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Health Basket 2023: Should cancer preventive treatment be preferred over life-extending medicine? Oncologists are divided Israel today


The question posed to the Medicines Basket Committee that is meeting these days is particularly difficult: whether to finance medicines that are given to cancer patients in an early stage and lead to a full recovery, or to budget for medicines that add a few months to the lives of metastatic cancer patients • "The top priority is to give what heals. Even if only one patient recovers Absolutely - it's a lot," says Prof. Ido Wolf of Ichilov • Other senior oncologists claim that a longer study is needed to make sure that the early treatment does prevent the recurrence of the disease

It is very possible that in a decade the treatment of cancer will look like this: after the diagnosis and the examination of the molecular profile of the tumor, the patient will receive only one treatment - without chemotherapy, for its many side effects - radiation or surgery.

And after a few months of follow-up tests, it will be confirmed that the cancer cells have disappeared from his body.

And if it sounds imaginary and futuristic, it is more or less the story of Eli G. from Tel Aviv (42), a security man and father of two children.

Since he was diagnosed last summer with cancer in the lower part of the digestive system, Eli receives an infusion of medicine once every three weeks, while "skipping" chemotherapy and radiation - and possibly surgery as well.

Indeed, two follow-up tests showed that his tumor had shrunk by half within three months of treatment.

"This is nothing less than a revolution in oncology," declares Dr. Ofer Margalit, a senior oncologist specializing in gastrointestinal tumors at Sheba, who treats Eli. "The drug Eli received replaces all existing measures, brings healing, quality of life and prevention of suffering in gastrointestinal tumors.

He receives an infusion of the immunotherapy drug Keytruda, which engages and activates his immune system and teaches it to recognize the cancer cells and destroy them.

When he arrived at Shiba, even before the diagnosis, it was after he had lost 25 kg of his weight and was in severe pain."

Why did you decide that this treatment was suitable for him?

"We debated whether to go the standard route and give him chemotherapy, or the new treatment. I pushed for the immunotherapy treatment, because Eli arrived in a very turbulent state and we feared that he would not withstand the chemotherapy. He benefited greatly from the immunotherapy treatment both in terms of side effects and in terms of quality of life. The improvement was dramatic, and he with an excellent quality of life. If we manage to avoid surgery - it is already a profit, because from such surgery patients may leave with a disability."

It sounds totally futuristic.

What actually happened here?

"Oncology is divided into three eras. At first there was chemotherapy, which blindly harms cell division - whether it is a cancer cell or a hair cell or the mucous membranes of the digestive tract. Later, an era of biological drugs began, which target certain proteins that drive the cancer process, and there were beautiful successes such as Herceptin for cancer The breast. About a decade ago, the third era of immunotherapy began - the activation of the immune system against the tumor itself. Over the years, we also discovered that immunotherapy works better the more mutations the tumor has and is more different from a normal cell. This increases the chance that the immune system cells will know how to recognize and attack it. Breakthrough The way last summer was that immunotherapy is also effective for the treatment of local and early disease. The patients do not receive chemo, radiation or surgery, but six months of immunotherapy. And in the group tested, all patients - 14 out of 14 - achieved a complete response. In all tests - biopsy, imaging tests and local examination - They did not see a tumor or cancerous cells in their body."

However, to cool the enthusiasm, Dr. Margalit explains that the treatment may only be suitable for 2% of this particular cancer of the digestive system, whose tumor has a high rate of mutations (MSI-High), and qualifies that "the follow-up time for the patients is currently only one year .

Theoretically, it could be that in two years something will return, but as of the current follow-up time - it worked for 100%."

"In the last month or two, I started leaving the house, and I'm trying to get back to my routine. There's also a lot of psychological work, and it's a process. Right now, the plan is to continue treatment and review," says Eli.

"It is much easier than the possibility of surgery. This treatment does not have the side effects that are usually there. My hair did not fall out, and we also saved surgery and radiation. Right now we are on a good trend. We have to be optimistic. My ambition is to feel good and return to work and a normal life."

Mittal Davidov recovered thanks to the new treatment for cancer during pregnancy: "Today I take two pills in the morning and two in the evening, I feel good and plan to return to work. I am lucky that I found the doctor who insisted on giving her this treatment", photo: Efrat Eshel

A change in the therapeutic approach

Indeed, in recent years there has been a lot of progress in tailored treatments for cancer.

Immunotherapy treatments, previously given to metastatic patients, are now also given in the first disease stages, as are biological and hormonal treatments.

Eli's treatment is still in the research phase, but this year eight drugs designed for patients with an early-stage disease that is not metastatic were submitted to the drug basket.

The treatments are sometimes given in combination with chemotherapy, and sometimes before or immediately after surgery.

All of these treatments are changing the treatment approach to cancer: drugs that have so far been intended for metastatic patients and have proven their effectiveness are moving forward and can be given to new patients at an early stage.

And the exciting and significant news: studies show that for some patients who receive the treatment, this results in a real cure from the disease, at higher rates than we knew before.

These days, decisive discussions are taking place in the Medicines Basket Committee on whether to include this year the treatments for patients diagnosed at an early stage.

The dilemma intensifies because the budget for the medicine basket is limited and stands at NIS 550 million for patients with all diseases.

It is possible that the treatments given to patients in the early stages will come at the expense of the treatments for the metastatic, difficult and advanced patients, who will not receive new drugs this year, so the patients' eyes are on the committee's decision which is expected in early January.

The drugs submitted this year to the basket committee for early treatment are intended for prostate cancer patients, breast cancer patients of several types, lung cancer patients, melanoma patients, esophageal cancer patients and kidney cancer patients.

"The special thing about these drugs is that they can lead to a complete cure. Not only to extend life by a few months, but to cure. All of these must go into the basket, and only after them, if there is a budget left, everything else," says Prof. Ido Wolff, director of the oncology system at Ichilov and head of the National Council for the treatment of malignant diseases.

This is after the oncologists chose the eight early treatments as the most important treatments in their opinion that were submitted to the drug basket this year out of more than 40 treatments.

In a conversation with Shishibat, Prof. Wolff explains: "Thanks to these drugs, the disease will not return, and patients will recover from cancer. It is not for nothing that the oncology association ranked them first as a priority in the drug basket. They will make more people healthy. But this is a treatment that is given to large groups of people and at the stage Illness early, and it is very expensive. The state will not be able to pay for all these drugs. The question is where do you cut the line and where is the limit. In our opinion, the top priority is to give what cures and only after that the other drugs."

These drugs - including Linferza, Opdivo, Keytruda and Abiraterone - are well-known and well-known, but for the first time they also began to give them to early stages of the disease and not only to advanced or metastatic and difficult patients.

"All these drugs have been given for years for metastatic diseases. This is the first time that they are talking about treating them for an early disease that has the power to cure people from cancer," says Prof. Wolff.

"It's not 100% effective, but if one out of ten patients can recover thanks to this treatment - that's a lot. If there's a treatment that I know is healing or life-saving, I have to offer it to the patient."

Alongside the research hope and the enthusiastic recommendations of the oncologists, there are also those in the health system who claim that the time is not yet ripe to provide these treatments with public funding (see box).

These are expensive treatments that are given to large groups of patients, without knowing who will benefit from the treatment.

On top of that, there is still no data collected over time showing that indeed the tumor does not return and what is the life expectancy of those patients.

Therefore, some believe that it is worth waiting for further studies.

Along with this, there is also a fear that if generous funding is provided for the early treatments, patients whose metastatic disease will remain unanswered.

Dr. Ofer Margalit, an oncologist from Sheba: "This is nothing less than a revolution in oncology.

The patients receive no chemo, no radiation, and no surgery, but six months of immunotherapy, and in the group that was tested, all the patients achieved a complete response," Photo: Dobrot Sheba

Cancer in pregnancy and complete healing

Mittal Davidov (35) was diagnosed with breast cancer two years ago, in November 2020. She was in her fourth pregnancy, carrying a mutation of a gene that increases the risk of getting breast and ovarian cancer and the daughter of a mother who got cancer and died.

"During the first weeks of my pregnancy, I got in the shower one day, and I felt a small lump in my breast. It bothered me. At first I tried to behave normally, thinking that maybe it was pregnancy hormones. There were tense weeks and at the end I decided to get checked," she recalls.

Davydov was sent for a biopsy and a mammogram.

When she was 13 weeks pregnant, she came to the doctor to receive the test results.

"We went to a breast surgeon and he told me the hardest thing to accept in life - that it was a cancerous tumor that was starting to develop. At first I didn't understand what cancer had to do with it, I'm pregnant. I didn't know how to react and the thought crossed my mind, what am I doing with the child? He also talked about the option of an abortion. In a week The time and a half that passed until I met with an oncologist was very difficult for me. I thought about myself and the pregnancy and the need to take care of the family."

Prof. Ido Wolf of Ichilov: "Thanks to these drugs, patients will recover, but this is a treatment given to large groups and at an early stage of the disease, which is very expensive. The question is where do you draw the line", photo: Koko

Fortunately for Davidov, the doctor she finally came to, Dr. Shlomit Shahar Maichilov, explained to her that it was possible to continue the pregnancy and undergo chemotherapy treatments without harming the fetus. "I decided that with all the costs involved, I would keep the child," says Davidov.

"I started a series of 12 chemotherapy treatments during pregnancy, they followed me there with a magnifying glass. I used to come to Ichilov to do chemo and a few days later to the high-risk pregnancy ward. On the one hand, you are fighting for your life, and on the other hand, you are giving life. I will never forget coming to receive chemo and crying to the nurse that everyone There are adults there, and me, pregnant, instead of sitting with a friend in a cafe is in this place. It was a delusional time. But you see the tests of the fetus, that it is developing and normal, so you hold on to hope."

In the end, Davidov safely gave birth to baby Adir, now one and a half years old, who joined his older brothers, 11 years old, 9 years old and 5 years old. after birth".

Davydov underwent excision and reconstruction surgery, after which she underwent a difficult period of recovery and recovery while caring for a small baby.

After she also underwent radiation therapy, she came to Dr. Shahar to discuss continued treatment, with the biological drug Linferza.

"The doctor informed me that a new study on the subject had just been completed.

We usually gave the treatment to patients who already had metastases and saw that it was also effective for those whose disease was discovered at an early stage.

She really fought for me to get this treatment, did everything to help me.

Save me trial and error with other treatments.

Now I take two pills in the morning and two in the evening and continue to follow up for four to five months.

I feel well and plan to return to work in January.

The effects of the pill are fatigue and slightly low blood counts, but nothing that bothers me in everyday life.

This pill is very effective for those who are pregnant, and if you know that you have been diagnosed, whether it is in the ovary or in the breast - it is effective in preventing the recurrence of the disease."

Dr. Faluch-Shimon of Hadassah: "When we give the early treatment, we have a good chance that there will be more women whose disease will not return.

This can be a lifesaver.

Most women will make a considerable profit from the medicine", Photo: Tzachi Miriam

What is your message to other women?

"It is very important to be alert and pay attention to any changes in the breast, pregnancy and breastfeeding. Always go for a check-up, because if there is any doubt - there is no doubt. If you are not satisfied with the doctor, you can go for additional opinions. In retrospect, I am lucky that I found the doctor who insisted on giving me this treatment ".

The medicine that Davidov receives reduces by 37% the risk that her disease will return and improves her survival by 32%.

In fact, after a four-year follow-up of the patients treated with Linfarza - close to 90% of them are still alive.

Dr. Shani Faluch-Shimon, director of the breast oncology unit at Hadassah, says: "There are three drugs for breast cancer patients that were submitted to the drug basket this year and that reduce the risk of the disease returning.

The treatments are intended for women with early breast cancer who are at increased risk of recurrence of the disease.

We want to take advantage of the window of opportunity that comes with early detection and reduce the risk that the disease will return in the future.

The treatment is real news for patients with early breast cancer, who are at high risk of the disease returning.

It increases the cure rate and improves the overall survival of the patients.

The three drugs save lives.

The goal of early treatment is full recovery."

But in some patients the disease will still return.

"True, but when we give the early treatment we have a good chance that there will be more women whose disease will not return. This can save lives and prevent the disease from returning permanently. Most women will make a considerable profit from the medicine."

Dr. Guy Ben-Bezalel, an oncologist from Sheba: "There is a dissonance here between the individual, who wants to prevent a recurrence of the disease at all costs, versus the interest of the general population.

In my opinion, we are running too fast for the preventive treatment, at the expense of the treatment of the metastatic disease", photo: Dovrot Sheba

Early treatment and a disappearing tumor

N. (76), a pharmacist by profession from East Jerusalem, was diagnosed with stage 2 lung cancer and a lump of about 4.5 cm. She is a heavy smoker in the past. She also benefited from early treatment, which led to the disappearance of the tumor.

A year ago she received three treatments with the immunotherapy drug Opdivo , along with chemotherapy. She then underwent surgery, and a pathological sample found no remnants of disease in her body. In fact, today she is only monitored once every three months.

According to a study recently published in the leading journal "New England Journal of Medicine", the treatment N. received was able to eliminate the tumor in 24% of the patients.

For comparison, in patients who received the conventional treatment until now - only chemotherapy and then surgery - only 2.2% of the tumors disappeared.

It was also found that the immunotherapy treatment in combination with chemotherapy reduced the tumor in nearly 40% of the patients.

Dr. Hadas Gantz-Sorotsky, senior oncologist, specialist in lung cancer and breast tumors in Tel Hashomer, says: "Early treatment is dramatic for certain patients.

It is intended for patients with lung cancer whose disease was diagnosed at an early stage and who, despite chemotherapy and surgical removal of the tumor, have significant disease recurrence rates - up to 45%.

In patients who are diagnosed with stage 3 disease, there is even a 76% recurrence of the disease.

And when the disease returns, it is metastatic and significantly shortens life.

Therefore, it was necessary to find another treatment.

We saw that the addition of immunotherapy, in this case nivolumab (Opadivo), demonstrated amazing results and could move many patients to a state of recovery.

In a comparison between patients who received Opdivo treatment with chemo and those who received only chemo, a pathological examination found that 23-40% of them were completely free of cancer.

It's a fantastic response."


"Research phase too early", photo: Yehoshua Yosef

The opposing side:

"We don't know

if these treatments really cure"

Not everyone is enthusiastic about early treatment.

Some believe that a longer study is needed to substantiate the claim that it does lead to healing.

And above all - that the treatment that seems promising at the level of the individual patient is also broadly promising so that it would be justified to provide it with public funding in the medicine basket.

Iris Ginzburg, a former member of the Medicines Basket Committee, believes that the members of the Basket Committee should examine in depth the clinical proof of medicines intended for early treatment: "In any long-term preventive treatment, the question arises of how long the follow-up done in the study is and if it is sufficient to prove benefit in terms of non-recurrence Tumor. In many cases, such indications are submitted at a research stage that is too early, where the time period being tested is not long enough. These are treatments that are given for long periods of years, after which it must be examined to what extent the treatment actually prevented the recurrence of a tumor compared to control groups.

"Unlike other oncology treatments, where patient survival is examined in terms of months of life, in order to prove the effectiveness of adjuvant treatment, it is necessary to follow up for more than a decade in order to quantify the life extension resulting from it. These are drugs that are given for a long time and their budgetary cost is high - but their benefit is difficult More to prove than in short treatments."

"The commercial motivation here is very high, but in order to prove the effectiveness of a treatment that prevents the recurrence of the disease, a very long follow-up is required," says Dr. Guy Ben-Bezalel, a senior oncologist from Sheba. "Classically, once you have a treatment that prevents the recurrence of a metastatic disease - It's called curative treatment, and we as doctors rank it as a high priority treatment.

But we don't really know until the end if these treatments are necessarily curative.

In a declared way, the treatment is given to people who have undergone chemotherapy and surgery, these are people for some of whom - whether you do something or do nothing - the cancer will not return.

There is no way to know who are those patients with residual disease who need the treatment.

I estimate that in the coming years there will be tests that will be able to tell which patients need the preventive treatment."

How do you explain the enthusiasm for the early treatment?

"There is a dissonance here between the individual, who wants to prevent the recurrence of a disease at all costs, versus the general population. These decisions are very difficult. In my opinion, they are rushing too quickly to the issue of preventive treatment, at the expense of the treatments for the metastatic disease. I, as a doctor, am also torn, because I am the one who will meet the same A BCC cutaneous melanoma patient who has a huge tumor on the skin, which causes him significant suffering, but since his disease is advanced, there is no treatment for it in the medicine basket."

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Source: israelhayom

All news articles on 2022-12-22

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