KEY TAKEAWAYS
- The phase 3 SUNLIGHT trial compared FTD/TPI with bev to FTD/TPI alone in treating refractory metastatic colorectal cancer.
- This study revealed that both treatment groups sustained QoL, but the combination of FTD/TPI and bev showed a longer delay in HRQoL decline compared to FTD/TPI alone.
In the SUNLIGHT trial, health-related quality of life (HRQoL) assessments were carried out at the beginning, throughout the treatment, and at the end using specific questionnaires: EORTC QLQ-C30 and EQ-5D-5L. These metrics measured the average shifts from initial values, with specific points indicating significant changes, and the duration until any decline. Additionally, a thorough analysis evaluated the time until a distinct drop in EQ-5D-5L utility score and visual analog scale was detected.
Of the 492 patients (pts) in the trial, over 97% in both groups had baseline quality of life data. Given the diminished completion rate after these points, the review was limited to 12 cycles for combination treatment and 6 cycles for monotherapy. Throughout the treatment, the baseline scores of both questionnaires remained comparable in both arms without any significant alterations. No enhanced symptom load was detected using the QLQ-C30 symptom areas.
The combination therapy resulted in a lower likelihood of significantly declining global health status, outlasting the monotherapy. Sensitivity tests, considering the progression of the disease and mortality as substantial declines, indicated that HRQoL deteriorated notably later for combination therapy. A consistent outcome was also found using the EQ-5D-5L utility score and VAS, suggesting those under the combined treatment were less prone to deteriorate than those under monotherapy.
Quality of life was consistently upheld across both treatment paths. However, there was an evident delay in the time until a marked decline in HRQoL metrics when using FTD/TPI combined with bev compared to FTD/TPI as a standalone treatment.
Source: https://www.annalsofoncology.org/article/S0923-7534(23)00166-7/fulltext
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04737187
Prager, G., Taieb, J., Fakih, M., Ciardiello, F., Cutsem, E.V., Elez, E., Cruz, F., Wyrwicz, L., Stroyakovskiy, D., Pápai, Z., Poureau, P., Liposits, G., Cremolini, C., Bondarenko, I., Modest, D., Amellal, N., Hassan, H., Skanji, D., Tabernero, J. O-9 Health-related quality of life associated with trifluridine/tipiracil in combination with bevacizumab in refractory metastatic colorectal cancer: An analysis of the phase 3 SUNLIGHT trial. https://doi.org/10.1016/j.annonc.2023.04.024