Acute myeloid leukemia, a new therapy changes the standard of care for 40% of patients
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About 3,300 Italians are affected each year by acute myeloid leukemia, a particularly aggressive blood cancer. Of these, about 40% are unable to undergo standard chemotherapy, because they are elderly and frail, often due to other pathologies. For these patients, a new therapy is now available, venetoclax in combination with a hypomethylating agent (azacitidine), which is radically changing treatment prospects: it improves overall survival and remission rates, with rapid and lasting responses. Without forgetting the quality of life, which is preserved. The steps forward in the treatment are highlighted in the conference “InnoVENtion in AML- Reaching new goals with venetoclax in AML treatments”, which closes today in Naples.
Leukemia: types, subtypes and therapies
The illness
“Acute myeloid leukemia is an aggressive and heterogeneous hematological neoplasm, which arises in the bone marrow, the ‘factory’ of blood cells – says Felicetto Ferrara, Director of Hematology at the Cardarelli Hospital in Naples -. The disease is characterized by the uncontrolled proliferation of pathological cells, blasts, in the bone marrow, peripheral blood and other organs. The mother cell that produces blood cells is altered, its physiological path is diverted and thus leukemia is determined. Among the causes are DNA mutations, which can be determined by exposure to radiation, carcinogenic chemicals or the aging process. Anemia, tiredness, pallor related to the reduction of red blood cells, bleeding and bruising, related to platelet deficiency, and finally infections are the main symptoms. The alterations of the blood count values lead to the diagnosis, which also passes through the bone marrow sampling. The median age at diagnosis is 68 years. However, elderly or frail patients, because they are affected by other pathologies, are not able to tolerate standard intensive chemotherapy, followed by allogeneic stem cell transplantation, if indicated”.
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Increase survival
Unfortunately, the 5-year survival after diagnosis is about 28%, a percentage that is even lower for those who are not suitable for intensive chemotherapy, of which only 5% are alive at 5 years. “Until now, only supportive therapies were available for these patients, therefore no active treatments, or hypomethylating drugs administered as single agents, with low response rates, in no more than 20% of cases, and a survival of around 10-12 months – continues Ferrara -. The category of patients ineligible for intensive chemotherapy, therefore, is the one that historically has shown the worst prognosis and for which innovative therapeutic options have so far been limited. Today that is no longer the case.” The approval of the reimbursement of venetoclax plus azacitidine by AIFA has completely changed the scenario. “In the pivotal VIALE-A study of over 400 patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy, the combination treatment venetoclax plus azacitidine was more effective than azacitidine alone. Furthermore, the data have been confirmed in ‘real life’, ie in daily clinical practice. This is why it is important that this therapy is offered to all patients who are entitled to it”, underlines Ferrara.
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The measure of effectiveness
Minimal residual disease (MRD) defines a small number of cancer cells that remain in the body during or after treatment. These cells cause no obvious symptoms and can only be detected with very sophisticated laboratory technology. “It is important to check whether or not there is MRD, because it can help the haematologist understand if the treatment is working. Achievement of minimal negative residual disease has strong prognostic value for both progression-free survival and overall survival. In the VIALE-A study, 41% of patients treated with azacitidine plus venetoclax achieved minimal residual disease negativity compared with 32% in the control arm,” explains Adriano Venditti, Director of Hematology at the University of Rome Tor Vergata.
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Guarantee access to therapies
“It is essential – underlines Giuseppe Toro, National President of AIL (Italian Association against Leukemia, Lymphoma and Myeloma) – to adopt virtuous models to ensure rapid and uniform access to innovative therapeutic mechanisms, especially in aggressive pathologies such as myeloid leukemia acute, in which the timely availability of therapeutic treatments can certainly mean greater possibilities of cure. Now it is necessary to continue networking – Institutions, the scientific community, Associations and industry – so that all eligible patients can benefit from the new therapeutic options. This requires increasingly integrated and multidisciplinary assistance throughout the country. Therefore, multidisciplinary collaboration, timely access to innovative therapies and structuring of integrated care in hematology centers must be the cornerstones of the treatment of this blood cancer”.
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An innovative drug
Venetoclax received the designation of full innovation from AIFA, which allowed the inclusion of innovative drugs in the Fund. “Today 18 oncological drugs are registered in the Fund – says Davide Petruzzelli, Coordinator of FAVO Hematological Neoplasms and President of La Lampada di Aladino ETS -. These are examples to follow, because in this way rapid and uniform access to treatment in the area is guaranteed, avoiding the additional time required for inclusion in the regional therapeutic handbooks. Acute myeloid leukemia, in most cases, has an insidious onset, and the patient passes in a short time from a state of complete well-being to a condition of severe impairment of health. The emotional impact of a sudden diagnosis of acute myeloid leukemia is devastating for both the patient and their family members. The timeliness of the diagnosis, immediate access to treatment and a support service, including psychological support for the patient, are central to the patient, right from the initial stages. Time is life for patients. Even the doctor must be able to dedicate more time to the patient and less to the bureaucratic aspects. This means more attention to communication with the patient, to respond to his needs and to keep him informed on the therapeutic path ”.
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