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"Step by step," insists the head of Medical Oncology at the Gregorio Marañón Hospital, Miguel Martín. With this philosophy, breast cancer research is besieging the tumor and leaving fewer and fewer opportunities. The latest to land in the therapeutic arsenal is to add the use of a drug, ribociclib, to hormone therapy to reduce the risk of relapse in patients with the most common subtype of breast cancer.

HR-positive and HER2-negative luminal breast cancer is the most common subtype and accounts for nearly 70% of all breast tumor cases. In Spain this group would be formed by about 24,000 women, since the estimate of new cases of breast cancer in our country is around 34,750. It is estimated that one in eight Spanish women will have breast cancer at some point in their lives, according to the Spanish Society of Medical Oncology (SEOM).

The new approach, which has been presented today as one of the great novelties at the Congress of the American Society of Clinical Oncology (ASCO), aims to use this CDK4/6 inhibitor in adjuvancy, responsible for blocking the action of an abnormal protein that sends signals to cancer cells to multiply. with endocrine therapy. "When we talk about adjuvancy we do it to try to cure patients at the earliest possible stage," explains Martín.

Until now, patients with a breast tumor of the luminal type that are not serious, with few affected lymph nodes, after the initial approach of surgery and pharmacotherapy "receive a hormonal treatment only," says Martín. However, a quarter do not work "and relapse. And once they have reached this point the average survival drops to six years."

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Therefore, the moment of detection is also key: survival in stage I is more than 98% and instead in stages IV survival drops to 24%, point out from SEOM. In this case, the study called Natalee has served to validate that there is a reduction in relapses of around 3.5%. A figure not less, if it translates into lives and impact on society, as Martín explains. "This percentage may not be much, but we speak first of a curative context and second of that a relapse is very costly at the clinical, labor and social level."

In Spain, 761 patients (out of a total of 5,101) from 40 centres have already benefited from this new therapeutic combination. This represents 15% of those recruited for the study worldwide, which places our country in the second with more 'representation' after the United States, out of a group of 20.

Another point that underscores the impact of ribociclib in adjuvant hormone therapy is thatthe study was stopped early by the Independent Committee for Data Monitoring (CIMD). This only happens when one of the objectives set is reached prematurely, in this case to achieve disease-free survival, that is, to cure patients.

What is the impact of using this new combination?

In this case, the figures support the decision: at the time of the pause in the comparative analysis between the combination of therapies and receiving only the hormonal one, 189 people in the adjuvant group with ribociclib (7.4%) experienced a relapse compared to 237 people in the hormone therapy group (9.2%).

Dennis J. Slamon, director of Clinical-Translational Research and director of the Revlon-UCLA Women's Cancer Research Program at the UCLA Jonsson Comprehensive Cancer Center in Los Angeles, said: "Current approved targeted therapies can only be employed in a small population of patients diagnosed with early HR-positive and HER2-negative breast cancer. , leaving many without an effective treatment option to reduce the risk of the cancer returning."

Because as Martin is sure, "we have been reducing the relapse rate in all types of breast cancer from 40%, and the goal is zero. We won't get to zero, but we will stay close. We are going little by little in each specific type of tumor and offering solutions to each of them".

Therefore, Slamon insists on the significant unmet needs to both reduce the risk of recurrence and provide a tolerable treatment option that keeps patients cancer-free without disrupting their daily lives. "The Natelee study has sought to observe whether adding ribociclib to standard adjuvant endocrine therapy works successfully, so its design was specific to address these unmet needs."

As for the side effects, Martin explains that "there are no major toxicities. We have used doses of 400 mg [compared to the 600 mg approved in the Summary of Product Characteristics]. There may be nausea and gastrointestinal problems, as more common. Also some decrease in the leukocyte count, but without translating into infections."

How is the drug used in Europe?

The current approved use in Europe of Kisqali, which is how Novartis' molecule, ribociclib, responds commercially, is the treatment of women with locally advanced or metastatic breast cancer with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, in combination with an aromatase inhibitor or fulvestrant as initial hormone therapy, or in women who have received previous hormone treatment. In pre- or perimenopausal women, hormonal treatment should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist, as pointed out in the European Medicines Agency (EMA) SmPC.

"It's risky to test a drug at earlier stages, because it takes more time and more investment. And it doesn't work every time. But here it has been seen that adjuvant in early stages has a high impact, "says Martín.

  • Breast cancer
  • cancer
  • Oncology
  • Pharmacology

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