Testing for ALK+ Cancer
Doctors can diagnose all types of lung cancer with a biopsy. There are two main types of biopsies available. A tissue biopsy is still considered the “gold standard” and involves removing bits of your tumor tissue to examine under a microscope. A liquid biopsy involves taking a sample of blood or other body fluid to test for cancer cell fragments. Each type of biopsy has advantages and disadvantages, and sometimes it is best to get both types of biopsies if possible.
Finding out if your cancer is ALK positive, however, requires an extra step. A more detailed study—known as biomarker testing—looks for the ALK gene fusion and other gene errors inside your tumor that might be causing it to grow. Sometimes, this study is called molecular profiling, NGS (next-generation sequencing), or genomic testing.
The Benefit of ALK Biomarker Testing
If your test shows you have ALK+ lung cancer, your doctor can prescribe a special kind of medicine called an ALK TKI (short for “ALK tyrosine kinase inhibitor”). These modern medicines specifically target the ALK gene abnormality that makes cancer cells grow and spread in patients with the ALK biomarker.
For almost all patients with ALK+ non-small cell lung cancer, these FDA-approved targeted therapies work better than traditional chemotherapy. Studies show that ALK TKIs can help dramatically slow cancer progression, offer better quality of life, and help patients live longer.
Current medical guidelines in the United States and around the world recommend that: For patients with advanced ALK+ lung cancer that has not yet been treated, an ALK TKI medicine is the first treatment they should start.
When Should I Talk to My Doctor About Biomarker Testing?
The best time to ask your doctor about biomarker testing is before you have a biopsy done. That helps to ensure that the tissue sample they remove is big enough to check for cancer cells and to separately study for any ALK gene fusion or other biomarker that could be treatable.
If you’ve already had a tissue biopsy but aren’t sure if your doctor ordered biomarker testing, be sure to ask about it. It may not be too late for testing, even if you’ve started treatment. Our Doctor Discussion Guide can help you start the conversation.
You should also talk to your doctor about biomarker testing if your cancer grows or spreads after you’ve started taking a TKI medicine. The biomarker results are especially important for selecting the next treatment.
What Kind of Biomarker Test Should I Ask For?
Medical guidelines in the United States currently recommend that all patients diagnosed with non-small-cell lung cancer should have comprehensive biomarker testing as soon as possible.
“Comprehensive” means the test uses one tissue sample to check for the ALK gene fusion and many other known cancer biomarkers at the same time. This in-depth study is also called next generation sequencing or NGS.
Other ways to test for biomarkers include FISH and immunohistochemistry. These tests, however, only check for a small number of biomarkers. That’s why experts recommend that NGS testing should be part of any biomarker evaluation.
Knowing if you have ALK or any other biomarker known to drive cancer helps your care team choose the most effective treatment for you.
How Is Comprehensive Biomarker Testing Done?
Biomarker testing can be done with a tissue sample or a blood test, also called a liquid biopsy. Many oncologists choose to test both because the blood test results come back quickly. If positive for the ALK gene fusion, then TKI therapy can be started sooner. However, the blood test cannot detect all ALK+ lung cancers, so you may need to wait a few more weeks for your complete tissue testing results before your doctor knows all the biomarkers your cancer has that can be treated.
Tissue Sample Biopsy
Testing a sample of tumor tissue with next-generation sequencing (or NGS) is the best way to detect ALK fusions or other cancer biomarkers. There are different ways to collect this sample, depending on tumor size or location. It usually involves removing tissue with a needle or a small surgical procedure and requires an experienced cancer team. If you had a biopsy or surgery already, sometimes there is leftover tissue that can be tested.
The sample is then sent to a special lab, either at your hospital or an outside company. With comprehensive testing (also called next-generation sequencing), technicians can test one tissue sample for the ALK fusion and dozens of other treatable biomarkers at the same time. It can take 2 to 4 weeks for your doctor to get the results of this in-depth study that shows all the treatable biomarkers in your unique tumor.
Liquid Biopsy
A liquid biopsy is a quicker way to test for the ALK fusion and other cancer biomarkers. But this type of biopsy often fails to detect the cancer. It involves a simple blood test to look for traces of DNA that cancer cells shed into the bloodstream (known as circulating tumor DNA, or ctDNA). While positive results are usually accurate, you could get a false negative result if your cancer isn’t shedding much ctDNA. Liquid biopsy results can take about 1 week.
How Do I Make Sense of My Biomarker Test Report?
Don’t try to understand a biomarker test report on your own! Ask your doctor to fully explain your test results—including which biomarkers your biopsy sample tested positive for and how the results will affect your treatment options.
This fact sheet by Lungevity (pdf), can also help you understand some basics about reading a biomarker test report.
Is Biomarker Testing Ever Repeated?
Yes. It’s common for lung cancer tumors to change over time or for ALK+ lung cancer to become resistant to a targeted therapy after a while (meaning your current ALK TKI medicine isn’t working as well.) In that case, your doctor may want to re-test your tumor to get more up-to-date information about your cancer and help you choose a different treatment.
Is Biomarker Testing Covered by Insurance?
When your doctor orders biomarker testing, the cost is usually covered by health insurance. But it’s a good idea to check with your plan to make sure. Your doctor’s office staff can often help with this.
Understanding the Stages of Your ALK+ Lung Cancer
Cancer staging is a rating (0-4) of the size and any spread of your cancer. Like biomarker testing, it’s an important factor that helps your doctor plan your treatment. Based on the tests you have before and during treatment, your doctor will tell you what stage of non-small cell lung cancer (NSCLC) you have.
A very small, early-stage lung tumor. Cells have not spread outside your lungs or into deeper lung tissues.
Your cancer tumor is a bit larger than stage 0 (4 cm or less), but it has not spread to other parts of your body.
Your cancer may be a little larger than stage 1 (more than 4 cm) and/or has spread to the lymph nodes near your lungs.
Your cancer has spread further into the chest lymph nodes outside your lungs or has gotten bigger in the nearby lymph nodes.
Cancer has spread beyond the lungs and lymph nodes to other areas of your body (metastasis). The most common areas are the other lung, brain, bones, liver, and the adrenal glands on top of your kidneys. Patients with ALK+ NSCLC are at particular risk for brain metastasis.
Your doctor may give your cancer a more detailed stage number with letters (eg, 3A, 3B, etc).
When is ALK+ Lung Cancer Usually Diagnosed?
Most patients who develop ALK+ lung cancer are not diagnosed with it until their cancer has reached stage 4.
Early symptoms of lung cancer can look like common illnesses:
- A cough that doesn’t go away
- Hoarseness
- Wheezing
- Shortness of breath
- Coughing up blood
- Weak or tired feeling
- Chest pain with deep breathing, coughing, or laughing
- Weight loss without trying or loss of appetite
Most patients diagnosed with ALK+ lung cancer don’t have known risk factors for lung cancer, such as smoking or age older than 70.
The good news is that all of the FDA-approved treatments for ALK+ NSCLC have proven to work for stage 4 (metastatic) disease.
Prognosis for People with Stage 4 ALK+ Lung Cancer
Things are looking WAY up for people with ALK+ lung cancer. Before 2000, people diagnosed with stage 4 non-small cell lung cancer (NSCLC) had a 2% chance of surviving for 5 years, according to the National Cancer Institute. Today, those statistics have improved dramatically.
Two studies found that the median survival for people with stage 4 ALK+ NSCLC ranged from 6.8 years to 7.5 years with the right care. Median means half of those patients lived less, and half lived longer than the median figure. Based on continuing improvements in care, we would expect survival in ALK+ NSCLC to continue to increase.
- More patients being diagnosed and treated earlier than Stage 4
- Greater use of biomarker testing for detection and monitoring
- Improved treatment options
- More insights about how to overcome treatment resistance
- Dozens of ongoing research studies
More People are Living Longer with Advanced ALK+ Lung Cancer
600%
increase in survival at 5 years.
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