Tertiary prevention

Breast cancer, a new strategy to prevent recurrences

Aifa approves reimbursability of ribociclib in adjuvant. Oncologists: 'The risk does not end after five years'. But knots remain on access and regional inequalities

by Francesca Cerati

9 March 2026

Schermo del computer nella sala radiologica dell'ospedale: bella donna adulta multietnica in piedi a seno nudo sottoposta a procedura di screening mammografico. Schermo che mostra le scansioni mammografiche dei tessuti mammari densi.

3' min read

Translated by AI

Versione italiana

3' min read

Translated by AI

Versione italiana

In early breast cancer, the challenge does not end with the end of initial treatment. Even after surgery and hormone therapy, in fact, the risk of the disease recurring can accompany patients for many years.

This is the background to the recent decision of the Italian Medicines Agency (Aifa), which has approved the reimbursability of ribociclib in combination with endocrine therapy for certain patients with hormone receptor-positive and HER2-negative early-stage breast cancer at high risk of recurrence. This is the most frequent form of breast cancer, accounting for about 70% of cases.

In Italy, breast cancer remains the most diagnosed neoplasm among women, with almost 54,000 new cases estimated by 2025. And while treatments have greatly improved the prognosis, recurrence remains a real fear. "In early-stage breast cancer, the fear of a possible recurrence continues to be a real concern for many women," notes Rosanna D'Antona, president of Europa Donna Italia. "Looking to the future with greater confidence and feeling protected against a possible return of the disease are fundamental needs of patients

The risk is not over after five years

One of the points on which the oncologists insist is precisely the widespread perception that the risk runs out after the first few years of follow-up. "There is the idea that after five years the problem is solved, but that is not really the case," explains Giuseppe Curigliano, professor of medical oncology at the University of Milan and president-elect of the European society for medical oncology (Esmo). Unfortunately, a residual risk of recurrence can persist even 20 years after diagnosis. Even patients with very small tumours can have a risk of relapse of around 7-10%'.

The tumour we are talking about is endocrine-responsive HR+/HER2-, the most common subtype. 'The message we have to give is that zero risk does not exist,' adds the oncologist. 'Even in women with small tumours or lymph node-negative tumours, recurrence remains possible, albeit with lower probability.

Clinical study data

The reimbursement approval is based on the results of the international phase III Natalee 1 trial, which evaluated the addition of ribociclib to endocrine therapy in over 5,000 patients. The data showed a 28.4% reduction in the risk of recurrence compared to hormone therapy alone, with improved five-year invasive disease-free survival (85.5% versus 81%)

'A 28% risk reduction is clinically very relevant,' Curigliano emphasises. 'When explaining a therapy to a patient, it must be made clear that the statistical benefit is derived from the average of all patients treated. But even an absolute improvement of a few percentage points is important in a potentially curable disease'.

Another significant finding concerns the reduction of distant metastases, about 30 per cent in the study. 'If we reduce the number of patients who develop metastases, over time this will also translate into a survival benefit,' adds the oncologist.

The issue of access to care

In Italia, reimbursability currently only concerns patients with positive lymph nodes, while the study data show a benefit even in some cases with negative lymph nodes but high biological risk.

"In Germany and the UK, the drug is already available for these patients as well," Curigliano notes. "This creates a disparity that is difficult to understand within the European Union."

At the national level, there is also the issue of regional differences. 'It is possible that some regions make the treatment available more quickly than others,' adds the oncologist. 'In Italia, there is still a certain heterogeneity in the timing of access to the drugs.

In this scenario, the role of Breast Units and multidisciplinary management becomes central. "It will be crucial to correctly identify eligible patients and discuss each case after surgery, assessing biological and clinical risk factors," explains Curigliano.

Innovation and Sustainability

Alongside the clinical data, the introduction of the therapy is also accompanied by economic evaluations. An analysis conducted by Novartis together with Bocconi University's Cergas research centre estimated that the initial investment in treatment could be offset over time by the reduction in costs associated with metastatic disease.

'Reducing recurrences also means reducing the overall burden on the healthcare system in the long run,' says Roberta Rondena, Country Value & Access Head of Novartis Italia. 'Intervening in the early stages of the treatment pathway can avoid more complex treatments, hospitalisations and productivity losses related to disease progression.

According to the analysis, the initial cost increase would be offset over time by lower health and social costs. "This approach makes it possible to read innovation not just as a cost, but as an investment," adds Rondena.

"Tertiary prevention"

The concept that emerges is that of tertiary prevention: intervening after diagnosis, but before the disease recurs or progresses. "We often talk about primary prevention or screening," Rondena concludes, "but acting early in the disease to reduce the risk of recurrence is also a form of prevention that can improve outcomes for patients and the sustainability of the healthcare system.