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Issue 3
23 March, 2012
EBCC: The Bulletin
After mixed results from the SWOG and
FACT trials, the SoFEA phase III trial provides
further evidence on the role of fulvestrant
in combination with anastrozole in advanced
breast cancer. SoFEA is a late-breaking trial fea-
turing at EBCC-8 and is the only study of fulves-
trant in the setting of acquired AI resistance.
ptimal endocrine treatment for post-meno-
pausal women with advanced ER+ breast
cancer progressing on a non-steroidal (NS) aroma-
tase inhibitor (AI) is unclear. The EFECT study
showednodifference inefficacy between the steroi-
dal antioestrogen fulvestrant (F) and the steroidal AI
exemestane (E) in this setting. Pre-clinical data
suggest F may be more effective in a low oestrogen
environment. Two recent trials of F combined with
anastrozole (F+A) compared with A alone in
first-line setting gave mixed results. SoFEA investi-
gated F+A in patients with acquired resistance to
previous AI compared with F alone and with E
alone (2LBAEBCC-0725:
Fulvestrant Alone or with
Concomitant Anastrozole Vs Exemestane Following
Progression On Non-steroidal Aromatase Inhibitor –
First Results of the SoFEA Trial (CRUKE/03/021 &
CRUK/09/007) (ISRCTN44195747)
In SoFEA, a multicentre randomised partially
blinded phase III study led by Stephen Johnston of
Royal Marsden NHS Trust, London, UK, postmeno-
pausal women were allocated to F 250mgmonthly
with 500mg loading dose plus A 1mg daily (F+A
n=243), F plus placebo (n=231), or E 25mg daily
(n=249). Patients should have responded to pre-
vious NSAI in metastatic setting for more than 6
months or received more than 12 months NSAI as
adjuvant and should be progressing on NSAI at
trial entry. Primary endpoint was progression-free
survival (PFS). Secondary endpoints included objec-
tive response rate (ORR), clinical benefit rate (CBR),
overall survival (OS), and tolerability. Serum estra-
diol (E2) levels were measured in a subset of
patients at baseline and at 3 months.
723 patients at a median age of 64 years were
enrolled from82 centres in theUK and four in South
Korea. Prior AI had been given as adjuvant treat-
ment to 18 percent of patients for a median of 27.9
months, and to 82 percent of patients for locally ad-
vanced/metastatic disease for a median of 19.3
months. Treatment was well tolerated: serious ad-
verse events were rare.Median PFSwas 4.4months,
4.8 months, and 3.4 months for F+A, F and E, re-
spectively. As expected, longer PFS was positively
correlatedwith duration of prior AI exposure but no
interactionwith treatment was observed.No differ-
ences were observed for ORR, CBR and OS. 90.4 per-
cent of patients had E2 levels below 3.0pmol/l at
baseline,while at 3months E2mean values differed
as expected between patients treatedwith F+A (2.8
pmol/l) and F (15.0 pmol/l), confirming oestrogen
suppression with F+A.
In summary, SoFEA provides no evidence that
F+A (with F loading dose) is more effective than F
alone or E in patients with acquired resistance to
NSAI. Median PFS in SoFEA is similar to EFECT, and
the lack of added benefit for F+A is consistent with
Keynote Symposium: Key Messages to Take
Back to Your Practice on Monday Morning
Hall D
Date: 23/03/2012
From: 16:00 to 16:15
Late Breaking Trial on F+A
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