title: Phase II study of sequential hormonal therapy with anastrozole/exemestane in advanced and metastatic breast cancer.
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 > or = 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.
authors.affiliation: INT G Pascale, Naples, Italy. eiaffaioli@hotmail.com
authors.forename: R V
authors.initials: RV
authors.lastname: Iaffaioli
authors.forename: R
authors.initials: R
authors.lastname: Formato
authors.forename: A
authors.initials: A
authors.lastname: Tortoriello
authors.forename: S
authors.initials: S
authors.lastname: Del Prete
authors.forename: M
authors.initials: M
authors.lastname: Caraglia
authors.forename: G
authors.initials: G
authors.lastname: Pappagallo
authors.forename: A
authors.initials: A
authors.lastname: Pisano
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.forename: F
authors.initials: F
authors.lastname: Fanelli
authors.forename: G
authors.initials: G
authors.lastname: Ianniello
authors.forename: S
authors.initials: S
authors.lastname: Cigolari
authors.forename: C
authors.initials: C
authors.lastname: Pizza
authors.forename: O
authors.initials: O
authors.lastname: Marano
authors.forename: G
authors.initials: G
authors.lastname: Pezzella
authors.forename: T
authors.initials: T
authors.lastname: Pedicini
authors.forename: A
authors.initials: A
authors.lastname: Febbraro
authors.forename: P
authors.initials: P
authors.lastname: Incoronato
authors.forename: L
authors.initials: L
authors.lastname: Manzione
authors.forename: E
authors.initials: E
authors.lastname: Ferrari
authors.forename: N
authors.initials: N
authors.lastname: Marzano
authors.forename: S
authors.initials: S
authors.lastname: Quattrin
authors.forename: S
authors.initials: S
authors.lastname: Pisconti
authors.forename: G
authors.initials: G
authors.lastname: Nasti
authors.forename: G
authors.initials: G
authors.lastname: Giotta
authors.forename: G
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000077384:Anastrozole; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy; D009570:Nitriles / Q000008:administration & dosage / Q000627:therapeutic use*; D014230:Triazoles / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000730:Androstadienes; D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole; C056516:exemestane