Clinical practice guidelines, such as those developed and published by the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology, guide diagnosis, management and treatment of patients with cancer.
In 2010, the National Comprehensive Cancer Network started publishing guidelines for patients. Patients can use these guidelines, which cover a variety of tumor types, as a tool to help them discuss their cancer and treatment with their physicians.
Clinical practice guidelines are written for doctors. Some insurers and the Centers for Medicare and Medicaid Services also use guidelines to help determine what treatments to cover. Patients are less likely to have heard of these guidelines, despite their substantial influence on care.
Cancer Today spoke with medical oncologist Gabrielle Rocque of the University of Alabama at Birmingham Comprehensive Cancer Center about clinical practice guidelines and how oncologists treating breast cancer use them.
Rocque and her colleagues recently published several studies on guideline concordance—or how often patients receive treatment in keeping with clinical practice guidelines. They assessed how breast cancer patients fare when clinicians prescribe treatments in accordance with guidelines versus when they deviate from guideline recommendations, referred to as providing nonconcordant care.
Q: What are clinical practice guidelines and how do they influence cancer care?
A: Clinical practice cancer guidelines are what oncologists refer to when we want to understand the standard of care and how we should treat our patients. The NCCN guidelines are, for example, developed by a cohort of cancer-specific experts who have undertaken a rigorous process to evaluate and grade the available evidence, synthesize this evidence and come up with recommendations. These guidelines are constantly being updated to incorporate new evidence to keep them up to date.
Q: What are some of the limitations of clinical guidelines?
A: It’s important to recognize that guidelines are intended to guide, and that while the majority of patients should be receiving guideline-based care, not every patient’s treatment should fall within guideline suggestions. There are rational and appropriate reasons to deviate from guideline suggestions.
I think sometimes [guidelines] can be narrowly focused and that may limit good choices for patients, particularly those with contraindications to specific treatments. The concern for guideline use is when guidelines are applied to a degree where there is no ability for clinical judgment, which is problematic.
Q: What do your recent studies show about how guidelines are used in the care of breast cancer patients?
A: We did two separate studies on guideline concordance, the first in patients who were initially diagnosed with metastatic breast cancer and the second in patients initially diagnosed with early-stage disease who then had secondary metastases. For the group that was diagnosed initially with metastatic disease, the nonconcordance was 19 percent. Among the patients with secondary metastases, 18 percent of the patients we analyzed received nonconcordant therapy.
There were a few different types of nonguideline care in each group. For example, in those with secondary metastatic disease, the most common type of nonconcordant treatment was HER2-targeted monotherapy, rather than in combination with chemotherapy as is recommended. Other common deviations were the addition of bevacizumab [Avastin] to regimens in the metastatic and post-surgery settings.
I was surprised about the frequency of patients treated with HER2-targeted monotherapy. These patients did relatively well with the treatment. One way to interpret this real-world data is to recognize that there are gaps in the available data, particularly for older patients in their 70s who are not well represented in clinical trials. This makes it difficult for clinicians to apply the guidelines, which are based on trial results, to some of these patients.
Q: What were the implications of nonconcordance with clinical guidelines?
A: There were both mortality and cost implications. Our work suggests there are potentially patient mortality differences and that the type of nonconcordant care a patient receives matters. In addition, patients who received treatment nonconcordant with guidelines incurred higher costs. These additional costs for patients could potentially be covered by the patients themselves or by secondary insurance, charity care or assistance programs. For patients who were initially diagnosed with late-stage breast cancer, those who received nonconcordant care had more than $1,800 increased cost per month to Medicare compared to those who received guideline-concordant care.
Q: Based on your studies, do you think guidelines are being used correctly in breast cancer care?
A: The vast majority of patients we analyzed are being treated according to guidelines and receiving the standard-of-care therapies. But for those patients that are not being treated according to guidelines, we need to do a better job of tracking why there is deviation and what are the outcomes for those patients.
From our studies of breast cancer patients, there were some subgroups that did well with the non-concordance and some that did worse compared to guideline-treated patients.
This needs to be investigated, because we may learn that there are some patient subpopulations for which the guidelines are not optimal, for example, for those patients that are consistently excluded from clinical trials. But we are never going to know that if we just go by blanket statements that oncologists should never deviate from guideline-based care. Guidelines are wonderful, but they do not replace clinical judgment.
Q: How can patients learn more about what treatment is recommended for their cancer?
A: In another study we did, we found that breast cancer patients, for the most part, were unfamiliar with the concept of guidelines. However, when we explained it to them, they wanted to know if they were receiving guideline-consistent treatment. So there is an opportunity to educate our patients more and use tools like the NCCN patient-facing guidelines, which are a great resource.
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