title: Fulvestrant in heavily pre-treated patients with advanced breast cancer: results from a single compassionate use programme centre.
abstract: OBJECTIVE
  Fulvestrant ('Faslodex') is an oestrogen receptor (ER) antagonist with no agonist effects. The drug was administered to heavily pre-treated patients with advanced breast cancer (ABC). Patients received Fulvestrant after disease progression (PD) on a previous endocrine treatment or as maintenance treatment after chemotherapy.
  
  
  METHODS
  Fifty-seven postmenopausal women with ER and/or progesterone receptor-positive ABC resistant to previous endocrine treatments prospectively received fulvestrant 250 mg via intramuscular injection q 28.
  
  
  RESULTS
  Twenty-seven patients received fulvestrant after PD and 30 received it as maintenance therapy after chemotherapy. All patients received fulvestrant as second-up to eight-line endocrine treatment for ABC. One patient (2%) had a partial response (PR) and 24 patients (42%) had stable disease > or =12 weeks (SD), including 11 patients who had SD > or =24 weeks. Thirty-two patients (56%) had de novo PD. Clinical benefit (CB; PR + SD > or =24 weeks) occurred in 12 patients (21%). Patients treated as maintenance and treated upon PD had 0 and 4% PR, 43 and 41% SD (including 20 and 19% SD > or =24 weeks), 57 and 55% PD, respectively. Overall, median time to progression (TTP) was 3 months. No differences in CB rate (20% vs. 23%), TTP (3 months vs. 3 months) and time to treatment failure (3 months vs. 3 months) were observed between patients receiving fulvestrant as maintenance therapy and those treated at PD on prior endocrine treatment. No grade 2-4 NCI-CTC toxicity was recorded.
  
  
  CONCLUSIONS
  Fulvestrant treatment was associated with prolonged CB and was well tolerated in this group of heavily pre-treated patients with ABC. The outcomes appeared to be similar for patients treated upon PD and those receiving fulvestrant as maintenance therapy.
authors.affiliation: Unit for Medical Care, Division of Medical Oncology, European Institute of Oncology, 20141, Milan, Italy. chiara.catania@ieo.it
authors.forename: Chiara
authors.initials: C
authors.lastname: Catania
authors.forename: Gilda
authors.initials: G
authors.lastname: Ascione
authors.forename: Laura
authors.initials: L
authors.lastname: Adamoli
authors.forename: Tommaso
authors.initials: T
authors.lastname: De Pas
authors.forename: Marta
authors.initials: M
authors.lastname: Medici
authors.forename: Lucia
authors.initials: L
authors.lastname: Franceschelli
authors.forename: Elena
authors.initials: E
authors.lastname: Verri
authors.forename: Elena
authors.initials: E
authors.lastname: Magni
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Sanna
authors.forename: Rosalba
authors.initials: R
authors.lastname: Torrisi
authors.forename: Aron
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: Franco
authors.initials: F
authors.lastname: Nolè
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D004645:Empathy; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004965:Estrogen Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000077267:Fulvestrant; D006801:Humans; D007273:Injections, Intramuscular; D008875:Middle Aged; D015397:Program Evaluation; D011446:Prospective Studies; D011960:Receptors, Estrogen / Q000032:analysis / Q000037:antagonists & inhibitors; D011980:Receptors, Progesterone / Q000032:analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D004965:Estrogen Antagonists; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D000077267:Fulvestrant; D004958:Estradiol