Abstract 111P
Background
Refractory colorectal cancer remains a therapeutic challenge in clinical practice. The phase III Sunlight trial demonstrated longer overall survival (OS) with trifluridine–tipiracil [FTD–TPI] and bevacizumab combination in comparison with FTD-TPI in advanced colorectal cancers. But toxicity of the FTD-TPI is still a concern in this setting.
Methods
This was a retrospective observational study of patients with advanced colorectal cancer treated between April 2023 to June 2024 at Manipal Hospital Bangalore, India. All patients progressed on 3 or more lines of chemotherapy which included Folfox/ Capox/ Folfiri regimens in combination with bevacizumab or EGFR inhibitors (depending on the RAS mutation). Patient received FTD–TPI (from days 1 to 5 and days 15 to 19) along with Bevacizumab (5mg/kg) every 2 weeks in a 28-days cycle. The treatment response with progression free survival (PFS), overall survival (OS) and safety profile were analyzed.
Results
23 patients were included in the study. The median age was 61 years with 17 males (74%) and remaining females. Colon was the primary site in 16 patients (70%), and rectum in 7(30%). Molecular profile showed KRAS mutation in 12 (52%), NRAS mutation in 2 (8.6%), TP53 in 5 (21.7%), BRAF V600E mutation in 2 (8.6%) and 1 patient each with MMR deficient and Her 2 neu amplification. Of note, 2 patients with RAS wild-type at diagnosis were found to have KRAS mutation on repeat testing at progression. The median PFS was 5 months. The median OS was not reached, and the OS rate at 12 months was 53%. Common adverse events encountered were fatigue, cytopenia, diarrhoea and nausea. Dose reduction was required in 39% of the patients and discontinuation of the combination was required in 2 patients (8.6%) due to poor tolerance.
Conclusions
We observed that FTD–TPI plus bevacizumab was an effective combination in refractory metastatic colon cancer inspite of progression on multiple lines of therapy. The 2 weekly dosing ensured compliance and was better tolerated in our heavily pre-treated patients. Larger studies with this 2 weekly scheduling would validate this regimen for wider clinical use.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
S. N. Padmini, A. Rauthan.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.