April 5, 2012 — Five common cancer procedures and tests have been identified that are not supported by evidence and should no longer be used, according to the American Society of Clinical Oncology (ASCO).
Oncologists should stop the unnecessary use of chemotherapy in patients with advanced cancers who are unlikely to benefit, and should limit their use of colony-stimulating factor (CSF) drugs in patients undergoing chemotherapy.
They should also curb their use of advanced costly imaging technologies for staging of early breast and prostate cancers, and for detecting breast cancer recurrences.
These recommendations, compiled after an extensive review of the literature and with input from more than 200 ASCO members, were published online April 3 in the Journal of Clinical Oncology.
The move is part of the Choose Wisely campaign, organized by the American Board of Internal Medicine, in which many different medical specialties identified tests and procedures that could be skipped. In total, 45 procedures and tests were deemed unsupportable by evidence.
This campaign started when Howard Brody, MD, PhD, professor of family medicine at the University of Texas in Galveston, challenged each medical specialty to take a critical look at its field and identify 5 practices that are commonly performed despite a lack of evidence (N Engl J Med. 2010;362:283-285).
"At ASCO, we took that challenge to heart," lead author Lowell Schnipper, MD, from the Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, and chair of the ASCO Cost of Care Task Force, said in a statement
"By tackling the overuse of treatments and tests for some of the most common cancers, we hope to achieve substantial improvements in the quality of cancer care in the United States," he added.
Avoiding treatments that have little or no benefit means that "we also do our part to address the unsustainable cost increases that threaten our nation's healthcare," said Michael Link, MD, president of ASCO.
Stop Chemotherapy
Perhaps the most controversial of the new proposals is the recommendation to stop using or to withhold chemotherapy in patients with advanced solid tumors who are unlikely to benefit, and to focus instead on symptom relief and palliative care.
This whole area has stirred fierce debate in recent years, and attempts in the United States to introduce legislation for end-of-life discussions were stalled after accusations that this was a form of "soft euthanasia" and that these were "death panels" to persuade people not to use medical resources.
In their paper, Dr. Schnipper and colleagues emphasize that stopping chemotherapy is recommended only for a specific subgroup of patients with advanced solid tumors — those with low performance states (3 or 4) who are not eligible for a clinical trial, and in whom there was no benefit from previous evidence-based interventions and no strong evidence supporting the clinical value of further anticancer treatment.
"If a patient's cancer has grown during 3 different regimens, the likelihood of treatment success is so poor and toxicity so high that further anticancer treatment is not recommended," the authors write.
They cite results from the largest series of patients with nonsmall-cell lung cancer (NSCLC) from the M.D. Anderson Cancer Center in Houston, Texas, which showed that only 2% had a documented response to third-line chemotherapy, and 0% had a response to fourth-line chemotherapy (Lung Cancer. 2003;39:55-61).
However, despite the evidence for lack of effect, administering nth-line chemotherapy is common, the authors note. They cite several studies showing that many NSCLC patients receive 4 lines of chemotherapy, and that many patients with solid tumors are still being given chemotherapy within days of death. "This practice is not being driven by profit, but by a desire to help patients," the authors note, and "by the inability of patients, families, and their oncologists to make end-of-life transitions."
Oncologists admit that they find this difficult, as previously reported by Medscape Medical News. Stopping chemotherapy can feel like failure and "giving up," and sometimes patients or their relatives can demand more — in one instance, because the "chemotherapy cheers her up."
"Stopping anticancer treatment should always be accompanied by appropriate palliative and supportive care and referral to a hospice," the authors state.
"Best practice would be continuation of palliative care started concurrently at the time of diagnosis for 'any patient with metastatic cancer and/or high symptom burden," they add. This reiterates the recentprovisional clinical opinion issued by ASCO.
Limit Use of G-CSF Products
Another recommendation related to chemotherapy is to cut down on the use of granulocyte CSF (G-CSF) products for the primary prevention of the chemo-induced adverse effect of febrile neutropenia.
Two G-CSFs are available in the United States: filgrastim (Neupogen) and sargramostim (Leukine).
ASCO guidelines state that G-CSFs are recommended in patients who have "a high risk" (more than 20%) of developing febrile neutropenia as a complication of chemotherapy.
In practice, however, there is a "clear overuse of these agents." Use is inconsistent; the products are used both appropriately and inappropriately, the authors write. They note that these products are "costly" and should be used only in patients who are at high risk of developing febrile neutropenia, as specified in the guidelines.
Stay Away From High-Tech Imaging
The remainder of the new recommendations steer oncologists away from using advanced imaging technology in specific groups of cancer patients.
One instance is patients with early-stage prostate cancer and early-stage breast cancer, who have a low risk for metastasis. In these cases, advanced imaging technologies, such as positron emission technology (PET), computed tomography (CT), and radionuclide bones scans, should not be used to determine whether the cancer has spread, the authors note.
"These tests are often used in staging evaluation of low-risk cancers, despite a lack of evidence suggesting that they detect metastatic disease or survival," the authors state. "Unnecessary imaging can lead to harm through unnecessary invasive procedures, overtreatment, and misdiagnosis."
In addition to the potential harm from unnecessary exposure to ionizing radiation, as well as anxiety, there is also a huge monetary cost from such scans, the authors note.
The list price of a fluorodeoxyglucose PET with concurrent CT scan is around $2500 to $5000, depending on the scan and location. In many instances, patients are directly responsible for a portion of these costs.
The other instance where advanced imaging is discouraged is in patients who have been treated for breast cancer with curative intent who are now asymptomatic.
"The majority of patients with breast cancer diagnosed today present with early-stage, node-negative disease that is found on screening mammography," the authors write.
"As a result of earlier diagnosis and the efficacy of adjuvant therapies...most of these women have a normal life expectancy and a low risk of recurrence."
Several studies have now shown that in such patients, there is no benefit from routine imaging with PET, CT, or radionuclide bone scans, or from serial measurement of serum tumor markers, including CEA, CA 15-3, and CA 27-29, the authors state.
In addition to no benefit, there might be harm from false-positive results, leading to unnecessary invasive procedures, overtreatment, and misdiagnosis, they add.
Instead, such patients should be followed with mammography, with careful attention paid to patient history and physical examination, they suggest. Breast magnetic resonance imaging is not recommended for routine surveillance, because it has a high-false positive rate.
Lower Cost to Patients and Society
Reconsidering the use of these top 5 cancer treatments, tests, and procedures is likely to improve the value of cancer care, the authors note. This means achieving the desired clinical outcome at the lowest cost to the patient and society.
At the same time, each patient with a life-threatening disease is a challenge. In each case, the oncologist must take the unique features of each individual into consideration when making decisions on the management of their cancer, they add.
Dr. Schnipper reports serving as a consultant for ITA partners. Several of his coauthors report consultancy agreements with a number of pharmaceutical companies. Coauthor Douglas Blayney, MD, from Stanford Cancer Center in California, reports owning stock in Abbott, Amgen, Bristol-Myers Squibb, Express Scripts, Johnson & Johns, and United Healthcare.
J Clin Oncol. Published online April 3, 2012. Abstract
The American Society of Clinical Oncology (ASCO) has released another list of oncology practices that should be stopped because they are either not supported by evidence or are wasteful.
The "top 5 list" of recommendations from ASCO is part of the Choosing Wisely campaign, an initiative of the American Board of Internal Medicine (ABIM) Foundation. A central aim of the Choosing Wisely campaign is to reduce wasteful healthcare expenditures.
Last year, ASCO became one of the first of 9 medical societies to join the campaign, noted Olatoyosi Odenike, MD, from the University of Chicago, who moderated a presscast on the new list. The list was unveiled as part of the 2013 Quality Care Symposium, which takes place later this week in San Diego, and is sponsored by ASCO.
The 2013 list addresses a wide range of practice issues: the use of antiemetic drugs; chemotherapy in metastatic breast cancer; advanced imaging in disease surveillance; prostate-specific antigen (PSA) testing in prostate cancer; and targeted therapies.
The ABIM Foundation asked ASCO to contribute a second list this year, said list lead author Lowell Schnipper, MD, from the Beth Israel Deaconess Medical Center in Boston.
The organization did so because the 2012 list was "well received" by oncologists and because "eliminating unnecessary testing or interventional procedures" is part of the mission of ASCO's Value in Cancer Care Task Force, he explained. "We felt it important to go further," Dr. Schnipper noted.
The list from Dr. Schnipper and his coauthors was published online October 29 in the Journal of Clinical Oncology.
The authors of the 2013 top 5 list had money on their minds. "The rising cost of healthcare continues to threaten the vigor of the US economy," they write in their opening sentence. Cancer care is only a "fraction" of healthcare costs in the United States, but oncology expenditures continue to rise, from $125 billion in 2010 to a projected $158 billion in 2020, they point out.
Approximately 700 ASCO committee members were asked what they would add to the list, and 115 suggestions were received. The Value in Cancer Care Task Force members selected 11 finalists, and 140 oncologists voted to select the top 5 list.
The list is comprised of "suggestions" that can serve as a "foundation of discussion" between physicians and patients, who will ultimately make their own choices, said Dr. Schnipper. "These top 5 are not meant to be legislative dicta to pass along to our professional colleagues," he said.
The ASCO 2013 Top 5 List in Oncology
| Number 1 |
| Appropriate antiemetics for patients on chemotherapy regimens should be based on the regimens' risk of causing nausea and vomiting |
We should use "the right drug for the right circumstance," said Dr. Schnipper.
Oncologists customarily choose an antiemetic drug based on the likelihood (low, moderate, or high) that a particular chemotherapy program will cause nausea or vomiting, write the list authors.
But they are clearly concerned about the overuse of new, highly effective agents that are very expensive and unneeded with certain chemotherapy regimens that are either low or moderately emetogenic.
These drugs, known as 5-HT3 serotonin receptor antagonists, are appropriate for use with chemotherapy programs that "are almost certain to produce severe or persistent nausea or vomiting," say the authors.
Although Dr. Schnipper said that the guidelines do not focus on any one of these drugs, he singled out an agent during the presscast.
Palonosetron is an "excellent, excellent antiemetic" that "performs extremely well" with chemotherapy regimens that present a high risk of vomiting and nausea. It is also "very, very expensive," he added.
Palonosetron is more expensive than other agents in this class, such as granisetron or ondansetron, he said.
The list authors recommend that when adults receive highly emetogenic chemotherapy, they should receive the following antiemetic regimen: the 3-drug combination of an NK1 receptor antagonist (days 1 to 3 for oral aprepitant and day 1 only for intravenous aprepitant), a 5-HT3 receptor antagonist (day 1 only), and dexamethasone (days 1 to 3 or 1 to 4).
They also provide antiemetic regimen recommendations for low and moderately emetogenic chemotherapies.
| Number 2 |
| Use single-drug chemotherapy when treating an individual for metastatic breast cancer unless the patient needs urgent symptom relief |
Single-agent chemotherapy is the "time-tested approach" for treating the "majority of patients with metastatic breast cancer," said Dr. Schnipper. Combination chemotherapy does not add to survival, and its toxicity can "detract" from quality of life, he added. It is also more expensive.
The authors point out that "combining multiple cytotoxic agents is clearly beneficial when chemotherapy is used as an adjunct to potentially curative breast surgery and radiation therapy. In the metastatic setting, this is not the case.
| Number 3 |
| Avoid using advanced imaging technologies — PET, CT, and radionuclide bone scans — to monitor for a cancer recurrence in patients who have finished initial treatment and have no signs or symptoms of cancer |
PET and PET/CT, which are "expensive," have not been proven as surveillance tools to improve outcomes, said Dr. Schnipper.
"Until high-level evidence demonstrates that routine surveillance with PET or PET/CT scans helps prolong life or promote well-being after treatment for a specific type of cancer, this practice should not be done," according to an ASCO press statement on the top 5 list.
These scans can also give false-positive results, which can cause a patient to undergo additional unnecessary or invasive procedures or treatments or to be exposed to additional radiation, said Dr. Schnipper.
| Number 4 |
| Do not perform PSA testing for prostate cancer screening in men with no symptoms of the disease who are expected to live less than 10 years |
Multiple studies have shown that men who are older than 70 years do not gain a survival benefit from prostate cancer treatment at this stage of life, said Dr. Schnipper.
The ASCO committee was "quite affected" when reviewing the many ways in which men of this age can have negative effects from treatment, he added.
For men with a life expectancy of more than 10 years, ASCO has previously recommended that physicians discuss with patients whether PSA testing for prostate cancer screening is appropriate. However, this recommendation is at odds with the highly publicized guidance from the US Preventative Services Task Force, which does not recommend the testing for men of any age who are otherwise healthy.
| Number 5 |
| Do not use a targeted therapy unless a patient's tumor cells have a specific biomarker that predicts a favorable response to that therapy |
Targeted therapies are "phenomenally expensive medications," said Dr. Schnipper. The use of targeted therapy should be limited to patients who have an assay-verified tumor biomarker that provides a "red or green light" as to whether the tumor cells are susceptible to the therapy.
Specific cancers have genetic abnormalities that predict response to targeted therapies. For example, patients with non-small cell lung cancer (NSCLC) need to be tested for an EML4-ALK translocation before being treated with crizotinib, patients with metastatic NSCLC need to be tested for specific EGFR gene mutations before being treated with afatinib, and patients with melanoma need to be tested for BRAFV600E or V600K mutations before being treated with vemurafenib, dabrafenib, or trametinib.
Some of the list authors, including Dr. Schnipper, report financial relationships with industry, as detailed in the paper.
J Clin Oncol. Published online October 29, 2013. Abstract
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