Appalachian Kentucky (AK) has a disproportionally high breast cancer mortality rate. Postmastectomy radiotherapy (PMRT) in N2/N3 nodal disease improves survival and locoregional recurrence. We evaluated Kentucky patient compliance to the quality measure of PMRT received within one year of diagnosis. A population-based retrospective review of patients who received mastectomy with N2/N3 nodal disease from 2006 to 2015 was obtained through the Kentucky Cancer Registry. A total of 1489 patients met the inclusion criteria. Of these, 1104 (66.6%) received PMRT. AK patients were less likely to receive PMRT (58.3%) than non-AK patients (70%, P < 0.001). After adjusting for significant factors, private insurance, education level, treatment center, and receipt of adjuvant chemotherapy were independently associated with PMRT compliance. Patients who received PMRT had improved overall survival (OS, P < 0.0001) and disease-free survival (DFS, P < 0.0001). Appalachian status was not a major factor in OS (P= 0.1929) or DFS (P = 0.5840). Nearly two decades after the recommendation of PMRT, compliance remains poor in Kentucky. PMRT continues to be a major factor in survival and recurrence in this population. Interventions focusing on improving insurance coverage, education level, and guideline adherence in nonacademic centers are needed to improve compliance.

e13023 Background: Neglected breast cancer occurs due to delay in seeking care. While this is primarily an issue in developing countries it is also observed in high income countries in regions such as Appalachia. We aim to describe the epidemiology of neglected breast cancers seen in our institution. Methods: A patient with a neglected breast cancer should have signs of advanced breast cancer and had at least a 6 month delay from onset of symptom. Patients with inflammatory breast cancer were excluded. Kentucky Cancer Registry (KCR) was queried to find patients that presented to Markey Cancer Center of the University of Kentucky between 1/1/2010 and 12/30/2016 with a diagnosis of breast cancer and initial consultation notes that had any of the following terms – “ulcer,” “open wound,” “neglected,” “fungating,” “ulcerated,” “eschar,” “necrosed,” “advanced.” IRB approval was obtained. Descriptive statistics were done and survival analysis was done through Kaplan Meier method. Results: Seventy-six patients were initially identified and upon further chart review 41 met the criteria for analysis, of which 18 patients had died from metastatic disease. The median age of our population was 58.1 years (range: 28-77). 75.6% of patients had either a fungating or ulcerated mass at diagnosis. Overall 63.4% had hormone receptor-positive cancer, 45% had HER2-positive cancer and 7% had triple negative disease. Majority of patients presented with Stage IV disease (58.5%) and the rest had stage III disease. Patients who presented with stage III disease had a median progression free survival of 1.9 years. After diagnosis of stage IV disease, patients lived for a median of 1.9 years. Median time of survival from diagnosis of neglected breast cancer was 2.6 years. Conclusions: We observed a high rate of HER2-positive disease among patients with neglected breast cancer. In our single-institution study, the prognosis of patients with neglected breast cancer was observed to be poor. Further studies will focus on surveying patients who are alive, to understand reasons for the delay in seeking care.

BACKGROUND:Although adjuvant therapy (AT) is a necessary component of multimodality therapy for pancreatic ductal adenocarcinoma (PDAC), its application can be hindered by post-pancreaticoduodenectomy (PD) complications. The primary aim of this study was to evaluate the impact of post-PD complications on AT utilization and overall survival (OS). METHODS:Patients undergoing PD without neoadjuvant therapy for stages I-III PDAC at a single institution (2007-2015) were evaluated. Ninety-day postoperative major complications (PMCs) were defined as grade ≥3. Records were linked to the Kentucky Cancer Registry for AT/OS data. Early AT was given <8 wk; late 8-16 wk. Initiation >16 wk was not considered to be AT. Complication effects on AT timing/utilization and OS were evaluated. RESULTS:Of 93 consecutive patients treated with surgery upfront with AT data, 64 (69%) received AT (41 [44%] early; 23 [25%] late). There were 32 patients (34%) with low-grade complications and 24 (26%) with PMC. With PMC, only six of 24 patients (25%) received early AT and 13 of 24 (54%) received any (early/late) AT versus 35 of 69 (51%) early AT and 51 of 69 (74%) any AT without PMC. PMCs were associated with worse median OS (7.1 versus 24.6 mo, without PMC, P < 0.001). Independent predictors of OS included AT (hazard ratio [HR]: 0.48), tumor >2 cm (HR: 3.39), node-positivity (HR: 2.16), and PMC (HR: 3.69, all P < 0.02). CONCLUSIONS:Independent of AT utilization and biologic factors, PMC negatively impacted OS in patients treated with surgery first. These data suggest that strategies to decrease PMC and treatment sequencing alternatives to increase multimodality therapy rates may improve oncologic outcomes for PDAC.

406 Background: Recent long-term results from the ESPAC-3 trial suggest that while completing adjuvant therapy (AT) is necessary after resection of pancreatic adenocarcinoma (PDAC), early initiation of AT before 8 weeks may not be associated with improved overall survival (OS). The primary aim of this study was to evaluate the impact of early vs. late AT initiation on OS in a statewide population-based analysis. Methods: Among all patients with stage I-III PDAC in the Surveillance Epidemiology and End Results (SEER) - Kentucky Cancer Registry (KCR) from 2004-2012, those undergoing pancreatectomy were stratified by postoperative chemotherapy/radiotherapy delivery and timing. Patients with preoperative therapy, no AT, or postoperative therapy beyond 16 weeks, were excluded. Remaining patients were stratified into 2 groups defined as “early” (<8 weeks) and “late” AT (8-16 weeks). A Cox regression model was created to analyze the impact of AT timing, adjusting for clinicopathologic variables. Results: Of the 4,882 total patients with PDAC, 1,193 (24%) underwent pancreatectomy. Of these, only 364 (30%) received AT within 16 weeks. With median age 65 years (range 20-101), 86% patients were stage II and 76% were node-positive. Median time to AT initiation was 52 days (range 5-111). Timing of AT did not affect OS (median OS: early AT, 19.5 vs. 19.7 mo, late AT, p=0.63). Median OS for stages I, II, and III were 46.1, 19.3, and 8.6 mo, respectively (p<0.001). Poorly/undifferentiated tumors were associated with worse median OS 17.6 vs. 21.3 mo for well/moderately differentiated tumors (p<0.001). Lymph node positivity was associated with worse median OS 18.1 vs. 25.8 mo for node negativity (p<0.001). On multivariate analysis, factors that affected OS included stage (II, HR 2.54, p=0.022; III, HR 5.16, p<0.001), node positivity (HR 1.57, p=0.008), poorly/undifferentiated grade (HR 1.50; p=0.002), but not AT timing. Conclusions: In this SEER-KCR analysis, there was no difference in OS between early and late AT initiation. Despite its proven value, the ideal window for AT initiation remains unknown as tumor biology continues to trump current treatment regimens.

BACKGROUND: Category 1 guidelines emphasize multimodality therapy (MMT) for patients with gastric cardia cancer (GCC). These patients are often referred to thoracic surgeons for "esophagogastric junction" cancers rather than to abdominal surgeons for "proximal gastric" cancers. This study sought to determine the ideal surgical approach using national datasets evaluating morbidity/mortality (M/ M) and overall survival (OS).STUDY DESIGN: Patients with resected GCC were identified from the 2005 to 2012 ACS-NSQIP dataset and the 1998 to 2010 SEER dataset. Multivariate 30-day M/ M analyses were performed using NSQIP. Survival analyses were derived from SEER and stratified by surgical approach.RESULTS: There were 1,181 NSQIP patients with GCC included; 81.8% had esophagectomies and 18.1% had gastrectomies. Major postoperative M/ M occurred in 33.2%/3.7% patients after gastrectomy vs 35.0%/ 2.4% after esophagectomy (p = 0.260). Although a major postoperative complication (odds ratio 12.8, p < 0.001) was an independent predictor of mortality on multivariate analysis, surgical approach was not. Of the 3,815 SEER patients included, 71.1% had esophagectomies and 28.9% had gastrectomies. Radiation use (surrogate for MMT) was administered more often with esophagectomy vs gastrectomy (42.9% vs 29.6%, p < 0.001). Unadjusted median overall survival (OS) favored esophagectomy (26.0 vs 21.0 months, p = 0.025). However, multivariate analysis confirmed age (hazard ratio [HR] 1.01), T/ N stages (HR 1.12/ 1.91), and radiation use (HR 0.83, all p <= 0.018), but not surgical approach (HR 0.95, p = 0.259), as independent predictors of OS.CONCLUSIONS: Tumor biology and MMT, rather than surgical approach, dictate oncologic outcomes for GCC. Therefore, the decision of esophagectomy vs gastrectomy for GCC should be based on proximal and distal tumor extent and the multidisciplinary strategy with the lower rate of complications and the higher rate of MMT completion. (C) 2015 by the American College of Surgeons

422 Background: While adjuvant therapy (AT) completion is a necessary component of multimodality therapy for pancreatic adenocarcinoma (PDAC), its timing and utilization can be hindered by complications after pancreaticoduodenectomy (PD). The primary aim of this study was to evaluate the impact of post-PD complications on AT utilization and overall survival (OS). Methods: Patients treated with PD for PDAC at a single institution (2000-2012) were evaluated. Data on 90-day complications were extracted from the electronic medical record with postoperative major complications (PMC) defined as Grade ≥3. Patient records were linked to the Surveillance Epidemiology End Results - Kentucky Cancer Registry for AT and OS data. Early AT required a first dose before 8 weeks, while late was 8-16 weeks. Initiation after 16 weeks was not considered adjuvant. Chi-square statistics, Kaplan-Meier plots, and log-rank tests were used to examine associations among complication status and AT timing, AT utilization, and OS. Results: Of 84 total patients, 54 (64%) received AT (34 [41%] early; 20 [24%] late). Rates of patients with 90-day complications were as follows: 44 (52%) Grade ≥1, 37 (44%) Grade ≥2, and 18 (21%) Grade ≥3. Low-grade (Grades 1-2) complications were not associated with late AT or lack of AT (both p>0.082). However, PMC were associated with lower rates of AT (7/18, 39% with PMC vs. 47/66, 71% without PMC, p=0.011). Even patients who recovered from PMC were less likely to meet the early 8-week window (4/18, 22%, patients with PMC, vs. 30/66, 46%, patients with no PMC, p=0.039). PMC were associated with worse median OS (6.1 mo, 95% confidence interval, CI, 1.6-12.1, vs. 20.8 mo, 95% CI 17.3-23.8, with no PMC, p<0.001), while low-grade complications were not (all p>0.079). Conclusions: In this series,low-grade complications had minimal effects on AT timing, AT utilization, and OS, but PMC were associated with late and decreased AT utilization and negatively impacted OS.These data suggest that strategies to decrease PMC and/or treatment sequencing alternatives to increase multimodality completion rates in high-risk patients may improve oncologic outcomes.

BACKGROUND:Select patients with peri-ampullary cancers require concomitant colon resection (CR) during a pancreaticoduodenectomy (PD) for margin-negative resections. This study analysed the impact of concomitant CR on major morbidity (MM) and mortality.METHODS:National Surgical Quality Improvement Program (NSQIP) patients undergoing PD for peri-ampullary cancers were identified from 2005 to 2012. A 4 : 1 propensity-score matched analysis isolated the impact of CR upon PD. Risk factors for 30-day MM and mortality were analysed to determine post-operative sequelae of PD+CR.RESULTS:From 10 965 PD and 159 PD+CR patients, 624 and 156, respectively, were selected for 4 : 1 matched analysis. PD+CR resulted in a higher MM and mortality (50.0% and 9.0%) versus PD alone (28.8% and 2.9%, respectively, P < 0.001). Multivariate analysis identified risk factors for MM after PD: concomitant CR [odds ratio (OR)-3.19, P < 0.001], smoking (OR-1.92, P = 0.005), a lack of functional independence (OR-3.29, P = 0.018), cardiac disease (OR-2.39, P = 0.011), decreased albumin (per g/dl, OR-1.38, P = 0.033) and a longer operative time (versus median time, OR-1.56, P = 0.029). Independent predictors of mortality included concomitant CR (OR-3.16, P = 0.010), ventilator dependence (OR-13.87, P < 0.001) and septic shock (OR-6.02, P < 0.001).CONCLUSIONS:CR was an independent predictor of MM and mortality after a PD. Patients requiring PD+CR should be identified pre-operatively, maximally optimized and referred to experienced surgeons at expert centres.

Tzeng, Ching-Wei D MD; Beck, Sandra J. MD, FACS; Hourigan, Jon S. MD, FACS, FASCRS; Evers, Mark B MD; McGrath, Patrick C. MD, FACS; Davenport, Daniel L. PhD Author Information

264 Background: Previous investigation has suggested that early stage, lymph node negative pancreatic adenocarcinoma (PAC) has a relatively good prognosis and adjuvant therapy provides little benefit over surgery alone. The purpose of our trial was to evaluate patients with stage I-II PAC receiving surgical resection to determine their clinical characteristics, overall outcome, and the impact of adjuvant therapy on survival. Methods: Utilizing the population-based registry data from the Kentucky Cancer Registry (KCR) we identified patients with lymph node negative, AJCC I-II, PAC who underwent pancreatic resection during the years of 1995-2008. Patients were further stratified by receipt of surgery alone versus surgery with adjuvant chemotherapy or chemoradiation. Clinical and pathologic data included patient demographics, tumor characteristics, and lymph node status. Kaplan-Meier and Cox-regression survival analyses were performed. Results: During the study period, 203 patients meeting criteria were identified from the KCR. Median survival (MS) for the entire cohort was 21.7 months. The majority of patients were >70 years old, Caucasian, had well or moderately differentiated tumors and tumors <5cm. 46% (n=94) and 54% (n=109) of patients had stage I and II disease respectively. When stratified by surgery only (n=119, 59%) versus adjuvant therapy (n=84, 41%), only younger age predicted receipt of adjuvant therapy (p=0.002). Adjuvant therapy provided no benefit over surgery alone regardless of stage (stage I MS: 21.5 vs. 24.7 months, p=0.97 and stage II MS: 24.2 vs. 18.0, p=0.13, respectively). By multivariate analysis, only tumor size >5cm predicted worse survival (HR 2.32, CI 1.21-4.45, p=0.012). Age, stage, adjuvant therapy, differentiation, and lymph node retrieval had no impact on survival. Conclusions: Our data indicate that the survival for surgically resected early stage, lymph node negative pancreatic adenocarcinoma remains poor and is not improved by the addition of adjuvant chemotherapy. These findings should be considered when designing future adjuvant therapy trials for this deadly disease.

The National Institutes of Health Consensus Development Conference on Treatment of Early-Stage Breast Cancer brought together surgical, radiation, and medical oncologists, biostatisticians, psychologists, nurses, and other health care professionals as well as the public to address: the roles of mastectomy versus breast conservation, the role of adjuvant therapy, and the use of prognostic indicators in the treatment and management of early-stage breast cancer. Following 2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. Among their findings, the panel recommended that (1) breast conservation treatment is an appropriate method of primary therapy for the majority of women with Stage I and II breast cancer and is preferable because it provides survival equivalent to total mastectomy and axillary dissection while preserving the breast; (2) the majority of patients with node negative breast cancer are cured by surgery or by surgery and radiation without further therapy; (3) there is clear evidence that the rate of local and distant recurrence is decreased by both adjuvant combination cytotoxic chemotherapy and by adjuvant tamoxifen; (4) the decision to use adjuvant treatment should follow a thorough discussion with the patient regarding the possible risks and toxicities of therapy and its impact on quality of life; (5) and patients with tumors less than or equal to 1 centimeter have an excellent prognosis and do not require adjuvant therapy outside of clinical trials. The full text of the consensus panel's statement follows.