Trifluridine plus tipiracil and bevacizumab is a new standard of care for refractory metastatic colorectal cancer
January 2023
Findings from the phase III SUNLIGHT trial were presented at the 2023 ASCO Gastrointestinal Cancers Symposium, demonstrating that the combination of bevacizumab (commercial name: Avastin®) plus trifluridine/tipiracil (commercial name: Lonsurf®) promoted an improvement in overall survival and progression-free survival in patients with metastatic colorectal cancer (mCRC) that had become refractory or unresponsive to previous treatment.
Bevacizumab is a type of intravenous (given through a vein) therapy used in the treatment of mCRC. It works by interfering with a process known as angiogenesis, which involves the creation of new blood vessels. This process is important for tumour growth, therefore blocking angiogenesis can slow tumour growth.
Trifluridine/tipiracil is a type of oral (given through the mouth) chemotherapy used to treat mCRC that has been previously treated with 5-FU, oxaliplatin, irinotecan-based chemotherapy, and targeted therapies such as bevacizumab, cetuximab, and panitumumab. This treatment is absorbed by tumour cells and interferes with their ability to divide and replicate.
The study
The trial enrolled patients who had mCRC and had received at least two previous colorectal cancer treatments. By comparing patients who received trifluridine/tipiracil plus bevacizumab versus those that received trifluridine/tipiracil alone, the researchers were able to determine whether adding the targeted therapy provided any survival benefit to this subset of patients.
The primary endpoint (the main result that is measured at the end of the study to see if a given treatment worked) of the study was overall survival (OS), which is the length of time that patients with the disease are still alive after the start of treatment.
The average OS was 7.5 months vs. 10.8 months for the trifluridine/tipiracil and trifluridine/tipiracil/bevacizumab group, respectively.
The 12-month OS rates (the percentage of patients who are still alive for the specific period of time after the start of treatment) were 30% vs 43%, respectively.
Progression-free survival (PFS) was another result that was examined in this study and measures the length of time during and after the treatment of a disease that the patients live with the disease but it does not get worse.
Average PFS was 2.4 months vs. 5.6 months for the trifluridine/tipiracil and trifluridine/tipiracil/bevacizumab group, respectively.
The 12-month PFS rates (the percentage of people who did not experience new tumour growth or cancer spread) were 1% and 16%, respectively.
Adverse events (any unwanted medical occurrence that is associated with the use of the treatment) of grade 3 or higher were reported in 70% vs. 72% of patients in the trifluridine/tipiracil and trifluridine/tipiracil/bevacizumab group, respectively.
The novel combination therapy provided a statistically significant and clinically meaningful improvement in OS with an acceptable safety profile.
Take home message
The new combination therapy of trifluridine/tipiracil plus bevacizumab is supported by findings from the phase III SUNLIGHT trial as the new standard of care for the treatment of patients who have refractory mCRC that has progressed after two previous lines of therapy.
Since the trial, the FDA has approved the use of trifluridine/tipiracil plus bevacizumab for metastatic colorectal cancer patients. In Canada, the combination has been approved by Health Canada for the treatment of metastatic colorectal cancer and has been recommended by Canada’s Drug Agency for reimbursement. Read more about the approval here.
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