Lonsurf Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: SUNLIGHT Trial
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On May 4, 2023, Gerald W. Prager and colleagues published the results of the SUNLIGHT Phase 3 clinical trial in The New England Journal of Medicine. This study evaluated the efficacy and safety of combining Lonsurf (Trifluridine/Tipiracil) with Bevacizumab (Avastin) in patients with refractory metastatic colorectal cancer (mCRC).
Study Design: SUNLIGHT Trial
The international, randomized, open-label trial enrolled 492 patients with metastatic colorectal cancer who had received a maximum of two prior chemotherapy regimens for metastatic disease. Participants were randomized 1:1 into two groups:
- Lonsurf + Bevacizumab Group (N=246): Lonsurf (35 mg/m² twice daily on days 1–5 and 8–12 of a 28-day cycle) + Bevacizumab (5 mg/kg on days 1 and 15).
- Lonsurf Monotherapy Group (N=246): Lonsurf (35 mg/m² twice daily on days 1–5 and 8–12).
The primary endpoint was overall survival (OS).
Key Efficacy Results
The trial demonstrated a clear survival benefit for the combination therapy:
- Median Overall Survival (OS): 10.8 months for the combination group vs. 7.5 months for the Lonsurf monotherapy group (Hazard Ratio [HR] = 0.61).
- Median Progression-Free Survival (PFS): 5.6 months (Combination) vs. 2.4 months (Monotherapy) (HR = 0.44).
- One-Year OS Rate: 43% (Combination) vs. 30% (Monotherapy).
Safety Profile
The most common adverse events in both groups were hematological, including neutropenia, nausea, and anemia. No treatment-related deaths were reported in either group. The addition of Bevacizumab to Lonsurf was considered manageable and well-tolerated.
Conclusion
The SUNLIGHT trial results establish Lonsurf plus Bevacizumab as a new standard-of-care option for patients with refractory metastatic colorectal cancer, offering a significant survival advantage over Lonsurf monotherapy in the third-line setting.
Source: The New England Journal of Medicine - SUNLIGHT Trial Results
#ColorectalCancer #mCRC #Lonsurf #Bevacizumab #Avastin #SUNLIGHTTrial #CancerResearch
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