Annual Meeting Proceedings Part 1 - American Society of Clinical ...

110s Cancer Prevention/Epidemiology
1600^ General Poster Session (Board #9B), Sat, 1:15 PM-5:15 PM
Correlation of high body mass index and circulating tumor cell positivity in
patients with early-stage breast cancer. Presenting Author: Uta Ortmann,
Heinrich Heine University , Duesseldorf, Germany
Background: The prognostic relevance of both body mass index (BMI) and
circulating tumor cells (CTC) has been confirmed in different trials for
patients with early breast cancer. This analysis evaluates the correlation
between high BMI and CTC positivity as risk factors for reduced disease free
and overall survival. Methods: Data of 3658 patients of the SUCCESS A trial
have been analyzed. CTC count and BMI were documented before (N �
2026) and after (N � 1504) chemotherapy. Within this trial patients with
early breast cancer were randomized to two chemotherapy regimens and
received either 3 cycles of fluorouracil, epirubicin and cyclophosphamide
followed by 3 cycles of docetaxel (FE100C-Doc) or 3 cycles of fluorouracil,
epirubicin and cyclophosphamide followed by 3 cycles of docetaxel and
gemcitabine(FE100C-DG). In addition, patients were randomized to zoledronic
acid either for 2 or 5 years. CTC were analyzed using the CellSearch
System (Veridex, USA). Different groups of bodyweight were classified
according to the WHO’s international definition: Underweight (BMI � 18,5
kg/m2 ), normal range (BMI � 18,5- � 25), overweight (BMI �25- � 30),
obesity (BMI � 30). Correlation between CTC count and BMI was analyzed
using frequency-table methods. Results: At study entry 24 (1.2%) patients
were underweight, 952 (47%) patients were normal weight, 658 (32.5%)
patients were overweight and 392 (19.4%) patients were obese. Before the
start of chemotherapy, CTC were detected in 435 (21.5%) patients. We did
not find a correlation between CTC positivity and BMI (p�0.94). After
chemotherapy CTC were detected in 330 (16,3%) patients. Again, there
was no statistically significant correlation between BMI and CTC positivity
(p�0.86). In particular, CTC positivity was not observed more frequently in
obese patients neither before (p�0.70) nor after chemotherapy (p�0.95)
compared to patients with a BMI � 30 kg/m2 . Conclusions: As compared to
patients with normal BMI, there was no significant difference in the
prevalence of CTC in underweight, overweight and obese patients, respectively,
neither before nor after chemotherapy. The risk factors obesity and
prevalence of CTC seem to be independent prognostic factors.
1602 General Poster Session (Board #9D), Sat, 1:15 PM-5:15 PM
Correlation of BMI with tumor stage in early breast cancer patients (pts):
Pooled analysis of the German SUCCESS A, B, and C trials. Presenting
Author: Carola Anna Melcher, Department of Gynecology and Obstetric,
Heinrich Heine University, Duesseldorf, Germany
Background: Independent from known prognostic factors, e.g., tumor size
and nodal status, obesity is a risk factor for poor disease free, distant
disease free, and overall survival in breast cancer. The aim of this analysis
was to examine the correlation of the body mass index (BMI) with tumor
characteristics in early breast cancer. Methods: We analyzed the data of
7,997 pts with early, node positive or high risk node negative primary
breast cancer treated with adjuvant taxan-based chemotherapy within the
German multicenter phase III SUCCESS A, B, or C trials. The pts’ tumor
stage at primary diagnosis was classified according to the UICC tumor-nodemetastasis
(TNM) classification. Additionally, the tumor’s hormonereceptor
status and HER2/neu status were determined. Before enrollment
into the study each patient was grouped according to the WHO global
database on BMI. Contingency table methods were used to analyze the
correlation of BMI and tumor characteristics. Results: Among the 7,997 pts
100 (1.3%) pts were underweight, 3,556 (44.5%) pts were normal weight,
2,569 (32.1%) pts were overweight and 1,772 (22.2%) were obese. Of all
pts 4,508 pts (56.4%) suffered from a pT2-4 tumor, 4830 (60.4%)
showed lymph node involvement (pN1-3) and 7509 (93.9%) had G2-3
tumors. 5839 pts (73.0%) showed positivity for ER or PR and 935 (11.7%)
for HER2/neu. Overweight and obese pts had significantly larger tumors
compared to pts with normal BMI (p�0.0001; p�0.0001). Furthermore,
overweight and obesity were associated with a significantly higher rate of
lymph node involvement (p�0.0001; p�0.0003) respectively. In contrast
neither grading, tumor histology, ER/PR-status nor HER2/neu-overexpression
were correlated with BMI. Conclusions: These data are the first to show
in a large number of pts that both obese and overweight women suffering
from primary breast cancer have significantly larger tumors and more often
positive axillary lymph nodes. As there are no differences in tumor biology,
the advanced tumor stage might be due to more difficult and delayed
detection of breast cancer and lymph node lesions in these women.
1601 General Poster Session (Board #9C), Sat, 1:15 PM-5:15 PM
Evolution and landscape of clinical trials for breast cancer patients.
Presenting Author: Semih Dogan, Institut Gustave Roussy, Villejuif, France
Background: Recent advances in cancer research are expected to have
dramatically changed the way clinical trials are being done. In an effort to
outline new trends of clinical research in the breast cancer area, we have
evaluated the evolution of clinical trials started between 2006 and 2011.
Methods: 622 clinical trials, started during the first semester 2006, the
second semester 2008 and the first semester 2011, were analyzed. The
data source was Clinicaltrials.gov. 30 items were included in the database.
Results: The overall number of patients included in prospective clinical
trials increased over these periods (n�67,820, n�91,429, n�98,417).
However, when large epidemiological cohorts are excluded, a significant
fall in the number of patients is seen (n�67,820, n�44,554, n�37,417).
The absolute number of therapeutic trials also decreased during this time
(n�93, n�99, n�78), mainly related to the dramatic fall in the number of
trials testing conventional treatments (n�40, n�24, n�20). In the
meantime, the number of trials testing targeted agents remained similar
(n�46, n�67, n�50). Interestingly, in the same time, the number of trials
testing a targeted agent in a population defined by a biomarker increased
(n�1, n�6, n�14). At the opposite, prospective studies aimed at
validating biomarkers did not increase, and remained only driven by large
consortiums. As illustration, when we exclude RxPONDER trial, the
biomarker-validation studies opened in 2011 planned to include only 2
493 patients, representing 2% of the breast cancer research field.
Prospective trials testing social sciences and supportive care (n� 70,
n�72, n�70) tend to become as important as therapeutic trials. Finally,
large epidemiological cohorts opened in 2011 will represent more than
60% of the patients included in clinical trials. Conclusions: The part of
cohorts and social sciences in breast cancer research is increasing and
represents now the majority of the clinical research activity. When the
analysis focuses on therapeutic trials, the breast cancer field recently
shifted to targeted agents and early data suggest that therapeutic research
is increasingly incorporating companion biomarker. Analysis on all 2,762
clinical trials done between 2006 and 2011 will be presented.
1603 General Poster Session (Board #9E), Sat, 1:15 PM-5:15 PM
Effect of gender on age-specific effects for ulcerated malignant melanomas.
Presenting Author: Blakely S. Richardson, University Hospitals Case
Medical Center/Case Western Reserve University School of Medicine,
Cleveland, OH
Background: Gender, age at diagnosis, and ulceration are all independent
prognostic factors for melanoma. The purpose of this study was to further
examine the interactions among gender, age, and melanoma ulceration.
Methods: Using the NCI’s SEER 17 Registries Database (2004-2008), we
assessed ulceration status among White men and women with malignant
melanoma, stratified by younger (ages 10-39 years) and older (ages 40-84
years) ages at diagnosis as well as by tumor depth. The analysis was
restricted to melanomas common to both age groups, i.e. superficial
spreading, nodular, and unclassified melanomas. There were 2905 older
men, 301 younger men, 1624 older women and 276 younger women that
fit our criteria. Relative risks were expressed as incidence rate ratios (IRR)
with 95% confidence intervals (CI). Results: At every tumor depth, IRRs for
ulcerated melanomas were significantly higher for older than younger
persons (IRR�1.0). The trend, however, was different in men as compared
to women. In men, the IRR (older to younger) rose continuously with
increasing depth [�1.0mm: IRR 7.81 (CI 6.18-9.98), 1.01mm-�2.0mm:
IRR 9.71 (CI 7.55-12.68), 2.01mm-�4.0mm: IRR 11.04 (CI 8.78-
14.06); and �4.01mm: IRR 12.26 (CI 9.60-15.87)]. On the other hand,
in women, IRR (older to younger) was stable for all depths �4.0mm then
nearly doubled for melanomas �4.01mm [�4.01mm: IRR 8.00 (CI
5.85-11.20)]. The IRR trend analysis was statistically significant for men
(p � 0.01) but not for women (p � 0.34). Conclusions: Our study confirms
that older age at diagnosis is associated with higher incidence rates of
ulcerated malignant melanomas. This large-scale population-based analysis
also shows an effect modification by gender and tumor thickness,
suggesting different biologic behavior in melanoma in younger and older
men and women. Future studies should further investigate tumor biology
differences in these populations and the interactions among gender, age at
diagnosis, and ulceration in melanoma.
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