In the Literature – March 2016
In This Article
- ASCO Issues Guidelines for Developing Clinical Pathways That Promote Value-Based Care
- Second Cancer Risk Is High After Hodgkin Lymphoma
- Cancer Screening May Not Save Lives, a New Analysis Suggests
ASCO Issues Guidelines for Developing Clinical Pathways That Promote Value-Based Care
When appropriately designed and implemented, oncology clinical pathways can provide detailed, evidence-based treatment protocols for delivering quality cancer care for patients with specific cancer types and stages. However, with the growing adoption of clinical pathways, oncologists and other experts have raised concerns about the manner in which these pathways are being developed and implemented, pointing to their potential to impede the delivery of high-quality cancer care.
In response to these concerns, the American Society of Clinical Oncology (ASCO) released a policy statement outlining a series of recommendations to ensure that clinical pathways in oncology promote—rather than diminish—value-based patient care. The policy statement was published online on January 12, 2016, in the Journal of Oncology Practice (Zon RT, et al. Epub ahead of print).
Recognizing that the use of clinical pathways provides a tool for enhancing quality and value, the ASCO Task Force on Clinical Pathways, which was tasked with reviewing the evolving landscape of oncology pathways and developing recommendations, cited concerns from ASCO members and other stakeholders. The concerns about pathways included inadequacies related to care quality, criteria, transparency, conflicts of interest, and provider input. Another concern was the growing administrative burden on oncology practices, which limits the time spent with their patients.
The ASCO policy statement includes the following 9 key recommendations to improve the development and processes of oncology pathways:
- Pursue a collaborative, national approach to minimize the unsustainable administrative burdens associated with the unmanaged proliferation of oncology pathways
- Adopt a process for the development of oncology pathways that focuses on consistency and transparency for all stakeholders
- Ensure pathways target the full spectrum of cancer care, from diagnostic evaluation through medical, surgical, and radiation treatments, and include imaging, laboratory testing, survivorship, and end-of-life care
- Update pathways continuously to reflect new scientific knowledge, along with insights gained from clinical experience and patient outcomes
- Recognize patient variability and autonomy; it is important for stakeholders to recognize that 100% concordance with oncology pathways is unreasonable, undesirable, and potentially unsafe
- Implement pathways in ways that promote administrative efficiencies among oncology providers and payers
- Promote education, research, and access to clinical trials in oncology pathways
- Develop robust criteria to support certification of oncology pathway programs; pathway programs should be required to qualify based on these criteria, and payers should accept all oncology pathway programs that achieve certification through this process
- Support research focused on understanding the impact of pathways on care and outcomes.
The task force concluded that, “When used appropriately, oncology pathways can be instrumental in managing value-based payment models being proposed and used going forward. However, oncology pathways must be developed and used appropriately and efficiently to guide care recommendations and coverage policies.”
Second Cancer Risk Is High After Hodgkin Lymphoma
Treatment advances in Hodgkin lymphoma have increased long-term survival, but cure has come at a price. Studies have shown that Hodgkin lymphoma survivors have an increased risk for treatment-related subsequent malignant cancers. The effect of newer treatments aimed at balancing treatment efficacy and toxicity on the long-term risk for a second cancer remains unknown. In a new study, researchers investigated the long-term risk for a second cancer and the changes in risk among Hodgkin lymphoma survivors in the Netherlands (Schaapveld M, et al. N Engl J Med. 2015;373:2499-2511).
The study included 3905 patients who had been treated for Hodgkin lymphoma between 1965 and 2000. Patients were aged between 15 and 50 years at diagnosis (median age at diagnosis, 28.6 years) and had survived at least 5 years after receiving treatment. Information for second cancers was taken from medical records, from questionnaires sent to general practitioners, and by record linkage with the Netherlands Cancer Registry since 1989.
Of the cohort, 48.7% of patients were treated between 1989 and 2000, 30.6% were treated between 1977 and 1988, and 20.7% were treated between 1965 and 1976.
The treatment varied in this study, and included radiation therapy only (27.3%), chemotherapy only (12.1%), and combined radiation and chemotherapy (60.5%). The median follow-up was 19.1 years, and 27.5% of patients were followed for at least 25 years.
During follow-up, 1055 second cancers were diagnosed in 908 survivors, which corresponds to a risk of 4.6 times as high as the incidence of cancer in the general population.
At 30 years after treatment, the cumulative incidence of a second cancer among survivors was 33.2% versus 9.6% in the general population; at 40 years, the risk was 48.5% compared with 19.0% in the general population.
Breast cancer contributed most to the overall absolute excess risk in this cohort (24.9 cases of breast cancer per 10,000 person-years among men and women), representing 20.4% of the excess risk for any second cancer in the cohort, followed by lung and gastrointestinal cancers and non-Hodgkin lymphoma. The cumulative incidence of second cancers did not differ significantly during the 3 study periods.
The risk for a second cancer after treatment for Hodgkin lymphoma was not lower among patients who received treatment between 1989 and 2000 than among those who were treated in earlier periods, despite advances in treatment. Clinicians treating patients who are newly diagnosed with Hodgkin lymphoma need to balance the risks for radiation- and for chemotherapy-related late toxic effects against the risk for failing to control the primary disease. In addition, awareness of the increased risk for second cancers is crucial for survivors of Hodgkin lymphoma and for their care providers.
Cancer Screening May Not Save Lives, a New Analysis Suggests
Despite decades of research, evidence remains unclear that cancer screening saves lives; however, clear evidence points to the harm of screening, according to a recent analysis calling for higher standards of evidence for cancer screening (Prasad V, et al. BMJ. 2016;352:h6080).
In this new analysis, lead investigator Vinay Prasad, Assistant Professor, Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, and colleagues argued that overall mortality should be the benchmark against which screening tests are judged.
Of the studies included in this analysis, 7 of 12 large randomized screening trials showed discrepancies between disease-specific mortality and overall mortality. The investigators cited 2 principal reasons why screening tests that prevent cancer deaths do not significantly reduce overall mortality. Studies may be underpowered to detect a small improvement in overall benefit. It is also possible that disease-specific mortality reductions may be offset by deaths associated with harmful effects of the test themselves.
For example, the investigators pointed to “off-target deaths,” which are more likely to increase with false-positive screening results, overdiagnosis of nonharmful cancers, and detection of incidental or benign conditions. Empirical analyses showed that primary screening studies pay minimal attention to the harms of screening of 57 studies reviewed, only 7% quantified overdiagnosis and only 4% reported the rates of false-positive results.
The strongest evidence that testing for cancer may save lives comes from the National Lung Cancer Screening Trial, which included more than 53,000 heavy smokers, who were randomized to low-dose computed tomography (CT) or chest x-rays. The CT group showed a 20% relative reduction in lung cancer deaths and a 6.7% relative reduction in overall mortality.
However, the absolute risk reduction in overall mortality was only 0.46%, and several limitations undermined this narrow margin.
To determine whether screening saves lives, the researchers said larger trials that have the statistical power to evaluate for overall mortality are needed. A trial for colorectal cancer, for instance, may require 4 million participants to determine the effect on overall survival compared with 150,000 for disease-specific death.
They acknowledged that studies of this size could cost upward of $1 billion, but they suggested that conducting such trials in large national observational registries would dramatically reduce the economic burden associated with cancer care.
Screening trials could also ascertain all causes of death among all the participants to monitor for any increase in off-target deaths, which would be an improvement over current standards. Primary study data should be made available to all, in a usable format for re-analyses.
Without conclusive evidence that screening saves lives, the researchers recommended that clinicians discuss the limitations of screening with patients and encourage participation in open studies. The call for higher standards of evidence will enable rational, shared decision-making between healthcare providers and patients, they concluded.