Colorectal cancer, new drug combination doubles survival in metastatic patients |

Approved in Italy and available as first-line treatment for the approximately 800 patients with a BRAF mutation who can benefit from it each year.

Colon cancer, a new drug combination improves survival in metastatic patients

Approved in Italy and as first-line therapy, it can be used in around 800 patients with BRAF mutations each year.

, Italy has become the first country in Europe to advance through the National Health Service with a new combination treatment for patients with BRAF mutation and metastatic colorectal cancer, one of the most aggressive forms of the disease.The treatment method lasts twice as long compared to the standard.A combination of two molecularly targeted drugs, encorafenib and cetuximab, in combination with traditional chemotherapy, went from being the "last step" to treating First.About 800 people benefit from it every year, that is, 8-10% of patients with metastatic disease carrying a BRAF mutation, about 48,000 new cases are registered every year in Italian tumors.

While Europe is waiting for the official green light from the EMA (European Medicine Agency), at the level of the GOIM (Southern Italy Oncology Group), the Italian Medicines Office (Aifa) has shortened the deadline, setting up the first access to treatment through the procedures provided by Law 648/96.This instrument allows technical medicines to be available before the end of the European bureaucratic process if there is an urgent clinical need and significant scientific evidence.AIFA's approval was announced at the GOIM Congress, which is taking place in Bari.

Doubles the life (and exceeds 30 months)

"Aifa's decision was based on data from the randomized phase III BREAKWATER study that evaluated the association of chemotherapy with encorafenib and cetuximab compared to standard care in patients with metastatic colon cancer with a BRAF (V600E) mutation," explained two clinical studies by Fortunato Ciaardiellor.in Oncology at the Luigi Vandelli University of Naples.

The result, the subject of publication in the New England Journal of Medicine, showed that the new combination doubles the overall survival of patients, which changes from a median of about 15-16 months to more than 30. «This treatment represents a turning point for a patient population that until a few years ago had very limited therapeutic options and a very rapid progression of the disease.Historically, approximately half of these patients never received second-line therapy.The use of molecular target therapy only at an advanced stage does not allow to recover the clinical benefits observed in the studies.Although the early introduction of molecular target therapy, associated with chemotherapy, radically changed the clinical history of the disease, making it easier to manage and doubling life expectancy."

Testing for the mutation should be performed at the start of treatment.

For each patient, knowing whether their cancer has a specific genetic mutation can make a big difference.In fact, this information now forms the basis of many cancer treatments: oncologists choose a drug or combination of drugs based on the so-called "molecular profile" of the tumor.However, the necessary tests are not always performed to determine the presence of any mutated genes, both because they are often not reimbursed and because health care type analysis requires very sophisticated equipment.

"Identifying the BRAF mutation directly in metastatic disease allows you to adjust the treatment options to the most effective option - says Stefania Napolitano, researcher in medical oncology at the Vanvitelli University -. That is, to have access to treatment that has been shown to give the highest benefit when used as first-line treatment. Colorectal cancer can no longer be considered a single disease: there are different biological types of recognition, the different biological types of theRequire recognition.Precision medicine, in this case, is not a slogan, but a concrete tool that allows you to double survival."The real innovation introduced in Italy is therefore the first line access.

Law 648/96 avoids delays, which is invaluable for patients

In the United States, based on the results of a breakthrough study, this approach has already entered clinical practice last year as a new therapeutic context.does – the process provided for by Law 648/96 shows that the National Health Service has the tools to make new treatments available when there is solid scientific evidence and they can have a direct impact on survival, in such advanced stages of the disease.In this case he did it for one of the most aggressive forms of colorectal cancer, a type of cancer that affects almost equally men and women and whose incidence is increasing in the population under 50 years of age.It confirms its commitment to translate scientific evidence into concrete benefits for cancer patients, actively contributing to reducing therapeutic disparities and improving standards of care”.