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PURPOSE: To examine outcomes of incidental liver lesions on baseline breast magnetic resonance imaging (MRI) that were further evaluated with dedicated abdominal imaging. METHODS: Consecutive breast MRI reports from 2011–2016 were retrospectively reviewed to identify incidental liver lesions. Only patients without prior breast MRI, without prior abdominal imaging, and with subsequent abdominal imaging were included. Patient demographics, breast MRI indication, and final liver lesion diagnosis were recorded. RESULTS: Of 131 women (mean age 53.8 years), 94/131 (71.8%) underwent breast MRI for extent of disease evaluation, 25/131 (19.1%) for high-risk screening, 11/131 (8.4%) for implant evaluation, and 1/131 (0.8%) for problem-solving. Of 131 liver lesions (6–80 mm), 117/131 (89.3%) were deemed benign on subsequent abdominal imaging; 10/131 (7.6%) probably benign; and 4/131 lesions (3.1%) were confirmed breast cancer metastases. Metastatic liver lesions identified on breast MRI were more likely for women with a current diagnosis of breast cancer than for women without a current diagnosis of breast cancer: 4.3% vs 0%. Similarly, metastatic liver lesions identified on breast MRI were more likely for those with a higher prognostic stage (2 or 3) vs a lower prognostic stage (0 or 1) or no current breast cancer: 11.1% vs 0%. CONCLUSION: Baseline breast MRIs showing incidental liver lesions showed unsuspected liver metastases only in women with a current diagnosis of clinical stage 2 or 3 breast cancer. This suggests breast MRI indication and clinical staging of current breast cancer, if present, can help plan management and decisions to obtain follow-up of liver lesions.

Introduction: Lutetium-177 (177Lu)-DOTATATE received FDA approval in 2018 to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (NETs). Little data are available on response and outcomes for well-differentiated (WD) high-grade (HG) NETs treated with 177Lu-DOTATATE. Materials and Methods: Patients with WD HG NETs treated with 177Lu-DOTATATE at MSK from 2018 to 2020 were identified. Demographics, response (RECIST 1.1), and progression-free survival (PFS) were determined. Next-generation sequencing (NGS) was performed in the archival tumor. Results: Nineteen patients, all with progressive, heavily treated disease, were identified. Sites of tumor origin were: pancreas (74%), small bowel (11%), rectum (11%), and lung (5%); median Ki-67 was 32% (range 22–56). Thirteen patients (68%) completed all four 177Lu-DOTATATE cycles. Best response (N = 18 evaluable) was: 5/18 (28%) partial response, 8/18 (44%) stable disease, and 5/18 (28%) disease progression. Median PFS was 13.1 months (95% CI: 8.7–20.9). Most common treatment-related toxicities were thrombocytopenia (9 patients, 47%; G3/4, 1 patient, 5%), anemia (7 patients, 37%; G3/4, 2 patients, 11%), leukopenia (6 patients, 32%; G3/4, 0 patients), and liver function test elevation (4 patients, 21%; G3/4, 0 patients). NGS results were available from 13/19 tumors (68%). The most observed alterations were in MEN1 (6/13, 46%) and DAXX (4/13, 31%). No RB1 alterations identified. Conclusion: We observed a meaningful disease control rate of 72% during treatment of WD HG NETs with 177Lu-DOTATATE. In this heavily pre-treated population, more than half of patients received all four treatment cycles with toxicities largely bone marrow-related. As would be expected in WD NETs, the vast majority had alterations in chromatin remodeling genes and no RB1 alterations.

The purpose of the current study was to develop a deep learning technique called Golden-angle RAdial Sparse Parallel Network (GRASPnet) for fast reconstruction of dynamic contrast-enhanced 4D MRI acquired with golden-angle radial k-space trajectories. GRASPnet operates in the image-time space and does not use explicit data consistency to minimize the reconstruction time. Three different network architectures were developed: (1) GRASPnet-2D: 2D convolutional kernels (x,y) and coil and contrast dimensions collapsed into a single combined dimension; (2) GRASPnet-3D: 3D kernels (x,y,t); and (3) GRASPnet-2D + time: two 3D kernels to first exploit spatial correlations (x,y,1) followed by temporal correlations (1,1,t). The networks were trained using iterative GRASP reconstruction as the reference. Free-breathing 3D abdominal imaging with contrast injection was performed on 33 patients with liver lesions using a T1-weighted golden-angle stack-of-stars pulse sequence. Ten datasets were used for testing. The three GRASPnet architectures were compared with iterative GRASP results using quantitative and qualitative analysis, including impressions from two body radiologists. The three GRASPnet techniques reduced the reconstruction time to about 13 s with similar results with respect to iterative GRASP. Among the GRASPnet techniques, GRASPnet-2D + time compared favorably in the quantitative analysis. Spatiotemporal deep learning enables reconstruction of dynamic 4D contrast-enhanced images in a few seconds, which would facilitate translation to clinical practice of compressed sensing methods that are currently limited by long reconstruction times.

Purpose To evaluate the gender and racial diversity of plenary session speakers in the annual meetings of Society of Abdominal Radiology (SAR) over 2016 to 2020. Materials and methods The brochures of the SAR annual meetings were reviewed for plenary session speakers and titles. Publicly available institutional profiles and social media were reviewed by the investigator in order to infer gender and race. Gender assessments were men, women, transgender men, transgender women or gender non-binary. Race was classified as White, Black or African American, American Indians and Alaskan Natives, Asian, Native Hawaiian and Pacific Islander and Multiracial. Statistical analysis was performed using chi square and T-tests. Results Based on self-reported data, the SAR has 64% male and 36% female members. Over 2016–2020, plenary session speakers were more likely to be men [69.6% (183/263)] than women [30.4% (80/263)] (p-value = 0.0007). No speakers could be reliably identified as transgender, gender non-binary or gender expansive. In 2016, there were 24% women plenary speakers. This proportion was 28% in 2017, 33% in 2018 and 36% in 2019, and 30% in 2020. When assessing racial distribution, white speakers accounted for the majority of plenary speakers, ranging from 61 to 78%. Asians speakers accounted for 22 to 35%. There were no Black and African American, American Indian & Alaskan Native, Native Hawaiian & Pacific Islander plenary speakers (0%). Multiracial speakers were represented from 2018 to 2020, accounting for 2–4% speakers (p-value Conclusions Plenary speakers at SAR Annual Meetings from 2016–2020 were more likely to be men, but with the proportion of women presenters increasing over time. White speakers represented the majority of plenary session speakers, followed by Asians. No plenary session speakers were identified as Black or African American or Native Americans. Graphical Abstract

Artificial Intelligence (AI) continues to shape the practice of radiology, with imaging of hepatocellular carcinoma (HCC) being of no exception. This article prepared by members of the LI-RADS Treatment Response (TR LI-RADS) work group and associates, presents recent trends in the utility of AI applications for the volumetric evaluation and assessment of HCC treatment response. Various topics including radiomics, prognostic imaging findings, and locoregional therapy (LRT) specific issues will be discussed in the framework of HCC treatment response classification systems with focus on the Liver Reporting and Data System treatment response algorithm (LI-RADS TRA).

Categorization of radiological images according to characteristics such as modality, scanner parameters, body part etc, is important for quality control, clinical efficiency and research. The metadata associated with images stored in the DICOM format reliably captures scanner settings such as tube current in CT or echo time (TE) in MRI. Other parameters such as image orientation, body part examined and presence of intravenous contrast, however, are not inherent to the scanner settings, and therefore require user input which is prone to human error. There is a general need for automated approaches that will appropriately categorize images, even with parameters that are not inherent to the scanner settings. These approaches should be able to process both planar 2D images and full 3D scans. In this work, we present a deep learning based approach for automatically detecting one such parameter: the presence or absence of intravenous contrast in 3D MRI scans. Contrast is manually injected by radiology staff during the imaging examination, and its presence cannot be automatically recorded in the DICOM header by the scanner. Our classifier is a convolutional neural network (CNN) based on the ResNet architecture. Our data consisted of 1000 breast MRI scans (500 scans with and 500 scans without intravenous contrast), used for training and testing a CNN on 80%/20% split, respectively. The labels for the scans were obtained from the series descriptions created by certified radiological technologists. Preliminary results of our classifier are very promising with an area under the ROC curve (AUC) of 0.98, sensitivity and specificity of 1.0 and 0.9 respectively (at the optimal ROC cut-off point), demonstrating potential usefulness in both clinical as well as research settings.

Introduction This prospective study assessed the safety and outcomes of selective internal radiation therapy (SIRT) using yttrium-90 ( 90 Y) resin microspheres as a salvage therapy for liver-predominant metastases of colorectal cancer in patients with documented progression after hepatic arterial chemotherapy (HAC) and systemic chemotherapy. Patients and Methods We recruited 19 patients who had received a mean of 2.9 prior lines of chemotherapy and ≥ 1 line of HAC. Dose-limiting toxicities (grade 3 or higher) were catalogued using Common Terminology Criteria for Adverse Events version 3.0. At 4 to 8 weeks and 3 to 4 months post SIRT, responses were assessed by carcinoembryonic antigen (CEA), and quantitative imaging using Response Evaluation Criteria in Solid Tumors (RECIST) and PET Response Criteria in Solid Tumors (PERCIST). Liver progression-free survival (LPFS), progression-free survival (PFS), and overall survival (OS) were calculated using Kaplan-Meier methodology. Results Median follow-up was 31.2 months after SIRT. Within 6 weeks of SIRT, 3 patients (15.8%) experienced grade 3 toxicity. There was no incidence of radiation-induced liver disease. Responses by RECIST, PERCIST, and CEA were, respectively, 0%, 20%, and 32% at 4 to 8 weeks and 5%, 33%, and 21% at 3 to 4 months post SIRT; 53% of patients had stable disease (by RECIST) at 3 to 4 months. Of 19 patients, 4 (21.1%) had liver ablation, 9 (47%) received additional HAC, and 17 (89%) received systemic chemotherapy after SIRT. Median LPFS, PFS, and OS after SIRT were 5.2 months, 2.0 months, and 14.9 months, respectively. Conclusion SIRT was well tolerated and did not prohibit subsequent treatment, resulting in a median OS of 14.9 months in this heavily pretreated population.

Background and Objectives Solid and cystic splenic masses discovered on imaging studies often pose diagnostic and management dilemmas. This study analyses a large series of splenectomies to identify preoperative factors associated with malignant splenic masses. Methods Pathology records at a single institution were reviewed for all splenectomies. Those performed as a component of a larger resection, such as staging or debulking were excluded. Demographic and clinicopathologic factors were obtained. Univariate and multivariate analyses identified factors associated with an increased risk of malignancy. Results Between 1986 and 2012, 2,743 patients underwent a splenectomy, 148 of which were performed for lesions identified on imaging. The indications were suspicion of malignancy (120, 81%), growth over time (28, 19%), or symptoms (39, 26%). Resected splenic lesions were malignant in 93 patients (63%); the most common pathologies included ovarian cancer (n = 39), melanoma (n = 14), and colorectal cancer (n = 9). On multivariate analysis of clinicopathologic factors, a previous history of cancer was the only independent predictor of malignancy in the splenic lesion (odds ratio 6.3; 95% CI, 2.32–16.97; P = 0.001). Conclusion While the spleen is an uncommon site of metastatic disease, in patients with a history of cancer, splenic masses selected for resection are frequently malignant. J. Surg. Oncol. 2013; 108:521–525. © 2013 Wiley Periodicals, Inc.

This study was designed to evaluate the relationship between the minimal margin size and local tumor progression (LTP) following CT-guided radiofrequency ablation (RFA) of colorectal cancer liver metastases (CLM).An institutional review board-approved, HIPPA-compliant review identified 73 patients with 94 previously untreated CLM that underwent RFA between March 2003 and May 2010, resulting in an ablation zone completely covering the tumor 4-8 weeks after RFA dynamic CT. Comparing the pre- with the post-RFA CT, the minimal margin size was categorized to 0, 1-5, 6-10, and 11-15 mm. Follow-up included CT every 2-4 months. Kaplan-Meier methodology and Cox regression analysis were used to evaluate the effect of the minimal margin size, tumor location, size, and proximity to a vessel on LTP.Forty-five of 94 (47.9 %) CLM progressed locally. Median LTP-free survival (LPFS) was 16 months. Two-year LPFS rates for ablated CLM with minimal margin of 0, 1-5 mm, 6-10 mm, 11-15 mm were 26, 46, 74, and 80 % (p 0.011). Minimal margin (p = 0.002) and tumor size (p = 0.028) were independent risk factors for LTP. The risk for LTP decreased by 46 % for each 5-mm increase in minimal margin size, whereas each additional 5-mm increase in tumor size increased the risk of LTP by 22 %.An ablation zone with a minimal margin uniformly larger than 5 mm 4-8 weeks postablation CT is associated with the best local tumor control.

Purpose To identify and compare predictors of local tumor progression (LTP)-free survival (LTPFS) after radiofrequency (RF) ablation and microwave (MW) ablation of colorectal liver metastases (CLMs). Materials and Methods This is a retrospective review of CLMs ablated from November 2009 to April 2015 (110 patients). Margins were measured on contrast-enhanced computed tomography (CT) 6 weeks after ablation. Clinical and technical predictors of LTPFS were assessed using a competing risk model adjusted for clustering. Results Technique effectiveness (complete ablation) was 93% (79/85) for RF ablation and 97% (58/60) for MW ablation (P = .47). The median follow-up period was significantly longer for RF ablation than for MW ablation (56 months vs. 29 months) (P .001). There was no difference in the local tumor progression (LTP) rates between RF ablation and MW ablation (P = 0.84). Significant predictors of shorter LTPFS for RF ablation on univariate analysis were ablation margins 5 mm or smaller (P .001) (hazard ratio [HR]: 14.6; 95% confidence interval [CI]: 5.2–40.9) and perivascular tumors ( P = .021) (HR: 2.2; 95% CI: 1.1–4.3); both retained significance on multivariate analysis. Significant predictors of shorter LTPFS on univariate analysis for MW ablation were ablation margins 5 mm or smaller (P .001) (subhazard ratio: 11.6; 95% CI: 3.1–42.7) and no history of prior liver resection (P .013) (HR: 3.2; 95%: 1.3–7.8); both retained significance on multivariate analysis. There was no LTP for tumors ablated with margins over 10 mm (median LTPFS: not reached). Perivascular tumors were not predictive for MW ablation (P = .43). Conclusions Regardless of the thermal ablation modality used, margins larger than 5 mm are critical for local tumor control, with no LTP noted for margins over 10 mm. Unlike RF ablation, the efficiency of MW ablation was not affected for perivascular tumors.

Introduction Schwannomas are usually benign nerve sheath tumors, which typically arise in the head, neck, spinal cord and extremities. Schwannoma of the biliary tract is an extremely rare finding. Patients generally lack symptoms and seek medical attention when tumor growth causes obstructive jaundice. Preoperative diagnosis is difficult and resection is the treatment of choice. Methods A 54 year-old female with history of back and right labia minor melanoma for which she underwent complete excision and right inguinal lymph node dissection more than 10 years ago, was evaluated for new onset gastroesophageal reflux symptoms and found to have markedly abnormal liver enzymes. Imagining studies revealed intrahepatic ductal dilatation and a 5.2 cm mass in the porta hepatis that was not consistent with cholangiocarcinoma or hepatocellular carcinoma. Multiple percutaneous biopsies of the mass failed to provide a definitive diagnosis. With a high clinical suspicion of metastatic melanoma and no other evident sites of disease, operative intervention was undertaken for diagnosis and definitive treatment. Results Diagnostic laparoscopy was performed initially, but access to the mass was difficult, given its location. Subsequently, the patient underwent laparotomy, with tumor excision, common bile duct resection and hepato-jejunostomy. Pathologic examination and analysis were consistent with cellular schwannoma. Postoperatively, the patient recovered uneventfully, and liver function studies returned to normal. Conclusion Schwannomas are uncommon tumors, which very rarely arise from the biliary tract and cause biliary obstruction. Exploration is indicated in order to establish the diagnosis and to render definitive treatment.

Solid and cystic splenic masses discovered on imaging studies often pose diagnostic and management dilemmas. This study analyses a large series of splenectomies to identify preoperative factors associated with malignant splenic masses.Pathology records at a single institution were reviewed for all splenectomies. Those performed as a component of a larger resection, such as staging or debulking were excluded. Demographic and clinicopathologic factors were obtained. Univariate and multivariate analyses identified factors associated with an increased risk of malignancy.Between 1986 and 2012, 2,743 patients underwent a splenectomy, 148 of which were performed for lesions identified on imaging. The indications were suspicion of malignancy (120, 81%), growth over time (28, 19%), or symptoms (39, 26%). Resected splenic lesions were malignant in 93 patients (63%); the most common pathologies included ovarian cancer (n = 39), melanoma (n = 14), and colorectal cancer (n = 9). On multivariate analysis of clinicopathologic factors, a previous history of cancer was the only independent predictor of malignancy in the splenic lesion (odds ratio 6.3; 95% CI, 2.32-16.97; P = 0.001).While the spleen is an uncommon site of metastatic disease, in patients with a history of cancer, splenic masses selected for resection are frequently malignant.

The major ampullate glands of the spider Nephila clavipes contain approximately 0.2 microliter each of a highly concentrated (approximately 50%) solution of silk fibroin. Therefore, the reservoir of silk in these glands presents an ideal opportunity to observe prefolded conformations of a protein in its native state. To this end, the structure and conformation of major ampullate gland silk fibroin within the glands of the spider N. clavipes were examined by 13C NMR spectroscopy. These results were compared to those from silk protein first drawn from the spinneret and then denatured. The 13C NMR chemical shifts, along with infrared and circular dichroism data, suggest that the silk fibroin in the glands exists in dynamically averaged helical conformations. Furthermore, there is no evidence of proline residues in U-(13)C-D-glucose-labeled silk. This transient prefolded "molten fibril" state may correspond to the silk I form found in Bombyx mori silk. There is no evidence of the final beta-sheet structure in the ampullate gland silk fibroin before final silk processing. However, the conformation of silk in the glands appears to be in a highly metastable state, as plasticization with water produces the beta-sheet structure. Therefore, the ducts connecting the ampullate glands to the spinnerets play a larger role in silk processing than previously thought.

358 Background: BRCA1, BRCA2, and PALB2 germline mutations are associated with an increased risk of PC. Other BRCA-associated cancers have demonstrated increased sensitivity to PARP inhibitors (PARPi) and early trials have shown activity of PARPi in untreated BRCAmut PC. We evaluated theactivity of V in patients with previously treated BRCA/PALB2mutPC. Methods: Eligibility: BRCA1/2, or PALB2mutPC, at least 1 and up to 2 prior treatment regimens, measurable stage III/IVPC; ECOG 0-1. Treatment Plan: V 300mg BID (N= 3 pts), then V 400mg BID day1- 28. Primary endpoint: RECIST 1.1 response rate (RR). Statistical plan: Single-arm, non-randomized, open-label, phase II, two-stage design, unacceptable RR 10%, promising 28%, type I, II error rates 10%. Secondary endpoints: progression-free survival (PFS), duration of response, overall survival, safety, tolerability and archival tumor analyses. Results: Between 05/12 and 12/13, N= 16 enrolled. Male= 8, Female= 8. Median age= 52 years (range 43- 77). BRCA1 mut=5. BRCA2 mut=11. N= 1AJCC stage III PC, N= 15 AJCC stage IV PC. N= 8 and N= 8 (50%) had 1 and 2 prior lines of therapy respectively. N= 13 (81%) received prior platinum therapy. Response: N= 1 unconfirmed PR (PR at 4 months (mo), POD at 6 mo), N= 4 stable disease (SD), N= 10 progressive disease (PD); N= 1 inevaluable (12 days of V only due to disease-related complications). Median PFS was 52 days (range 12 to 423). Three pts treated at 400mg V were dose-reduced for toxicity. Six pts had V related grade 3 toxicity including fatigue (N=3), hematologic (N=2) and nausea (N=1). No therapy-related grade 4-5 toxicities were observed. Conclusions: V was well tolerated. While no confirmed partial responses were observed, single-agent activity of V in previously treated PC was noted, and N= 4 (25%) remained on study with SD for ≥ 4mo (4, 6, 6, 9 mo). A randomized phase II trial evaluating cisplatin,gemcitabine +/- V is underway in untreated BRCA/PALB2mutPC (NCT01585805). Results of correlative studies will be presented. Acknowledgements: Lustgarten Foundation. NCI.AbbVie. Clinical trial information: NCT01585805.

Purpose: To evaluate whether outcomes of trans-arterial chemoembolization (TACE) are inferior in patients 465 years old with hepatocellular carcinoma (HCC). Materials and Methods: A retrospective review of all patients who underwent TACE for the treatment of HCC between 2000 and 2010 was performed. Two groups (o1⁄4 65 years and 465 years of age) were compared based on ChildPugh score (CP), tumor/node/metastasis (TNM) stage, hepatitis B (HBV) or C (HCV) positivity, tumor number and size, number of TACE sessions and regimen used. Imaging outcomes were assessed based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) to calculate tumor response and time to progression (TTP). Tumor response was defined as Complete or Partial Response. Disease control was defined as Stable Disease, and Complete or Partial Response. A p value o1⁄40.002 was deemed statistically significant. Results: A total of 179 treatments were performed in 97 patients, 42 of whom were 4 65. The groups had similar Child-Pugh status (p1⁄40.91), TNM stage (p1⁄40.37), HBV (p1⁄40.57), HCV (p1⁄40.1), tumor number (p1⁄40.27), tumor size (p1⁄40.61), number of treatments (p1⁄40.03) and drug type (p1⁄40.44). Tumor response was observed in 63.6% (35/55) in patients o1⁄465 and 57.1% (24/42) in those 465 (p1⁄40.52). Disease control was achieved in 69.0% (38/55) of patients o1⁄465 and 73.8% (31/42) in those 465 (p1⁄40.61). The mean time to progression was 245 days for patients o1⁄465 and 130.5 days for those 465 (p1⁄40.11). Conclusion: During a similar follow-up period, the efficacy of TACE for the treatment of HCC in elderly patients is comparable with that in a younger population. TACE should be considered a reasonable locoregional therapeutic option in elderly patients with HCC.

TPS4144 Background: Germline mutations in BRCA1, 2 predispose to PC (Lal, G. Cancer Res, 2000). 5-8% PC have BRCA 1,2 mutations; higher in Ashkenazi Jewish (10-15%). Pre-clinical data demonstrates that platinums and poly-ADP ribose polymerase inhibitors (PARPi) have activity in BRCA-mutated PC models. Early clinical data supporting (Lowery, M. Oncol, 2011). We are evaluating the role of platinum agents and PARPi, veliparib (ABT-888), in BRCA or PALB2-mutated PC. Methods: Arm A, B: Includes non-randomized phase to optimize V dose combined with G, C (Arm A). Subsequently randomized phase II study will evaluate G, C +/- V. Primary endpoint: RECIST 1.1 response rate (RR) G, C, V (Arm A) and G, C (Arm B). Secondary endpoints: Progression-free survival, safety, disease-control rate, overall survival and correlatives involving pre, post biopsies to evaluate mechanisms of sensitivity, resistance to platinums, PARPi. Arm C: Evaluates single-agent V in previously-treated PC. Primary and secondary endpoints similar. Eligibility: BRCA, PALB2-mutated, measurable, stage III/IV PC; Untreated (Arm A, B), ≤ 2 lines therapy (Arm C); ECOG 0-1 (Arm A, B), ECOG 0-2 (Arm C). Treatment Plan: Arm A, B: V PO BID d1-12 (Arm A), q 3 weeks, G 600mg/m2 IV, C 25mg/m2IV, both d3, 10, q 3 weeks (Arm A, B). Arm C: V 400mg PO BID d1-28 q 4 weeks. Biostatistics: Arms A, B: Simon’s 2-stage minimax design per arm. Unacceptable RR 10%, promising 30%, type I, II errors 10%. N= 16 stage I, +N= 9 (stage II). If ≥ 5/25, then promising. If both arms promising, option to add N= 10, allows distinction between RR 20% and 40%, 83% power. Arm C: Simon’s 2-stage, single-arm, uninteresting RR 10%, promising if ≥ 28%. N= 15 stage I, +N= 18 (stage II). Promising RR ≥ 6/33. Total N 47- 95. Contingency for slow accrual. Progress to Date: Accrual: Arm A (non-randomized): 13 screened, N= 5 enrolled. Arm C: 9 screened, N= 4 enrolled. Israeli, Canadian, other U.S. sites opening 2013. Funding and acknowledgements: National Cancer Institute, Lustgarten Foundation. NCT01585805. Clinical trial information: NCT01585805.

Purpose To determine the factors that are independent predictors of subsequent radiologic necrosis following embolotherapy of HCC. Materials and Methods From Dec 2007 and Mar 2012, 101 pts with Okuda stage I or II HCC not amenable to resection, with adequate liver function were randomized to HAE with Bead Block (BB, n=51) or TACE with LC Bead (n=50) loaded with 150 mg of doxorubicin. 72 patients (BB, n=35; LC, n=37) underwent pre-procedure triphasic CT, immediate post-procedure non-contrast CT 15 min after embolization, and followup triphasic CT 3 weeks post treatment. 135 index tumors were assessed. TCR was determined based on change in Hounsfield units (HU) of the index tumors between pre-procedure and immediate post-procedure scans (Grade 0, 120 HU change). Radiologic tumor necrosis was measured on the 3 week followup CT by calculating the ratio of necrotic and overall tumor volumes using semi-automated volumetric analysis software developed at our institution. Univariate and multivariate regression was performed to determine whether demographic factors, tumor characteristics, embolic agent, and TCR were predictors of the degree of necrosis. Results Demographics and initial tumor characteristics between the BB and LC groups were comparable: median age 68 vs 55 (p Conclusion Tumor contrast retention, but not embolic agent, is an independent predictor of radiologic necrosis following embolotherapy for HCC.

143 Background: HAE using particles is a method of treatment for HCC. The added role of doxorubicin has never been fully understood biologically. To date, no study has demonstrated any difference in outcome using HAE versus trans-arterial chemoembolization (TACE). Methods: Patients (pts) with unresectable Okuda stage I or II HCC with adequate liver function were randomized to BB or LC loaded with 150 mg of doxorubicin. Pts were evaluated by multiphasic CT 2-3 weeks post-treatment. Progression by RECIST and/or evidence of ≤5% necrosis was considered treatment failure. Otherwise pts were followed with CT every 3 months until progression or death. Pts with either recurrent tumor or new tumor outside the treated area could be re-treated. The primary objective was response rate (RR) by RECIST. With 50 pts in each arm response rates can be estimated to within +/- 14%. Secondary objectives included assessing safety and tolerability, time to progression (TTP), progression free survival (PFS), and overall survival (OS). Quantification of tumor necrosis (TN) using CT volumetric data was correlated with outcome. Analyses were intention-to-treat. Results: Between December of 2007 and March of 2012, 101 pts were randomized, 51 to BB and 50 to LC. Demographics in the two groups were comparable: median age was 67, 77% were male and 81% were Okuda I. Median number of embolizations was 2 in both arms. There was no difference in adverse events, the most common being post-embolization syndrome of pain, fever, nausea, or vomiting (84% in both groups). There was no difference in RR: BB 11% vs LC 9% (p=0.58). Median TTP was not reached. 12 month TTP was 49 versus 56% (p=0.84), median PFS was 7 versus 9 (p=0.6), and OS 14 versus 16 months (p=0.7) for BB and LC respectively. Change in TN/tumor volume post treatment did not predict OS in either group (p=0.28). Conclusions: No difference in response was noted between pts treated with BB versus LC. Given the comparable safety profile, TTP, PFS and OS, HAE should be considered a reasonable and cost-effective therapeutic option and may be preferable to LC. Clinical trial information: NCT00539643.

363 Background: Emerging literature has suggested the benefit of capecitabine/temozolomide (C/T) therapy in metastatic pancreatic NETs (pNETs) as first line therapy. We conducted a retrospective analysis of the efficacy of (C/T) therapy in all patients with metastatic NETs treated at MSKCC. Methods: Using the electronic pharmacy database, we included all patients’ ≥ 18 years of age who received C/T combination therapy for pNETs between 1/2003-10/2010. Primary endpoint was the overall response rate (ORR). Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Response rates were evaluated by a radiologist using CT scans and per RECIST 1.1. MGMT tumor expression was conducted to correlate with response. Results: Twenty patients (mean age 64, 35% female) were identified. There were 16 (80%) pNETs (1 functional, 15 nonfunctional), 2 (10%) carcinoid, 1 high grade biliary (5%) and 1 (5%) gastric neuroendocrine carcinoma. Eight tumors were low grade (1 carcinoid, 7 pNET), 8 intermediate grade (7 pNET, 1 carcinoid), and 4 high grade (2 pNET, 1 stomach, 1 biliary). Twelve (60%) received C/T in the first-line setting and 8 in the relapsed setting. Six (30%) had a partial response and 7 (35%) had stable disease. There were no complete responses ( Table 1 ). With a median follow-up of approximately 3 years, the PFS was 16.4 months. Four pNET patients had unresectable disease at presentation and 2/4 were resected and rendered free of disease after C/T therapy. There were no high grade responders. Liver tumor burden (0%, 50%), number of prior treatments, and tumor grade did not predict response. Grade 3-4 events potentially related to C/T included neutropenia (1/20, 5%), nausea (3/20 15%), diarrhea (1/20, 5%), and fatigue (3/20, 15%). Conclusions: Combination C/T for the treatment of pNETs is an effective regimen for well differentiated NETs irrespective of tumor burden and prior treatment. No responses were seen in our carcinoid patients. MGMT expression will be presented at the meeting. [Table: see text]

152 Background: Natural history studies suggest that intraductal papillary mucinous neoplasm (IPMN) is a field defect of pancreatic ductal instability. The risk of malignancy is well known, but it is unclear if the radiographic abnormality is the predominant site at which this progression occurs. This study analyzes the prevalence and site of pancreatic ductal adenocarcinoma (PDAC) progression in patients initially selected for radiographic surveillance. Methods: Patients evaluated for pancreatic cystic lesions between 1995-2010 were reviewed. Patients were included if they were followed for > 6 months for a cystic lesion with either a documented cyst fluid CEA >/= 200 ng/mL or pathologic confirmation of an IPMN. Results: Of the 157 patients initially selected for surveillance, 97 (62%) eventually underwent resection. The median length of surveillance prior to operation was 15 mo (range: 6-193 mo). Pathologically confirmed carcinoma in situ (high grade dysplasia, n=22) or invasive carcinoma (n=18) was identified in 40 patients. Of the 18 patients who were found to have invasive carcinoma, 10 had main duct IPMN (56%), 5 had branch duct (28%), and 3 had combined (17%). Four of the 18 patients who developed invasive cancer during surveillance (22% of those resected for carcinoma and 3% of those followed) developed PDAC in a region of the gland distinct from the radiographically identified lesion for which surveillance was recommended. Invasive carcinoma was diagnosed a median of 24 mo after the original IPMN diagnosis. During follow-up (median = 8 months from the cancer diagnosis), 1 patient died of disease, 2 are cancer-free, and 1 patient is alive with recurrence. Conclusions: In this study, 11% of patients with IPMN initially selected for surveillance developed invasive disease; 22% of those tumors arose in an area of the gland distinct from the initially identified lesion. Diagnostic and operative strategies for IPMN should consider the cancer risk in the entire gland. [Table: see text]

625 Background: Prospective evaluation of the safety of Selective Interval Radiation Therapy (SIRT) using yttrium 90 microspheres (Y90) in patients with colon cancer liver metastases (CLM) who failed hepatic arterial (pump) and systemic chemotherapy. Methods: This prospective single center study, assessed the safety, dose limiting toxicities (DLT) and the maximum tolerated dose (MTD) of Y90 in a selected, heavily pretreated population. Upon IRB and FDA approval individualized Y90 doses were calculated according to a volumetric method and the body surface area (BSA) method as instructed by the company. SIRT treatment was administered in three escalating dose levels (cohorts): the first cohort received 70%, the second 85%, and the third 100% of the calculated dose. All patients received chemotherapy as deemed by the patients' medical oncologist post SIRT treatment. DLT was defined as new, post treatment, grade 3 toxicities, and evaluated according to the NCI Common Toxicity Criteria (NCI-CTC) 3.0. Response to treatment was evaluated by imaging (using a combination of WHO, RECIST, modified RECIST and SUV changes) and CEA levels. Kaplan Meier methodology was employed to calculate Progression Free (PFS) and Overall (OS) Survival. Results: From September 2009-2011, 19 patients received Y90. Common complaints post treatments were: grade 1-2 fatigue and grade 1 fever, which are known side effects of SIRT. No DLTs were observed. Grade 3 hyperbilirubinemia was recorded for two patients and was attributed to progressive disease; one patient in the third cohort suffered grade 3 nausea and pain. Twelve patients (70.6%) responded (defined as stable disease or better) while five (29.4%) progressed-this was based on evaluations from initial post treatment imaging. Two patients’ imaging is pending. Median PFS and OS were 6 [95%CI: 3.2-9.7] and 16 [95%CI: 5.8-17.6] months respectively. Conclusions: It is safe to administer the entire dose of Y90 in patients with CLM who progressed despite prior pump and systemic chemotherapy. Oncologic outcomes are promising.

e14516 Background: Defining prognosis in our patients with metastatic well-differentiated NETs poses a significant challenge because of tumor heterogeneity and varying degree of aggressiveness. Som...