2023-05-03 23:08:52
Patients with metastatic colorectal cancer will have a new treatment option. The results of the SUNLIGHT study, coordinated by Josep Tabernero, show that the combination of chemotherapy (Trifluridine/tipiracil ) plus an immunotherapy drug (bevacizumab) improves survival in these patients who had previously been treated with two standard chemotherapy regimens and for whom there was a significant lack of options.
The results of the study are published today in “The New England Journal of Medicine” and mean, according to ABC Salud Elena Élez, head of the Colorectal Cancer Group at the Vall d’Hebron Institute of Oncology (VHIO) and medical oncologist at Vall d’Hebron University Hospital in Barcelona, ”a change of scenery in the treatment of colorectal cancer refractory to other treatments”.
Colorectal cancer is one of the most common tumors in both men and women. It accounts for 15% of all tumors and presents an average survival at five years from diagnosis of 57%. According to the Spanish Network of Cancer Registries (REDECAN), colorectal cancer will be the most frequently diagnosed tumor in Spain in 2023 globally with 42,721 new cases –26,357 in men and 16,364 in women–.
In addition, according to data from the Spanish Society of Medical Oncology (SEOM), it is a very important cause of death, since in 2020 it was the second leading cause of death from tumors (15,125 deaths), only behind lung cancer ( 21,918 deaths).
The five-year survival rate in patients with metastatic disease is only 11%. «Around 50% of patients will end up developing metastases, so new treatment options are necessary to improve the survival and quality of life of these patients.», explains Josep Tabernero, director of VHIO and head of the Medical Oncology Service at Hospital Universitari Vall d’Hebron, who coordinated the SUNLIGHT study.
The study included 492 patients with metastatic colorectal cancer who had received prior treatment with two standard chemotherapy regimens.
Treatment is a combination of Trifluridine/tipiracil and the monoclonal antibody bevacizumab. Said antibody inhibits the VEGF growth factor related to the formation of blood vessels that promote tumor growth, in such a way that it stops the progression of the tumor.
“This is the first time that a third-line trial has been carried out in which the new therapeutic option is not compared with a placebo but with one of the existing standard treatments, which makes it possible to affirm that the improvements in the efficacy parameters are statistically and clinically significant,” says Tabernero.
Patients treated with trifluridine/tipiracil plus bevacizumab had a median overall survival of 10.8 months after initiation of treatment compared with 7.5 months for patients receiving trifluridine/tipiracil alone.
«When the increase in survival in metastatic colorectal cancer exceeds three months, it is considered by many evaluating agencies that the improvement is not only statistically significant but also clinically relevant. Therefore, these results point to the possibility of a new standard treatment option» explains Élez, who has led the clinical trial at the Vall d’Hebron University Hospital.
As researchers and oncologists we seek universal benefit for all patients.
Elena Elez
Head of the VHIO Colorectal Cancer Group and medical oncologist at the Vall d’Hebron University Hospital in Barcelona
The oncologist hopes that after these results, and those expected in the coming months, the approval of this regimen for patients at this stage will be accelerated. “Our job as doctors is to offer the best treatment to patients,” says the expert who is confident that approval times for this new line of treatment will speed up since in this group of patients “there is little therapeutic alternative.”
In addition, another relevant piece of information from the research, adds Élez, is that the benefit was seen in all subgroups, which, according to Tabernero. “indicates that Trifluridine/tipiracil plus bevacizumab is an option for all clinically relevant subgroups.”
“As researchers and oncologists, we seek universal benefit for all patients,” says Élez, since the so-called precision medicine barely reaches 1% of patients.
In this sense, Tabernero points out, «clinical benefits have been observed even in patients who had received prior treatment with bevacizumab. This supports the importance of continuing to inhibit blood vessel formation beyond tumor progression and suggests that adding bevacizumab to the third or last line of treatment may lead to improved survival in heavily pretreated patients.”
An accompanying commentary to the study in NEJM states that this study lays the foundation for prospective clinical trials testing biomarkers, such as RAS, in refractory colorectal cancer.
#combination #therapy #treat #colon #cancer #metastasis