An important result, because for the first time even in esophageal cancer, immunotherapy takes the effectiveness of the therapy a step forward, completely changing the scenario. The combination of immunotherapy and chemotherapy and dual immunotherapy can in fact change clinical practice in the treatment of patients with advanced cancer already as a first treatment. This is shown by a study presented at the Congress of the American Society of Clinical Oncology (ASCO) which involved 970 patients with advanced or metastatic squamous cell cancer of the esophagus, which in Italy represents 40% of cases, and never treated before. . “A study that rekindles a light on a pathology long considered a Cinderella because it has few therapeutic options and that pushes us to reconsider the way we manage these patients”, says Stefano Cascinu, Head of Oncological Medicine Unit IRCCS San Raffaele Hospital in Milan and Professor of Medical Oncology at the Vita-Salute San Raffaele University.
The results
The study considered two possible therapeutic regimens for these patients, the addition of nivolumab to chemotherapy and the single combination of two immunotherapy molecules, nivolumab and ipilimumab. In addition, both patients with PD-L1 biomarker expression (greater than or equal to 1%), a factor that is considered indicative of the efficacy of immunotherapy, and the entire randomized population were considered. “In the former, the combination of nivolumab plus chemotherapy showed a truly impressive advantage in terms of median overall survival compared to chemotherapy alone, equal to 15.4 months versus 9.1 months,” explains Cascinu. “The result achieved by the combination of the two immuno-oncological molecules, nivolumab and ipilimumab, was also excellent, equal to 13.7 months compared to 9.1 months of chemotherapy alone”. The results were substantially overlapping in all randomized patients, ie regardless of PD-L1 expression. “Median overall survival in this group was 13.2 months with the combination of nivolumab plus chemotherapy and 12.8 months with nivolumab and ipilimumab compared to 10.7 months with chemotherapy alone. The objective response rate is also better with combinations, ”adds Cascinu.
An effective and necessary option
Cancer of the esophagus is constantly increasing – in 2020, 2,400 new cases were estimated in Italy – and unfortunately about half of the patients reach the diagnosis at an advanced stage. For these patients, chemotherapy is the standard treatment, but the prognosis remains poor because survival does not exceed 10 months: a disease that progresses very rapidly with a strong impact on the quality of life. “Hence the importance of identifying new options. The significant clinical improvement in survival of these two treatment regimens highlights the impact of immunotherapy on the management of cancer and can bring new possibilities of treatment for patients with disease already at an advanced stage ”, Cascinu specifies. “Furthermore, dual immunotherapy is the first chemo-free treatment to show a survival benefit in these patients, who are often very frail and also affected by other pathologies. It can therefore represent an effective therapeutic alternative in people who cannot tolerate chemotherapy due to compromised general health conditions “.
Fragile patients
In fact, alcohol abuse and cigarette smoking are closely related to the scaly form of esophageal cancer. For the majority of men over 70 years of age, but the change in habits, starting with smoking, is leading to an important spread also in the female population. “They are very fragile patients for whom the chemo-free combination could really make a difference, but we must act quickly and unfortunately we cannot use these molecules today because they are not authorized in Italy”, concludes Cascinu. “It is necessary for Aifa to consider this urgency and find a way to allow even these patients, of whom little is said, to access the best therapeutic options”.
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