Triple Negative Breast Cancer and Survival, the Role of Immunotherapy Before and After Surgery

Immunotherapy before and after surgery changes clinical practice in triple-negative breast cancer. It proves it. Phase 3 Keynote-522 study presented today at the European Society for Medical Oncology (ESMO) congressThat in Barcelona brings together over 37 thousand oncologists from all over the world. The Keynote-522 study is the fourth in a series based on pembrolizumab That demonstrates an overall survival benefit in early-stage cancer.

The study marks a major step forward: in the high-risk early-stage form, the immunotherapy drug pembrolizumab in combination with chemotherapy before surgery and continued as monotherapy after surgery reduces the risk of death by 34% compared to the chemotherapy-placebo regimen (placebo plus chemotherapy followed by placebo after surgery). Immunotherapy before and after surgery therefore changes clinical practice for this type of cancer, experts say. In the study, the 5-year overall survival rate was 86.6% in patients who received pembrolizumab. compared to 81.7% in patients who received the chemotherapy-placebo regimen.

In 2023, 55,900 new cases of breast cancer were estimated in Italy. “Triple-negative breast cancer, which accounts for approximately 15% of diagnoses, does not have estrogen, progesterone and Her2 protein receptors – explains Giuseppe Curigliano, president-elect of Esmo, full professor of Medical Oncology at the University of Milan and director of the Development of new drugs for innovative therapies at the European Institute of Oncology in Milan – Therefore, it does not respond to hormone therapy and drugs that target Her2. It is the most aggressive form, in which the risk of distant relapse increases rapidly from diagnosis and peaks in the first 3 years. In the absence of therapeutic targets, treatment options have historically been limited and have consisted of surgery, radiotherapy and chemotherapy. Today, immunotherapy is added”.

“Keynote-522 is a groundbreaking, practice-changing study in a disease where there is a strong need for new treatment options,” Curigliano continued. “These important overall survival results add to the complete response and event-free survival data previously reported in the Keynote-522 study. Pembrolizumab plus chemotherapy as neoadjuvant treatment and then as a single agent after surgery reduced the risk of death by 34% compared to neoadjuvant chemotherapy, reinforcing the fundamental role of this immunotherapy regimen in the treatment of high-risk, early-stage triple-negative breast cancer. Results of this magnitude have never been seen before in such an aggressive disease.”

“The absence of estrogen and progesterone receptors and Her2 makes triple negative breast cancer more difficult to treat than other types of cancer, because it could only be treated with chemotherapy until recently and because it is generally characterized by greater biological aggressiveness,” emphasizes Saverio Cinieri, president of the Aiom Foundation. “The results of the Keynote-522 study change the outlook, thanks to the use of immunotherapy. It is important that the treatment setting, in the initial phases and at every decision-making juncture, is the responsibility of the Breast Units, that is, the breast care centers where a multidisciplinary approach can be guaranteed. The team’s work promotes the achievement of high levels of specialization in care, optimizing the timing of services, with the aim of improving the survival and quality of life of patients. In this way, it is possible to obtain appropriateness, coherence and continuity of the diagnostic-therapeutic pathways. Furthermore, triple-negative breast cancer mainly affects young women, so it is important that Breast Unit specialists also propose a fertility preservation program.”