A phase II study of sequential 5-fluorouracil, epirubicin and cyclophosphamide (FEC) and paclitaxel in advanced breast cancer (Protocol PV BC 97/01)
2001

Sequential Chemotherapy for Advanced Breast Cancer

Sample size: 69 publication Evidence: moderate

Author Information

Author(s): Riccardi A, Pugliese P, Danova M, Brugnatelli S, Grasso D, Giordano M, Bernardo G, Giardina G, Fava S, Montanari G, Pedrotti C, Trotti G, Rinaldi E, Poli M A, Tinelli C

Primary Institution: Università and IRCCS Policlinico S. Matteo, Pavia

Hypothesis

Sequential administration of FEC followed by paclitaxel could be better tolerated than an anthracycline and paclitaxel while having a similar antitumour effect.

Conclusion

Sequential FEC-paclitaxel is a suitable strategy for patients with metastatic breast cancer who have not been previously treated with anthracyclines and/or taxanes.

Supporting Evidence

  • The overall response rate was 65%.
  • Grade III–IV toxicity was acceptable.
  • Median time to progression was 13.2 months.
  • Median survival was 23.5 months.

Takeaway

This study tested a new way to give chemotherapy to women with advanced breast cancer, and it seemed to work well without causing too many side effects.

Methodology

Phase II multicentre study where FEC was followed by paclitaxel, administered 4 times every 21 days.

Limitations

Some patients did not complete therapy due to various reasons including treatment refusal and early death.

Participant Demographics

Patients with advanced breast cancer previously untreated with anthracyclines or paclitaxel.

Statistical Information

Confidence Interval

95% CI = 53–76

Digital Object Identifier (DOI)

10.1054/bjoc.2001.1897

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