs, and outcomes, with appropriate payments.
Click on the PDF icon at the top of this introduction to read the full article.