SUNLIGHT: effect of clinical prognostic factors at baseline

Last year, the phase III SUNLIGHT study demonstrated a significant benefit in progression-free (PFS) and overall survival (OS) with the addition of bevacizumab to trifluridine/tipiracil (FTD/TPI) in patients with refractory metastatic colorectal cancer (mCRC).¹ During ESMO 2024, results were presented of analysis looking into the impact of clinical prognostic factors on treatment outcomes in the SUNLIGHT study.² In this video, Prof Dr Eric Van Cutsem (University Hospitals Leuven) discusses these clinically relevant findings with Prof Dr Gerald Prager, digestive oncologist at the Medical University of Vienna and principal investigator of the SUNLIGHT trial.

SUNLIGHT is an international, open label, randomized, phase III study comparing FTD/TPI + bevacizumab to FTD/TPI alone in patients with refractory mCRC who had received no more than two previous chemotherapy regimens. The addition of bevacizumab to FTD/TPI led to a significant 3.3 months improvement in OS, corresponding to a 39% lower death risk for patients treated with the combination compared to FTD/TPI alone (HR[95%CI]: 0.61[0.49-0.77’ p< 0.001).¹ The aim of the presented post hoc analysis was to investigate the effect of clinical prognostic factors on the OS and PFS with FTD/TPI + bevacizumab and FTD/TPI alone in the SUNLIGHT study. For this analysis, patients with good prognostic characteristics (GPC) were defined as patients with less than 3 metastatic sites and who had metastatic disease for at least 18 months prior to randomization. All the remaining patients were included in the group with poor prognostic characteristics (PPC).

The prognostic relevance of these two groups was confirmed with a better OS and PFS for patients in the GPC group in both treatment arms. Importantly, the addition of bevacizumab to FTD/TPI led to a numerical and/or statistically significant benefit in OS and PFS in both prognostic groups. A significant clinical benefit was also obtained in the subgroup of GPC patients without liver metastases.²

As such, these findings further solidify FTD/TPI + bevacizumab as a standard of care treatment for patients with refractory CRC, irrespective of the prognostic profile at baseline.