​The dream of any oncologist and his patients is now also possible at the Fundeni Clinical Institute in Bucharest. Alina Tănase, the doctor who, a decade ago, developed a Western-standard bone marrow transplant unit here, saving the lives of hundreds of patients diagnosed with blood cancers, fought for her patients to now have access to the new frontier in cancer treatment – CAR-T cell therapies.

Alina TanasePhoto: Hotnews

“For medicine it’s a wonderful thing”

CAR-T cell therapies cause the patient’s own cells to be modified in the laboratory so that they precisely attack cancer cells. The new therapy is considered revolutionary precisely because it addresses patients who did not respond to all other lines of treatment and were basically doomed to palliation therapy, explains Dr. Alina Tănase, in an interview with HotNews.ro.

For now, in Romania, only patients with two types of blood cancer have access to this treatment – acute lymphoblastic leukemia in children and young adults and large B-cell lymphoma. However, 6 such therapies are approved in the world, for several types of cancer.

The first 6 Romanian patients who were administered this therapy were treated in the department led by Prof. Dr. Alina Tănase, at the Fundeni Clinical Institute in Bucharest.

“It’s a different kind of therapy, it’s every oncologist’s dream to find a cell that, introduced into the blood, destroys the tumor. It is an extraordinary thing for us, as doctors, to always be able to offer a chance, to have a treatment option for a patient for whom there was no option until now. For medicine it is a wonderful thing”, declares Dr. Alina Tănase, in an interview granted to HotNews.ro.

The Fundeni Clinic Institute is the first hospital in Romania whose patients have access to CAR-T cell therapy, considered revolutionary in the treatment of some types of blood cancer.

How CAR-T therapies work, the revolutionary new cancer treatment

CAR-T therapy is not only an innovative treatment, but one that modifies the mechanism of action against cancer cells, explains Dr. Alina Tănase: “Because it uses the patient’s own cells that he modifies in the laboratory, so the patient’s own cells, modified in the laboratory so that it precisely attacks the disease cells. So we’re not talking about a one-size-fits-all medicine, we’re talking about a strictly personalized medicine.”

This process takes several weeks, emphasizes Alina Tănase: “It is not a medicine available immediately as you prescribe it, precisely because we are talking about living cells. After we harvest them and send them to these labs, they come back in about 4-6 weeks as a drug. A medicine in the true sense of the word, but for that patient, a strictly personalized medicine.”

For now, in Romania, only patients with two types of blood cancer have access to this treatment – acute lymphoblastic leukemia in children and young adults and large B-cell lymphoma. However, 6 such therapies are approved in the world, for several types of cancer – all hematological diseases – says doctor Alina Tănase: “As experience increases, new products with other indications appear and certainly in the coming years we will have such drugs for more patients.”

It is not a treatment that works immediately, but the patient is monitored for weeks, at first every 4 hours, explains the doctor. For example, patients first receive a cytostatic treatment that resembles pre-transplant treatment: “Our role as a transplant center is that in the first 14 days we monitor very carefully the administration and possible side effects of these drugs, because they can be side effects formidable and that is why these patients are cared for in specialized transplant centers. We put this infusion of cells on the catheter and for 14 days we monitor carefully, every 4 hours, because a wide range of complications is described. Among the most important I would mention cytokine release syndrome. It is a complication that can lead the patient to Intensive Care. And from the studies and the experience so far, about 40% of patients, so not few, need Intensive Therapy and very careful monitoring from this point of view. So it must be evaluated very strictly. There is another complication that I would like to mention and that is neurological toxicity. At the moment when the modified cells stick to the tumor cell, it is destroyed and all the contents of the tumor cell spill into the blood, these toxins released in the patient’s blood also reach the head and then can cause high neurological toxicities. And we have some protocols to monitor the patient: for example, we ask him to write the same phrase several times a day, because it is shown that the first change is the change in writing. Plus everything that means constant: fever, blood pressure, pulse and all very strict monitoring. It’s a treatment with big side effects and to get it right, it has to be in a specialized center.”

And after discharge, “we check the patient’s blood for the existence of these CAR-T cells and evaluate the disease through imaging or specific methods. But it’s not a drug that works in a few days, it’s a drug that we can get a partial response in 30 days and a full response in 60 days. Each patient reacts in his own way due to this absolutely unprecedented specificity, whereby the active cells travel through the patient’s blood and attack the tumor where it is encountered. I hope we have very good evaluations in these patients and match the results of the studies that led to this registration.”

How many patients can the Romanian state afford to treat and what is the solution for more patients to have access?

Since it is a very expensive treatment – on the order of several hundred thousand euros for a single patient – I asked Alina Tănase how many Romanian patients currently have access to treatment settled by the National Health Insurance Agency.

For now, 20 patients can be treated annually in Romania, but “for sure, the number of patients will increase as our experience increases, as more patients are sent to such therapies. And indeed, it is a very expensive therapy, because the process of producing this drug is extremely complicated.”

In Romania, in the ward at the Fundeni Institute headed by Alina Tănase, 6 patients, both adults and children, have received this therapy so far. The 6 patients are doing well but are still being evaluated.

This new therapy gives results in the case of 80% of patients with acute leukemia and 60% of patients with large B-cell lymphoma, says doctor Alina Tănase: “But there are very high percentages for the category of patients to whom it is addressed, because they are patients in whom we have exhausted the other therapeutic lines and many of them were destined to a palliative therapy. For this category, you have no other treatment options, and to have these success rates is a wonderful thing for medicine.”

Because the procedure is very expensive and takes a long time – doctors are looking for a free place in the platform of all the centers that administer CAR-T cells in Europe, they have to harvest and send to the laboratory viable, controlled cells that can be transformed into -a quality medicine – Alina Tănase would like Romania to make the construction of such a laboratory a national project:

“I think that for a very wide access of patients to such therapies it would be extraordinary to have a country project in which to build these types of drugs in a specialized laboratory in Romania, because this therapy will certainly grow and include more many hematological diseases and maybe all the studies that are going on will lead to the registration of these drugs on other neoplasms and then we will have a very large number of patients who need such therapies and the construction of such a laboratory where we can do us this modification and to produce this drug in clinical trial for Romanian patients. I think it would be an extraordinary thing to increase accessibility for such therapies”, is the solution that doctor Alina Tănase sees.

First CAR-T therapy approved in 2017: “It was a revolution in international hematology”

We asked Alina Tănase how long it took between the moment when the first CAR-T therapy was approved and the moment when she arrived at the Fundeni Institute: the first drug was approved by the FDA (United States Drug Approval Authority – n. ed.) in 2017 and “was a revolution in international hematology. It was very quickly approved, after the publication of the study that showed extraordinary results. In 2018, the same drug was approved in Europe, and surely in the meantime all scientific forums were discussing these results. It took 3 years of effort and team work to have this therapy here. It was not simple. For example, we had to export cells with the approval of the National Transplantation Agency and import medicines. It is a different circuit and all these steps had to be taken according to Romanian legislation. We had to do trainings and each team had to have a multidisciplinary collaboration. It cannot be approved if you do not have a neurologist on the team, an Intensive Care doctor and you have access to Intensive Care within 5 minutes. All these steps, from the pharmacist to Intensive Care and neurologist, to the transplant ward, we had to go through all these stages of preparation and quality control of the process.”

Alina Tănase sees this therapy as something extraordinary. Especially since it means a chance for patients for whom, until now, there was no treatment option: “It’s an extraordinary thing, I think we have to fight for every chance, and when you have a drug that only you have heard and seen the clinical trials is a great achievement for the doctor. And I think our patients were also extremely brave. We started this program on the first patients, and I think they had tremendous courage to be the first, to enter this program and put their lives in our hands. I would say ‘thank you’ for this, it’s been a few years that we’ve been trying to implement these therapies and at this point we’ve succeeded.”

He says that it was teamwork at the Fundeni Institute to get here, and now he hopes that his hospital will be a trailblazer and that these therapies will be available in other centers in Romania, in order to have access to them as soon as possible many patients: “It was a team effort, in everything that means the medical team, the administrative team, patients, the press. Because it was a hotly debated topic in the press, everyone said wow, it’s a different kind of therapy, and it’s every oncologist’s dream to find a cell that, when introduced into the bloodstream, destroys the tumor. It is a great satisfaction that you were able to give it a chance and maybe after the Fundeni Clinical Institute this program will expand to other centers and then more and more patients will have this chance.”

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