Young, non-smokers with advanced lung cancer. A single mutation is responsible.

• In Poland, there are approximately 23,000 new lung cancer diagnoses every year, and every tenth patient has a mutation in the EGFR gene.
• The disease often affects young adults, aged 40-50, with no history of smoking.
• "We have three groups of patients: those eligible for surgery, those inoperable, who receive chemoradiotherapy, a radical treatment method, and those with metastases, who receive osimertinib with or without chemotherapy," explains oncologist Dr. Mateusz Polaczek.
• - Currently, osimertinib can be used in patients with early lung cancer after tumor resection, i.e. as postoperative treatment, and in patients with metastatic disease, i.e. as palliative treatment. We cannot administer the drug to patients treated with chemoradiotherapy, even though we have a study confirming the effectiveness of such therapy - he adds.

Luiza Jakubiak, Health Market: As of July 1, 2025, reimbursement will be expanded to include first-line treatment with osimertinib in combination with chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation. What group of patients are we talking about?

Dr. Mateusz Polaczek: Considering that there are approximately 23,000 new lung cancer diagnoses every year, and that every tenth patient has a mutation in the EGFR gene, this is currently quite a large group of patients.

The profile of patients with this mutation is quite specific. The disease often affects young adults, aged 40-50, with no history of smoking.

Are there any specific symptoms that distinguish non-smokers who develop lung cancer from smokers?

These symptoms are the same as for any other lung cancer and, unfortunately, nonspecific: cough, shortness of breath, hemoptysis. Sometimes, there are also symptoms related to cancer metastases, such as bone pain. Therefore, these are all symptoms that lung cancer, even those with an EGFR mutation, can cause.

Since lung cancer is associated with smoking, and rightly so, even if a patient comes to the doctor with early symptoms of the disease, the moment to diagnose him intensively for lung cancer comes much later.

The earlier age of onset means that patients experience significant symptoms much later. A decade ago, we had a patient who ran the Warsaw Marathon on Sunday and became short of breath. After being admitted to the hospital, it turned out that he already had massive cancerous lesions in both lungs.

Since in this case we are talking about molecularly targeted therapy, what is the current state of diagnostics and mutation determination?

EGFR mutation testing has been standard practice in Poland for 15 years. Mutation testing is inexpensive and widely available using simple genetic testing, such as PCR.

Currently, it should be performed using multigene panels using the NGS method, which also make it possible to detect rarer variants of EGFR mutations.

It is also possible to perform a so-called liquid biopsy. EGFR is a gene in lung cancer, for which this diagnostic method is currently readily available and feasible.

What are the patient prognoses and what treatment options have we had so far?

The disease has a very dynamic course, so without proper treatment the prognosis is very unfavorable.

Molecularly targeted therapy has significantly changed the fate of these patients. However, treatment with a standalone EGFR tyrosine kinase inhibitor is often insufficient. Therefore, a search for new therapeutic methods has begun.

The mentioned therapy, in which we combine osimertinib with chemotherapy, is one of the strategies to intensify treatment to help these patients even more.

The therapy significantly improves the effectiveness of first-line treatment: it reduces the rate of early treatment failures and extends the time patients remain on first-line treatment, which is crucial.

This recent change in reimbursement by adding chemotherapy to an EGFR tyrosine kinase inhibitor makes it possible to achieve better treatment outcomes in young patients at a small additional financial cost.

Small groups of patients with rare mutations have the hardest time

What are the remaining unmet medical needs for patients with EGFR-mutated non-small cell lung cancer?

We have three groups of patients: those eligible for surgery, inoperable patients who receive chemoradiotherapy, a radical treatment method, and patients with metastatic disease who receive osimertinib with or without chemotherapy.

Currently, osimertinib can be used in patients with early lung cancer after tumor resection, i.e., as postoperative treatment, and in patients with metastatic disease, i.e., as palliative treatment. We cannot administer the drug to patients undergoing chemoradiotherapy, despite having a study confirming the effectiveness of such therapy. We are talking about a group of patients with inoperable, stage III non-small cell lung cancer.

In Poland, this indication is not currently reimbursed. It appears that we must wait until metastases appear before initiating treatment. It's important to remember that the more advanced the disease, the less responsive it is to treatment.

It's worth mentioning that patients with advanced or metastatic non-small cell lung cancer with an EGFR mutation have a second treatment option, which is also not yet reimbursed in Poland. These are two new molecules: lazertinib and amivantamab. Studies show that the combination of amivantamab with lazertinib is a more effective option than osimertinib alone.

This combination has a rather unfavorable side effect profile, but at the same time it is a therapy that has very good results in terms of hard endpoints, i.e., confirmed prolongation of survival when used initially.

Patient access to new therapies differs significantly from the current recommendations of scientific societies for this group of patients. Has there been significant improvement in recent years?

It's common knowledge that societies make recommendations based on available clinical trial and registration results. The needs we report stem from the fact that new drugs are becoming available in other European countries and the United States.

Although we are still awaiting reimbursement for many drugs or indications, Polish lung cancer patients currently have very broad access to various treatments. We are the absolute leader in Central Europe between the Baltic and Black Seas. Of course, we lag behind some Western European countries.

The greatest gaps in access to pharmacotherapy concern very small groups of patients with rare mutations. This problem affects several to several dozen patients each year in Poland.

I believe that the solution to access for narrow patient groups should be an individual application for funding for therapy for a given patient through the Emergency Access to Medical Technology Scheme. However, its current provisions are very restrictive, and to benefit from this mechanism, a patient must have exhausted all treatments currently financed from public funds. These absurd regulations regarding Emergency Access to Medical Technology Scheme should be changed.

Dr. Mateusz Polaczek, MD, PhD, Head of the 3rd Clinic of Lung Diseases and Oncology at the Institute of Tuberculosis and Lung Diseases in Warsaw

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