A registry of patients with inflammatory bowel diseases, ulcerative colitis (UC) and Crohn's disease (CD), was created at the University of Puerto Rico in 1995. Subjects with a documented diagnosis of IBD by clinical, radiologic, endoscopic, and/or pathologic criteria were recruited from the IBD clinics, support groups, and community practices, and demographic and medical data was collected. All entries from 1995 to 2009 were analyzed for demographics, family history, disease extent, extraintestinal manifestations, surgery, and smoking history. Results were described using summary statistics. 635 Hispanics living in Puerto Rico, 299 with UC and 336 with CD, were included. Mean ages were 40.3 for UC and 30.9 for CD. Over half (56%) of UC and 41% of CD were females. Family history was present in 19.3% of UC and 17.5% of CD. Surgery for IBD had been performed in 31.9% of UC and 51.2% of the CD patients. Over one-fourth of the patients reported extraintestinal manifestations, most frequently arthropathies. Our findings contribute to the limited epidemiologic and clinical data on Hispanics with IBD.

No abstract

No abstract

e11610 Background: Achieving a pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) has been associated with improved disease free survival (DFS) and overall survival (OS). The Residual Cancer Burden Score (RCB) method is a useful tool that predicts DFS and OS after NAC. We present the results of pts with either triple negative or HER2 positive breast cancer treated with a novel NAC. Methods: 34 pts with localized breast cancer >1 cm with HER2+ (N=19) or triple negative breast cancer (TNBC) (N=15) were treated with this novel regimen consisting first of TEC (docetaxel 75 mg/m2, epirubicin 80 mg/m2, and cyclophosphamide 500 mg/m2) + PEG Filgrastim x 4 cycles. Following the 4th course, TNBC patients received 4 additional TEC cycles if they achieved CR by MRI, or were switched to a non cross-resistant regimen (vinorelbine, bevacizumab, capecitabine) if they had < CR. HER2+ pts received TEC x4 followed by docetaxel + trastuzumab x 4. RCB score was used to measure pathologic response. Pretreament PET scan was done and repeated after course 1 in order to correlate with RCB. Results: Median age was 56 (58 for Her2+ and 49 for TNBC). RCB= 0 (pCR) was achieved in 76%, while only 1 responded poorly (RCB=3). There was no significant difference in the pCR rate between Her2+ and TNBC patients (74% vs 80% respectively), but there was a difference in the rate of pCR without DCIS and invasive cancer between these two (see table, p=0.034). Pts with SUV drop > 5% after 1st TEC had 84% pCR while none with < 5% achieved pCR (p=0.001). Comparison of our results with other NAC regimens reported in the literature is summarized in the table below. Conclusions: This novel chemotherapy approach results in a high pCR rate and RCB 0-1, which have been associated with improved clinical outcomes. Early PET can predict pCR. Although sample size is modest, results are encouraging and deserve further evaluation. Clinical trial information: NCT 00830544. [Table: see text]

e11015 Background: Oncotype Dx (OD) is a commercially available gene-profiling test that has been shown to be effective in predicting risk of recurrence after therapy with CMF or Tamoxifen. The aim of our study is to develop a method that uses easily available clinical data to predict cases with favorable OD category (ODC). Methods: We identified 145 ER+/Her-2 neg cases that had information on histologic grade (HG), PR status and Oncotype Dx Category (ODC). Of these, 75 also had information on Ki-67. We evaluated HG, ER status, PR status, Nottingham score and tumor size for their correlation with ODC using multiple regression analysis. Results: The median tumor size was 12.0 mm (0.6-45). 33.7% were HG 1, 54% were grade 2, and 12% were grade 3. 88% were invasive ductal carcinomas, 9% were invasive lobular carcinomas, 3% were other types. The median OD score was 15 (0-57) with 86 (59%) ODC=1, 53 (37%) ODC=2 and 6 (4%) ODC=3; median Ki-67 was 11% (1-50). In a multivariate analysis excluding Ki-67, the only factors that were significantly correlated with ODC were PR status and HG (p= 0.004). PR status had the strongest overall association with ODC (P=0.008). Defining PR> 60% with HG=1 as a positive result we calculated the positive predictive value (PPV) or the capacity to predict cases with ODC=1, as 85% and negative predictive value (NPV) as 46%. None of the cases with PR> 60% and HG=1 had an ODC=3 (high risk). A patient with a favorable ODC=1 was considered as a positive case for purpose of calculating PPV, NPV, sensitivity and specificity. Sensitivity to detect positive cases was 26% and specificity was 93%. We explored a 2nd model that included Ki-67 and found that only PR >60% and Ki-67 >11% significantly correlated with ODC (p=0.004). PR status again had the strongest overall association with ODC (P=0.007) followed by Ki-67 (P=0.019). HG was not significant in the 2nd multivariate model because of its strong correlation with Ki-67. PPV for this 2nd model was 79% and NPV=50%. Conclusions: 1-Pts who have PR>60% with HG=1 are highly likely to have a favorable ODC=1, however the ODC of pts with either PR<60% or HG>1 is not predictable with either of our two models. 2- The use of Ki-67 doesn’t add much to the capacity of the model to predict ODC. 3- PR is the strongest predictive factor in the model.