Prof. Dr. Georgi Chernev: We have created a new method for treating melanoma

Prof. Dr. Georgi Chernev: We have created a new method for treating melanoma
Prof. Dr. Georgi Chernev: We have created a new method for treating melanoma

Prof. Dr. Georgi Chernev is the head of the polyclinic for dermatology, venereology and dermatological surgery "Onkoderma", and from 2016 until now he also works at the Dermatology and Venereology Clinic at the University Hospital of the Ministry of the Interior in Sofia. Over the past three and a half years, he has performed over 1,300 operations on skin tumors. He is the founder and chairman of BDDH - the Bulgarian Society of Dermatological Surgery.

Although winter is not a risky season for developing skin cancer, it is the time when signs of such a disease may appear. That's why we offer an interesting conversation with the skin cancer specialist.

- Prof. Chernev, you have introduced a new algorithm for the treatment of melanoma, not only for Bulgaria, but also worldwide. What is innovative about the method?

- I must say that melanoma is a serious problem and for the moment still unsolved in terms of firstly the increasing incidence of the disease. In the last year, according to official data, more than 193,000 cases were registered worldwide, of which approximately 100,000 were people with advanced or invasive melanomas.

Worryingly, an increasing incidence is generally observed everywhere in the world, and this is not only in relation to early diagnosed melanomas. This is the main problem.

And for Europe alone, in 2012 we had about 100,000 new cases, of which 22,000 were fatal. These are patients in whom surgery in most cases cannot help or helps partially. And these patients usually undergo additional targeted therapies. A rough calculation shows that the cost of melanoma therapy reaches, or may reach, about $630,000 for combined targeted therapy over a 3-year period.

To a patient! I mean combination therapy with Braf/MEK inhibitors. Immunotherapy with drugs such as ipilimumab/pembrolizumab - mono- or combined therapy - are also extremely expensive, with the final arithmetic in terms of sums being analogous. The main open question remains: how to reduce the number of advanced cases of skin melanoma? And, of course, how to save a large part of this money with a view to redirecting it to other, more pressing sectors.

What is the recipe for this? Is there even one?

- My answer would be categorical in this regard: early prevention, radicality in surgical interventions, as well as changing the basic algorithms for a clinical approach. In the absence of a general change, we could talk about a monthly update of the recommendations for clinical management or, as a last resort, if this does not work - an individualized approach with a signed informed consent of each suitable patient.

What are the currently accepted methods of treating melanomas according to the AJCC recommendations?

- Within the surgical treatment of melanomas, we always have two operations or an approach involving two surgical sessions, which must be carried out in a precisely defined way and time. It starts with the first resection, with a mandatory safety margin of 0.5 cm in all directions. This is the so-called according to some colleagues or authors, excisional biopsy, but it often has the character of a serious surgical intervention.

The term is confusing for a number of colleagues, but it is essential as a concept and as a manipulation. It is also defined as the first step in the surgical treatment of melanoma. And depending on the established histological, postoperative tumor thickness, reexcision is also done (excision - cutting, removal of a part of tissue or organ), which can have a margin of surgical certainty between 0.5 to 1.5 in all directions (additionally). The resection fields within the second operation are determined depending on the established histopathological Breslow tumor thickness.

If the tumor thickness is up to 1 mm, reexcision is done without removing the so-called draining or sentinel lymph node, the additional margin of surgical safety being 0.5 cm in all directions, respectively. For tumor thickness between 1 and 4 mm, lymph node determination and removal is strongly recommended and combined with reexcision of the primary cicatrix. For melanomas with a tumor thickness of 1 to 2 mm, a surgical safety margin of 1 cm (total resection margin achieved within 2 interventions) in all directions (combined with the parallel removal of a draining lymph node) is recommended.

For those thicker than 2 mm and up to 4 mm or thicker melanomas - the resection field is respectively 2 cm (total resection field achieved after 2 surgical interventions) in all directions (again combined with a draining lymph node).

For tumors larger than 4 mm, the removal of the draining lymph node is somewhat controversial and is decided subsequently depending on each patient and whether clinically and instrumentally we have evidence of advanced disease or not. It is suggested that if there are no enlarged lymph nodes, the therapist's position regarding localization and removal of the draining lymph node could be wait-and-see, but re-excision is strongly to strongly recommended. The approach and recommendations are individualized for each patient. However, a total resection margin of 2 cm in all directions is again strongly recommended and should be adhered to.

What is the number of melanoma patients per year worldwide and what is the cost of surgical treatment? Does your created method or new algorithm have a bearing on pricing policy? Is it suitable for all melanoma patients?

- In short, we are talking about two hundred thousand people undergoing two operations. The price of only the second is about 5000 dollars or euros in different countries of the world. When creating a new algorithm to eliminate the second operation or reduce the number of surgical interventions to one, for example, this inevitably leads to about a billion dollars in direct difference in the cost of treating melanoma patients as a whole, relative to he alth insurance systems worldwide.

This should not need comment, although minor adjustments regarding the selection of groups suitable for this innovation would be possible. In this case, I am referring to achromatic melanomas and those with medium to smaller tumor thickness and regression zones present. For them, this algorithm would not always be successful, risky or inappropriate. But their number is generally minimal compared to the general morphology of other melanomas.


Prof. Dr. Georgi Chernev

Within our 20 years of experience in the surgical treatment of cutaneous melanomas, we believe that we may have developed a new, highly reliable melanoma treatment algorithm in which the currently mandatory second operation is spared to the patient and of the he alth insurance system. We believe that this new methodology has superiority over the previous one and that it significantly surpasses it in terms of, first, success rate, referring here to the absence of relapses in the following few years, and second, it is financially more acceptable or advantageous for the state he alth insurance systems.

What advantages does the new methodology provide for patients?

- I mentioned that we have developed such an algorithm in which the second operation is dropped. It aims to reduce the number of patients who reach advanced stages of melanoma. According to our observations at the moment, we believe that there is a possibility that over 50-60%, even more, of the patients operated on according to the aforementioned methodology, will not progress or reach more advanced stages. The aim of the methodology was to optimize the approach and save the second surgical intervention for the patient in order to reduce recurrences. That is, sparing patients and saving money.

Subsequently, we also receive the information expected by us from the controlling/observing patients at a later stage oncologically, that the people treated by this method are well and unlike other similar cases treated by means of 2 surgical interventions (according to the recommendations of AJCC), do not show a tendency to relapse. The reasons for this are as follows. First, full control of the patients and of the procedure performed within a single surgical session through the formation of an interdisciplinary team and video surveillance/imaging, that is, self-control within the team.

Secondly, minimizing the potential for delays in histology results through an individual stacked algorithm for obtaining histology/immunohistochemistry. Third, lack of a second surgical session, which is currently often performed by different teams (when following the AJCC melanoma treatment algorithms). Fourth, accurate mention, marking and archiving of resection areas in documentation and epicrisis.

How many patients worldwide are on target therapy? Is there a relationship between the methodology you created and the need for targeted therapy?

- You are giving me a hard time with these questions. I doubt that an absolutely accurate answer is possible in principle. But let's think aloud and share some more interesting data from the world's he alth media and magazines

Currently in America alone according to their news media there are over one million melanoma patients.

In sharing this data, no one mentions categorically whether these patients survived the melanoma disease or lived with it - controlling it with targeted therapy or, accordingly, without it. If we accept the fact that these melanomas are invasive or the patients are on targeted therapy (after complete elimination of the tumor tissue), the cost of which over a period of 3 years is about 630,000 dollars, then rough arithmetic shows that 630 billion is paid for the treatment of melanomas in America alone - 630 billion over three years or 210 billion per year for targeted treatment of melanoma patients living with it, survivors or not yet clear what. Only in America!

If the data shared by the American he alth information media is inaccurate, or of those 1 million, only half have invasive melanomas, then the treatment would cost about 105 billion a year in America alone. But what is suggested is that patients who are on therapy for advanced melanoma, that is, those at an advanced stage or still at risk, are probably being targeted. For example, with locoregional advanced disease/or distant metastases, cleared surgically, but at the same time subject to systemic treatment.

I exclude the fact that targeted therapy is already discussed in earlier stages, aiming for a possible preventive effect, even when there are no locoregional distractions. This was published in "Lancet Oncology", with Prof. Klaus Garbe - a good friend of ours - participating as a co-author of the article. Whether the news media is targeting all these groups I mentioned is not clear. It's troubling that no one wants to talk about how much it's costing the taxpayer to treat them.

And only for America, it reaches colossal amounts - from about 105 or 210 billion dollars per year. We believe that with this one-step/one-step algorithm of melanoma therapy, costs can be reduced dramatically and reach at least or at least half of what they were before. And in short order. The lack of exact official amounts regarding this targeted therapy complicates our overall calculation and makes us only guess as to the exact one.

Here we are talking about huge capitals that move from the pharmaceutical industry, from the he alth insurance systems in unclear or not always clear (both in the past and currently) directions. That's why the topic is extremely hot. We are the first in the world to introduce this algorithm, formalized in a number of prestigious medical journals.

It is our opinion that our algorithm does not allow for the free time intervals that actually exist between the two surgical sessions (under current treatment algorithms). It is within these intervals that patients seek a second and third opinion, control of histopathology with at least 2 more pathologists, ultimately delaying the second surgical intervention, and it practically becomes meaningless and leads to progression. Progression in turn requires huge funds…

- Are your results presented outside Bulgaria? Can you summarize what is most important?

- Of course! We also presented the algorithm at the World Congress of Dermatology in Milan-2019, and colleagues from the international world guild showed great interest in the innovation. If I had to systematize, I would mention the following facts.

We achieve exactly the same end results as the AJCC guidelines, but within a single surgical session, eliminating or minimizing the potential for errors due in part to the variability/freedom of action as well as the inaccuracy of certain points in the AJCC recommendations!

Refining this algorithm was the result of hard, four-year work and daily analysis and comparison of results.

Do you plan to continue research in this direction? Should we expect news?

- We have quite a few other similar ideas and recommendations that we will formalize very soon through the change in clinical behavior in surgical treatment methods and algorithms again.

We hope this will drastically reduce the incidence of melanoma worldwide by at least 40% minimum, although we have much bolder expectations. But even if we were to reduce this incidence by even 20%, as well as the huge costs in terms of treatment, that would be a spectacular success. It is available. The beginning is given, the results are phenomenal.

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