1. ¹INT G Pascale, Naples, Italy
2. ²Med Onc Pozzuoli, Naples, Italy
3. ³Frattamaggiore H, Naples, Italy
4. ⁴Department of Oncology, PF Calvi Hospital, Noale, Venise, Italy
5. ⁵Med Onc Taranto H, Naples, Italy
6. ⁶Med Onc Benevento H, Naples, Italy
7. ⁷MED ONC SA H, Naples, Italy
8. ⁸Med Onc Nola, Naples, Italy
9. ⁹Fatebenefratelli Benevento H, Naples, Italy
10. ¹⁰Med Onc Potenza H, Naples, Italy
11. ¹¹ASL BA 1, Naples, Italy
12. ¹²Med Onc INT Bari, Naples, Italy by the Southern Italy Oncology Group (GOIM)

Correspondence: Dr RV Iaffaioli, Tr Michele Pietravalle, 54 – 80131 Naples, Italy. E-mail: eiaffaioli@hotmail.com; roberta.formato@tin.it

Received 4 October 2004; Revised 7 March 2005; Accepted 7 March 2005; Published online 26 April 2005.

Abstract

Hormonal therapy is the preferred systemic treatment for recurrent or metastatic, post-menopausal hormone-receptor-positive breast cancer. Previous studies have shown that there is no cross-resistance between exemestane and reversible aromatase inhibitors. Exposure to hormonal therapy does not hamper later response to chemotherapy. Patients with locally advanced or metastatic, hormonal receptor positive or unknown, breast cancer were treated with oral anastrozole, until disease progression, followed by oral exemestane until new evidence of disease progression. The primary end point of the study was clinical benefit, defined as the sum of complete responses (CR), partial responses (PR) and >24 weeks stable disease (SD). In all, 100 patients were enrolled in the study. Anastrozole produced eight CR and 19 PR for an overall response rate of 27% (95% CI: 18.6–36.8%). An additional 46 patients had long-term (>24 weeks) SD for an overall clinical benefit of 73% (95% CI: 63.2–81.4). Median time to progression (TTP) was 11 months (95% CI: 10–12). A total of 50 patients were evaluated for the second-line treatment: exemestane produced one CR and three PR; 25 patients had SD which lasted 6 months in 18 patients. Median TTP was 5 months. Toxicity of treatment was low. Our study confirms that treatment with sequential hormonal agents can extend the period of time during which endocrine therapy can be used, thereby deferring the decision to use chemotherapy.