Miller, Robert C.

97 Background: A diagnosis of EC significantly impairs patient (pt)’s survival and quality of life (QoL). We explored the relationship between pt-assessed QoL and survival. Methods: The Mayo Clinic Romero (formerly Esophageal Adenocarcinoma-Barrett's Esophagus) Registry prospectively collects clinical data during a pt's treatment course. QoL is recorded at enrollment (baseline) and annually using a validated 12-item Linear Analog Self-Assessment (LASA). A 10-pt scale is applied; ≤5 was termed clinically deficient QoL. Initial TNM staging, clinical (age, sex, prior chemotherapy, and esophagectomy), and socioeconomic variables (marital/employment status) were analyzed using Cox proportional hazards regression models. Results: 836 pts were analyzed. Median age was 64 years. 166, 506 and 164 pts had early, locally advanced, and metastatic EC, with 5-year survival rates of 75.1%, 33.6%, and 8.1%, respectively (P≤.0001). Poorer survival rates were seen in clinically QoL deficient pts in the following categories: Overall QoL (Hazard Ratio [H.R.] 0.66; 95% C.I., 0.54-0.80; P≤.0001) and LASA subsets for physical (H.R. 0.68; 95% C.I., 0.57-0.82; P≤.0001), emotional well-being (H.R. 0.69; C.I., 0.57-0.84; P=.0003), and social activity (H.R. 0.76; C.I., 0.63-0.91; P=.0028). No difference in survival was observed for marital or employment status, familial support, and financial/legal concerns. Pts with esophagectomy prior to LASA evaluation had improved survival (H.R. 0.68; 95% C.I., 0.55-0.85; P=.0005). No survival difference was observed whether pts received chemotherapy, before or after their baseline LASA evaluation. Conclusions: A strong association exists between pt’s overall survival and better overall QOL, physical, emotional well-being, and social activities. Using LASA to clinically monitor QoL at specified intervals may afford providers the opportunity to intervene when patients begin to experience QoL decline. The determinants of clinically deficit QoL and its impact on survival warrant further translational and prospective research.

523 Background: This study was done to assess the toxicity and efficacy of IMRT for anal cancer in a multi-institutional setting. Methods: Records of 152 total patients (pts) were reviewed retrospectively. Data on disease control and toxicity were collected as well as pt and treatment characteristics. Acute (<6 months) and late (>=6 months) severe toxicity (grade >=3) were recorded at each institution. Four were excluded for either presence of metastatic disease (2) or stage TX (2). There was data for late toxicity on 120 pts. Results: T stage was T1 in 28, T2 in 79, T3 in 29 and T4 in 12 pts. N stage was N0 in 77, N1 in 40, N2 in 19 and N3 in 12 pts. The median age was 56 yrs and median follow-up was 26.8 months. Cumulative IMRT dose was 51.25 Gy (median) (range: 4.32-61.2 Gy) in a median of 28 fractions (2-34). Chemotherapy was given in all but 2 pts and the most common regimen was 5- fluorouracil plus mitomycin-C. The median total elapsed treatment time was 40 days. Local control at 3 yrs was 87% and was significantly worse for patients with T3-4 disease (79% vs 90% at 3 years; p=0.04). There was no correlation between dose and local control. Regional control, distant control and overall survival were 97%, 91%, and 87% at 3 yrs, respectively. Nodal status was associated with regional and distal control as well as overall survival (p<0.01 for each). The most common acute severe toxicity was hematologic (41%). Severe acute GI, skin or other toxicity was 11%, 20% and 1% respectively. There were two grade 5 toxicities (hematologic and GI). Severe late toxicity was limited to skin (1%) and GI (3%). Conclusions: IMRT resulted in excellent local control in this multi-institutional cohort of pts. Although T stage did predict for worse local control, most pts with T3-4 disease were controlled with IMRT. Nodal status predicts for regional and distal control as well as overall survival. Severe toxicity was acceptable with this technique.

88 Background: There is not yet a consensus on the efficacy and safety of IMRT for the treatment of patients with esophageal carcinomas. We report on our experience with outcomes and toxicity with IMRT for these patients. Methods: Fifty-five patients with esophageal carcinoma were treated with IMRT at our institution from 12/2008 and 12/2014. Medical records were retrospectively reviewed. All patients received concurrent chemotherapy (majority 5-FU with oxaliplatin). Thirty-one (56%) patients underwent surgery. Fifty (91%) received 50.4 Gy in 28 fractions. Seventy-three percent of cases were adenocarcinoma. Regions include mid-thoracic (15%), lower thoracic (64%), and GE junction (22%). Clinical uT-stages were as follows: T1 (2%), T2 (20%), T3 (69%), and T4a (5%). Clinical N-stages were as follows: N0 (33%), N1 (53%), N2 (13%), and N3 (2%). Results: Median follow-up for all patients was 15 months (1.5 - 64.5) and 25.5 months (1.5 - 64.5) for patients who were alive at follow-up (n = 31). Fifty-one (93%) patients completed RT. Of the 31 patients who underwent surgery, 9 (29%) were found to have a complete pathologic response. Site of first recurrence was local (n = 2, 4%), regional (n = 3, 6%), and distant (n = 14, 26%). At 12 and 24 months, overall survival was 72% and 58%, freedom from recurrence was 78% and 65%, and freedom from distant recurrence was 78% and 68%. On univariate analysis, improved OS was noted with patients who underwent surgery (RR 0.29) or were cN0 (RR 0.27). Twenty eight patients (51%) experienced > / = CTCAE v.4grade 3 acute toxicity; notable were hematologic (n = 14, 25%), esophagitis (n = 6, 11%), acute coronary event (n = 1, 2%), and post-chemoRT pneumonia (n = 1, 2%). Fifteen patients (31%) experienced > grade 3 late toxicity; notable were esophageal stricture (n = 7, 14%), post-op pneumonia (n = 3, 6%), post-CRT pneumonia (n = 2, 4%), and COPD exacerbation (n = 1, 2%). Conclusions: Patient receiving IMRT with concurrent chemotherapy for esophageal carcinomas have good LC rates, with or without surgery. Majority of patients are able to finish treatment with acceptable rates of late toxicity. Patient who underwent surgery or were cN0 had better OS.

524 Background: Psychosocial distress during radiotherapy (RT) for gastrointestinal tumors is poorly characterized. Since 2012, patients receiving RT in our clinic have been prospectively screened for causes of distress. The results of our screening were reviewed in order to elucidate concerns of GI cancer patients and to delineate patterns within patient reported distress (PRD). Methods: Patients treated with RT at our institution receive a 30 question PRD survey that also includes a linear analog measure of overall distress at the start and during RT. The PRD survey asks patients to rate forms of distress on a scale of 1 to 5 (5 being the most distressed). The survey also asks patients to rate overall distress according to the National Comprehensive Cancer Network (NCCN) Distress Thermometer on a scale 0 to 10. The reported results were retrospectively reviewed in patients receiving definitive RT for GI cancers from 04/02/2012 to 08/05/2015. Results: PRD surveys were completed by 113 patients, 55 (48.7%) male and 58 (51.3%) female. Median age was 65 years (range 28 to 93). The most common tumor histology was adenocarcinoma, 67 (59.3%). 105 patients (93.0%) received chemotherapy and 66 (58.4%) underwent surgery. Overall, NCCN distress thermometer results ranged from 0 to 10, with a median of 4.3. The mean distress scores for the top five complaints ranged from 1.27 to 2.63. Top distresses were “How will I feel during treatment” (2.63), “Fatigue” (2.45), “Pain that affects daily functioning” (2.35), “Out of pocket medical costs” (2.31), and “Sleep difficulties” (2.31). The least concerning complaints were “Housing during treatment” (1.27), “A loved one relying on me for their physical care” (1.30), “Spirituality” (1.33),“Family communication about my illness”(1.37), and “Transportation” (1.38). Conclusions: Patients’ major concerns were aligned with daily quality of life, such as fatigue, pain and insomnia. Highest reported distress was linked with the process of RT and side effects associated with treatment. Medical expenses were also perceived as a burden. Medical providers should identify psychosocial stressors during RT in order to effectively communicate and provide resources to improve quality of life.

46 Background: Accountable Care Organizations (ACO), as proposed by the Affordable Care Act, will change the delivery of health care in the United States. ACO serve as a network of providers with primary care providers (PCP) set up as gate-keepers for referrals to specialists. Within the next several years, many trends will emerge and drive progress of change, requiring oncologist to take a lead role to adapt to the evolving landscape of health care. Methods: Literature search of internet-based and academic sources for oncology and the Affordable Care, with a focus on ACO formation. Results: Four main expected trends and strategies to adapt to changes were formulated. Trend 1: Changes in referral patterns towards oncologists. Referral will be based on outcome data and ACO membership. Strategy: Increase communication and education to PCP and other providers. Endorse multidisciplinary clinics, which have shown to improve guideline compliance, coordination, and communication. Trend 2: Formation of large scale oncology provider groups collaborating with PCP/ACO. Physicians will be able to provide around the clock care to patients with the goal of reducing hospital visits. Strategy: Establish oncology homes with goal of reducing inpatient and ED visits by providing telephone symptom management, daily questionnaires and opportunities for end of life discussions. Trend 3: Reimbursement reform to oncologists based on quality measures. ACO can bill fee for service basis and eligibility for bonus payments based on outcomes. Strategy:Adherence to evidence based guidelines chosen by evaluating efficacy, toxicity and cost have been proven to increase quality of patient care. Trend 4: Development to pathway driven medicine.ACO structure lends to a centralized governance committee responsible in choosing guidelines for treatment within an ACO. Strategy: Oncologists should provide a voice for the field and patients when different guidelines are chosen. Conclusions: In the context of the Affordable Care Act, oncology specialists are encouraged to participate in the new organization model to ensure best outcomes for both physicians and patients. Awareness of future trends and ways to contribute will be the first step in adapting to implementation of the Affordable Care Act.

75 Background: The focus of palliative radiotherapy (RT) is on improving quality of life (QOL) for patients with serious illnesses by eliminating or decreasing physical symptoms. The importance of assessing distress levels in palliative care patients is recognized due to the relevance of QOL, as treatment is given to provide symptom-relief rather than curative results. We sought to identify the most common causes of patient reported distress during palliative RT. Methods: Retrospective review was performed for patients who received palliative RT from 11/1/2012 to 6/4/2015 for various types of metastatic cancer at our institution. All patients completed a Patient Reported Distress (PRD) questionnaire with 30 specific questions and an overall distress thermometer prior to beginning treatment. The PRD survey quantified 30 areas of current concern ranging in patient-reported values from 1 to 5 in addition to a linear analog measure from 0 to 10 of overall reported distress in the last month. Results: Completed PRD surveys were available for a total of 297 patients, 149 (50.2%) female and 148 (49.8%) male. All patients were undergoing external beam radiation therapy for treatment of metastatic disease. 49 (16%) received chemotherapy and 46 (9%) underwent surgery. Overall distress ranged from 0 to 10, with a median of 5.0. The mean distress scores for the top five concerns ranged from 1.4 to 2.7. Top distresses were “Fatigue” (2.7), “Pain that affects daily functioning” (2.6), “How will I feel during treatment” (2.5), “Sleep difficulties” (2.4), and “Out of pocket medical costs” (2.3). Least troubling symptoms were “Transportation” (1.4), “A loved one relying on me for their physical care” (1.5), “My job” (1.5), “Housing during treatment” (1.5), “Spirituality” (1.5), and “Anger” (1.5). Conclusions: Patients demonstrated concern for distress related to interruption of activities of normal life, such as tiredness and insomnia, pain, and overall burdens from treatment. Medical costs were also a major concern. Importantly, housing and transportation were not issues in the current study but could be of concern in other regions. Providers should be aware that patients’ primary concerns may not be directly related to the symptom being palliated.

211 Background: Distress is known to be elevated in patients receiving cancer therapy, such as palliative radiotherapy (PRT). Many patients will experience distress during treatment and it is not always addressed in part due to a lack of guidance regarding the significance of distress. Methods: All RT patients in our clinic are asked to complete a patient reported distress (PRD) survey during treatment course. PRD forms consist of 30 categorical questions that assess distress subscales. Patients have the option to rate each question from 1 (low distress) to 5 (high distress). The survey also includes the National Comprehensive Cancer Network distress thermometer, which allows patients to rate overall distress level from 0 (no distress) to 10 (extreme distress). Patients’ records were retrospectively reviewed to abstract the needed information to assess survivorship. Results: 270 patients were included from 01/18/2012-08/07/2015. Overall PRD was analyzed as a continuous and a categorical variable (low: 0-3, moderate: 4-6, high: 7-10). Continuous and categorical variable PRD did not show a correlation of distress to survival (P = 0.26) and (P = 0.10) respectively. A correlation was noted in moderate distress category (RR: 1.51, P = 0.034), however, this was not noted in high distress category (RR: 1.25, P = 0.33). There was no statistical significant correlation with the adjusted variables. Patients with primary site of gastrointestinal cancer had worst prognosis (RR: 1.34, P: 0.14), while hematological origin had best prognosis (RR: 0.35, P: 0.038).Age had the strongest correlation with survival, as older patients receiving RT had poorer survival (RR: 1.13, P: 0.079). Conclusions: This study suggests that PRD is not predictive of survival in PRT. The primary goal of PRT is to improve quality of life (QoL) by assessing, anticipating and alleviating suffering; not necessarily improve survival. It also demonstrated that the most common stressors were related to reversible short-term side effects of RT such as fatigue and pain rather than long-term stressors related to daily activities and social measures which might affect QoL. It is imperative to explore assessment tools to mitigate suffering and improve strategies to enhance QoL in all medical disciplines.

79 Background: A significant percentage of cancer patients experience psychosocial distress with the highest prevalence observed in breast cancer patients. The importance of psychosocial distress screening and assessment in women with breast cancer has clearly been established. Patients in our clinic are screened for distress. The results were reviewed in an attempt to better understand the psychosocial distress of breast cancer patients undergoing radiotherapy. Methods: Patients treated curatively for breast cancer prospectively completed the 30 question patient reported distress (PRD) survey that also included a linear analog measure of overall distress. The recorded clinical results of the PRD survey were retrospectively assessed in patients receiving breast radiotherapy from June 1, 2013 to February 2, 2015. Results: Completed PRD questionnaires were available on 179 female patients. 21 (12%) were treated for ductal carcinoma in situ and 91 (51%), 35 (20%), and 32 (18%) were treated for invasive carcinoma Stages I, II, and III. 85 (47%) received chemotherapy. Overall distress ranged from 0 to 10, with a median value of 5. Mean distress scores per category ranged from a low of 1.25 to a high of 2.52. Top concerns in descending order of importance were: “How will I feel during treatment” (2.52), “Fatigue” (2.46), “Sleep difficulties” (2.32), “How will I feel about appearance related to treatment” (2.23), & “Pain that affects daily functioning” (2.19). Least distressing symptoms “Spirituality” (1.25), “Housing during treatment” (1.26), “Control of anger” (1.28), “End of life concerns” (1.32), & “Transportation” (1.34). Conclusions: Distress over tumor related issues ranked low among women’s concerns in comparison to distress related to the side effects of therapy concerning treatment related discomfort, fatigue, and changes in appearance, and anxiety. Pain was a significant concern, although in this group of patients receiving definitive, adjuvant or neoadjuvant therapy, this was likely related to treatment associated discomfort rather than from disease progression. These findings highlight the importance of careful patient education and communication of the expected symptoms and effects of therapy.

9 Background: We examined patient-reported fatigue scores and overall survival (OS) in patients with esophageal cancer (EC) enrolled in the Mayo Clinic Esophageal Adenocarcinoma and Barrett's Esophagus Registry (EABE). Methods: 1,481 patients enrolled in the EABE between September 2001 and January 2009 returned a baseline quality of life questionnaire including a Linear Analog Self Assessment (LASA) fatigue score which was scored on a 0-10 scale, with 0 as the most extreme fatigue. Patients were categorized as having clinically deficient fatigue (DF) if they reported a score of ≤ 5 and clinically non-deficient fatigue (nDF) if they reported a score of > 5. Kaplan-Meier methodology and Cox models explored OS in relation to fatigue scores in patients with EC. Results: A total of 667 patients with EC were included in the EABE, of which 659 returned a registry questionnaire with a valid LASA fatigue score recorded. Median age at the time of registry entry was 65 years (range 23-92). A total of 392 (59%) and 267 patients (41%) reported DF and nDF, respectively. On univariate analysis, patients with nDF had improved 5-year survival compared to patients with DF. In patients having esophagectomy prior to LASA, those reporting nDF had improved survival compared to patients with DF. Similarly, in patients having no esophagectomy prior to LASA, those with nDF had improved survival compared to those with DF. Among the 368 patients with locally advanced EC (LAEC), those reporting nDF had improved 5-year overall survival compared to patients with DF (28% vs 17%, HR = 0.67, p = 0.003). This remained significant on multivariate analysis (HR = 0.71, p = 0.015). Conclusions: Patient-reported fatigue is associated with overall survival in patients with LAEC. As a result, fatigue scores should be considered as a stratification factor in future clinical trial design. [Table: see text] No significant financial relationships to disclose.

251 Background: To assess the effect of adjuvant therapy in gallbladder adenocarcinoma (GBC). Methods: Retrospective review was conducted at five institutions to identify pts who had surgery for confirmed dx of GBC from 1985-2008 (N = 189). Pts were excluded if they had chemo alone (N = 8), path other than adenoca (N= 7), carcinoma in situ (N=1), < 30 days of follow-up (N = 2), or missing data (N=14). Of the remaining 156 pts, 58 received surgery only and 98 received adj RT ± chemo. Kaplan-Meier was used for overall survival (OS) and Cox proportional hazards to compare risk factors. Results: Median age of dx was 64.4, 68.0% were female, 37.9% had ≥ stage 2b, 37.2% had + nodes, and 32.1% had + margins. Overall, 35.9% of the patients had simple cholecystectomy (SC) only and 64.1% had radical resection (ER). mOS for pts treated with surgery alone was 49.7 months (95% CI: 24.8 to Inf). On univariate analysis, + margins (HR 2.72, p<0.001) was associated with worse OS, whereas ER compared to SC improved survival in both univariate (HR 0.46, p<0.001) and multivariate (HR 0.53, p=0.033) analyses after adjusting for node/margins, T-stage, adj RT, age, gender, and institution. mOS for the entire cohort vs. adj RT (median 50.4 Gy) ± chemo was 30.7 months (95% CI: 19.2 to 46.9) vs. 26.9 months (95% CI: 15.5 to 39.1). But, compared to surgery alone, the adj group was more likely to have had node +, margin +, or T-stage 3+ (all p<0.001). The adj RT group was also less likely than surgery alone pts to have undergone ER (p = 0.007). On multivariate analysis, decreased OS was also found for node + (HR 2.09, p=0.004), margin + (HR 1.84, p=0.043), and T3/T4 disease (HR 2.37, p=0.002). After adjusting for surgical extent, node, margin, T stage, age, gender, and institution, there was improved OS with adj therapy (HR: 0.43, p = 0.020). When stratified by surgical extent, the risk estimate for adj RT improved OS among those with SC (n=56; HR 0.20, p=0.135) and ER (n=100; HR 0.46, p=0.067), but was not statistically significant. Conclusions: ER was associated with improved OS, whereas node/margin+ and T-stage 3+ were associated with worse survival. In multivariate analysis, adj RT improved OS after surgery. Given the poor prognosis of GBC patients with advanced disease, consideration of adj therapy is appropriate. No significant financial relationships to disclose.