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Gefitinib treatment in hormone-resistant and hormone receptor-negative advanced breast cancer
M D Green1, P A Francis, V Gebski
1Department of Medical Oncology, Western and Royal Melbourne Hospitals, Parkville, Victoria, Australia. michael.green@mh.org.au
Background:
Acquired and de novo endocrine resistance in breast cancer (BC) may be associated with overexpression of epidermal growth factor receptor (EGFR). Gefinitib is an orally active selective EGFR inhibitor which might benefit advanced breast cancer (ABC) patients either with acquired hormone resistance or with hormone receptor (HR)-negative tumors.
Patients And Methods:
A two-arm multicenter phase II trial of oral gefitinib 500 mg/day was planned in two groups of 45 patients with ABC for whom chemotherapy was not currently indicated. Group 1 had hormone-resistant BC defined as HR-positive BC with progression after treatment with tamoxifen and an aromatase inhibitor. Group 2 had HR-negative BC. Tumor response was assessed every 8 weeks. The primary end point was the clinical benefit rate (CBR).
Results:
Forty patients with hormone-resistant BC had a CBR of 0%. Two of 25 HR-negative BC patients showed stable disease (less than a 50% reduction and less than a 25% increase in the sum of the products of two perpendicular diameters of all measured lesions and the appearance of no new lesions) at 24 weeks resulting in a CBR of 7.7% (95% CI 0.9% to 25.1%). Enrollment ceased due to the low CBR. Toxicity resulted in treatment interruption (46%), dose reduction (20%) and withdrawal (11%) of patients.
Conclusion:
At a dose of 500 mg/day, gefitinib monotherapy resulted in a low CBR and no tumor response was identified.
Insights
Gefitinib monotherapy showed low clinical benefit rates in advanced breast cancer (ABC) patients with hormone resistance or hormone receptor-negative tumors. The study found no significant tumor response, leading to early trial cessation.
Area of Science:
- Oncology
- Pharmacology
Background:
- Endocrine resistance in breast cancer (BC) may link to epidermal growth factor receptor (EGFR) overexpression.
- Gefitinib, an EGFR inhibitor, was investigated for advanced breast cancer (ABC) with hormone resistance or hormone receptor (HR)-negative status.
Purpose of the Study:
- To evaluate the efficacy of gefitinib monotherapy in patients with advanced breast cancer.
- To determine the clinical benefit rate (CBR) of gefitinib in two distinct patient groups.
Main Methods:
- A phase II trial administered oral gefitinib 500 mg/day to two groups of 45 patients with ABC.
- Group 1: HR-positive BC with acquired hormone resistance. Group 2: HR-negative BC.
- Primary endpoint: clinical benefit rate (CBR).
Main Results:
- Hormone-resistant BC patients (n=40) had a 0% CBR.
- HR-negative BC patients (n=25) showed a 7.7% CBR, with two achieving stable disease.
- Trial enrollment ceased due to low CBR; significant toxicity observed.
Conclusions:
- Gefitinib monotherapy at 500 mg/day demonstrated a low CBR in advanced breast cancer.
- No significant tumor response was identified, indicating limited efficacy.
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