A new test in the fight against lung cancer

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(BPT) - As a pulmonologist, Dennis Clifford had diagnosed more than 800 cases of lung cancer in his career. But his own diagnosis of advanced lung cancer in 2014 came as a shock.

“Cancer was never on my radar screen as something that would even happen to me,” says Clifford. “At first, I thought it was pneumonia.”

Clifford is one of the nearly 225,000 people diagnosed with lung cancer in the United States each year. Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fourth of all cancer deaths — more than breast, prostate, and colorectal cancers combined. Only 15 percent of lung cancer cases are diagnosed at an early stage. Most cases are diagnosed like Clifford’s was — as metastatic — the most advanced stage when the cancer has already spread to other areas of the body.

Today, it is understood that there are two basic types of lung cancers: small cell and non-small cell lung cancer (NSCLC). Approximately 85 percent of all people with lung cancer in the US have the NSCLC type, and about 15 percent of people diagnosed with NSCLC have a biomarker, or “mutation,” known as epidermal growth factor receptor (EGFR) mutation-positive.

Due to the advancement of science, there are more treatment options available than ever before, including many new therapies that are able to target specific types of cancer, such as those that are EGFR mutation-positive. It is therefore important for people who are diagnosed with lung cancer to be tested for specific biomarkers to understand what type of cancer they have to help determine which treatment options may be the most effective.

Genetic Testing

For those diagnosed with lung cancer, tumor testing can help them figure out the right treatment by identifying whether a mutation exists, and if so, what type.

“All the appropriate testing was done and I was very fortunate to have my tumor be EGFR mutation-positive, which is a very important mutation to have because we have tools that can actually address that,” said Clifford.

Treatment for EGFR mutation-positive NSCLC that is advanced often includes tyrosine kinase inhibitor (TKI) targeted medicine, which is designed to slow down the growth of cancer cells or shrink the size of the tumors for a period of time.

But lung cancer can change over time and new mutations can emerge, causing these targeted treatments to stop working and the disease to worsen. Since there are many kinds of mutations, biomarker testing is often recommended again when lung cancer advances to identify what these new mutations are and determine appropriate options.

Clifford was one of the nearly two-thirds of people with NSCLC who are EGFR mutation-positive and see their disease worsen and acquire a new cancer mutation called T790M after being treated with a first-generation EGFR TKI medicine. For most, a tissue biopsy is recommended to learn more about the type of cancer. In Clifford’s case, when his disease advanced, his doctors wanted to know whether any new mutations had developed that might allow him to try a different targeted medicine. However, due to his poor clinical status he was ineligible for a tissue biopsy.

“It was really discouraging when I found out that I was ineligible for a biopsy, due to my advanced disease.”

A New Test

For some people with advanced forms of the disease, there is now a new test available to identify some types of lung cancer. Just recently, the US Food and Drug Administration (FDA) approved a non-invasive option to determine whether the T790M mutation is present in people with the EGFR gene who have had previous treatment with an EGFR TKI that has since stopped working, which is one of the requirements for options such as treatment with TAGRISSO® (osimertinib). TAGRISSO is the only FDA-approved targeted medicine for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after an EGFR TKI medicine.

Clifford says, “When I found out that there was a way to identify my tumor type by drawing blood, I was elated. My doctor advised we would have blood drawn, send it to be tested, and we would have an answer in a week to ten days.”

Blood-based testing for the presence of the mutation is recommended only when a tumor biopsy cannot be obtained. In some cases, the T790M mutation may not be detected in the blood- based test. Therefore, if a patient’s disease is progressing, yet tests negative for the T790M mutation with a blood-based test, they and their physicians should re-evaluate the feasibility of tissue-based testing to confirm the presence of the EGFR T790M mutation.

If you or someone you love is living with lung cancer, talk to your doctor about whether you are a candidate for blood-based testing to determine if a genetic mutation is present. Once you know your tumor status, talk to your doctor about treatment options that are right for you.

Please see the Important Safety Information below for additional information.

Talk to your doctor about any questions you may have about lung cancer testing or TAGRISSO. To learn more, visit www.TAGRISSO.com.

TAGRISSO® (osimertinib) Indication and Important Safety Information

TAGRISSO is a prescription medicine used to treat non-small cell lung cancer (NSCLC). TAGRISSO may be used when your NSCLC has spread to other parts of the body and:

  • has a certain type of abnormal epidermal growth factor receptor (EGFR) gene, and
  • you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine and it has stopped working

Your doctor will perform a test to make sure that TAGRISSO is right for you. TAGRISSO may cause serious side effects, including:

  • lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung problem symptoms, including trouble breathing, shortness of breath, cough, or fever.
  • heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking TAGRISSO and during treatment. Call your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded.

Before taking TAGRISSO, tell your doctor if you:

  • have lung or breathing problems
  • have heart problems, including a condition called long QTc syndrome
  • have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
  • are pregnant or plan to become pregnant. TAGRISSO can harm an unborn baby. Tell your doctor right away if you become pregnant during TAGRISSO treatment or think you may be pregnant.
    • Females who are able to become pregnant should use an effective birth control during TAGRISSO treatment and for 6 weeks after the final TAGRISSO dose.
    • Males who have female partners that are able to become pregnant should use effective birth control during TAGRISSO treatment and for 4 months after the final TAGRISSO dose.
  • are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during TAGRISSO treatment and for 2 weeks after your final TAGRISSO dose. Talk to your doctor about the best way to feed your baby during this time.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine.

The most common side effects of TAGRISSO are:

  • diarrhea
  • rash
  • dry skin
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TAGRISSO. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information including Patient Information.

3248000 Last Updated 10/16




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