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What is a patient deprived of hope to do? Can he escape the sentence? Are clinical trials just the door through which they can escape? This is what American patients have been doing for a long time. They use drugs that are unavailable to Poles. We talk to Professor Dariusz Kowalski from the Oncology Center – M. Skłodowska-Curie Institute in Warsaw about modern lung cancer treatment in our country and about the opportunities for patients in clinical trials.
Zuzanna Opolska, Medonet: Professor, why is lung cancer diagnosed so late in Poland (stage IIIB and IV)?
Professor Dariusz Kowalski: Unfortunately, the number of lung cancer patients is growing exponentially. We have almost 1,5 million new cases in the world, including 23 in Poland. In addition, there are patients who have been treated radically and are under observation, where there is a risk of recurrence, and patients who have been treated palliatively, who have achieved a longer survival time, but are also under observation. We diagnose lung cancer late for several reasons. First, there is an extremely insidious tumor, which is usually asymptomatic in the early stages. 95 percent the sick were former or current smokers. The main symptom is cough, and in smokers, the cough is associated either with direct damage to the bronchial epithelium or with accompanying chronic lung disease. I do not know a smoker who is concerned about his cough. And it is precisely the cough and hoarseness that he should not take lightly. Secondly, potential patients with frequent infections or general weakness are underestimated by family doctors. It often happens that a sixty-year-old who has been smoking intensively for forty years goes to a clinic with pneumonia. As a result, he is given an antibiotic, which of course is the correct procedure. But if the same patient shows up with a new infection in three weeks, he should not be prescribed an antibiotic again, but should be referred to a conventional chest radiograph. In Poland, the time between the appearance of the first symptoms and going to a specialist is definitely too long.
The level of awareness of Poles is low, 57 percent. of us declare a lack of knowledge about lung cancer …
Yes, we also have cancerophobia. We think it’s better not to know. Until the doctor diagnoses the cancer, I don’t have it and I’m healthy. Unfortunately, that’s not how it works. The early stage of detection allows us to offer the patient more solutions. We have to push for the educational aspect and GPs should react faster. Another thing is that there is no national lung cancer screening program. The American study showed that the introduction of the so-called low-dose computed tomography in groups at increased risk of developing the disease, compared to conventional chest radiograph increases survival by 20%. However, this program is very costly and controversial. Some experts believe that the benefits of screening are exaggerated. Therefore, perhaps we should invest in education and in changing the way we communicate about cancer.
In recent years, we have observed an increase in the incidence and mortality of lung cancer in women, while the results in men have stabilized. Why is this happening?
In the case of men, we are dealing not with stabilization, but with a decrease in the number of cases. These are not only Polish conditions, it is the same throughout Europe and the United States. Americans started the fight against addiction the earliest and have the first results in the form of the results of epidemiological studies. We need to educate women who, unfortunately, smoke more. Slimes are just as addictive and carcinogenic as regular cigarettes. And smoking them makes us inhale the smoke deeper, more abruptly, and puff more times.
What are the risk factors for lung cancer?
Mostly smoking. It is the most dangerous but eliminable carcinogen. The risk of lung cancer increases in proportion to the duration of smoking and the number of cigarettes smoked. Other factors are occupational exposure, exposure to radon or asbestos, diet, genetic burden and environmental factors. 20/30 years after quitting the addiction, the risk of cancer drops dramatically and is approaching the level of non-smokers.
And e-cigarettes? Data on the sale of electronic cigarettes in Poland say about 1,5 million consumers …
This is a new epidemic. “Therapeutic nicotine” is just a marketing gimmick. Electronic cigarettes are neither safe nor help to break the addiction. The World Health Organization has issued a statement that the risk of lung cancer is very similar and that e-cigarettes should be treated like normal cigarettes.
The five-year survival rate of lung cancer patients is 13,4%. It is one of the worst prognosis neoplasms, are the treatment attempts ineffective?
It all depends on the histological type. 85 percent Lung cancers are non-small cell carcinomas and in low-stage clinical advancement, surgical treatment of this tumor plays an essential role. Unfortunately, in most patients the cancer is locally advanced and cannot be treated with radical treatment (surgery) or with dissemination. Until recently, in the arsenal of weapons apart from surgery, we only had radiation and chemotherapy. From the moment the methods of molecular biology appeared, our procedure has become much more effective. When I started work twenty years ago, a patient who survived three months was a great success. The six-month survival at the dissemination stage was almost a miracle. Now, when we identify the molecular abnormalities of the tumor that we can target, we treat the patient with dissemination for two, three, or five years. It’s almost like a chronic disease, the person gets an infusion and goes home, or they wake up and take a pill. However, it should be remembered that these are drugs dedicated to specific groups of patients. That is why we are constantly waiting for the possibility of using new drugs that give hope and a chance to extend good quality life for other patients.
What is the availability of new treatments for lung cancer?
We are a country in the European Union and in terms of population we have great potential for the use of new drugs. Unfortunately, we are also one of the last countries to introduce them for reimbursement. The procedures and attitudes of the regulator are to blame, and he must understand that the era of classic cheap cytostatics is gone forever. Genetically engineered drugs have a different price. If we want to treat our patients well, we have to pay for it. In the United States, when two or three positive studies of the third phase study are published, the US Food and Drug Administration (FDA) grants registration for a specific indication and drugs are practically available automatically to patients. In Poland, three, four or five years pass from the registration of a preparation to its reimbursement. It’s a drama. This time should be absolutely shortened.
Can molecularly targeted therapy and immunotherapy replace chemotherapy?
It all depends on the method of treatment, but classic chemotherapy has long been replaced by targeted therapy. If a patient has a specific molecular disorder and we have a specific drug for it, he or she gets it in the first or second line of treatment. Classic chemotherapy is still in the sequence and I think we will not eliminate it that soon. However, when it comes to immunological or immunocompetent drugs, today one of them has received US registration for the first-line treatment based on a positive phase III study. There is currently no such registration indication in the European Union. However, we have registration in Europe for the second-line treatment, i.e. in patients whose previous treatment did not work. Unfortunately, these drugs are not covered by reimbursement, so they cannot be used in Polish patients.
Clinical trials are a chance for patients to access new drugs. What are they and where can we find useful information?
Unfortunately, we do not have a nationwide database. The best is the American -https: //clinicaltrials.gov/. There you can find information on clinical trials, including those registered and conducted in Poland. We can also find constantly updated information on the website of the Cancer Center. Clinical trials in which our center participates create real opportunities for the patient to access innovative therapies. Some molecular disorders are very rare and affect 1-2 percent. cases. Until a specific drug is registered, this is the patient’s only hope. Most clinical trials are conducted in the United States and Western Europe. In Poland, the percentage of participants is still too low, however, also in Poland, research in the field of lung cancer is carried out and Polish patients can apply for these tests. Patient organizations and patient portals, e.g. www.zwrotnikraka.pl or www.immuno-onkologia.pl, know and talk about the research more and more. These pages contain information in Polish about some studies conducted in Polish centers with the use of immuno-oncology therapies. I am glad that the research has recently been demythologized. Previously, they were associated with the colloquially understood “experiment” and the patient acting as an experimental rabbit. Designated institutions supervise the correctness of conducting clinical trials in Poland. And the safety of participants is ensured by applying the principles of Good Clinical Practice. The patient may withdraw from participation in the study at any time, if he / she deems it to be in his interest.
What conditions must be met to qualify for the study?
Clinical trials are strictly protocol-related and the fact that a patient would like to participate in them does not mean that they will be able to. We have defined the so-called entry criteria each of which must be met and exit criteria of which none can be met. The researcher conducting the study and recruiting patients for the study decides about the patient’s qualification.
And what factors preclude participation in the study?
One key – lack of recognition.
What is the so-called Document of Informed Consent?
It is the most important document in the qualification and participation of the patient in a clinical trial. Its form has changed a lot in recent years. Previously, informed consent documents were easy to read, understand and accept. At the moment, they are more complex and less readable, and may consist of several or several dozen pages. When in doubt, the patient always has the opportunity to discuss all aspects of the study with the principal investigator or the treating physician, who is called the co-researcher. The patient must personally sign and date two copies of the form. One form is attached to the documentation and the other is given to the patient. If it is impossible to express consent in writing, the consent given orally in the presence of two witnesses is considered equivalent. Such consent should be recorded in the medical records. Only then can we start any procedures for clinical trial qualification. Thus, signing the document opens the way for the patient to participate in the study, but does not necessarily ensure participation. During the procedure, it may turn out that the patient does not meet one of the inclusion criteria.
What are the benefits and risks of clinical trials?
Risks come with any treatment method. While using a new drug, undesirable effects may appear, but also in the course of the therapy used, there are a number of side effects. We can predict some of them because they are conditioned by the mechanism of action, while others are not. In Polish conditions, clinical trials enable the use of innovative drugs that are known and available on the market. As well as access to completely new drugs that have not yet been registered, but have been tested to such an extent that they can potentially be active against a specific molecular disorder and bring tangible benefits to patients.
Lung cancer patients and their families who need information and support during treatment may apply to patient organizations operating in Poland, associating patients with lung cancer:
· Lung Cancer Association in Gdańsk: www.rakpluca.org.pl and
· Lung Cancer Association, Szczecin Branch: www.rakpluca.szczecin.pl
Professor Dariusz Kowalski, MD, PhD – Head of the Conservation Department of the Lung and Chest Cancer Clinic of the Oncology Center-Institute Maria Skłodowskiej-Curie in Warsaw. A specialist in the field of Clinical Oncology and Oncological Radiotherapy. Member of the scientific societies IASLC, AACR, PTOK, PTO.