Lonsurf Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: SUNLIGHT Trial

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:

1. 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).
2. 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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