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Data regarding changes in functional status and health-related quality of life (HRQOL) before and after surgery are lacking. We identified colorectal cancer patients from the SEER-Medicare Health Outcomes Survey (MHOS) linked database to evaluate the association between HRQOL and survival. HRQOL survey data captured physical/mental health, activities of daily living (ADLs), and medical comorbidities. Patients who underwent surgery with HRQOL surveys prior to cancer diagnosis and ≥ 1 year after diagnosis were selected. Patient, disease, and HRQOL measures were analyzed in regard to overall survival (OS), disease-specific survival (DSS), and non-DSS. Of 590 patients included, 55% were female, 75% were Caucasian, and 83% had colonic primary. Disease extent was localized for 52%, regional for 41%, and distant for 7%. Median OS was 83 months. Decreased OS was independently associated with age ≥ 75 (HR 1.7, p

As the US transitions from volume- to value-based cancer care, many cancer centers and community groups have joined to share resources to deliver measurable, high-quality cancer care and clinical research with the associated high patient satisfaction, provider satisfaction, and practice health at optimal costs that are the hallmarks of value-based care. Multidisciplinary oncology care pathways are essential components of value-based care and their payment metrics. Oncology pathways are evidence-based, standardized but personalizable care plans to guide cancer care. Pathways have been developed and studied for the major medical, surgical, radiation, and supportive oncology disciplines to support decision-making, streamline care, and optimize outcomes. Implementing multidisciplinary oncology pathways can facilitate comprehensive care plans for each cancer patient throughout their cancer journey and across large multisite delivery systems. Outcomes from the delivered pathway-based care can then be evaluated against individual and population benchmarks. The complexity of adoption, implementation, and assessment of multidisciplinary oncology pathways, however, presents many challenges. We review the development and components of value-based cancer care and detail City of Hope’s (COH) academic and community-team-based approaches for implementing multidisciplinary pathways. We also describe supportive components with available results towards enterprise-wide value-based care delivery.

BACKGROUND AND OBJECTIVES Studies reporting outcomes after pelvic exenteration for rectal cancer are limited. The objective of this study was to evaluate early postoperative and oncologic outcomes in a national multi-institutional cohort. METHODS Using the National Cancer Database (NCDB), which collects data from over 1500 commission on cancer (CoC)-accredited hospitals, we analyzed patients undergoing pelvic exenteration for T4b rectal adenocarcinoma. RESULTS There were 1367 pelvic exenterations performed in 552 hospitals. Median age was 60 years, the majority of patients (n = 831; 60.8%) were female. Neoadjuvant radiation was used only in 57%; 24.3% of resections had positive margins. Following exenteration, 30-day mortality rate, 90-day mortality rate, and readmission rates were: 1.8%, 4.4%, and 7.4%. Age ≥ 60 years and higher Charlson-Deyo comorbidity index were independently associated with increased 90-day mortality (P

Purpose Bowel dysfunction is a common, persistent long-term effect of treatment for rectal cancer survivors. Survivors often use dietary modifications to maintain bowel control. There are few evidence-based interventions to guide survivors on appropriate diet modifications for bowel symptom management. The purpose of this paper is to describe the development and design of the Altering Intake, Managing Symptoms (AIMS) intervention to support bowel dysfunction management in rectal cancer survivors. Methods The AIMS intervention is a ten-session, telephone-based diet behavior change intervention delivered by trained health coaches. It uses dietary recall, participant-completed food and symptom diaries, and health coaching guided by motivational interviewing to promote bowel symptom management and improved diet quality. Based on the Chronic Care Self-Management Model (CCM), the AIMS Intervention is designed to improve self-efficacy and self-management of bowel symptoms by coaching survivors to appropriately modify their diets through goal setting, self-monitoring, and problem-solving. The intervention targets survivors with stage I-III rectosigmoid colon/rectum cancer who are 6 months post-treatment, 21 years and older, and English-speaking. Conclusions The design and development process described in this paper provides an overview and underscores the potential of the AIMS intervention to positively impact the quality of long-term survivorship for rectal cancer survivors. An ongoing pilot study will inform the design and development of future multi-site Phase II and III randomized trials.

// May Cho 1, * , Jun Gong 1, * , Paul Frankel 2 , Timothy W. Synold 3 , Dean Lim 1 , Vincent Chung 1 , Joseph Chao 1 , Daneng Li 1 , Yuan Chen 4 , Stephen Sentovich 5 , Kurt Melstrom 5 , Gagandeep Singh 5 , Eloise Luevanos 1 and Marwan Fakih 1 1 Department of Medical Oncology, City of Hope National Medical Center, Duarte, CA, USA 2 Department of Statistics, City of Hope National Medical Center, Duarte, CA, USA 3 Department of Cancer Biology, Beckman Research Institute of City of Hope, Duarte, CA, USA 4 Department of Molecular Medicine, Beckman Research Institute of City of Hope, Duarte, CA, USA 5 Department of Surgical Oncology, City of Hope National Medical Center, Duarte, CA, USA * These authors contributed equally to this work Correspondence to: Marwan Fakih, email: mfakih@coh.org Keywords: binimetinib, MEK inhibitor, FOLFOX, metastatic colorectal cancer, refractory disease Received: May 12, 2017 Accepted: June 30, 2017 Published: July 18, 2017 ABSTRACT Background: This was a first in-human, open-label, dose-escalation phase I study conducted to evaluate the maximum tolerated dose (MTD), safety, and efficacy of the combination of oral binimetinib and FOLFOX. Materials and Methods: Patients with metastatic colorectal cancer (mCRC) who progressed on prior standard therapies received twice daily binimetinib continuously or intermittently with FOLFOX. Dose-limiting toxicities (DLTs) were assessed in the first 2 cycles of study treatment. Pharmacokinetic (PK) analysis of 5-FU and oxaliplatin was performed at the MTD in an expanded 6 patient cohort. Results: Twenty-six patients were enrolled and assessed for safety. In the dose-escalation phase, no DLTs were noted in all binimetinib dosing schedules and the MTD of binimetinib in with FOLFOX was 45 mg orally twice daily. There were no significant differences in the PKs of 5-FU or oxaliplatin with or without binimetinib. Continuous dosing of binimetinib produced SD at 2 months in 9 of 13 evaluable patients and a median PFS of 3.5 months. Nine of 10 patients had PD at 2 months on the intermittent arm. Conclusions: Oral binimetinib and FOLFOX has a manageable toxicity profile and showed some evidence of antitumor activity in heavily pretreated mCRC patients.

52 Background: Older adults with cancer often have age-associated vulnerabilities and challenges, especially during hospitalization. Geriatric assessment (GA) can help identify such vulnerabilities, generate recommendations, and guide the choice of interventions. Recently, GA-driven interventions have been shown to decrease chemotherapy toxicity among older adults with cancer in the outpatient setting. However, few studies have examined its role in the inpatient setting. Our purpose was to evaluate the feasibility of GA-driven interventions among hospitalized older adults with cancer. Methods: Hospitalized patients, age 75+, with a solid tumor malignancy were eligible. Each patient completed a GA while hospitalized at T1 (Timepoint 1) and one-month post discharge T2 (Timepoint 2). An Advanced Practice Nurse (APN) reviewed the T1 GA, provided targeted care utilizing GA results and implemented interventions based on predefined triggers built into the GA’s various domains. An APN also completed follow-up visits by phone at 1 week and 1 month post discharge. The primary outcome was feasibility, defined as the percentage of participants who received GA-guided interventions and was pre-specified as successful if > 80% were given recommendations. A secondary outcome of the study was to capture unplanned readmissions within 1 month post discharge. Results: Between 9/19/2017 and 5/3/2019, 49 patients were eligible and 40 were enrolled, an 82% participation rate. The median age was 80.5 years (range 75-88), 58% male, 63% Non-Hispanic white, 18% Hispanic, 15% Asian, 70% > a high school education, 73% married/partner, and 48% had stage IV cancer. Most common cancer types: GI (28%), GU (23%), lung (20%). All 40 patients (100%) had ≥ 1 predefined trigger in the GA generating interventions and completed ≥ 2 follow-up visits with the APN. In total, 857 interventions were recommended, and the mean number of interventions generated per patient was 11. The top 4 interventions were Occupational Therapy/Physical Therapy (n = 66), Social Work (n = 52), Nutrition (n = 39), and Pharmacy (n = 36). Overall 89% of GA-guided interventions were implemented. Unplanned hospital readmission was low with only one patient readmitted within 30 days (3%). Conclusions: Among hospitalized adults over age 75 with cancer, using GA to identify vulnerability, and provide GA-driven multidisciplinary interventions is feasible. Further studies are warranted to examine the impact of GA-driven interventions on outcomes among hospitalized older adults with cancer.

A combined subjective and objective wireless monitoring program of patient-centered outcomes can be carried out in patients before and after major abdominal cancer surgery.To conduct a proof-of-concept pilot study of a wireless, patient-centered outcomes monitoring program before and after major abdominal cancer surgery.In this proof-of-concept pilot study, patients wore wristband pedometers and completed online patient-reported outcome surveys (symptoms and quality of life) 3 to 7 days before surgery, during hospitalization, and up to 2 weeks after discharge. Reminders via email were generated for all moderate to severe scores for symptoms and quality of life. Surgery-related data were collected via electronic medical records, and complications were calculated using the Clavien-Dindo classification. The study was carried out in the inpatient and outpatient surgical oncology unit of one National Cancer Institute-designated comprehensive cancer center. Eligible patients were scheduled to undergo curative resection for hepatobiliary and gastrointestinal cancers, were English speaking, and were 18 years or older. Twenty participants were enrolled over 4 months. The study dates were April 1, 2015, to July 31, 2016.Outcomes included adherence to wearing the pedometer, adherence to completing the surveys (MD Anderson Symptom Inventory and EuroQol 5-dimensional descriptive system), and satisfaction with the monitoring program.This study included a final sample of 20 patients (median age, 55.5 years [range, 22-74 years]; 15 [75%] female) with evaluable data. Pedometer adherence (88% [17 of 20] before surgery vs 83% [16 of 20] after discharge) was higher than survey adherence (65% to 75% [13 of 20 and 15 of 20] completed). The median number of daily steps at day 7 was 1689 (19% of daily steps at baseline), which correlated with the Comprehensive Complication Index, for which the median was 15 of 100 (r = -0.64, P .05). Postdischarge overall symptom severity (2.3 of 10) and symptom interference with activities (3.5 of 10) were mild. Pain (4.4 of 10), fatigue (4.7 of 10), and appetite loss (4.0 of 10) were moderate after surgery. Quality-of-life scores were lowest at discharge (66.6 of 100) but improved at week 2 (73.9 of 100). While patient-reported outcomes returned to baseline at 2 weeks, the number of daily steps was only one-third of preoperative baseline.Wireless monitoring of combined subjective and objective patient-centered outcomes can be carried out in the surgical oncology setting. Preoperative and postoperative patient-centered outcomes have the potential of identifying high-risk populations who may need additional interventions to support postoperative functional and symptom recovery.

Colon and rectal cancer represents the third most common cancer in the USA. Therefore, emergencies related to colorectal cancer are quite frequent. The most common emergencies related to primary colorectal cancer are perforation and obstruction. There are multiple surgical and nonsurgical methods to address these problems. In addition, there are multiple emergencies that affect the colon which stem from cancers outside the colon. These include severe colitis caused from ischemia, drugs, infection, and neutropenia. Treatment is often conservative in nature, with surgery reserved for extreme cases. Finally, there are multiple anorectal emergencies which are prominent in the cancer patient including but not limited to hemorrhoids, anal fissure, and anorectal abscess.

Postoperative adjuvant chemotherapy improves survival and reduces the rate of recurrence for patients with stage III colon cancer and may also improve survival in some subgroups of patients with stage II colon cancer. The recommended chemotherapeutic regimens, FOLFOX [Folinic acid (leucovorin) + 5-Fluorouracil (5-FU) + Oxaliplatin (Eloxatin)] or CapeOx (capecitabine + oxaliplatin), are more effective than past regimens, but also have more side effects. Since 5-year survival rates are improved 20–25 % with adjuvant therapy, all patients with stage III colon cancer should be evaluated for postoperative chemotherapy. For rectal cancer, neoadjuvant chemoradiotherapy is recommended for all clinical stage II and III disease to decrease recurrence. In addition, all clinical and/or histologic stage II and III rectal cancers should be considered for adjuvant chemotherapy. This chapter will review the indications, data, and outcomes for adjuvant therapy for colon and rectal cancer.

141 Background: Rectal cancer survivors often experience persistent long-term effects of treatment. Functional deficits, such as bowel dysfunction, are associated with poor quality of life (QOL). There is a lack of evidence-based interventions to address bowel dysfunction symptoms in rectal cancer survivors. The purpose of this abstract is to describe the development and design of the Altering Intake, Managing Symptoms (AIMS) intervention to manage bowel dysfunction in rectal cancer survivors. Methods: Survivors with stage I-III rectosigmoid colon or rectal cancer who are 6 months post-treatment, > 21 years, and English-speaking are eligible to participate. The AIMS intervention is a ten (30-40 minute) session, 4 month, telephone-based intervention delivered by trained health coaches. Outcome measures are assessed at baseline, 4 and 6 months, and include the MSKCC Bowel Function Tool, the COH-QOL-CRC, and adherence to cancer survivorship diet guidelines. Results: Based on the Chronic Care Self-Management Model (CCM), the AIMS intervention applies social cognitive theory to improve self-efficacy and self-management of bowel symptoms by coaching survivors to modify their diets to attenuate symptoms and enhance diet quality. Motivational interviewing-based behavioral approaches are applied, such as goal setting, self-monitoring, identification of barriers, and problem-solving. Monitoring of diet health involves review of 24 hour dietary recalls in conjunction with food and symptom diaries to promote survivor-directed behavior change resulting in improved bowel health. Conclusions: The AIMS intervention is among the first and few to address diet behavior changes for symptom management in rectal cancer survivors. It has the potential to positively impact the quality of long-term rectal cancer survivorship by integrating classic behavior change theories for cancer symptom management. Findings from the study will inform the design and development of future multi-institutional Phase II and III randomized trials. Clinical trial information: NCT03063918.

AIM: To investigate the impact of RAS and BRAF mutations on the pattern of metastatic disease and carcinoembryonic antigen (CEA) production. METHODS: In this retrospective study, we investigated the impact of RAS and BRAF mutational status on pattern of metastatic disease and CEA production. Only patients presenting with a newly diagnosed metastatic colorectal cancer (CRC) were included. Patients’ characteristics, primary tumor location, site of metastatic disease and CEA at presentation were compared between those with and without RAS and BRAF mutations. RESULTS: Among 174 patients, mutations in KRAS, NRAS and BRAF were detected in 47%, 3% and 6% respectively. RAS mutations (KRAS and NRAS) were more likely to be found in African American patients (87% vs 13%; P value = 0.0158). RAS mutations were associated with a higher likelihood of a normal CEA (< 5 ng/mL) at presentation. BRAF mutations were more likely to occur in females. We were not able to confirm any association between mutational status and site of metastatic disease at initial diagnosis. CONCLUSION: No association was found between RAS and BRAF mutations and sites of metastatic disease at the time of initial diagnosis in our cohort. Patients with RAS mutations were more likely to present with CEA levels < 5 ng/mL. These findings may have clinical implications on surveillance strategies for RAS mutant patients with earlier stages of CRC.

AIM: To predict node-positive disease in colon cancer using computed tomography (CT). METHODS: American Joint Committee on Cancer stage I-III colon cancer patients who underwent curavtive-intent colectomy between 2007-2010 were identified at a single comprehensive cancer center. All patients had preoperative CT scans with original radiology reports from referring institutions. CT images underwent blinded secondary review by a surgeon and a dedicated abdominal radiologist at our institution to identify pericolonic lymph nodes (LNs). Comparison of outside CT reports to our independent imaging review was performed in order to highlight differences in detection in actual clinical practice. CT reviews were compared with final pathology. Results of the outside radiologist review, secondary radiologist review, and surgeon review were compared with the final pathologic exam to determine sensitivity, specificity, positive and negative predictive values, false positive and negative rates, and accuracy of each review. Exclusion criteria included evidence of metastatic disease on CT, rectal or appendiceal involvement, or absence of accompanying imaging from referring institutions. RESULTS: From 2007 to 2010, 64 stageI-III colon cancer patients met the eligibility criteria of our study. The mean age of the cohort was 68 years, and 26 (41%) patients were male and 38 (59%) patients were female. On final pathology, 26 of 64 (40.6%) patients had node-positive (LN+) disease and 38 of 64 (59.4%) patients had node-negative (LN-) disease. Outside radiologic review demonstrated sensitivity of 54% (14 of 26 patients) and specificity of 66% (25 of 38 patients) in predicting LN+ disease, whereas secondary radiologist review demonstrated 88% (23 of 26) sensitivity and 58% (22 of 38) specificity. On surgeon review, sensitivity was 69% (18 of 26) with 66% specificity (25 of 38). Secondary radiology review demonstrated the highest accuracy (70%) and the lowest false negative rate (12%), compared to the surgeon review at 67% accuracy and 31% false negative rate and the outside radiology review at 61% accuracy and 46% false negative rate. CONCLUSION: CT LN staging of colon cancer has moderate accuracy, with administration of NCT based on CT potentially resulting in overtreatment. Active search for LN+ may improve sensitivity at the cost of specificity.

The open surgical approach to colon cancer surgery is still necessary in some cases. The results of open surgery are time-tested to be both effective and safe and may lag behind minimally invasive approaches with respect to only early postoperative recovery outcomes. The primary objectives of the operation are to remove the cancer with adequate surgical margins and to perform an appropriate lymphadenectomy. An open right hemicolectomy is typically a straightforward operation, but knowledge of the anatomy is necessary to avoid major complications. In patients with normal or low body mass index, the length of the incision for open right hemicolectomy can be similar to the length of the extraction site incision for the laparoscopic approach. This chapter provides a detailed, step-by-step description of the surgical technique for an open right colectomy.

679 Background: Pre-clinical studies have shown that the combination of MEK inhibitors and 5-FU improves antitumor activity and that MEK inhibition overcomes both 5FU and platinum resistance. This phase I study was conducted to determine the maximum tolerated dose (MTD) of the combination MEK162 and FOLFOX. Methods: Patients (pts) with metastatic colon or rectal cancer who progressed or failed prior 5FU, irinotecan, oxaliplatin and anti-EGFR therapy (in cases of RAS wild type tumors) received twice daily MEK162 in combination with every-2-week FOLFOX. Two dose levels of MEK162 (30mg and 45mg) were investigated in a standard 3 + 3 escalation design in combination with standard doses of FOLFOX without bolus 5-FU. Dose limiting toxicity (DLT) was defined as any treatment-related grade (G) 3 or 4 non-hematological toxicity (with the exception of G3 diarrhea or vomiting < 48 hrs) or G 4 neutropenia or thrombocytopenia within the first 2 cycles (4 weeks) of the treatment. Limited pharmacokinetic (PK) analysis of 5FU, oxaliplatin and MEK162 was performed at the MTD level. Results: 16 pts were enrolled (median age (range) 53 yrs (49-78); 11 men; ECOG 0/1 in 9/7 patients). No DLT was noted on the study. The MTD of MEK162 was 45 mg PO BID. An additional 6 pts (for a total of 12) were enrolled at the MTD for PK analysis and none of them developed DLT defining toxicities. A median of 8 cycles (range 1-19) was administered. Treatment-related ≥ grade 3 toxicities included anaphylaxis due to oxaliplatin (n = 1), CPK elevation (n = 2), neutropenia (n = 1), peripheral neuropathy (n = 3), thrombocytopenia (n = 1), retinal vascular disorder (n = 1), and acneiform rash (n = 1). 10 pts had SD at 2 months (m) by radiographic assessment, 5 of whom with stabilizations of > 5 months (5-10 months). There were no significant differences in the PKs of 5FU or oxaliplatin when administered with or without MEK162. Conclusions: The combination of MEK162 and FOLFOX has a manageable toxicity profile and promising antitumor activity in heavily pretreated metastatic colorectal cancer patients. Clinical trial information: NCT02041481.

Hypothesis There is an increase in the amount of time required to perform an operation when the procedure involves training a surgical resident. This increased time does not translate into a financial burden for the hospital. Design Retrospective review of prospectively collected data. During the study period, surgeons and residents were blinded to the study's intent. We compared the operative times of academic surgeons performing 4 common surgical procedures before and after the introduction of a postgraduate year 3 resident into a community teaching hospital. Between January 1, 2001, and June 30, 2002, 4 academic surgeons performed operations without a resident in a community hospital that was recently integrated into a tertiary medical center system. During that period, surgeons operated alone (hernia surgery) or assisted one another (laparoscopic cholecystectomy, colectomy, and carotid endarterectomy). From July 1, 2002, through March 31, 2003, these same 4 surgeons were assisted by a postgraduate year 3 resident on similar procedures. Setting Community hospital recently integrated into a tertiary medical center system. Participants Four experienced academic surgeons operating in the community setting and patients undergoing 1 of 4 surgical procedures (inguinal hernia repair, laparoscopic cholecystectomy, partial colectomy, or carotid endarterectomy) from January 1, 2001, through March 31, 2003. Intervention The introduction of a postgraduate year 3 surgical resident rotation into a community hospital in which the same academic surgeons had been performing operations without a resident for 18 months. Main Outcome Measures Mean operating time with and without a postgraduate year 3 resident participating in 4 common surgical procedures. Result For the 4 procedures studied, there was a significant increase in the operative time required to complete such procedures. Conclusions There is an increased time cost associated with the operative training of surgical residents. This "cost" primarily impacts the attending surgeon.

Background: There are still no standard endoscopic surveillance guidelines to detect neoplasia (dysplasia and/or cancer) following IPAA for IBD colitis. The aim of this survey study is to investigate the practice pattern of surveillance pouchoscopy for neoplasia in academic settings. Methods: Physicians who potentially take care of patients undergoing IPAA for IBD colitis were identified by searching literatures in MEDLINE. A questionnaire including practice pattern and opinions on ileal pouch surveillance was sent by email through REDcap. Univariable and multivariable analyses were performed. Results: A total of 118 physicians (86 gastroenterologists and 32 colorectal surgeons) were surveyed and 58 (49%) of them responded. One incomplete questionnaire and 5 physicians who do not routinely followup IBD patients with ileal pouch were excluded. Of the 52 eligible participants from 32 institutions, 6 (11%) were general gastroenterologists, 31(60%) were gastroenterologists specialized in IBD and 15 (29%) were colorectal surgeons. Forty-one physicians (79%) agree that it is necessary to perform routine pouch surveillance for neoplasia arising from ileal pouch or anal transitional zone/rectal cuff in all IBD patients undergoing IPAA and 22 (55%) think that the pouchoacopy solely for neoplasia should be performed every 2-3 years. Thirtysix physicians (69%) feel that pouchoscopy with biopsy is effective for the detection of neoplasia. Altogether 41 dysplasias and 15 cancers arising from ileal pouch or anal transitional zone/rectal cuff were reported to have been found within the past 5 years by 18 physicians (35%). There were no differences in the locations of pouch observation and biopsy during pouchocsopy examination between neoplasia detection and non-detection group. Colorectal surgeons found more pouch neoplasias than both gastroenterologists specialized in IBD and general gastroenterologists (61% vs 28% vs 11%, p 3 biopsies per location, 44% vs 82%, p=0.005). The median follow-up number of IBD pouch per year was significantly higher in neoplasia detection group (50 vs 25, p=0.041).