A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis
2008

Epirubicin and Ifosfamide in Ovarian Cancer Treatment

Sample size: 208 publication Evidence: moderate

Author Information

Author(s): Fruscio R, Colombo N, Lissoni A A, Garbi A, Fossati R, Ieda' N, Torri V, Mangioni C

Primary Institution: Clinica Ostetrica e Ginecologica, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy

Hypothesis

To test the feasibility and efficacy of epirubicin and ifosfamide added to first-line chemotherapy with cisplatin and paclitaxel in a phase II randomised clinical trial.

Conclusion

Both regimens showed good efficacy, but toxicity was heavier with the CIP regimen.

Supporting Evidence

  • Response rates were 85% in the CIP arm and 90% in the CEP arm.
  • Median overall survival was 51 months in the CIP arm and 65 months in the CEP arm.
  • 5-year survival rates were 43% for CIP and 50% for CEP.

Takeaway

This study looked at two different treatments for ovarian cancer and found that while both worked well, one caused more side effects than the other.

Methodology

Patients with histologically proven epithelial ovarian cancer were randomly assigned to receive first-line polychemotherapy with either cisplatin/paclitaxel/epirubicin or cisplatin/paclitaxel/ifosfamide for six cycles every 21 days.

Limitations

The study had no control arm with the standard carboplatin–paclitaxel chemotherapy, making it impossible to compare the OS obtained with the experimental regimens.

Participant Demographics

Women 18 years or older with histologically proven epithelial ovarian carcinoma.

Statistical Information

P-Value

0.0001

Confidence Interval

95% CI 77–93% for CIP arm and 95% CI 84–96% for CEP arm

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604231

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