Outcomes from the SUNLIGHT Study in Metastatic Colorectal Cancer
A comprehensive review of outcome data from the SUNLIGHT clinical trial in patients with refractory metastatic colorectal cancer.
This is a synopsis of an Insights series featuring Marwan G. Fakih, MD, of City of Hope, and Atif Hussein, MD, MMM, FACP, of Memorial Healthcare System.
Dr Fakih reviewed efficacy and safety outcomes from the phase 3 SUNLIGHT trial of trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil in refractory metastatic colorectal cancer. The combination showed superior median overall survival of 10.8 versus 7.5 months for trifluridine/tipiracil alone, exceeding the primary endpoint. Progression-free survival, the key secondary endpoint, doubled from 2.4 months with trifluridine/tipiracil alone to 5.6 months with trifluridine/tipiracil plus bevacizumab. Overall and progression-free survival benefits persisted across all subgroups regardless of RAS status, primary tumor location, ECOG performance status, and other factors.
The safety profile reveals increased grade 3/4 neutropenia of 43% vs 32% for trifluridine/tipiracil alone, attributed to extended trifluridine/tipiracil treatment duration with bevacizumab. Otherwise, diarrhea, nausea and vomiting were similar between arms, emphasizing the favorable toxicity profile of trifluridine/tipiracil rechallenge with bevacizumab.
In summary, SUNLIGHT met its primary and secondary endpoints, demonstrating improved survival outcomes with manageable toxicity when combining trifluridine/tipiracil with bevacizumab rechallenge after progression on standard therapies in refractory metastatic colorectal cancer. Based on these data, Drs Fakih and Hussein consider trifluridine/tipiracil plus bevacizumab a new standard of care third-line option for metastatic colorectal cancer, now FDA-approved for patients progressing after oxaliplatin, irinotecan, bevacizumab, and fluoropyrimidine treatment.
*Video synopsis is AI-generated and reviewed by Cancer Network editorial staff.
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