Choosing Wisely®: ASCO Member Perspectives on the “Top Five” List in Oncology

Jul 02, 2012

ASCO identifies common tests and treatments with no proven meaningful benefit; the goal—to improve quality and value in patient care

“Less is more” is an aphorism frequently cited when people try to improve their quality of life with decluttered closets, smaller portions of dessert, or less-hectic social calendars. But does “less is more” also apply to quality in health care? ASCO and the American Board of Internal Medicine (ABIM) believe that there are circumstances in which doing less—and avoiding the related consequences of overtreatment and increased costs—is indeed the highest quality of care.

The ABIM’s Choosing Wisely® campaign represents the nexus of quality and value in health care and demonstrates that the best care for patients doesn’t always mean doing more, or doing everything, rather doing only those tests, procedures, and treatments that are right for the patient and supported by evidence. ASCO’s participation in the campaign reflects its commitment to ensuring that patients receive meaningful benefit from every test and treatment and for each dollar spent—maximizing quality and value with a focus on safety, effectiveness, and patient-centered care.

As one of the nine organizations participating in the Choosing Wisely campaign, ASCO contributed a Top Five list of common, costly tests, procedures, and/or treatments in oncology that are not supported by evidence and that should be questioned. The resulting list affirms that evidence-based medicine is the key to providing high-quality, high-value care to patients with cancer and emphasizes the importance of oncologist-patient discussions about the best, most effective care for the individual patient.
 

“Clarifying a framework for what is or is not appropriate in each of the five situations facilitates a dialogue between physicians and patients,” said Patricia A. Ganz, MD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center and David Geffen School of Medicine, and a member of ASCO’s Cost of Cancer Care Task Force. “No one is telling a practitioner to never do one of these procedures, but the Top Five list highlights the level of evidence and the concern about their overutilization.”

Indeed, in the past year, individuals and organizations alike have expressed concern about the perils of overtreatment and the drawbacks of screening, with controversies erupting over such topics as routine mammography for women under age 50 and widespread PSA screening for prostate cancer, particularly in the recent wake of the results of the NCI’s PLCO trial (see the Current Controversies in Oncology column in the May 2012 issue of ASCO Connection for a debate on this topic).

A happy consequence of this laser focus on quality is the opportunity to relieve patients and the health care system of cost burdens associated with ineffective but expensive tests and treatments. The cost of cancer care has also been a theme in recent lay and scientific media, with stories about patients who face being bankrupted by high copays for scans and treatments or who are unable to finish a prescribed course of therapy because they cannot afford to refill their prescriptions (the subject of a presentation by Lee Schwartzberg, MD, FACP, at the 2011 ASCO Annual Meeting).

“Most people in the United States are coming to realize that we have a serious health care finance ‘bubble’ that we have to fix before it collapses like the stock market and the housing market. The Choosing Wisely campaign is a golden opportunity to improve care at a cost we can afford,” said Thomas J. Smith, MD, FACP, FASCO, of Johns Hopkins Medical Institutions and Sidney Kimmel Comprehensive Cancer Center and a member of ASCO’s Cost of Cancer Care Task Force.

Combining an unequivocal commitment to quality and recognition of real value with a sensitivity to the cost of care, Choosing Wisely and the Top Five list dovetail with ASCO’s mission of making a world of difference in cancer care.

The inception of Choosing Wisely

In 2010, Howard Brody, MD, PhD, Director of the Institute for Medical Humanities and a family medicine professor at the University of Texas, challenged medical specialty societies to identify five tests and treatments that are commonly performed in their respective fields despite a lack of evidence that they provide meaningful benefit to major categories of patients. Dr. Brody’s commentary, “Medicine’s Ethical Responsibility for Health Care Reform—The Top Five List,” was published in the New England Journal of Medicine and caught the attention of ASCO’s Cost of Cancer Care Task Force. Compelled by the common-sense and evidence-focused suggestion of Dr. Brody’s article, the Task Force took the initiative to identify the “Top Five” list for oncology procedures.

“I was glad that our professional Society was able to take a leadership role in defining these Top Five recommendations,” Dr. Ganz said. “The list was organically generated and builds on ASCO guidelines.”

Inspired by the same article, the ABIM began developing a national campaign to promote sensible stewardship of health care resources throughout the medical specialties. “Choosing Wisely®: The Five Things that Physicians and Patients Should Question” promotes conversations between physicians and patients about appropriate interventions and avoiding unnecessary or ineffective care.

A subcommittee of the Cost of Cancer Care Task Force worked to identify practices in oncology that were both common and lacking sufficient evidence for widespread use. Upon joining the Choosing Wisely campaign, the members of the subcommittee conducted a literature search to ensure the proposed list of items were supported by available evidence in oncology; the proposed Top Five list was approved by the full Task Force. The list was then presented to the ASCO Clinical Practice Committee, a group comprising community-based oncologists and the presidents of ASCO’s 48 State/Regional Affiliates. Advocacy groups were asked to weigh in to ensure the recommendations would achieve the dual purpose of increasing physician-patient communication and changing practice patterns. Overall, more than 200 clinical oncologists reviewed, provided input, and supported the list, which was finalized and approved by the ASCO Board of Directors.

“These recommendations aren’t so different from the way most oncologists currently approach patient care—most share the view that our best treatments work in those patients most likely to benefit, and that specific testing should be used judiciously. These recommendations are certainly reasonable and will likely improve the care of patients with cancer,” said ASCO member David R. Spigel, MD, of Tennessee Oncology and the Sarah Cannon Research Institute, who was also quoted in an article in The Tennessean regarding the Top Five list. “However, as good as recommendations and guidelines are, it is important that decisions in care are made together with the patient in front of you. Hopefully, these will always line up.”

ASCO member Ahmed M. Elzawawy, MD, of the International Campaign for Establishment and Development of Oncology Centres (ICEDOC) and the South and East Mediterranean College of Oncology (SEMCO), also spoke in support of the campaign. The Top Five list “reflects, in a scientific and organized way, the wishes of manyprofessional cancer care providers in the world to achieve better-value, affordable, holistic care for patients,” he said. “The complexities of the increasing total cost of cancer management require in-depth exploration of evidence-based approaches to maximize the value of cancer care.”

Top Five in oncology

ASCO’s Top Five list in oncology identifies five common procedures that are not supported by evidence in most patient situations. These test and treatment options should not be administered unless the physician and patient have carefully considered if their use is appropriate in the individual case (for example, if the patient is enrolled in a clinical trial in which these procedures are part of the trial protocol and necessary for participation).

  1. Don’t use cancer-directed therapy for patients with solid tumors with the following characteristics: low performance status (3 or 4), no benefit from prior evidence-based interventions, not eligible for a clinical trial, and no strong evidence supporting the clinical value of further anticancer treatment.
    • Studies show that cancer-directed treatments are likely to be ineffective for patients with solid tumors who meet the above stated criteria.
    • Exceptions include patients with functional limitations due to other conditions resulting in a low performance status or those with disease characteristics (e.g., mutations) that suggest a high likelihood of response to therapy.
    • Implementation of this approach should be accompanied with appropriate palliative and supportive care

Overtreatment near the end of life is common. For example, a sample of more than 5,000 patient charts reviewed as part of ASCO’s Quality Oncology Practice Initiative (QOPI®; asco.org/qopi) showed that nearly 12% of patients received chemotherapy within the last 14 days of life, even though evidence indicates that such treatment generally does little to improve survival or quality of life.

Instead of cancer-directed therapy, ASCO recommends that physicians prioritize palliative care and symptom management in patients with advanced solid tumors who have a low performance status (capable of only limited self-care, confined to bed or chair more than 50% of waking hours), received no benefit from multiple prior evidence-based interventions, are ineligible for a clinical trial, and in the absence of strong evidence (such as actionable mutations) supporting the clinical value of further anti-cancer treatment. This approach is most likely to enhance quality of life, improve patient comfort and dignity, and in some cases, can increase survival.


Sources

  • Azzoli CG, Temin S, Aliff T, et al. J Clin Oncol. 2011;29:3825-31.
  • Ettinger DS, Akerley W, Bepler G, et al. J Natl Compr Canc Netw. 2010;8:740-801.
  • Carlson RW, Allred DC, Anderson BO, et al. J Natl Compr Canc Netw. 2009;7:122-92.
  • Engstrom PF, Benson AB 3rd, Chen YJ, et al. J Natl Compr Canc Netw. 2005;3:468-91.
  • Smith TJ, Hillner BE. N Engl J Med. 2011;364:2060-5.
  • Peppercorn JM, Smith TJ, Helft PR, et al. J Clin Oncol. 2011;29:755-60.

 

  1. Don’t perform PET, CT, and radionuclide bone scans in the staging of early prostate cancer at low risk for metastasis.
    • Imaging with PET, CT, or radionuclide bone scans can be useful in the staging of specific cancer types. However, these tests are often used in the staging evaluation of low-risk cancers, despite a lack of evidence suggesting they improve detection of metastatic disease or survival.
    • Evidence does not support the use of these scans for staging of newly diagnosed low-grade carcinoma of the prostate (stage T1c/T2a, prostate-specific antigen [PSA] less than 10 ng/ml, Gleason score less than or equal to 6) with low risk of distant metastasis.
    • Unnecessary imaging can lead to harm through unnecessary invasive procedures, overtreatment, unnecessary radiation exposure, and misdiagnosis.

One study estimated that as many as 99% of men with low-risk prostate cancer do not benefit from these scans. That same study suggested that up to $80 million could be saved each year by using these tests only for patients who are likely to benefit based on available evidence, yet a recent review of Medicare data found that over one-third of men with low-risk prostate cancer underwent such high-cost scans.


Sources
  • Makarov DV, Desai RA, Yu JB, et al. J Urol. 2012;187:97-102.
  • National Comprehensive Cancer Network: NCCN clinical practice guidelines in oncology (NCCN guidelines)-Prostate cancer. Version 4.2011.
  • Thompson I, Thrasher JB, Aus G, et al. J Urol. 2007;177:2106-30.

 

  1. Don’t perform PET, CT, and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis.
    • Imaging with PET, CT, or radionuclide bone scans can be useful in the staging of specific cancer types. However, these tests are often used in the staging evaluation of low-risk cancers, despite a lack of evidence suggesting they improve detection of metastatic disease or survival.
    • In breast cancer, for example, there is a lack of evidence demonstrating a benefit for the use of PET, CT, or radionuclide bone scans in asymptomatic individuals with newly identified ductal carcinoma in situ (DCIS), or clinical stage I or II disease.
    • Unnecessary imaging can lead to harm through unnecessary invasive procedures, overtreatment, unnecessary radiation exposure, and misdiagnosis

Use of PET, CT, or radionuclide bone scans to find metastatic disease in patients found to have early-stage breast and prostate cancers has not been shown to extend survival, is costly, and in some cases may even lead to harm. False-positive results from these tests raise the risk of unnecessary invasive procedures and overtreatment, which can ultimately impact quality of life and potentially shorten survival.


Source
  • Carlson RW, Allred DC, Anderson BO, et al. J Natl Compr Canc Netw. 2011;9:136-222.

 

  1. Don’t perform surveillance testing (biomarkers) or imaging (PET, CT, and radionuclide bone scans) for asymptomatic individuals who have been treated for breast cancer with curative intent.
    • Surveillance testing with serum tumor markers or imaging has been shown to have clinical value for certain cancers (e.g., colorectal). However, for breast cancer that has been treated with curative intent, several studies have shown there is no benefit from routine imaging or serial measurement of serum tumor markers in asymptomatic patients.
    • False-positive tests can lead to harm through unnecessary invasive procedures, overtreatment, unnecessary radiation exposure, and misdiagnosis.

ASCO recommends against using routine blood tests for measurement of the carcinoembryonic antigen (CEA), CA 15-3, and CA 27-29 biomarkers, as well as routine use of advanced imaging tests (PET, CT, radionuclide bone scans) to screen for cancer recurrences in this population.

Most individuals diagnosed with breast cancer today have early-stage disease and, after the institution of proper treatment, have a low chance of recurrence. Yet many undergo screening tests as part of routine surveillance in an attempt to detect recurrences. The available medical evidence indicates that even when such tests do identify early metastases, there is no difference in survival. Moreover, as a consequence of false-positive results, these tests can lead to invasive procedures, overtreatment, and misdiagnosis that can severely impact patients’ quality of life.


Sources
  • Locker GY, Hamilton S, Harris J, et al. J Clin Oncol. 2006;24:5313-27.
  • Desch CE, Benson AB 3rd, Somerfield MR, et al. J Clin Oncol. 2005;23:8512-9.
  • Carlson RW, Allred DC, Anderson BO, et al. J Natl Compr Canc Netw. 2009;7:122-92.
  • Khatcheressian JL, Wolff AC, Smith TJ, et al. J Clin Oncol. 2006;24:5091-7.
  • Harris L, Fritsche H, Mennel R, et al. J Clin Oncol. 2007;25:5287-312.

 

  1. Don’t use white cell stimulating factors for primary prevention of febrile neutropenia for patients with less than 20% risk for this complication.
    • ASCO guidelines recommend using white cell stimulating factors when the risk of febrile neutropenia, secondary to a recommended chemotherapy regimen, is approximately 20% and equally effective treatment programs that do not require white cell stimulating factors are unavailable.
    • Exceptions should be made when using regimens that have a lower chance of causing febrile neutropenia if it is determined that the patient is at high risk for this complication (due to age, medical history, or disease characteristics).

There is growing evidence that suggests these therapies are misused, overused, and cost health systems millions of dollars. Evidence shows that despite clinical guidelines on the use of CSFs from ASCO and other organizations, their utilization varies across the United States. One study estimated that 10% of patients at very low risk (less than 20%) for febrile neutropenia received these treatments unnecessarily. The CanCORS (Cancer Care Outcome Research and Surveillance Consortium) study evaluated a large Medicare cohort of patients with lung and colorectal cancer and demonstrated that only 17% of patients treated with high-risk chemotherapy regimens received appropriate G-CSFs, while 18% of patients with intermediate risk of febrile neutropenia and 10% of patients with low risk received G-CSFs.


Source

  • Smith TJ, Khatcheressian J, Lyman GH, et al. J Clin Oncol. 2006;24:3187-205.

Related resources, patient conversations

ASCO has assembled a variety of resources for health care professionals and patients related to the Choosing Wisely campaign (asco.org/topfive):

  • Links to the lists submitted to ABIM from nine medical societies and to a PDF of ASCO’s Top Five list in oncology
  • “American Society of Clinical Oncology Identifies Five Key Opportunities to Improve Care and Reduce Costs: The Top Five List for Oncology,” published ahead of print in the Journal of Clinical Oncology on April 3, 2012. This article contains complete explanations of the recommendations and an extensive bibliography of the supporting studies
  • FAQs for oncology professionals on the Top Five list
  • Video captured from an ASCO University e-seminar on “Five Things Physicians & Patients Should Question”

Readers with subscriptions to the 2012 ASCO Annual Meeting Virtual Meeting (asco.org/vm) can watch captured slides and audio from Educational Sessions addressing the cost of care:

  • Cost of Lung Cancer Care: Screening, Personalized Medicine, and Palliative Care
    (Faculty: Bernardo Haddock L. Goulart, MD; Natasha B. Leighl, MD, FRCPC; Craig Earle, MD)
  • Cost of Cancer Care: Affordability, Access, and Policy
    (Faculty: Thomas J. Smith, MD; Richard Sullivan, PhD, MBBS; Sean R. Tunis, MD, MSc)
  • Affordability of Cancer Care: A Global Perspective
    (Faculty: Eduardo L. Cazap, MD; Peter Boyle, PhD, DSc; Ian Tannock, MD, PhD; Tanja Cufer, MD, PhD; Richard L. Schilsky, MD; Thomas J. Smith, MD)
  • Doing It Right, and for Less: Implementing Practice Changes to Manage the Growing Complexities, Inefficiencies, and Costs of Cancer Care
    (Faculty: Adam Brufsky, MD, PhD; Bruce E. Hillner, MD; Henry O. Otero, MD)

Patient conversations and resources

If patients have questions about the list or request interventions that run counter to the Top Five recommendations, such as additional chemotherapy that is unlikely to have further value, Dr. Thomas Smith advised, “Be honest and truthful. Remember to ask, ‘You are asking me to give you chemo that has side effects with little chance of benefit. Can you tell me what you are hoping for? What is important to you, in the time that you have left?’”

In addition to provider-patient conversations, patients can find more information at cancer.net/topfivelist. Here patients can access a summary geared toward a lay audience—including background information, resources, and questions for patients to ask—and listen to a podcast by ASCO CEO Allen S. Lichter, MD, on “The Top Five List in Oncology—What This Means for Patients.”

—By Virginia AndersonSenior Writer/Editor

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