SOHO Italy 2025 | The management of CLL: an Italian perspective

In our country we have a universalistic national health system which allows each physician to prescribe the effective drug approved by EMA and by the Italian Drug Agency with some restrictions based on inclusion criteria in the trials. The drug is dispensed free of charge to all the patients who need the drug according to indications and irrespective of their income. The GIMEMA working party on CLL established a collaboration with the Italian Drug Agency to assess the effectiveness in the real world of targeted therapy. Every prescribing physician needs to record the patient data, the clinical data on occasion of each prescription so that the web monitoring platform is able to record drug interruptions and drug definite withdrawal to the patient. So that time to treatment discontinuation is an effective endpoint. And in this web platform registry, we are able to capture 100% of the Italian population received that drug. That being said, we set out to analyze the effectiveness of the first BTK inhibitors, ibrutinib, in first-line CLL with 17p- and in the relapsed refractory setting. And we were able to document that the paper published that the time to treatment discontinuation in over 700 patients who received ibrutinib for first-line CLL with 17p- or TP53 aberration was 37 months, which compares favorably with the other papers published in many countries. And likewise, we were able to show that the persistence on therapy of patients who received ibrutinib for relapsed refractory patients, this is a vast population of over 3,300 patients with a minimum follow-up of 16 months, while in this patient time to treatment discontinuation was 31 months median time, and 52% of the patients were still receiving ibrutinib in relapsed refractory setting at two years. And interestingly, the effectiveness of this drug was independent of the experience of the center. Experienced center and less experienced center had the same outcome with time-to-treatment discontinuation overall survival, which compared favorably with many other analogous papers published in the literature. That being said, we are able to follow the ESMO guideline when designing treatment for the patient in first line and second line, and we basically use risk stratification based on genetics. A favorable risk group with the mutated immunoglobulin gene without 17p-, without TP53 aberration, and without complex karyotype is generally treated with fixed-duration treatment. The patient with high-risk disease, as defined by the presence of P53 aberrations or complex karyotype, is usually treated in the majority of centers with continuous exposure to second generation BTK inhibitors. And in a sort of intermediate risk group defined by the presence of an unmutated immunoglobulin gene without P53 aberration and without complex karyotype, we decide, based on a number of factors whether to prefer continuous treatment or fixed duration and this clearly should entail a strong interaction between patients and physician young patient comorbidities easy to access the hospital may favor a fixed duration whereas patient with limited access to the hospital or with some comorbidities may be submitted preferentially to continuous treatment.

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