Background: The multicentre, retrospective NEMESI study examined the clinical practice in the Italian Oncology Centers, with a focus on ER, Ki67 and HER2 status in the EBC adjuvant chemotherapy
(CT). We report here parameters influencing the decision to administer adjuvant CT and the selection of treatment. Methods: NEMESI described adjuvant treatment of EBC in Italy between Jan 1 and
June 30, 2008. Participating Centers were selected among those censed by the Italian Association of Medical Oncology, in order to closely represent the Italian scenario. In total, 1894 consecutive
patients (pts) from 63 Centres (30 from each Centre) were included. Inclusion criteria: age ≥18 years, surgical EBC histological diagnosis (stage I-II TNM AJCC version VI), ≥1 cycle of
adjuvant CT and/or hormone therapy. Negative biological expression was defined as: ER and PgR <10%, HER2 negative <3+ by ICH and/or FISH not amplified. Results: Biological expression was:
HER2+: 305 (16.1%) pts, HER2-: 1,463 (77.2%), missing: 126 (6.7%); ER+: 1,538 (81.2%), ER- 352 (18.6%), missing: 4 (0.2%); Ki67 or MIB-1 >19%: 842 (44.5%), Ki67 or MIB-1 <20%: 999 (52.7%),
missing: 53 (2.8%). 1095/1894 (57.8%) pts received adjuvant CT. In 1841/1894 (97.2%) pts, a biological subtype was identified by matching ER, HER2, Ki67 or MIB1. In the ER+/HER2- group, Ki67/MIB1
is crucial for the prescription of adjuvant CT: 37.5% and 62.3% of pts received adjuvant CT with Ki67/MIB1<20% and with ki67/MIB1>19%, rispectively. Among 1061/1095 pts receiving adjuvant CT,
type of treatment was not influenced by biological classifications. Conclusions: Ki67/MIB1 plays a key role in the decision to prescribe adjuvant CT in endocrine-sensitive EBC. Type of CT selected
is not influenced by biological subtype. Sponsored by Sanofi-Aventis Italy.
|
CMF-like
N %
|
Anthracyclines
N %
|
Anthra and Taxanes
N %
|
Taxanes
N %
|
Total
|
|
Not Classified
|
9
|
14.8
|
26
|
42.6
|
23
|
37.7
|
3
|
4.9
|
61
|
|
ER+ HER2+ Ki67>19
|
4
|
3.7
|
57
|
53.3
|
43
|
40.2
|
3
|
2.8
|
107
|
|
ER+ HER2+ Ki67<20
|
3
|
5.8
|
22
|
42.3
|
27
|
51.9
|
0
|
0.0
|
52
|
|
ER+ HER2- Ki67>19
|
26
|
9.7
|
131
|
48.7
|
101
|
37.5
|
11
|
4.1
|
269
|
|
ER+ HER2- Ki67<20
|
29
|
10.1
|
137
|
47.9
|
106
|
37.1
|
14
|
4.9
|
286
|
|
ER- HER2+ Ki67>19
|
4
|
4.9
|
44
|
53.7
|
33
|
40.2
|
1
|
1.2
|
82
|
|
ER- HER2+ Ki67<20
|
0
|
0.0
|
10
|
58.8
|
7
|
41.2
|
0
|
0.0
|
21
|
|
ER- HER2- Ki67<20
|
3
|
11.1
|
13
|
48.1
|
9
|
33.3
|
2
|
7.4
|
27
|
|
ER- HER2- Ki67>19
|
16
|
10.0
|
80
|
50.0
|
57
|
35.6
|
7
|
4.4
|
160
|
|
Total
|
94
|
8.9
|
520
|
49.0
|
406
|
38.3
|
41
|
3.9
|
1061
|