mFOLFOX in Second-Line Biliary Tract Cancer: ABC-06 Trial Results

At the ASCO 2019 Annual Meeting held in Chicago, researchers presented the findings of the ABC-06 Phase 3 clinical trial. This study evaluated the efficacy and safety of adding mFOLFOX chemotherapy to active symptom control (ASC) as a second-line treatment for patients with advanced biliary tract cancer (BTC) who had progressed on Gemcitabine and Cisplatin.

Study Design: ABC-06 Trial

The trial randomized 162 patients who had failed first-line therapy into two groups:

1. ASC Group (N=81): Active symptom control alone.
2. ASC + mFOLFOX Group (N=81): ASC plus mFOLFOX chemotherapy (Oxaliplatin 85 mg/m², L-folinic acid 175 mg/m², 5-FU 400 mg/m² bolus, followed by 5-FU 2,400 mg/m² 46-hour infusion every two weeks).

The primary endpoint was overall survival (OS).

Key Survival Results

The addition of mFOLFOX provided a statistically significant improvement in survival:

• Median Overall Survival: 6.2 months for the ASC + mFOLFOX group vs. 5.3 months for the ASC group.
• Survival Rates:
  • 6-Month OS: 50.6% (ASC+mFOLFOX) vs. 35.5% (ASC).
  • 12-Month OS: 25.9% (ASC+mFOLFOX) vs. 11.4% (ASC).
• Hazard Ratio (Adjusted): 0.69, indicating a significant survival benefit for the combination group.

Efficacy and Safety

• Progression-Free Survival (PFS): 4.0 months in the mFOLFOX group.
• Disease Control Rate: 33% in the mFOLFOX group.
• Safety: Adverse events were higher in the mFOLFOX group (59% vs. 40%). Common side effects included fatigue (19%), neutropenia (12%), and infection (18%).

Conclusion

Dr. Thomas Yau and the ABC-06 investigators concluded that adding mFOLFOX to ASC significantly improves overall survival in patients with advanced biliary tract cancer who have failed first-line Gemcitabine and Cisplatin. This trial establishes mFOLFOX as a new standard-of-care option for second-line therapy in advanced BTC.

Source: ASCO 2019 - ABC-06 Trial Abstract No: 4003

#BiliaryTractCancer #Cholangiocarcinoma #mFOLFOX #ABC06 #ASCO2019 #CancerResearch #SecondLineTherapy

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