Phase II study of sequential hormonal therapy with anastrozole/exemestane in advanced and metastatic breast cancer
2005

Sequential Hormonal Therapy for Advanced Breast Cancer

Sample size: 100 publication Evidence: moderate

Author Information

Author(s): Iaffaioli R V, Formato R, Tortoriello A, Prete S Del, Caraglia M, Pappagallo G, Pisano A, Fanelli F, Ianniello G, Cigolari S, Pizza C, Marano O, Pezzella G, Pedicini T, Febbraro A, Incoronato P, Manzione L, Ferrari E, Marzano N, Quattrin S, Pisconti S, Nasti G, Giotta G, Colucci G

Primary Institution: INT G Pascale, Naples, Italy

Hypothesis

Can sequential therapy with anastrozole and exemestane improve clinical outcomes in patients with advanced breast cancer?

Conclusion

The study confirms that sequential hormonal therapy can extend the time during which endocrine therapy is effective, delaying the need for chemotherapy.

Supporting Evidence

  • Anastrozole produced an overall response rate of 27%.
  • Exemestane showed a clinical benefit rate of 44% in patients who progressed after anastrozole.
  • The median time to progression for anastrozole was 11 months.
  • Low toxicity was reported with both treatments.
  • Sequential hormonal therapy can delay the need for chemotherapy.

Takeaway

This study shows that using two hormonal treatments one after the other can help women with advanced breast cancer feel better for longer without needing stronger treatments like chemotherapy.

Methodology

Patients received anastrozole until disease progression, followed by exemestane until further progression, with evaluations for clinical benefit and response rates.

Potential Biases

Potential bias due to patient expectations regarding chemotherapy as a preferred treatment option.

Limitations

The study was limited by a high dropout rate in the second-line treatment and the subjective nature of some patient-reported outcomes.

Participant Demographics

Patients aged 30–93 years, median age 66, with a mix of prior treatments and metastatic disease sites.

Statistical Information

Confidence Interval

95% CI: 18.6–36.8% for overall response rate; 95% CI: 63.2–81.4% for clinical benefit.

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602579

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