– A new treatment for metastatic colorectal cancer which is based on combining a chemotherapy (Trifluridine/tipiracil) with the immunotherapy drug bevacizumab has increased the survival of patients with this disease who had not responded well to standard chemotherapy. The new therapeutic option for these patients has been tested in the SUNLIGHT study, coordinated by Josep Tabernerodirector of the Vall d’Hebron Institute of Oncology (VHIO) and head of the Medical Oncology Service of the Vall d’Hebron University Hospital
Colorectal cancer has been the most frequently diagnosed tumor in Spain during 2022, with 43,370 new cases in both sexes, and ranks second after prostate cancer in men and after breast cancer in women, according to data from the Society Spanish Medical Oncology (SEOM). The five-year survival rate in patients with metastasis is 11%. “About 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”, Josep Tabernero has pointed out.
In it SUNLIGHT studio 492 patients with metastatic colorectal cancer who had previously received two standard chemotherapy regimens have participated. Half of them were treated with Trifluridine/tipiracil plus bevacizumab and the other half with Trifluridine/tipiracil alone. As Dr. Tabernero has explained: “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 allows us to affirm that the improvements in the efficacy parameters are statistically and clinically significant”.
Significant improvement in survival in colorectal cancer
Bevacizumab is a monoclonal antibody that inhibits the growth factor VEGF related to the formation of blood vessels that induce tumor growth, thus slowing down its development. Median overall survival for patients treated with the combination of trifluridine/tipiracil plus bevacizumab was 10.8 months after initiation of treatment compared with 7.5 months for patients treated with trifluridine/tipiracil alone. The results of the study have been published in The New England Journal of Medicine.
The median overall survival of patients with metastatic colorectal cancer treated with the new therapy was 10.8 months compared with 7.5 months for those treated with chemotherapy.
“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, so these results point to the possibility of a new standard treatment option” explained Elena Élez, head of the Colorectal Cancer Group of the Vall d’Hebron Institute of Oncology (VHIO) and medical oncologist at the Vall d’Hebron University Hospital in Barcelona, who led the clinical trial at the Vall d’Hebron University Hospital Hebron.
The researchers also observed significant improvements in the progression-free survival – the time from the start of treatment until the tumor grows back – which went from 2.4 months with standard therapy to 5.6 months with treatment that included bevacizumab. And it also increased the time that patients enjoyed before their health status and quality of life deteriorated again.
“All of these improvements were seen in all patient subgroups, regardless of laterality or tumor molecular profile,” states Dr. Tabernero, “indicating that Trifluridine/tipiracil plus bevacizumab is an option for all clinically relevant subgroups.” . “Clinical benefits have been observed even in patients who had received prior treatment with bevacizumab. This supports the importance of continue to inhibit the formation of blood vessels beyond tumor progression and suggests that adding bevacizumab in the third or last line of treatment may lead to better survival in heavily pre-treated patients,” he adds.
Trifluridine/tipiracil plus bevacizumab may become a new standard of care for patients with metastatic colon cancer whose tumor has progressed after receiving two lines of therapy. In order for this new therapeutic combination to be administered to patients who need it, it must be approved by the regulatory authorities. “It is important that we work on new therapeutic options that mean a clinical improvement in the survival of these patients, preserving their quality of life since, today, this is an unmet need” concludes Dr. Josep Tabernero.
Fuente: Vall d’Hebron Institute of Oncology (VHIO)