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Last updated: 2017-08-01

Lonsurf Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: SUNLIGHT Trial

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Lonsurf Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: SUNLIGHT Trial

Lonsurf Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: SUNLIGHT Trial

Medical Supporter — Information Notice

This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.

Any specific treatment plan must be assessed by a licensed physician in Japan

Medical Supporter — Information Notice

This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.

Any specific treatment plan must be assessed by a licensed physician in Japan

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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