340P - Fulvestrant after failure of adjuvant hormonal therapy: multicenter retrospective observational study

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer agents
Breast Cancer
Biological therapy
Presenter Ornella Garrone
Authors O. Garrone1, C. Bighin2, F. Vaira3, M. Donadio4, O. Alabiso5, M. Carapezza6, E. Baldini7, M.C. Merlano1, N. Biglia8, P. Pronzato9
  • 1Clinical Oncology, Azienda Ospedaliera St. Croce e Carle, 12100 - Cuneo/IT
  • 2Medical Oncology, Ist Naz Ric Cancro, Genova/IT
  • 3Medical Oncology, Ospedale Felettino, LA Spezia/IT
  • 4Oncoematology, Ospedale S. Giovanni Battista, Torino/IT
  • 5Medical Oncology, AOU Maggiore della Carità, Novara/IT
  • 6Medical Oncology, Ospedale degli Infermi, Biella/IT
  • 7Medical Oncology, USL 2, Lucca/IT
  • 8Gynecology, Ospedale Umberto I, Torino/IT
  • 9Oncologia Medica A, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT



Aromatase inhibitors (AI) are superior to TAM in the treatment of hormonal receptor positive metastatic breast cancer (MBC). Fulvestrant (F), an estrogen receptor antagonist demonstrated activity when used after failure of previous TAM or AI. Objective: To evaluate the position of F in the hormonal strategy sequence in hormonal responsive MBC related to the evolution of adjuvant hormonal therapy (HT).

Material and methods

MBC patients with disease progression after adjuvant HT or after treatment (CT or HT) for metastatic disease, candidate to receive F at the dose of 250 mg/ month (registered in AIFA database) from May 1st 2006 to July 31st 2008. The study registered the HT sequence in clinical practice. Overall 201 patients were collected from 13 Italian Centers. Main patients' characteristics are summarized in the table.

Table: 340P

Characteristics N 201 (%) Characteristics N 201 (%)
T size Tis-T1-T2 T3-T4 T Unk 138(68,6) 40 (20) 23 (11,4) PgR Pos Neg Unk 142(70,6) 33 (16,4) 26 (13)
Nodal Status N0 N+ Nx 54 (26,9) 120 (59,7) 27 (13,4) Adj CT Yes No Unk 105 (51,7) 94 (46,8) 3 (1,5)
ER Pos Neg Unk 169 (84) 12 (6) 20 (10) Adj HT Yes No Unk 141 (70,1) 46 (22,9) 14 (7)


ORR were: CR 2%; PR 7%; SD 43%; PD 41%; NE 7%. Eighty-six patients (43%) had visceral metastases. Median duration of F was 7 months (1-42); 8 patients are ongoing and for 1 patient the duration was unknown. 16, 39 and 56 patients received F as 1st, 2nd and 3rd line therapy respectively. For the remaining patients F was administered as more than the 4th line therapy. The possibility to obtain a benefit from F did not seem to correlate with the line of treatment. One of the 2 CR occurred in a patient with visceral disease (lung). Among the patients who progressed under treatment 42% had visceral disease, that was almost the same rate of the whole population. This data suggests that there is lack of correlation between the sites of disease and the probability of benefit. Toxicity was negligible.


More than 50% of the patients benefited from F notwithstanding 73% of them received the treatment as third or more line of HT. This study does not show any correlation between the sites of the metastases and the treatment results.


All authors have declared no conflicts of interest.