Phase II study of 5-fluorouracil (5-FU) and high dose folinic acid (HDFA) in hepatocellular carcinoma
1988

Study of 5-Fluorouracil and High Dose Folinic Acid in Liver Cancer

Sample size: 14 publication Evidence: low

Author Information

Author(s): A. Zaniboni, E. Simoncini, P. Marpicati, G. Marini

Primary Institution: Fondazione Beretta Spedali Civili

Hypothesis

The combination of 5-FU and high-dose folinic acid (HDFA) will improve treatment outcomes in nonresectable hepatocellular carcinoma (NHC) compared to 5-FU alone.

Conclusion

The combination of HDFA and 5-FU did not produce better results than 5-FU alone in treating NHC.

Supporting Evidence

  • No response was seen in any of the 14 evaluable patients.
  • 6 patients had stabilization of disease for a median duration of 82 days.
  • Median survival was 98 days with no difference between stable or progressive disease.

Takeaway

Doctors tried a new medicine combination to help people with liver cancer, but it didn't work any better than the old medicine.

Methodology

14 untreated patients with NHC were treated with HDFA and 5-FU, and responses were evaluated after at least two cycles.

Limitations

The study had a small sample size and no responses were seen in any of the patients.

Participant Demographics

12 males and 2 females, median age 47.3 years.

Statistical Information

Confidence Interval

<20% at the 95% confidence interval

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