2023-11-08 08:59:02
by Vera Martinella
With these innovative medicines it is possible to reduce the risk of disease progression or patient death. Among the innovations exhibited at the Esmo conference are also those to reduce the risk of relapses in early-stage tumors
They are called conjugated antibodies and they promise to change the treatment for the better of many types of tumors that still cannot be treated effectively, such as breast cancers that are inoperable from diagnosis or metastatic. Two large studies with these innovative drugs have, in fact, been at the center of the attention of the experts gathered in recent days in Madrid for the congress of the European Society for Medical Oncology (Esmo) with promising results for specific subtypes of breast cancer. What is it about? In practice they are drugs composed of two parts: a monoclonal antibody designed to specifically recognize and bind to a very specific target, present only on cancerous cells and not on healthy ones, which brings with it a powerful chemotherapy – replies Saverio Cinieri, president of Italian Association of Medical Oncology (Aiom) —. On the one hand, this allows for great therapeutic efficacy, because the chemotherapy transported and “released” on the target to be hit has great destructive power; on the other hand, however, the toxicity for normal cells (and therefore for the patient’s organism) is very low given that the treatment is targeted.
Lo studio TROPION-Breast01
The results of the TROPION-Breast01 trial were illustrated during the presidential session of the Esmo conference, the one dedicated to the most important innovations: they indicate that the datapotamab deruxtecan conjugated antibody reduced the risk of disease progression or death by 37% compared to chemotherapy. The trial (phase three, the last before the final approval and entry onto the market of a medicine) enrolled 732 patients with hormone-positive (HR), HER2-low or negative inoperable or metastatic breast cancer, previously treated with hormonal therapy and at least one chemotherapy. There are approximately 52 thousand people with metastatic breast cancer in Italy – says Michelino De Laurentiis, director of the Department of Breast and Thoraco-pulmonary Oncology at the National Cancer Institute IRCCS Fondazione Pascale in Naples -. Despite the initial benefits of endocrine therapy, most patients with HR-positive and HER2-low or negative metastatic breast cancer experience disease progression, requiring further treatment with chemotherapy. The results show that datapotamab deruxtecan reduced patients’ risk of disease progression or death by more than a third and, overall, had fewer serious treatment-related side effects than standard chemotherapy, showing its potential to become a new standard of care in a therapeutic context where there is an unmet clinical need.
Lo studio DESTINY Breast 04
Similar results were also recorded by the DESTINY-Breast04 trial with the antibody conjugate trastuzumab deruxtecan and by the TROPiCS-02 trial with sacituzumab govitecan: For now we have no information that helps us understand which of these three antibody conjugates should be given to each patient and whether it might be useful to use them in sequence with each other comments Sarat Chandarlapaty, oncologist at the Memorial Sloan Kettering Cancer Center in New York. Updated data from the DESTINY Breast 04 study were also illustrated in Madrid, which compared standard chemotherapy or trastuzumab deruxtecan in 557 patients (always with an inoperable or metastatic HER2-low type carcinoma): at an average follow up of 32 months, survival was almost 23 months for those who received the innovative drug, compared to 17 for chemo, with a 42% reduction in the risk of death.
The monarchE study
New confirmations arrive, then, for those with early-stage cancer. In particular, for hormone receptor-positive (HR+), human epidermal growth factor receptor type 2 (HER2-), lymph node-positive, early stage breast cancer at high risk of recurrence, updated data were presented. five years into the monarchE trial. The trial evaluated the use of abemaciclib for two years in combination with endocrine therapy compared to hormone therapy alone. The five-year period is a consolidated point of reference for studies on breast cancer in the adjuvant phase (post surgery) and represents an important milestone for patients and clinicians in this setting with the aim of recovery – explains Lucia Del Mastro, director of Medical Oncology Clinic of the IRCCS Policlinico San Martino Hospital, University of Genoa —. The results demonstrate an effect that extends beyond the completion of two years of treatment with abemaciclib, with the invasive disease-free survival and distant recurrence-free survival curves continuing to separate, confirming confidence in the role of abemaciclib as an adjunct to endocrine therapy for patients at high risk of recurrence. And the benefits tend to continue even after the end of the treatment, which lasts two years – continues Valentina Guarneri, director of Oncology 2 of the Veneto Oncology Institute IRCCS in Padua -. The effect is very evident on local and distant relapses, which are responsible for metastatic disease: avoiding them implies not only extending survival, but also increasing the probability of recovery. The evolution of the disease from initial to metastatic stage in fact has negative repercussions on the survival and quality of life of patients. The 5-year data from the study represents a further step forward in bringing a greater number of people to recovery.
Lo studio NATALEE
In 2022, in Italy, 55,700 new cases of breast cancer were estimated, the most frequent in the entire population – recalls Cinieri -. Approximately 15% of HR+/HER2- breast tumors are at increased risk of developing metastases, which is why effective solutions are needed to reduce the risk of relapse. An objective that can also be achieved with the drug ribociclib, as highlighted by the latest results of an analysis of the NATALEE trial: after almost 28 months of follow-up, the survival benefits free from invasive disease remain constant with ribociclib in addition to therapy endocrine. From the latest observations, the risk of recurrence appears to have decreased in all subgroups, including patients with stage II cancer, those with negative sentinel lymph node or those over 65 years of age.
November 8, 2023 (modified November 8, 2023 | 07:59)
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