A Guiding Force in Treatment: National Guidelines and You
Published in the Winter 2014/2015 issue of LBBC's national newsletter, Insight.
Most businesses have “best practices” that they follow. Auto mechanics know the best way to install brakes. Florists know how to keep flowers in bloom for as long as possible. Teachers know what methods are most likely to inspire students.
When the business is getting you healthy through breast cancer treatment, those best practices come in the form of treatment guidelines that help doctors give you the best possible care. You may have had doctors tell you that guidelines do or do not recommend a certain test or treatment for you. But what are these guidelines, and how are they created?
“The whole purpose [of guidelines] is to have an evidence based approach for every aspect of care we provide to cancer patients,” says William J. Gradishar, MD, FACP, a professor of medicine at the Feinberg School of Medicine at Northwestern University and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, in Evanston, Illinois. Dr. Gradishar has served as a breast cancer guideline panelist for the National Comprehensive Cancer Network (NCCN) since the organization began.
History of Guidelines
The existence of widely followed, comprehensive cancer guidelines is relatively new, with two of the best known guideline organizations only creating them since the 1990s. NCCN, a nonprofit alliance of 25 of the country’s top cancer centers, was formed in 1995 to improve the quality and effectiveness of cancer care. The American Society of Clinical Oncology (ASCO) was founded in 1964, but it didn’t begin creating cancer treatment guidelines until 30 years later, in 1994. Its first breast cancer guideline was released in 1996.
Clifford A. Hudis, MD, is chief of the breast medicine service, co-leader of the breast disease management team and attending physician at Memorial Sloan Kettering Cancer Center, in New York City. Dr. Hudis has helped craft guidelines for both ASCO and NCCN. He says many factors likely led to the creation of guidelines at this time, including:
- a growing amount of randomized clinical trial data
- a growing understanding that standardizing treatment improves quality of care and controls cost
Thomas A. Buchholz, MD, FACR, FASTRO, is the executive vice president and physician-in-chief at the University of Texas MD Anderson Cancer Center, in Houston. He serves on an ASCO breast cancer guidelines committee and has contributed to the MD Anderson Care Pathway Guidelines for Breast Cancer. According to Dr. Buchholz, large institutions, such as MD Anderson, may create their own guidelines. Smaller cancer centers, though they may not have their own guidelines, may create pathways. Pathways are based on national guidelines and research and suggest what treatment should be given when more than one is considered a good option.
To learn more about how guidelines will be used in your treatment, ask your doctors these questions:
- What treatment guidelines do you (or does this facility) use?
- What do the guidelines say about the treatments you’re planning to give me?
- Why might you recommend treatment that is different from what the guidelines suggest?
Examples of Treatment Guidelines
Treatment guidelines often look at the stage and type of breast cancer and state the best course of treatment for most people who fit that category. For example, a recent ASCO guideline for people with metastatic HER2-positive breast cancer, which grows because of a protein called human epidermal growth factor receptor-2, recommends:
- Medicines that target the HER2 protein as the first treatment, except for select people who also have hormone-positive breast cancer, which grows in the presence of estrogen or progesterone. For these people hormonal therapy alone may sometimes be used.
- The combination of trastuzumab (Herceptin) and pertuzumab (Perjeta), two medicines that attack HER2 proteins, along with a taxane, a type of chemotherapy, as the first treatment, unless the person can’t have taxane-based chemotherapy.
- If the cancer grows despite HER2-targeted therapy, use of T-DM1 (Kadcyla), which pairs chemotherapy with a targeted medicine to deliver it directly to the tumor, as the next option.
Age is another factor that influences the guidelines. On the topic of breast cancer and fertility, NCCN recommends:
- Premenopausal women be told how chemotherapy may impact fertility and be asked if they want to try to become pregnant in the future. If they are interested, they should be referred to a reproductive endocrinologist before they start chemotherapy.
- Women be told not to become pregnant while they are receiving radiation therapy, chemotherapy or hormonal therapy, because these treatments can hurt the fetus.
- Though research is limited, women with breast cancer should be discouraged from using hormone-based birth control, whether or not they have hormone-positive breast cancer.
Other issues that might prompt a guideline include breast cancer subtype—such as newer guidelines for inflammatory breast cancer—and managing side effects.
How Guidelines Are Created
ASCO has 17 breast cancer guideline panels, each with about 15 members. The panels represent different aspects of breast cancer, such as stage and subtype.
Dr. Hudis says the process of creating guidelines consists of “experts getting together, critically reviewing the available evidence, identifying where there’s a consistency and where there are inconsistencies, and making judgments from that about what should be recommended as standard, when possible.”
Dr. Gradishar’s NCCN panel includes oncologists, surgeons, pathologists and other specialists. Members meet every summer to look at the guidelines in what Dr. Gradishar calls “excruciating” detail, to decide if changes should be made, based on the latest research findings. When there is breaking breast cancer news, as sometimes happens at big events like the annual San Antonio Breast Cancer Symposium, or when an important new study is published, a conference call may be scheduled. If the e vidence is very strong, that may lead to an immediate guideline change.
“The guidelines are not static. They’re dynamic,” Dr. Gradishar says.
Dr. Gradishar mentioned pertuzumab and trastuzumab as examples of medicines whose strong evidence of effectiveness caused the guidelines for HER2-positive breast cancer to be changed quickly. The purpose of quick changes is to help effective new treatments become available to as many people as possible, as quickly as possible.
Ultimately, the purpose of this process, Dr. Hudis says, is to “ensure that good information is translated into benefits for people with breast cancer.”
Treatment guidelines are not meant to speak to every situation. Every person experiences cancer differently, so it is important that your doctor tailor treatment to you.
“Oftentimes, the guidelines cannot cover every patient, tumor or other factors that can go into an individual decision making process,” says Dr. Buchholz. “They don’t include patient preferences, so it’s important for all oncologists to use these guidelines as a base, but then interpret these guidelines in the context of an individual patient.”
Christie Hutchison, 58, of Tulsa, Oklahoma, was diagnosed with triple-negative breast cancer in 2013. After a lumpectomy, chemotherapy and radiation, Christie completed her treatment in June 2014. She asked her oncologist for a PET scan, a test that uses images to find cancer cells in the body. She was told that post-treatment guidelines don’t encourage PET scans to screen for recurrence. She left the appointment confused about why she was discouraged from getting the test, when she knew other women who had gotten it.
“I do wish they would have explained more about what the guidelines were … and why some people did [get the test] and why some people didn’t,” Christie says.
Christie, who, along with her husband, Donnie, founded a breast cancer support group called Tulsa TNBC Exchange, later asked her oncologist to better explain why she shouldn’t get the test. Unless the stage, type or location of the cancer suggest a person needs the test, he said, he avoids PET scans because they are very sensitive and have a high rate of false-positive results: when a test shows cancer is still in the body, even though there isn’t any.
Her doctor’s decision was in line with NCCN guidelines that discourage PET scans after treatment for people with stages I-IIB breast cancer for a number of reasons, including that high rate of false-positive results.
If your therapy doesn’t follow guidelines, that does not mean you’re getting bad treatment, Dr. Gradishar says. But if a facility doesn’t treat most people according to guidelines, that could suggest a problem. For that reason, groups like the National Accreditation Program for Breast Centers look at how closely guidelines are followed before giving their endorsement. These programs want to ensure, for example, most people with hormone sensitive disease are receiving hormonal therapy, since it has been proven effective in many large, well-built clinical trials, he says.
A Reasonable Option
If you worry you’re missing out on a better treatment or you want to help doctors find the cancer treatments of the future, Dr. Gradishar advises that you look into clinical trials, research studies that compare new medical approaches to the kind of standard treatments featured in the guidelines.
“The guidelines are always based on the underlying premise that a well-conducted clinical trial is a reasonable treatment option,” he says.
Those clinical trials could show in the future that a new medicine is the best treatment for a particular type of breast cancer. By participating in trials, you could not only get early access to a new treatment, but could also shape the next generation of guidelines and help other people who have breast cancer.
“The reason we’re able to have a discussion about guidelines is that people participate in clinical research,” Dr. Hudis says.
Learn More About Guidelines
Guidelines are written for doctors, using medical terms. But many of them are available to you online at the websites of NCCN and ASCO. Some organizations also publish guidelines written for laypeople. One good resource is the NCCN Guidelines for Patients — online booklets that explain the guidelines in plain language. The booklets are divided by breast cancer stage, so you can find the information that applies to you. Find these resources at nccn.org/patients/guidelines.
If a doctor brings up a certain guideline or you read about one and want to know more, don’t hesitate to ask your healthcare team to tell you more about it. You deserve to understand why tests and treatments are being recommended or not. If your doctor isn’t open to your questions, consider getting a second opinion. Another doctor may be able to better explain why you should or shouldn’t have a certain test or treatment, or the new doctor may decide that in your situation, the test or treatment should be done.