Tagrisso For Lung Cancer With The EGFR Mutation
- A important new treatment option can delay disease progression by nearly nine additional months for patients with advanced lung cancer.
- The FDA backed using a drug called Tagrisso paired with chemotherapy based on results showing the combination reduced the risk of disease progression or death versus Tagrisso alone, which is currently the standard first treatment for non-small cell lung cancer that harbors mutations in a gene known as EGFR.
- This new FDA approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy (given alone) or with chemotherapy.
- This study highlights the importance of making sure your lung cancer is tested for any biomarkers like the EGFR mutation.
In 2015, the Food and Drug Administration (FDA) approved the targeted therapy osimertinib (brand name Tagrisso), which revolutionized treatment options for patients with EGFR-positive lung cancer. Now, for those who have advanced or metastatic EGFR-positive lung cancer, there may be an additional treatment option that has the potential to prolong your life.
Read MoreWhat is EGFR-mutated lung cancer?
“In general, lung cancers are driven by certain genetic mutations and if we discover that gene we may be able to treat the cancer with some targeted therapy that attacks that gene without affecting the rest of the body cells,” Dr. Mohamed Mohamed, a thoracic medical oncologist at Cone Health Cancer Center in Greensboro, told SurvivorNet.The National Comprehensive Cancer Network (NCCN) suggests testing for nine specific biomarkers (or mutations) before starting treatment for advanced lung cancer — one of those is EGFR.
The epidermal growth factor receptor (EGFR) gene produces the EGFR protein, which plays a role in the growth and division of normal cells. Mutant EGFR genes can produce unchecked cell growth and lead to the formation of several types of cancers, including lung cancers, especially non-small cell lung cancers (NSCLC).
EGFR testing is now done as a routine part of lung cancer workups.
“Until 2004, we did not have anything [on] lung cancer genes. In 2004, two papers came out at the same time: one from Dana-Farber, the other one from Memorial Sloan Kettering. That was the first discovery of a mutation in lung cancer: called EGFR mutation,” Dr Mohamed explained.
How common is EGFR-mutated lung cancer?
Annually, in the United States, more than 200,000 individuals receive a diagnosis of lung cancer, with 80-85% of these cases being attributed to NSCLC, the most common type of lung cancer.
The rate of EGFR-mutated lung cancer can vary depending on the population, but it typically comprises 15-20% of North American and European patients. It can be almost 50% in Asian populations.
What is locally advanced and metastatic lung cancer?
Lung cancer can present at any stage with the treatment options differing based on the specific stage of the lung cancer. The stage of a cancer essentially describes how large that cancer is and how much it has spread. Early stage cancers are typically smaller and have not spread to other sites outside the lung.
Locally advanced lung cancers are often larger and more invasive with more lymph nodes involved, while metastatic lung cancer has spread to distant parts of the body. When lung cancer spreads, it can go to several sites outside of the lung, most commonly to bones and the brain.
How does Tagrisso work for lung cancer patients?
It’s important to remember that not all lung cancers are alike. Certain lung cancers have genetic mutations that help them grow and spread, such as EGFR mutation. When these mutations exist, they can sometimes be targeted with specific therapies.
“If a lung tumor harbors an alteration of the EGFR gene, patients can respond to certain medications that block the function of the EGFR gene,” Dr. Balazs Halmos, director of the Multidisciplinary Thoracic Oncology Program at Montefiore Health Systems, explained to SurvivorNet.
“Tagrisso is one of the very effective EGFR targeting agents used widely in cases of advanced/stage 4 EGFR-positive lung cancer.”
Tagrisso belongs to a class of drugs called tyrosine kinase inhibitors (TKIs). It binds to the mutated EGFR protein on the surface of cancer cells. This prevents the protein from being activated.
The molecular signals that lead to uncontrolled proliferation are blocked and this ultimately inhibits cancer growth and survival.
Dr. Arun Krishna explains how Tagrisso is used for patients with EGFR-mutated lung cancer.
What is the new approval?
This new FDA approval was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine. A phase III trial offers the highest level of evidence for the benefit of a new treatment.
The study was performed at 150 centers across more than 20 countries, including in the US, Europe, South America and Asia.
The study enrolled 557 patients with advanced non–small-cell lung cancer who had not previously received treatment for advanced disease to receive osimertinib with chemotherapy or to receive osimertinib monotherapy (given alone).
The authors found that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy which is the first-line standard of care.
Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).
What is progression-free survival (PFS)?
Progression-free survival (PFS) is an all-encompassing term that tells you how long after a treatment someone goes without progression of their disease or death from any cause. The longer a PFS is, the longer a patient has gone without growth of the primary tumor or distant disease, appearance of new metastatic disease, or death. If you have a longer time without progression of disease this means you can potentially go a longer period of time without additional treatment or the need to change therapy.
Side effects of Tagrisso
Some of the more common side effects of this treatment include:
- Cough
- Difficulty breathing
- Dizziness or lightheadedness
- Vision changes
- Chest, groin or leg pain
- Headaches
- Speech slurring
- Weakness or numbness of the arms and legs
- Blood count abnormalities, such as a low red and white blood cell count
Some less common side effects include:
- Fever and chills
- Loss of speech
- Severe weakness of one side of the body
- Temporary blindness
- Diarrhea
- Skin rashes and lesions
Rare but serious and life-threatening side effects can also occur, such as:
- Serious lung problems
- Heart problems, such as a decrease in heart function
- Severe allergic reactions requiring hospitalization
Patients who experience any of these side effects should immediately alert their physician.
Questions to ask your doctor
Here are some questions you may consider asking your doctor to help understand your options.
- What stage is my NSCLC?
- Do I have an EGFR mutation? Can I be tested?
- Am I eligible to receive Tagrisso?
- How would you expect Tagrisso to help me?
- How is Tagrisso different from chemotherapy?
- What side effects would you expect me to experience being on Tagrisso?
- Are there ways to manage those side effects?
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