In the Western world, it is the most frequent among leukemia in adults: chronic lymphatic leukemia usually affects elderly people, often also affected by other diseases. A new therapeutic option is now available for them in Italy, acalabrutinib, which compared to the other drugs available has shown to be more tolerated. A non-trivial advantage, given precisely the average age of the patients and the probable concomitant administration of other medicines. “Chronic lymphocytic leukemia can have a negative impact on the quality of life of patients, who are often elderly over 70, also affected by other diseases – explains Paolo Ghia, Director of the Strategic Research Program on Chronic Lymphatic Leukemia at the IRCCS San Raffaele Hospital of Milan and Full Professor of Medical Oncology at the Vita-Salute San Raffaele University -. It is important to have new therapeutic options available, such as acalabrutinib, which can control the disease in the long term and improve the quality of life “.
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Studies
The AIFA evaluation that led to the drug’s repeatability examined the results of the ELEVATE-TN and ASCEND pivotal clinical studies: in the first case it was shown that acalabrutinib reduces the risk of disease progression or death by more than 80% compared to standard chemo-immunotherapy; in the second, conducted on patients with disease relapse, that acalabrutinib reduces the risk of disease progression or death by 69% compared to the control arm. “The efficacy of acalabrutinib has been demonstrated in terms of progression-free survival in all subgroups of patients, even in those with the most unfavorable genetic characteristics – continues Ghia, who is Principal Investigator of the studies at San Raffaele in Milan -. Furthermore, the better tolerability of acalabrutinib allows the patient to be kept on long-term therapy and better control of the disease “.
This result is highlighted in particular by another study, comparing with the current available ibrutinib therapy, conducted on 533 high-risk refractory relapsed chronic lymphocytic leukemia patients. Acalabrutinib has been shown to be equally effective, with a lower incidence of many adverse events related to this drug class, including atrial fibrillation, a cardiac arrhythmia that increases the risk of death secondary to stroke and cardiac complications, particularly dangerous in fragile patients with chronic lymphatic leukemia.
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A heterogeneous disease
Anemia, swollen lymph nodes, mild fever, fatigue, night sweats, involuntary weight loss are the main manifestations of this neoplasm, characterized by an accumulation of B lymphocytes, with specific phenotypic characteristics, in the peripheral blood, bone marrow and lymphatic organs (spleen, liver, lymph nodes). It is estimated that there are about 3,400 new cases in Italy every year.
Chronic lymphocytic leukemia is often diagnosed following the results of routine blood tests or done for other reasons, such as swollen lymph nodes in the neck, armpits, or groin. White blood cell counts can be elevated, even in the absence of specific symptoms. We are facing a very heterogeneous pathology and many patients have an inactive disease, without symptoms, which allows them to lead an absolutely normal life. Only in a minority of cases is immediate therapeutic intervention necessary. “In asymptomatic patients at the initial stage – says Antonio Cuneo, Director of the Hematology Operating Unit, University Hospital of Ferrara -, drug therapy is not implemented, but the so-called ‘watch and wait’ approach, that is ‘observe and wait’ , characterized by careful monitoring of clinical and laboratory parameters, until the disease becomes symptomatic or progresses. Only in this case is the drug therapy initiated “.
Chronic lymphatic leukemia: a future for patients to live despite the disease
by Irma D’Aria
When therapy is needed
With the onset of symptoms, the disease can cause a negative impact on quality of life. Other aspects to consider, in addition to the symptoms, are the emotional, social and functional consequences of living with a chronic disease. “Furthermore, the age of patients at diagnosis is about 70 years, chronic lymphatic leukemia is therefore part of a clinical picture where it is likely that other health problems are already present. Hence the importance of approving acalabrutinib, which can change the standard of care thanks to a powerful and highly selective mechanism of action, ”adds Cuneo. Acalabrutinib belongs to the class of BTK inhibitors, which has revolutionized the treatment of chronic lymphocytic leukemia. In recent years, thanks to new therapies, survival has improved in all patients, and this result is particularly evident in those with unfavorable genetic lesions, which make them unresponsive to standard chemo-immunotherapy.
The oral route of administration of this class of drugs also reduces the frequency of admissions to the hospital compared to traditional chemo-immunotherapy, an advantage that is not negligible especially in the periods of greatest spread of COVID-19 infection.
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