QoL preserved in patients with refractory mCRC treated with add-on bevacizumab

In the treatment of refractory metastatic colorectal cancer (mCRC), the addition of bevacizumab to trifluridine/tipiracil (FTD/TPI) does not appear to hurt the quality of life (QoL), with patients receiving add-on bevacizumab being able to maintain their QoL for a longer period than those receiving FTD/TPI monotherapy, according to a post hoc analysis of the phase III SUNLIGHT trial.

Data from EORTC QLQ-C30* and EQ-5D-5L** questionnaires showed that health-related (HR)QoL was similar at baseline between patients in the combination and monotherapy groups and remained stable throughout the treatment, with no clinically relevant changes over time. [ESMO GI 2023, abstract O-9]

“Patients treated with FTD/TPI plus bevacizumab or with FTD/TPI monotherapy did not show increased symptom burden as assessed by the QLQ-C30 symptom domains,” reported principal investigator Dr Gerald Prager of Medical University Vienna, Vienna, Austria.

Furthermore, patients in the combination group were less likely to experience a worsening of more than 10 points in the global health status (GHS) compared with those in the monotherapy group (median time to GHS worsening, 8.54 vs 4.7 months; hazard ratio [HR], 0.50, 95 percent confidence interval [CI], 0.38–0.65).

The findings were robust in an analysis that considered disease progression and death. The combination group experienced HRQoL deterioration, as measured by QLQ-C30, much later than the monotherapy group (median time to GHS worsening, 4.5 vs 2.07 months; HR, 0.49, 95 percent CI, 0.40–0.60).

Likewise, EQ-5D-5L utility scores and visual analogue scale scores showed that patients treated with the combination were less likely to have their HRQoL deteriorate before those treated with FTD/TPI monotherapy.

The positive HRQoL outcomes are in line with the primary results of SUNLIGHT, which showed that the combination of FTD/TPI plus bevacizumab yielded significant survival gains compared with FTD/TPI alone, with a predictable and manageable safety profile, according to Prager. The median overall survival increased by 3.3 months (10.8 vs 7.5 months; HR, 0.61, 95 percent CI, 0.49–0.77; p<0.001), while the median progression free survival went up by 3.2 months (5.6 vs 2.4 months; HR, 0.44, 95 percent CI, 0.36–0.54; p<0.001).

The takeaway is that keeping bevacizumab going on top of FTD/TPI did not negatively impact QoL in any way, commented Dr John Marshall from the Otto J Ruesch Center for the Cure of GI Cancers, Georgetown Lombardi Comprehensive Cancer Center, Washington, US.

Marshall, who was not involved in the study, pointed out that there are several ways the disease, the treatment, and their consequences impact the QoL for patients. “Cancer hurts, so there’s a pain symptom issue including the adverse effects of the medicine—neuropathy, fatigue, appetite change, bowel alteration, the list goes on.”

It is also important to note that bevacizumab is given via the intravenous (IV) route, he continued. “Sometimes IV medicines have adverse effects; bevacizumab, not so much. Remember that almost all these patients [in SUNLIGHT] had had prior bevacizumab [exposure], so they’ve experienced it before. The good news is that this [FTD/TPI plus bevacizumab] combination, which has quickly become a standard, did not have a big negative impact on QoL compared with … a single-agent oral therapy.”

The current analysis included 492 patients, including 239 and 241 in the combination and monotherapy arms, respectively. The cutoff point for the analysis was 12 cycles for FTD/TPI plus bevacizumab and 6 cycles for FTD/TPI monotherapy.

*European Organisation For Research And Treatment Of Cancer core quality of life questionnaire

**The five-level EuroQol five-dimensional questionnaire