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sector patients. The aim of this study is to characterize how assay results impact the
decision-making process and confidence of public sector physicians in Mexico to
determine adjuvant therapy. This is the first decision impact study of the Oncotype
DX assay in Latin America.
Methods: At total of 98 consecutive patients with ER + , HER2-, stage I-IIIa, N0/
N1-3 breast cancer from the Instituto Nacional de Cancerologia in Mexico City,
Mexico, were enrolled in the study. Via consensus discussion in multidisciplinary
team meetings, physicians completed pre- and post-assay questionnaires
regarding adjuvant treatment recommendations for each enrolled patient. The
primary endpoint was the overall change in physician treatment
recommendations resulting from the addition of the Recurrence Score® result in
the decision-making process.
Results: Pre- and post-assay results were available for 96 patients. Treatment
decisions changed for 31/96 (32%: 95% CI 23%-43%) patients; 17/62 (27%; 95%
CI 17%-40%) N0 and 14/34 (41%; 95% CI 25%-59%) N1-3 patients. Post-assay,
8/50 (16%) of patients initially recommended hormonal therapy (HT) were
recommended chemohormonal therapy (CHT) or CT, and 21/46 (46%) of
patients initially recommended CHT/CT were recommended HT alone. The
proportion of patients recommended CT decreased from 48% pre- to 34%
post-assay (p = 0.024), a decrease of 14% overall, 6% in N0, and 26% in N1-3
patients.
Conclusions: These results suggest that use of the 21-gene assay in the Mexican
public health system has an impact on adjuvant treatment recommendations and
may reduce the use of chemotherapy.
Pre-Assay
Post-Assay
Adjuvant Therapy HT alone CT + HT CT alone Total
HT alone 42 (44%) 7 (7%) 1 (1%) 50 (52%)
CT + HT 21 (22%) 23 (24%) 2 (2%) 46 (48%)
Total 63 (66%) 30 (31%) 3 (3%) 96
Disclosure: C. Yoshizawa: Genomic Health- Employment and Stockholder. E. Burke:
Genomic Health- Employment and Stockholder. C. Chao: Genomic Health-
Employment and Stockholder. All other authors have declared no conflicts of
interest.
290P BROWN FAT SEEN ON FDG PET/CT IS INCREASED IN
BREAST CANCER PATIENTS COMPARED TO THEIR AGE-
AND WEIGHT-MATCHED CONTROLS WITH OTHER CANCERS
K.H.R. Tkaczuk 1 , Q. Cao 2 , L. Jones 1 , M. Smith 2 , S. Chumsri 1 , J. Jenkins 2 ,
V. Dilsizian 2 , W. Chen 2
1 Medicine, University of Maryland Greenebaum Cancer Center, Baltimore, MD,
UNITED STATES OF AMERICA, 2 Radiology, University of Maryland, Baltimore,
MD, UNITED STATES OF AMERICA
Purpose: We previously found increased brown fat deposits in mammary tissue of
Rrca1 mutant breast cancer mouse models suggesting a potential role of brown fat
environment in the early breast tumorigenesis. The goal of the current human study
is to test the hypothesis that the prevalence of brown fat activity seen on FDG PET/
CT is increased in breast cancer (BC) patients.
Methods: We conducted a retrospective study to assess the distribution and
intensity of brown fat activity on FDG PET/CT in female BC patients compared to
age- and weight-matched control subjects with other cancers mostly colon cancer.
We analyzed 124 FDG PET/CT scans of BC patients done at the University of
Maryland and 124 age- and weight-matched control subjects who had FDG PET/
CT scan on the same day for staging of other cancers (the majority were colon
cancer).
Results: The prevalence of brown fat was higher in BC (12.9% or 16/124) than
in their age- and weight-matched control subjects (5.6% or 7/124) (p < 0.05).
When the data was stratified by age, among those who were ≤ 50 years old, the
prevalence of brown fat was 35.5% (11/31) in BC patients versus 9.1% (3/33) in
the controls (p 50 years of age,
there was no difference in brown fat prevalence between BC patients and
controls (5.4% or 5/93 vs 4.4% or 4/91; p = NS), respectively. Brown fat was
more commonly identified in the bilateral supraclavicular regions in BC patients
than controls (22 vs 6, p = 0.049). There was no difference in the intensity of
brown fat between the 2 groups (mean SUV max = 3.5 ± 1.5 in BC vs 3.4 ± 0.7 in
controls, p = NS).
Conclusion: The prevalence of brown fat seen on FDG PET/CT is increased in BC
patients compared to their age- and weight-matched controls with other cancers,
particularly in patients aged 2 cm, number of positive LN
(≥4), high tumor grade (G3), and negativity of hormone receptor in univariate
analyses. However, in multivariate analyses, number of positive LN ≥4 (HR = 2.47;
95% CI, 1.07-5.74; p = 0.035), high tumor grade (HR = 2.76; 95% CI, 1.08-7.09, p =
0.034), and over-expression of p53 (HR = 6.55; 95% CI, 2.40-17.85, p < 0.001) were
independent poor prognostic factors for RFS. And p53 over-expression was also
related to poor OS (HR = 3.93; 95% CI, 1.04-14.81, p = 0.044). Patients with high p53
expression (≥10% of positive cells) tended to have tumors with large size, higher
grade and lower hormone receptor positivity compared to those of low p53
expression.
Conclusions: p53 over-expression along with number of positive LN and tumor
grade was found to be useful biomarker to predict poor outcomes in patients with
LN-positive breast cancer receiving docetaxel-based adjuvant chemotherapy.
Disclosure: All authors have declared no conflicts of interest.
292P SERUM LEVELS OF VEGF PRE- AND POST-TREATMENT
WITH BEVACIZUMAB (BEV) FOR EARLY STAGE BREAST
CANCER (ESBC): ICORG 08-10
A.M. Canonici 1 , I. Parker 2 ,T.O’Shea 2 , B. Moulton 2 , G. Gullo 3 , M.J. Kennedy 4 ,
D. Tryfonopoulos 5 , N. Walsh 6 ,N.O’Donovan 6 , J.P. Crown 7
1 NICB, Dublin City University, Dublin, IRELAND, 2 ICORG, Dublin, IRELAND,
3 St Vincent’s University Hospital, Department of Medical Oncology, Dublin,
IRELAND, 4 Dept Medical Oncology, St James’s Hospital, Dublin, IRELAND,
5 Medical Oncology Unit, St Vincents University Hospital, Dublin, IRELAND,
6 National Institute for Cellular Biotechnology, Molecular Therapeutics for Cancer
Ireland, Dublin City University, Dublin, IRELAND, 7 Department of Medical
Oncology, St Vincents University Hospital, Dublin, IRELAND
Background: Angiogenesis, partly mediated by vascular endothelial growth factor
(VEGF), promotes metastases. BEV, an anti-VEGF monoclonal antibody which has
some efficacy in metastatic BC is being studied as an adjuvant treatment for ESBC.
However, there are no validated biomarkers, and the effects of BEV on VEGF levels
in pts with ESBC is unknown. We studied VEGF serum concentration in ESBC
receiving BEV.
Methods: 106 pts with HER-2 negative ESBC were included in this study. Patients
received 4 cycles of docetaxel (75 mg/m2) + cyclophosphamide (600 mg/m2) with
BEV (15 mg/kg) once every three weeks for one year. Serum samples were collected
prior to commencement of treatment, at 6 months and 12 months. The VEGF levels
in serum samples were determined, at each time point, using a VEGF enzyme-linked
immunosorbent assay (ELISA).
Results: VEGF concentration was determined in serum samples from 65 patients.
Serum VEGF was detectable in 62 of 65 patients and the median level in untreated
patients was 325.4 pg/ml (range 0.1 - 924.8 pg/ml). All of the 62 patients showed a
significant decrease in VEGF concentration after 6 and 12 months of treatment
(median 9 ± 42.1 pg/ml, p < 0.001 and 9 ± 43.9 pg/ml, p < 0.001 respectively). No
significant change in median VEGF levels observed at 12 months compared to 6
months (median 0 ± 60.3 pg/ml, p = 0.704). However, in 14 patients the levels of
VEGF detected at 12 months were higher than at 6 months following treatment (p =
0.045).
Conclusion: Adjuvant therapy with chemotherapy and BEV is associated with a
significant reduction in VEGF levels at 6 months.
Disclosure: All authors have declared no conflicts of interest.
ix108 | Abstracts Volume 23 | Supplement 9 | September 2012