Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer
2005

Comparing Two Chemotherapy Regimens for Advanced Biliary Cancer

Sample size: 54 publication Evidence: moderate

Author Information

Author(s): Rao S, Cunningham D, Hawkins R E, Hill M E, Smith D, Daniel F, Ross P J, Oates J, Norman A R

Primary Institution: Royal Marsden Hospital

Hypothesis

Does epirubicin, cisplatin, and infused 5FU (ECF) improve overall survival compared to 5FU, etoposide, and leucovorin (FELV) in patients with advanced biliary cancer?

Conclusion

ECF did not improve overall survival compared to FELV but was associated with less acute toxicity.

Supporting Evidence

  • The median overall survival for ECF was 9.02 months and for FELV was 12.03 months.
  • Objective response rates were similar for both arms: ECF 19.2% and FELV 15%.
  • There was significantly increased grade 3/4 neutropenia with FELV compared to ECF (53.8% vs 29.5%).
  • Symptom resolution was achieved with both regimens ranging from 20% to 92% for various symptoms.

Takeaway

Doctors wanted to see if one type of cancer treatment was better than another for patients with a serious liver cancer. They found that both treatments worked similarly, but one had fewer side effects.

Methodology

Patients were randomly assigned to receive either ECF or FELV, and the study measured overall survival and other health outcomes.

Limitations

The study was underpowered due to slow recruitment, limiting the ability to detect significant differences in survival.

Participant Demographics

Patients were primarily over 65 years old, with a mix of genders and performance statuses.

Statistical Information

P-Value

0.2059

Confidence Interval

95% CI: 6.46–11.51 for ECF; 95% CI: 9.3–14.7 for FELV

Statistical Significance

p=0.2059

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602576

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