The innovative strategy indicated for patients with a particularly aggressive form due to the mutation of the BRAFV600E gene. Genetic testing is a fundamental step before starting therapies
When colon cancer is discovered early on, more than 90% of patients manage to recover. In two out of ten cases, however, the cancer is already diagnosed in the metastatic stage and then a share of patients in whom, over time, the disease evolves into advanced forms. It is in these cases that a new innovative therapy available also in our country for the treatment of one of the most aggressive subtypes of colorectal cancer, that with mutation of the BRAFV600E gene may be useful: the Italian Medicines Agency (Aifa) has in fact approved the reimbursement of encorafenib, in combination with cetuximab, for patients who received previous systemic therapy.
The second deadliest cancer in Italy
With over 43,700 new cases registered every year, colorectal cancer is the second most frequent type of cancer in our country and also the second in the unlikely ranking of the deadliest, causing about 19,000 deaths a year. Nine out of 10 cases could be avoided because there is an effective, free (in Italy) and completely painless method to eliminate pre-cancerous lesions before they turn into a real neoplasm: the test for the detection of occult blood in the faeces. Despite this, the statistics indicate that colorectal cancer is an increasingly widespread cancer: the age group mainly affected is that between 60 and 75 years – he explains Alberto Sobrero, head of the Department of Medical Oncology of the San Martino Hospital in Genoa -. Five years after diagnosis I live, on average, 65% of patients (largely thanks to early diagnosis), but there are 20% of new cases that unfortunately are discovered already in an advanced stage, when most of the time the disease not suitable for surgery that can potentially lead to recovery. Thanks to the new therapies, survival improved – continues Sobrero -, but a strong unmet clinical need still remains for patients with the BRAF gene mutation. This alteration, which is identified in about 10% of cases, is associated with a decidedly worse prognosisbecause the tumor is more aggressive and for greater resistance to therapy.
Fundamental molecular characterization before treatment
The V600E mutation is the most frequent among BRAF mutations and the risk of mortality in these patients more than doubled compared to those not mutated. Thanks to the availability of the new combination encorafenib and cetuximab, treatment changes, with the possibility of delaying the progression of the disease and prolonging survival. Numerous researches conducted in recent years have highlighted that it is essential for a correct treatment of metastatic colorectal cancer to undergo genetic test all patients to choose the best treatment (among the many available) on the basis of the biological characteristics of the neoplasm and any genetic alterations present. they help to establish the cure – underlines Sobrero -. There are some gene alterations which, if present, can provide the clinician with very important information on the biological aggressiveness of the tumor and on the possibility of responding or not to treatment. One is precisely the mutation of BRAF, which must always be sought with a specific test. Today we have a new targeted therapy available, which becomes the standard of care in these mutation patients. Encorafenib, a BRAF inhibitor, in combination with cetuximab, a monoclonal antibody that inhibits the epidermal growth factor receptor, works to block the replication of diseased cells. Up to now, in this patient population, combinations of intensive chemotherapy have been used with poor results.
More powerful and longer-lasting strategy
The approval of the new treatment comes following the results of the phase 3 BEACON study which involved 665 patients in 200 centers, demonstrating improved survival and a reduction in the risk of death in participants treated with this combination of drugs compared to the group of check. It is the first and only phase 3 clinical trial specifically designed for people with metastatic colorectal cancer with BRAFV600E mutation, who have received one or two previous systemic therapies. Fortunato Ciardiello, Full Professor of Medical Oncology at the University of Campania Luigi Vanvitelli of Naples -. Median overall survival with encorafenib in combination with cetuximab reached 9.3 months compared with 5.9 months in the control arm consisting of chemotherapy plus cetuximab. At one year, 41.5% were alive compared to 24.8%, with a 40% reduction in the risk of death. The objective response rate (i.e. the share of patients who benefited) was 20% compared to 2%. Furthermore, the median progression-free survival (ie before the tumor started growing again) was 4.3 months compared to 1.5 months. The innovation of this regime is evident in the greater power and duration of action – adds Ciardiello -. It has also been shown to maintain health-related quality of life for longer, a very important goal for people with advanced disease. This is the first targeted therapy approved in this patient population, with no target therapies to date.
Tests for early detection and prevention: what to do or avoid
About 90% of colorectal cancers arise from precancerous lesions (adenomas or adenomatous polyps), which take years (between 7 and 15, on average) to transform into malignant forms. in this time window that screening with tests for the detection of occult blood in the faeces makes it possible to make an early diagnosis and eliminate the polyps before they have acquired dangerous characteristics. And if the tumor is discovered in the early stages, the chances of recovery are far greater. In 2020, incidence rates were down by 20% compared to the peak of 2013 – concludes Ciardiello -. The role of screening is also evident in the improvement of 5-year survival, which has increased from 52% in the 1990s to 65% today, also due to the efficacy of therapies in the most advanced stages. Unfortunately, the Covid pandemic has led to a sharp slowdown in secondary prevention programs. Incorrect lifestyles, in particular sedentary lifestyle, cigarette smoking, overweight, obesity, consumption of refined flours and sugars, red meats and sausages and reduced intake of vegetable fibers increase the risk of getting sick. Healthy habits are also important after diagnosis, both to prevent the onset of relapses and to improve the effectiveness of treatments.
April 20, 2022 (change April 20, 2022 | 10:47)
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