Phase II study of gefitinib in combination with docetaxel as first-line therapy in metastatic breast cancer
2006

Gefitinib and Docetaxel for Metastatic Breast Cancer

Sample size: 41 publication Evidence: moderate

Author Information

Author(s): F Ciardiello, T Troiani, F Caputo, M De Laurentiis, G Tortora, G Palmieri, F De Vita, M R Diadema, M Orditura, G Colantuoni, C Gridelli, G Catalano, S De Placido, A R Bianco

Primary Institution: Seconda Università degli Studi di Napoli

Hypothesis

Is the combination of gefitinib and docetaxel effective as first-line treatment for metastatic breast cancer?

Conclusion

The combination of gefitinib and docetaxel is an active and generally well-tolerated treatment for women with metastatic breast cancer who have not been previously treated.

Supporting Evidence

  • 54% of patients showed a complete or partial response to the treatment.
  • Neutropenia was the most common severe side effect, affecting 49% of patients.
  • Patients with estrogen receptor-positive tumors had a significantly higher response rate.

Takeaway

This study tested a new medicine called gefitinib with another medicine called docetaxel to see if they work better together for women with advanced breast cancer. They found that many women got better with this treatment.

Methodology

41 female patients with metastatic breast cancer received gefitinib and docetaxel in a phase II clinical trial to evaluate safety and effectiveness.

Limitations

The study had a small sample size and was not comparative.

Participant Demographics

All participants were female, with a median age of 58 years; 66% had estrogen receptor-positive tumors.

Statistical Information

P-Value

0.01

Confidence Interval

95% CI 45–75%

Statistical Significance

p=0.01

Digital Object Identifier (DOI)

10.1038/sj.bjc.6603141

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