A phase I study of regional 5-fluorouracil and systemic folinic acid for patients with colorectal liver metastases
1992

Study on 5-Fluorouracil and Folinic Acid for Colorectal Liver Metastases

Sample size: 10 publication Evidence: low

Author Information

Author(s): J.H. Anderson, D.J. Kerr, T.G. Cooke, C.S. McArdle

Primary Institution: University Department of Surgery, The Royal Infirmary, Glasgow; CRC Department of Medical Oncology, Glasgow University

Hypothesis

What is the maximum tolerated dose of intra-hepatic arterial 5-fluorouracil when combined with systemic folinic acid?

Conclusion

The study established that a dose of 1.5 g m-2 of 5-FU is recommended for further studies due to dose limiting toxicity observed at 2 g m-2.

Supporting Evidence

  • Patients experienced dose limiting toxicity at 2 g m-2 of 5-FU.
  • The main adverse effects were vomiting, diarrhoea, and oral ulceration.
  • Three patients were withdrawn from the study due to disease progression.

Takeaway

Doctors wanted to find out how much medicine they could safely give to patients with liver cancer. They found that a certain amount worked best without making people too sick.

Methodology

Patients received escalating doses of 5-FU as a 24-hour infusion with a fixed dose of intravenous folinic acid once per week.

Limitations

The study had a small sample size and was limited to patients with specific criteria.

Participant Demographics

Ten patients (seven males, three females) with a mean age of 58 years.

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