In Italy, 7 out of 10 patients with blood cancers are now alive 10 after diagnosis or are considered cured. A word, healing, which can rarely be used in oncology. This is also and above all thanks to the Italian research that continues to lead the way. Specifically in the past two years, the natural history of two diseases – the large B cell lymphoma and acute lymphoblastic leukemia – has changed radically thanks to the studies conducted in our country on two frontiers of immunotherapy: therapies with Car-T cells and with bi-specific antibodies. Many of the studies that are presented in these days in Milan, at the national congress of the Italian Society of Hematology (Sie) concern these two strategies. And among them, the real life study on nearly 200 patients with non-Hodgkin’s lymphomas aggressive treated in Italy with Car-T. The data is striking: today 40% of patients are considered cured, while previously only 5% survived at 6 months.
Lower mortality than with transplantation
“A result obtained with a single infusion, therefore without the need for maintenance therapy, in people without any therapeutic alternative”, underlines Paolo Corradini, President Sie: “At the same time, today just 5% of patients need intensive care for complications – which are being managed better and better – while mortality is around 3%: much lower than that for transplantation. With Gimema , we are also currently conducting a study on how these people return to life after therapy, but what we observe every day tells us that they have an exceptional quality of life, much better than post-transplant “.
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To date, 25 Car-T centers are active or are about to be activated throughout the peninsula. However, the patients treated treated to date are few compared to those expected: an exclusively organizational problem, underline the Sie experts, and which requires a greater effort in selecting and referring eligible patients from peripheral hospitals.
The near future of Car-T
A problem that must absolutely be overcome, because in the coming months it is expected that Car-T therapies will no longer be usable only after the third line of treatment, but already after the second. In addition, they are also entering the world of other lymphomas – in particular mantle and follicular lymphomas – and multiple myeloma (for which the European Commission has already approved the use of one of the two commercial therapies currently used in Italy).
“The disease causes 5,800 new cases to be registered every year in Italy”, continues Corradini: “In the KarMMa study on 128 heavily pretreated patients, the overall response rate reached 73%. The median overall survival exceeded two years. Very good results. important, if we consider that for these patients with multiple myeloma without alternative treatment, before the arrival of CAR T, the median life expectancy was between 6 and 9 months “. Finally, two international studies concern chronic lymphatic leukemia, with 8-9 patients treated in Italy with excellent results.
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The “bridge” antibodies for acute lymphoblastic leukemia
Spotlight also on bispecific antibodies for acute lymphoblastic leukemia. These molecules make it possible to build a “bridge” between the cells of the immune system and the leukemic cells, so that the former can go directly to the latter, and kill them.
“Acute lymphoblastic leukemia is a rare tumor of the lymphocytes, which causes almost 800 new diagnoses every year in our country. However, it is the most frequent in children: it represents 80% of leukemias and about 25% of all cancers in under 14. The incidence peaks between the ages of 2 and 5 and then decreases with increasing age, “he explains Pier Luigi Zinzani, president of the Sie training activities commission: “Two Italian studies can change the history of the disease.
In the first, in 149 patients, thanks to the combination of the sequence consisting of chemotherapy with a bispecific antibody, a complete response of 90% was shown and the molecular remission went from 73% to 96% after the addition of the antibody: this means that even molecular tests cannot ‘see’ diseased cells. The second study shows that it is possible to treat the disease without chemotherapy. Remission was achieved in 98% of cases “.
Costs and sustainability
But if the number of patients who can benefit from these therapies in the near future is much larger, will the system be able to bear the costs? “Aifa has obtained a payment mechanism based on the result, ensuring our country the most expensive drugs in the world at the lowest costs”, he replies Emanuele Angelucci, vice president Sie: “Full payment occurs one year after administration and we are reasoning that this time may not be sufficient to evaluate the efficacy. Both Car-T and bi-specific antibodies, however, are one- shot, this means that patients do not have to continue to follow a treatment for the rest of their life “.
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Covid, vaccines and thrombosis risk
Could not miss the Covid theme, vaccinations and thrombosis risk. “We know that the anti-Sars-Cov-2 vaccination may be less effective in people affected by a neoplastic haematological pathology and on active treatment with chemotherapy,” he explains. Sergio Siragusa, vice president Sie: “Almost all haematological therapies, in fact, are immunosuppressive and this could make vaccination less effective, but not dangerous. Sie has produced guidelines on the management of anti Covid vaccination in patients suffering from neoplastic and benign haematological diseases “.
In both cases, in fact, the type and timing of vaccination must take into account the concomitant therapy and the severity of the underlying disease, it being understood that no haematological disease and its therapy constitute a contraindication to vaccination. “Indeed – continues Siragusa – vaccination not only protects patients from the risks of infectious complications, but also from thrombotic complications that affect 4 to 20% of patients with active Covid-19 infection. The extremely rare cases of atypical thrombosis recorded in women under the age of 50 and subjected to viral vector vaccine are still being studied. Sie has produced an expert consensus on the management of patients who may have signs or symptoms suggestive of these very rare complications; to date, they are not new cases have been registered in Italy. It should be borne in mind that the risk of thrombosis that can occur following Covid is also much higher “.
In general, the Covid mortality rate of haematological patients highlighted by a study by the Sie last year is equal to 37%. The scientific society has suggested the use of mRNA vaccines for most patients suffering from haematological diseases.
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