SUNLIGHT: Trifluridine-Tipiracil and Bevacizumab in Refractory mCRC
Marwan G. Fakih, MD, reviews the study design for the SUNLIGHT clinical trial investigating trifluridine-tipiracil plus bevacizumab in patients with refractory metastatic CRC.
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 key details of the phase 3 SUNLIGHT trial evaluating trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil alone in refractory metastatic colorectal cancer. Eligible patients had ECOG performance status 0-1 and disease progression after fluoropyrimidine, oxaliplatin, irinotecan, and prior bevacizumab if given. The co-primary endpoints were overall survival and progression-free survival.
The rationale for combining trifluridine/tipiracil and bevacizumab was prior evidence that continuing anti-angiogenic therapy beyond progression improves outcomes. Specifically, 3 second-line trials added anti-angiogenics in patients with first-line anti-angiogenic therapy, demonstrating improved survival. Therefore, the SUNLIGHT trial assessed whether bevacizumab rechallenge further improves trifluridine/tipiracil efficacy in third-line treatment.
SUNLIGHT enrolled 246 patients per arm. Baseline characteristics, including age, metastatic burden, and prior treatment lines, were well-balanced. Most patients had RAS mutations, a poor prognostic marker, and ECOG performance status 0-1. The majority received 2 prior lines of therapy, with some having only one line, likely FOLFOXIRI.
In summary, Drs Fakih and Hussein reviewed the design and rationale of the phase 3 SUNLIGHT trial testing the novel strategy of combining trifluridine/tipiracil with bevacizumab rechallenge for refractory metastatic colorectal cancer. Key eligibility criteria included ECOG performance status 0-1 and disease progression after standard fluoropyrimidine, oxaliplatin, and irinotecan-based regimens plus prior bevacizumab. The results, demonstrating this combination's impact on the co-primary endpoints of overall survival and progression-free survival, will inform the potential role of bevacizumab rechallenge in improving outcomes for this patient population with limited remaining options.
*Video synopsis is AI-generated and reviewed by Cancer Network editorial staff.
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