Breast cancer, new drug reduces the likelihood that the disease will return

Breast cancer, new drug reduces the likelihood that the disease will return

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It is one of the greatest fears that every woman undergoing surgery for early stage breast cancer faces: that the disease may return. And this is the reason why, after surgery, the so-called adjuvant therapy is prescribed: a term that indicates, in fact, an “aid” to the main treatment (in this case surgery) to reduce the probability of local recurrences and metastases . “The risk is not the same for all patients – he specifies Lucia DelMastro, Professor of Medical Oncology and Director of the Medical Oncology Clinic at the IRCCS San Martino Policlinico Hospital in Genoa – There are at least three different types of breast cancer, with characteristics that influence this risk differently. But not only that: today we can estimate it for each individual patient”.

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Depending on the type of tumor, there are different adjuvant therapies, to which a new one is now being added: the Italian Medicines Agency has in fact approved the reimbursement of a new drug, abemaciclib, for those who have the most common type of breast cancer and are at high risk of recurrence.

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Who is the new therapy for?

We are talking about patients with an initial “hormone-sensitive” tumor (or, more correctly, hormone receptor positive and human epidermal growth factor type 2 receptor negative – HR+/HER2-). “In this case, ‘high risk’ patients are those with 4 or more positive axillary lymph nodes, or 1 to 3 positive lymph nodes and a tumor larger than 5 centimeters and/or histological grade 3 – explains Del Mastro -. It is about 15% of HR+/HER2- tumors and the arrival of abemaciclib in this category represents the first therapeutic option in over 20 years capable of reducing the risk of recurrence in a clinically significant way” .

Until now, in fact, in these cases after chemotherapy we continued with endocrine (or anti-hormonal) therapy alone. From today, however, the new oral drug can also be prescribed for the first two years after chemotherapy.

From the metastatic to the adjuvant stage

Abemaciclib is in a class of drugs called cyclin-dependent kinase (CDK) inhibitors, targeted therapies that block cancer cell replication. These drugs have revolutionized the treatment of metastatic breast cancers (always of the HR+/HER2- type, for which they have already been used for some time), significantly increasing survival. Anticipating treatment with abemaciclib in early stage tumors therefore represents an important novelty.

Increased recurrence-free survival by 35%

The efficacy of abemaciclib in the adjuvant phase was demonstrated by the monarchE study, whose updated data are published in the Lancet Oncology: at 4-year follow-up, the drug reduced both the risk of local recurrence and the risk of metastasis by 35% .

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The relapse-free rate was 85.5% in the abemaciclib plus endocrine therapy group compared to 78.6% in the endocrine therapy alone group, for an absolute difference of 6.9%. . In addition, the metastasis-free survival rate was 87.9% and 81.8%, respectively, with an absolute difference of 6.1%.

“In the various updates of the follow-up of the monarchE study, it was observed not only the maintenance of the reduction in the risk of recurrence but even an increase in this effect – adds Valentina Guarneri, Full Professor of Medical Oncology and Director of the School of Specialization in Medical Oncology at the ‘University of Padua – The reduction of the risk of distant metastases is an absolutely relevant aspect, because we know that it is what most affects the prognosis of these patients; therefore, what we expect is that this treatment will be able to increase the proportion of patients heal”.

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Side effects and quality of life

New data presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO) then demonstrated that efficacy is maintained even when it is necessary to reduce the doses of the drug to limit the adverse effects, which were mainly diarrhea and fatigue. The impact on quality of life was also evaluated: “And the data are reassuring – continues the oncologist – because there was no difference either between the two groups, or based on the age of the patients. Obviously, adding a treatment increases the need to pay attention to tolerability.In this sense, it is essential to educate the patients, and above all to monitor very carefully the first 2 months, to reduce the onset of moderate or severe side effects and optimize the adherence to treatment”.

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The optimal duration of “anti-hormonal” therapy

Once the two years with this new therapy have ended, treatment continues with endocrine therapy alone. The duration of which is now customized: “Initially the duration of endocrine therapy was only two years – continues Del Mastro – Subsequently it was shown that continuing it for 5 years brought important advantages in terms of reductions in relapses. In high-risk women, this limit has moved to 10 years. The range is therefore between 5 and 10 years, with an optimal duration between 7 and 8 years, always balancing benefits and adverse effects in a personalized way”.

Breast cancer is on the rise

Today, breast cancer affects around 55,000 women a year in Italy and, thanks also to screening, over 90% of these cases are discovered in the initial stage. “Unfortunately, however, the breast cancer trend is growing and diagnoses concern increasingly younger women – she reflects Rosanna D’Antona, President of Europa Donna Italia – We also know that a woman affected by breast cancer, especially if in the initial stage but with a high risk of developing relapses, experiences feelings of uncertainty, anxiety, fear for the future because she does not know if when the disease comes back. Knowing you can count on new adjuvant therapies-she concludes-she increases the hope of recovery, which we know is the main engine in tackling the therapeutic process “.

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