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PURPOSE: Describe the feasibility and implementation of an electronic health record (EHR)–integrated symptom and needs screening and referral system in a diverse racial/ethnic patient population in ambulatory oncology. METHODS: Data were collected from an ambulatory oncology clinic at the University of Miami Health System from October 2019 to January 2021. Guided by a Patient Advisory Board and the Exploration, Preparation, Implementation, and Sustainment model, My Wellness Check was developed to assess physical and psychologic symptoms and needs of ambulatory oncology patients before appointments to triage them to supportive services when elevated symptoms (eg, depression), barriers to care (eg, transportation and childcare), and nutritional needs were identified. Patients were assigned assessments at each appointment no more than once in a 30-day period starting at the second visit. Assessments were available in English and Spanish to serve the needs of the predominantly Spanish-speaking Hispanic/Latino population. RESULTS: From 1,232 assigned assessments, more than half (n = 739 assessments; 60.0%) were initiated by 506 unique patients. A total of 65.4% of English and 49.9% of Spanish assessments were initiated. Among all initiated assessments, the majority (85.1%) were completed at home via the patient portal. The most common endorsed items were nutritional needs (32.9%), followed by emotional symptoms (ie, depression and anxiety; 27.8%), practical needs (eg, financial concerns; 21.7%), and physical symptoms (17.6%). Across the physical symptom, social work, and nutrition-related alerts, 77.1%, 99.7%, and 78.8%, were addressed, respectively, by the corresponding oncology health professional, social work team member, or nutritionist. CONCLUSION: The results demonstrate encouraging feasibility and initial acceptability of implementing an EHR-integrated symptom and needs screening and referral system among diverse oncology patients. To our knowledge, this is the first EHR-integrated symptom and needs screening system implemented in routine oncology care for Spanish-speaking Hispanics/Latinos.

370 Background: Oral chemotherapy drugs are not always subject to the same safety standards as intravenous chemotherapy. Variability in safety practices can cause gaps in care, creating a need for continuous review of this process. This quality improvement (QI) project sought to improve provider and staff general knowledge on oral chemotherapy and on national safety standards through an educational intervention and to evaluate the implementation of an electronic medical record (EMR) integrated chemotherapy documentation template geared towards improving compliance with national safety standards pertinent to oral treatment. Methods: We used a pre/post-test design to compare knowledge following an educational session. A 15-question test covering national guidelines and safety standards relevant to oral chemotherapy were used to evaluate base knowledge before and after the session. We compared pre and post-test scores using paired t-tests. Then, a chemotherapy documentation template was developed in the EMR. The medical records of 44 patients at the center were reviewed four months before and 44 patients one month after the template’s introduction and documentation compliance was assessed using 24 national chemotherapy administration safety standards from the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative and the 2016 ASCO/Oncology Nursing Society Chemotherapy Administration Safety Standards. Comparison of compliance rates were performed using independent t-tests. Results: A total of 65 providers and staff participated in the educational session and completed both the pre and post-test. There was a statistical significance in knowledge gained from pre-test to post-test (p value of < 0.001). Additionally, from the 88 charts reviewed, there was a statistical improvement in compliance with national safety standards (p value of < 0.001). The participants (n = 29) also scored the documentation template as above average indicating overall ease of use and feasibility for continued use. Conclusions: This QI initiative improved provider knowledge and compliance with oral chemotherapy national safety standards. As a result, more centers should focus efforts on awareness and utilization of established national safety guidelines; critical to addressing the disparities in practice. Additionally, having a standardized workflow that prompts documentation within the EMR and discussion of the national standards is key to quality and safe practice.

When South Florida became a hotspot for COVID-19 disease in March 2020, we faced an urgent need to develop test capability to detect SARS-CoV-2 infection. We assembled a transdisciplinary team of knowledgeable and dedicated physicians, scientists, technologists and administrators, who rapidly built a multi-platform, PCR- and serology-based detection program, established drive-thru facilities and drafted and implemented guidelines that enabled efficient testing of our patients and employees. This process was extremely complex, due to the limited availability of needed reagents, but outreach to our research scientists and to multiple diagnostic laboratory companies and government officials enabled us to implement both FDA authorized and laboratory developed testing (LDT)-based testing protocols. We analyzed our workforce needs and created teams of appropriately skilled and certified workers, to safely process patient samples and conduct SARS-CoV-2 testing and contact tracing. We initiated smart test ordering, interfaced all testing platforms with our electronic medical record, and went from zero testing capacity, to testing hundreds of healthcare workers and patients daily, within three weeks. We believe our experience can inform the efforts of others, when faced with a crisis situation.

When South Florida became a hot spot for COVID-19 disease in March 2020, we faced an urgent need to develop test capability to detect SARS-CoV-2 infection. We assembled a transdisciplinary team of knowledgeable and dedicated physicians, scientists, technologists, and administrators who rapidly built a multiplatform, polymerase chain reaction- and serology-based detection program, established drive-through facilities, and drafted and implemented guidelines that enabled efficient testing of our patients and employees. This process was extremely complex, due to the limited availability of needed reagents, but outreach to our research scientists and multiple diagnostic laboratory companies, and government officials enabled us to implement both Food and Drug Administration authorized and laboratory-developed testing-based testing protocols. We analyzed our workforce needs and created teams of appropriately skilled and certified workers to safely process patient samples and conduct SARS-CoV-2 testing and contact tracing. We initiated smart test ordering, interfaced all testing platforms with our electronic medical record, and went from zero testing capacity to testing hundreds of health care workers and patients daily, within 3 weeks. We believe our experience can inform the efforts of others when faced with a crisis situation.

Formal training is an important mechanism to assist the new generation of nurse practitioners (NPs) entering the complex field of oncology. The growing number of patients with cancer and the expansion of treatment options demand structured oncology training to support the transition of novice advanced practice nurses to the field. Oncology NP fellowships are a potential solution for those seeking training centered on the management of patients with cancer. This article discusses the process of implementing an NP fellowship program at an academic cancer center, including benefits and barriers.

The phase III MPACT trial for metastatic pancreatic cancer (PC) showed improved overall survival (OS), progression free survival (PFS) and response rates (RRs) for first-line nab-paclitaxel (Abraxane) and gemcitabine (the AG combination) compared to gemcitabine monotherapy. The safety and efficacy of the AG combination has not been systematically studied as second-line therapy or beyond for metastatic PC. We conducted an IRB-approved retrospective analysis of all patients diagnosed between September 2010 and August 2014 with advanced refractory PC that received combination treatment with AG at our institution. Demographic and survival data were extracted from the registry. Patients received nab-paclitaxel 125 mg/m2 and gemcitabine 1,000 mg/m2 and on days 1, 8 and 15 of a 28-day cycle with subsequent dose modifications based on tolerance. Data on 59 patients was available; the median age was 61; 55% were male; 56% received AG as second line therapy and 44% received it as third-line or beyond. Five (10%) patients had a confirmed partial response (PR), 23 (47%) had stable disease (SD) and 21 (43%) had disease progression as their best response. Among the 31 (52%) patients who received prior gemcitabine, 18 (58%) had clinical benefit; 3 had a PR and 15 had SD. The median OS was 3.9 months and the median progression-free survival was 3 months. Toxicity was similar to what was reported in the MPACT trial. This retrospective analysis suggests that AG is active in PC patients previously treated with either fluoropyrimidine-based therapy or gemcitabine-based therapy with manageable toxicities.

173 Background: Electronic health record (EHR) integrated symptom monitoring using patient reported outcomes (PRO) has been associated with improved outcomes, including health-related quality of life (HRQoL), in cancer survivors. However, these improvements have been documented through reasonably high completion rates of PRO measures in predominantly non-Hispanic White patient populations using only English language assessments. This study aimed to 1) examine factors associated with the completion of PRO assessments and 2) test differences in referrals to cancer support services between PRO responders and non-responders in a cohort of cancer survivors with significant racial, ethnic, and primary language diversity. Methods: A retrospective analysis (October 2019-February 2021) was performed for patients who were assigned the My Wellness Check (MWC) program at a tertiary, comprehensive cancer center. MWC is an EHR-based PRO assessment and referral program that uses PROMIS computer adaptive tests for depression, anxiety, pain, fatigue, and physical function as well as a psychosocial needs assessment. MWC PRO questionnaire is available in English or Spanish based on patient preference. Demographic and clinical characteristics of patients were collected and incorporated in multivariable binary logistic regression model to examine factors associated with completion of the MWC PRO questionnaires. The frequency of referrals to cancer support services was compared by Chi-square test between MWC PRO responders and non-responders. Adjusted odds ratio (aOR) and 95% confidence interval (95%CI) were calculated. Results: Of the 5306 patients eligible to complete MWC PRO questionnaire, the majority were female (64.1%), White (86.9%), Hispanic (65.8%), English speaker (55.4%), and 46.0% were responders. Patients who were younger than 65 (aOR 1.39; 95%CI 1.22-1.59; p < 0.0001), female (1.23; 1.09-1.41; p = 0.0019), non-Hispanic/Latino (1.43; 1.25-1.64; p < 0.0001), living with partners ( = 1.28; 1.13-1.46; p = 0.0001), and receipt of active treatment (1.37; 1.18-1.58; p < 0.0001) were significantly associated with MWC PRO completion. Responders were referred to cancer support services more often than non-responders (16.6% vs 5.4%, p < 0.0001). Conclusions: Patient-level and clinical factors predict completion of PRO measures, and responders were more likely to have a referral to cancer support services. To optimize supportive care for ambulatory cancer patients, further research is needed to identify factors that can promote patient engagement, particularly in patients who are under-utilizers of such services.

339 Background: Uptake in lung cancer screening (LCS) in high-risk patients including minority populations has been low despite efforts to increase awareness in the community. During the COVID pandemic, most LCS programs were temporarily stopped and, in the months to follow experienced a significant reduction in referrals. Platforms including social media and direct mail marketing can provide a valuable tool to enhance patient engagement related to LCS and engagement of Hispanic populations who are active consumers of digital media. The objective of this study was to assess the short-term effectiveness of a targeted LCS digital and direct marketing campaign to increase visits to the institutional online educational content and referrals to a LCS program. Methods: A LCS marketing campaign including social media utilizing Facebook and Instagram platforms with programmatic banners, boosted organic social media posts, plus direct mail-in marketing in Spanish and English was started in the post-COVID period. A CRM (customer-relationship management) software was used to target adults ages 50-80, current or former smokers, who speak English and/or Spanish in the Miami tri-county area over a three-month period by a direct-mail campaign. Other campaign targeting qualifications included family history of lung cancer, and additional lung cancer risk factors including asbestos, chronic obstructive pulmonary disease, or emphysema. The CRM Direct mail campaign was sent 87,000 leads by postcard and 65,810 leads by email. Primary outcomes measures were visits to the University of Miami institutional LCS Web page, LDCT ambulatory referrals, and scheduled initial LDCT exams. Study period was baseline pre-COVID period (6/1/2019-12/31/2019), COVID-period (3/1/2020-9/31/2020) and digital awareness campaign in the post-COVID period (12/1/2020-5/31/2020). Results: Unique pageviews to the institutional LCS web pages were significantly higher during the digital awareness campaign compared to the pre-COVID period (8,805 vs 230 pageviews) with a high bounce rate during the campaign period of 79% and average time in site of 2:21 minutes. Mean scheduled initial LDCT volumes per month during the pre-COVID period were 12.4 (SD 4.6), versus 4.1 (SD 2.5) during the COVID period. There was a 3-fold increase in initial LDCT scans during the initial campaign period from 4.1 in the COVID period to 11.6 (p

e19011 Background: The National Lung Screening Trial (NLST) revealed a 20% reduction in lung cancer (LC) mortality when low-dose computed tomography (LDCT) was utilized for LC screening vs chest radiography. NLST participants were predominantly Non-Hispanic Whites, with only 1.8% Hispanics. The goal of our study was to investigate the attributes of a LC screening program in a largely Hispanic urban population and compare with NLST. Methods: We performed a retrospective analysis of 421 consecutive cases who underwent LDCT screening from 2016-2019 at University of Miami (UM), with similar inclusion criteria as the NLST. Demographic characteristics, smoking status, lung RADS, LC detection and compliance were examined & compared with NLST cohort using summary statistics and χ2 tests for categorical variables. Results: Demographic and smoking characteristics of the UM cohort didn’t resemble those of NLST LDCT cohort. UM cohort had a different racial and ethnic profile, with a higher percentage of Hispanics (47.3% vs 1.8%) and African Americans (15% vs 4.5%) in the UM cohort vs NLST cohort respectively (p < 0.001). UM cohort generally had lesser smoking intensity, and significantly fewer active smokers when compared to the NSLT cohort; 38.5% vs 48.1% respectively. The proportion of positive LDCT screens (Lung-RADS Class 3 or 4) in the UM cohort (14.1%) was almost similar to the NLST cohort (13.7%) (p = 0.81). The UM cohort had a higher LC detection rate (3.3%) than the NLST cohort (1.1%) (p < 0.001). In keeping with goals of screening, both cohorts had 50% or more LC cases detected at an early curable stage. Overall patient adherence to screening guidelines was more than 90% in NLST cohort; whereas almost a quarter of referred patients in UM cohort didn’t show for their initial decision-making visit and only 45% completed two or more scans. Conclusions: Our LDCT screening program was based in a Hispanic urban location (UM) with 47.3% Hispanics. Compared to NLST LDCT arm, the UM cohort had fewer active smokers, lighter smoking history, a more diverse population, somewhat higher LC detection rate, weaker adherence to screening related visits. More data is needed to understand obstacles to compliance with screening in minority populations.

The phase III MPACT trial for metastatic pancreatic cancer (PC) showed improved overall survival (OS), progression free survival (PFS) and response rates (RRs) for first-line nab-paclitaxel (Abraxane) and gemcitabine (the AG combination) compared to gemcitabine monotherapy. The safety and efficacy of the AG combination has not been systematically studied as second-line therapy or beyond for metastatic PC. We conducted an IRB-approved retrospective analysis of all patients diagnosed between September 2010 and August 2014 with advanced refractory PC that received combination treatment with AG at our institution. Demographic and survival data were extracted from the registry. Patients received nab-paclitaxel 125 mg/m2 and gemcitabine 1,000 mg/m2 and on days 1, 8 and 15 of a 28-day cycle with subsequent dose modifications based on tolerance. Data on 59 patients was available; the median age was 61; 55% were male; 56% received AG as second line therapy and 44% received it as third-line or beyond. Five (10%) patients had a confirmed partial response (PR), 23 (47%) had stable disease (SD) and 21 (43%) had disease progression as their best response. Among the 31 (52%) patients who received prior gemcitabine, 18 (58%) had clinical benefit; 3 had a PR and 15 had SD. The median OS was 3.9 months and the median progression-free survival was 3 months. Toxicity was similar to what was reported in the MPACT trial. This retrospective analysis suggests that AG is active in PC patients previously treated with either fluoropyrimidine-based therapy or gemcitabine-based therapy with manageable toxicities.

Background The efficacy of FOLFIRINOX for metastatic pancreatic cancer has led to its use in patients with earlier stages of disease. This study retrospectively analyzed a cohort of patients with locally-advanced pancreatic cancer (LAPC) treated with FOLFIRINOX. Methods Between 2008 and 2013, 51 treatment-naive patients with LAPC at a single institution received first-line FOLFIRINOX with neoadjuvant intent, at the full dose as described in the PRODIGE 4/ACCORD 11 study. Combined chemoradiation was administered for those who remained unresectable after maximum response to chemotherapy. The primary outcome measure was overall survival (OS), and secondary outcomes were progression-free survival (PFS) and margin-negative (R0) resection rate, and toxicity profile. Results A total of 429 cycles of FOLFIRINOX were given with a median of 8 cycles (range 2–29) per patient; 66% of cycles were full dose. After chemotherapy, 27 (53%) received chemoradiation. The median OS was 35.4 months (95% CI 25.8–45). Ten (4 borderline resectable and 6 unresectable) patients had successful R0 resections; those who had R0 resections had a significantly longer survival than those who did not (3-year OS rate 67% versus 21%, log rank p = 0.042). Increasing number of full-dose cycles was significantly associated with increased survival. The toxicity profile was similar to previous reports of this regimen. Conclusions FOLFIRINOX is feasible as neoadjuvant therapy for LAPC. Although the R0 resection rate was only 20%, the median OS of almost 3 years appears promising. Dose intensity and duration were associated with increased survival in this study, arguing against dose attenuated versions of this regimen.

Docetaxel and capecitabine combination is synergistic in preclinical models. We investigated the efficacy and toxicity of this combination as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma (mPC), pretreated with gemcitabine-based chemotherapy.Eligible patients were treated with capecitabine 800 mg/m(2) orally PO bid on days 1-14 in combination with intravenous docetaxel 30 mg/m(2) on days 1 and 8 of each 21-day cycle. The primary end point was overall response rate. Using a three-stage sequential design, two interim analyses for early stopping due to lack of efficacy were planned and conducted after 13 and 26 patients were accrued. Secondary end points included time to treatment failure, progression-free survival (PFS), overall survival (OS) and 50 % drop in CA19-9 levels.Forty-three patients were evaluable for toxicity and 42 evaluable for response, at a median age of 64 years. The majority of patients (74 %) had ECOG PS 0-1. Six patients (14 %) achieved a partial tumor response, and stable disease for ≥2 cycles was observed in 59 % of patients (n = 25). Thirty-five percent (n = 11/31) of patients had a ≥50 % decrease in CA19-9 levels. The median PFS was 3.7 months (95 % CI 2.1-4.3 months), and the median OS was 5.3 months (95 % CI 4.3-8.6 months). Treatment was generally well tolerated. Grade 3 toxicity and grade 4 toxicity were seen in 45 and 5 % of patients, respectively. One patient had a potential treatment-related mortality.The combination of capecitabine and docetaxel is active and well tolerated in mPC patients pretreated with gemcitabine-based therapy.

216 Background: The University of Miami’s Phase I Program is South Florida’s only academic Phase I center dedicated to drug development for cancer patients. On April 2018, Sylvester Comprehensive Cancer Center opened the Phase I/Experimental Therapeutics (ET) Clinic dedicated to research patients enrolled in Phase I clinical trials and established a multi-disciplinary care team. As Phase I clinical trials are evolving, it is necessary to improve on the patient experience as it pertains to research care. Methods: Using a Likert-type scale, dual language survey (English and Spanish), patients were asked 11 questions about the Phase I/ET Clinic visit ranging from the beginning of their Phase I clinical trial enrollment all the way to provider care during the visit. The survey was conducted from January 2019-April 2019 through a secure, HIPAA compliant online Research Electronic Data Capture software (REDCap). Results: Of the 30 patients that were approached, 26 responded (Renal 26.9%, Myelofibrosis 19.2%, Bladder 15.4%, Head and Neck 7.7%, Acute Myeloid Leukemia 15.4%, Myelodysplastic Syndrome 7.7%, and Other 7.7%). Our results found that 100% of research patients would recommend a Phase I clinical trial to another participant. In addition, 96.2% of patients felt there was continuation of their care through their clinical trial process. As a note, 19.2% of patients positively recognized a Phase I provider including Nurse Practitioners (NPs) and physicians. Of these 19.2% of patients, 50% praised an NP in the free text area of the survey. Lastly, 42.3% of patients positively mentioned the team support received in the Phase I Clinic in the free text area of the survey. Conclusions: Our conclusion based on survey results show that having committed providers and clinic space for research patients on a Phase I clinical trial provided an overall positive and personalized experience. Additionally, the survey reflects on how patients are more inclined to refer to a clinical trial due to a good experience. Future directions should look at developing a similar clinic for all phases of research considering the exceptional patient feedback emphasizing on provider care.

Topic Significance & Study Purpose/Background/Rationale Nurse practitioner (NP) graduate programs mainly focus on primary care and lack specialty training. It is important that new NPs entering the field of hematology are prepared to manage the complexity of patient care involved with the transplant and immunotherapy population. Inadequate training and mentoring can lead to poor job satisfaction, burnout, high turnover and suboptimal proactive care assessment and interventions impacting patient outcomes. Methods, Intervention, & Analysis In 2017, the Oncology NP fellowship was initiated. With the FDA approval of chimeric antigen receptor T-cell therapy came the vision to expand the fellowship to include a designated track for the transplant program. The NP fellow spends one year immersed in managing stem cell transplant and cellular therapy patients in the inpatient and outpatient setting under the guidance of a senior transplant NP and mentor. The program includes didactic and clinical experiences with a curriculum based on national guidelines and clear endpoints for successful completion (Figure 1). Findings & Interpretation It is critical to the development for NPs interested in practicing in specialty services have a standardized framework for training. This allows the NP the opportunity to gain the necessary knowledge and confidence to manage transplant and cellular patients effectively, provide quality care and become valuable members of the multidisciplinary team. Discussion & Implications The role of the transplant NP continues to evolve. It is vital to establish training programs to support the growing complexity of cancer care. Development of specialty training programs promotes a structural framework (Figure 2) and smooth integration of the new NP into transplant and cellular therapy programs.

101 Background: Oncology infusion centers play a crucial role in detection of malnutrition. In one month, the Sylvester Comprehensive Cancer Center chemotherapy infusion center in Miami (SCCC CTU) treats over 400 oncology patients. Research shows that 40-80% of patients with a cancer diagnosis are malnourished (Isenring et al., 2006). In April, 1.89% of patients seen at the Miami CTU were referred to an oncology nutritionist. The goal was to increase the percentage of patients referred by 2% by June through adequate screening and referral. Methods: SCCC Miami CTU nursing staff’s knowledge on the use of the Malnutrition Screening Tool (MST) and the referral process were assessed through a survey. The survey also functioned as an educational instrument. Additionally, one-on-one discussions about the referral process were conducted with the SCCC CTU nurse practitioners. Results: The survey was available to CTU RNs with a 35% completion rate. Results portrayed that 82.35% were aware of the MST screening tool; however, 88.25% were unaware of the appropriate code to refer patients to nutritionist. Therefore, if nutritional consults were placed, it was unlikely that the nutritionist would receive the request. Identified obstacles included having to call a provider to initiate a consult, lack of time for proper assessment and the availability of a nutritionist. Conclusions: Although results did not yield a significant increase of referrals through the use of the appropriate code, there was a 1.22% increase on the overall referrals placed. Lack of training and knowledge on the MST, improper use of the referral code, and the intricacy of the workflow, were contributing factors to the inadequacy in screening and referral process. Participation of all staff in education initiatives and interventions should be a vital component in improving quality care of oncology patients. [Table: see text]

nab-Paclitaxel has been shown to disrupt pancreatic cancer stroma and was effective in combination with gemcitabine in a phase I/II trial. This study was designed to determine the efficacy of nab-paclitaxel monotherapy in previously treated pancreatic cancer patients.In this phase II trial, patients with advanced pancreatic cancer who progressed on gemcitabine-based therapy, received nab-paclitaxel 100 mg/m over 30 minutes on days 1, 8, and 15 of a 28-day cycle. The primary endpoint was 6-month overall survival (OS). Secondary endpoints were response rate (by Response Evaluation Criteria In Solid Tumors), progression-free survival, safety, and toxicity profile.Among 19 patients treated, the median age was 61 years, 9 (47%) were male patients and 18 (95%) had stage-IV disease. The primary endpoint of the study was reached with a 6-month OS of 58% [95% confidence interval (95% CI), 33%-76%] and an estimated median OS of 7.3 months (95% CI, 2.8-15.8 mo). The median progression-free survival was 1.7 months (95% CI, 1.5-3.5 mo). One patient had a confirmed partial response and 6 (32%) had stable disease as their best response. Nonhematological toxicities were generally mild with grades 1-2 nausea, anorexia, hypocalcemia, and vomiting occurring in 63%, 47%, 37%, and 26% of patients, respectively. Grades 3-4 neutropenia, neutropenic fever, and anemia occurred in 32%, 11%, and 11% of patients, respectively. Only 2 of 15 available tumors stained positive for secreted protein acid rich in cysteine, and neither of these patients benefited from the therapy.nab-Paclitaxel was well tolerated, and it demonstrated preliminary evidence of activity in a subset of patients who progressed on gemcitabine-based therapy.

OBJECTIVE: Little progress has been made in the treatment of pancreatic cancer (PC). This study evaluated the clinical activity of gemcitabine, oxaliplatin, and cetuximab (GOC) in patients with locally advanced or metastatic PC. METHODS: The study primary endpoint was progression-free survival (PFS). Eligible, chemotherapy-naive PC patients were treated with gemcitabine (1000 mg/m(2) over 100 min) on day 1, oxaliplatin (100 mg/m(2)) on day 2, every 2 weeks, and weekly cetuximab, (loading dose of 400 mg/m(2) on cycle 1 day 1 and 250 mg/m(2) thereafter). It was expected that GOC treatment would extend the median PFS from 5.8 to 7.54 months, a relative increase of 30%, compared with gemcitabine and oxaliplatin (historical control). RESULTS: A total of 41 evaluable patients were enrolled. The overall response rate was 24%. Median PFS time was 6.9 months and median overall survival (OS) was 11.3 months. Patients with locally advanced disease had longer median PFS (12.4 vs. 4.7 mo) and OS (15.7 vs. 6.4 mo) compared with patients with metastatic disease. The most common grade 3 to 4 toxicities included neutropenia (32%), infection (with normal or grade 1 to 2 neutropenia, in 24%), neuropathy (17%), fatigue (15%), and rash (7%). Five patients (12%) discontinued study treatment without evidence of progression. Rash was not a significant prognostic factor affecting PFS or OS. CONCLUSIONS: GOC is a feasible combination with an acceptable toxicity profile. However, GOC did not significantly extend PFS in the overall patient population to consider it for further development.

The median survival of patients with metastatic pancreatic cancer is three to six months, making the diagnosis difficult to accept for patients, family, and healthcare providers. Therapeutic options are improving, but the treatment of advanced disease remains palliative. For oncology nurses, understanding the therapeutic and palliative options can provide these patients and their caregivers with additional information to make appropriate and individualized healthcare decisions.

82 Background: SCCC faces obstacles similar to programs challenged with the development of a cancer survivorship program. Informatics is one of the major limiting resources in continuing to improve and move the survivorship program forward at a large academic institution. An electronic order referral system is pivotal for success. Sylvester at UHEALTH has 7 campuses spread out over 60 miles in a heavily populated area of South Florida. UHEALTH developed a workflow that allowed providers to enter order referrals for identified patients. Methods: At UHEALTH, within EPIC, patients (PTS) have order referrals placed for their needs. The scheduling department contacts PTS to arrange their appointments. With the assistance of our EPIC team and oncology scheduling service, we developed a survivorship order referral. Its purpose was to streamline the process from identification of appropriate PTS, entering order referral and then scheduling PTS into open templates throughout the institution. This order referral is a useful tool within the electronic health record that assists in tracking and scheduling PTS for the survivorship clinic visit type created. The centralized survivorship clinic established itself at the same time the order referral pilot started. Results: UHEALTH piloted the order referral at main campus and 1 of our 6 satellite locations. The pilot showed that from the period of January 2017 - June 2017, providers referred 142 PTS to a survivorship clinic. PTS had the right to refuse the Survivorship visit, but it was important to offer the clinic and explain its purpose. After a successful 6-month period, we expanded the order referral to include three other satellite locations. Conclusions: It is our recommendation to other institutions who use EPIC to create an ambulatory order referral process for referring and scheduling identified PTS to a survivorship clinic. An EPIC order referral increases PTS referrals to survivorship. Institution specific analytics are tracked through order referrals placed and survivorship visit type appointments made. Further research is necessary to understand reasons for PTS refusing or cancelling survivorship appointments.

A gastrointestinal stromal tumor (GIST) is a soft tissue sarcoma that can occur anywhere along the gastrointestinal (GI) tract and is the most common noncarcinomatous malignancy of the GI tract. This article will review the pathology of GISTs, the molecular pathology related to c-kit, and disease management and will discuss a new drug approved in the management of GISTs, sunitinib malate. In addition, pharmacologic properties along with nursing considerations related to sunitinib malate will be reviewed.

Risk factors which interfere with cognitive function are especially important during the first 2 years of life - a period referred to as early child development and a time during which rapid growth and essential development occur. Malnutrition, a condition whose effect on cognitive function is well known, has been shown to be part of a vicious cycle with diarrhoeal diseases, and the two pathologies together continue to be the leading cause of illness and death in young children in developing countries. This paper reviews the burden of early childhood diarrhoeal diseases globally and the emerging evidence of their relationship with global disparities in neurocognitive development. The strength of evidence which indicates that the severe childhood diarrhoeal burden may be implicated in cognitive impairment of children from low- and middle-income counties is discussed. Findings suggest that greater investment in multi-site, longitudinal enteric infection studies that assess long-term repercussions are warranted. Furthermore, economic analyses using the concept of human capital should play a key role in advancing our understanding of the breadth and complexities of the health, social and economic ramifications of early childhood diarrhoeal diseases and enteric infections. This broadened awareness can serve to help advocate for more effective interventions, particularly in developing economies.

Although the monoamine oxidase-A (MAOA) gene has been linked to spatial learning and memory in animal models, convincing evidence in humans is lacking. Performance on an ecologically-valid, virtual computer-based equivalent of the Morris Water Maze task was compared between 28 healthy males with the low MAOA transcriptional activity and 41 healthy age- and IQ-matched males with the high MAOA transcriptional activity. The results revealed consistently better performance (reduced heading error, shorter path length, and reduced failed trials) for the high MAOA activity individuals relative to the low activity individuals. By comparison, groups did not differ on pre-task variables or strategic measures such as first-move latency. The results provide novel evidence of MAOA gene involvement in human spatial navigation using a virtual analogue of the Morris Water Maze task.

Little is known about how steroid hormones contribute to the beneficial effect of incentives on cognitive control during adolescent development. In this study, 27 adolescents with Congenital Adrenal Hyperplasia (CAH, mean age 15.6 years, 12 female), a disorder of cortisol deficiency and androgen excess, and 36 healthy participants (mean age 16.3 years, 18 female) completed a reward-based antisaccade task. In this mixed-saccade task, participants performed eye movements towards (prosaccades) or away (antisaccades) from a peripherally occuring stimulus. On incentive trials, monetary reward was provided for correct performance, while no such reward was provided on no-incentive trials. Consistent with the hypothesis, the results showed that healthy, but not CAH adolescents, significantly improved their inhibitory control (antisaccade accuracy) during incentive trials relative to no-incentive trials. These findings were not driven by severity of CAH (salt wasters vs. simple virilizers), individual hormone levels, sex, age-at-diagnosis, or medication type (dexamethasone vs. hydrocortisone). In addition, no significant differences between groups were found on orienting responses (prosaccades). Additional analyses revealed an impact of glucocorticoid (GC) dosage, such that higher GC dose predicted better antisaccade performance. However, this effect did not impact incentive processing. The data are discussed within the context of steroid hormone mediated effects on cognitive control and reward processing.

Background 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (FOLFIRINOX) is superior to gemcitabine in patients with metastatic pancreatic cancer who have a good performance status. We investigated this combination as neoadjuvant therapy for locally advanced pancreatic cancer (LAPC). Methods In this retrospective series, we included patients with unresectable LAPC who received neoadjuvant FOLFIRINOX with growth factor support. The primary analysis endpoint was R0 resection rate. Results Eighteen treatment-naïve patients with unresectable or borderline resectable LAPC were treated with neoadjuvant FOLFIRINOX. The median age was 57.5 years and all had ECOG PS of 0 or 1. Eleven (61 %) had tumors in the head of the pancreas and 9 (50 %) had biliary stents placed prior to chemotherapy. A total of 146 cycles were administered with a median of 8 cycles (range 3-17) per patient. At maximum response or tolerability, 7 (39 %) were converted to resectability by radiological criteria; 5 had R0 resections, 1 had an R1 resection, and 1 had unresectable disease. Among the 11 patients who remained unresectable after FOLFIRINOX, 3 went on to have R0 resections after combined chemoradiotherapy, giving an overall R0 resection rate of 44 % (95 % CI 22–69 %). After a median follow-up of 13.4 months, the 1-year progression-free survival was 83 % (95 % CI 59-96 %) and the 1-year overall survival was 100 % (95 % CI 85-100 %). Grade 3/4 chemotherapy-related toxicities were neutropenia (22 %), neutropenic fever (17 %), thrombocytopenia (11 %), fatigue (11 %), and diarrhea (11 %). Common grade 1/2 toxicities were neutropenia (33 %), anemia (72 %), thrombocytopenia (44 %), fatigue (78 %), nausea (50 %), diarrhea (33 %) and neuropathy (33 %). Conclusions FOLFIRINOX followed by chemoradiotherapy is feasible as neoadjuvant therapy in patients with unresectable LAPC. The R0 resection rate of 44 % in this population is promising. Further studies are warranted.

E7974, a synthetic analog of hemiasterlin, interacts with the tubulin molecule and overcomes resistance to other antitubulin drugs (taxanes and vinca alkaloids).In a phase 1 study, E7974 was given intravenously over a 2- to 5-minute infusion on day 1 of every 21-day cycle. Adult patients with advanced refractory solid tumors who had adequate organ function and Eastern Cooperative Oncology Group performance status 0 to 2 were eligible for this study. A modified Fibonacci schema was used. The maximal tolerated dose (MTD) was the dose where2 of 6 patients developed a dose-limiting toxicity (DLT).Twenty-eight patients (19 men and 9 women; median age, 64 years) treated at different cohort dose levels (0.18 mg/m(2) , 0.27 mg/m(2) , 0.36 mg/m(2) , 0.45 mg/m(2) , and 0.56 mg/m(2) ) received a total of 66 courses of E7974. The MTD was established at 0.45 mg/m(2) , where 1 of 6 patients experienced DLT (grade 4 febrile neutropenia). Of the 17 refractory colon cancer patients with a median of 3 prior treatments, stable disease was seen in 7 patients (41%). There were no tumor responses. Median progression-free survival was 1.2 months, and median overall survival was 6.7 months. In pharmacokinetic analysis, E7974 was characterized by a fast and moderately large distribution (37.95-147.93 L), slow clearance (2.23-7.15 L/h), and moderate to slow elimination (time to half-life, 10.4-30.5 hours).This study shows that E7974 once every 21-day cycle shows antitumor activity in patients with refractory solid tumors. The recommended phase 2 dose is 0.45 mg/m(2).

Oxaliplatin in combination with a fluoropyrimide is a treatment option for colorectal cancer patients in the adjuvant and metastatic settings. Very few hematological emergencies have been reported associated with Oxaliplatin. These include autoimmune hemolytic anemia, thrombocytopenia and pancytopenia. We present a case report of a patient who developed hematuria and disseminated intravascular coagulation while receiving the second cycle of FOLFOX and bevacizumab for metastatic colon cancer.

Objective To evaluate long-term change in fruit and vegetable intake following a group randomized trial of worksites. Methods Medium-sized blue-collar businesses in the Seattle metropolitan area were recruited. Intake was assessed using serial cross-sectional samples of current workforce at 3 time points. The multilevel 18-month intervention involved partnership with the companies. Long-term follow-up was at 4.4 years postbaseline. Statistical analysis used general linear models, adjusting for worksite random effects. Results Initially, 45 worksites were randomized, with 29 agreeing to participate in a new study. Fruits and vegetable intake increased, with larger sustained changes in the intervention worksites, resulting in a long-term differential change of 0.25 servings per day, 95% confidence interval (0.09 to 0.40). Conclusions Intervention sustained small effects at 4 years, including 2 years with no contact. Although effects were not large, this low-intensity intervention approach could provide an important public health model.

413 Background: The combination of nab-P and Gem improves survival compared to Gem alone in first-line therapy of metastatic pancreatic cancer. Efficacy data with this doublet in previously treated pts are scant. Our group presented preliminary results on 10 pts treated with this two-drug combination in the second and third line setting and herein present updated data on 59 pts. Methods: This IRB approved analysis identified all pts diagnosed with advanced refractory pancreatic cancer, treated with second-line Gem and nab-P at University of Miami and Sylvester Comprehensive Cancer Center between September 2010 and June 2014. Response by RECIST, CA19-9, and symptomatic improvement were assessed. Progression-free survival (PFS) and overall survival (OS) were calculated from the start of Gem + nab-P and were analyzed using the Kaplan-Meier method. Clinical benefit was defined as the percentage of patients with a partial response (PR) or stable disease (SD). Results: Data from59 pts were analyzed. The median age was 60; 55% were male; 54% received Gem + nab-P as second line therapy and 46% received it as third-line or beyond. Five (10%) pts had confirmed PR, 23 (47%) SD and 21 (43%) progressed. Among the 31 (52%) pts who received prior Gem, 18 (58%) had clinical benefit, 3 PR and 15 SD. The median OS was 3.9 months. The median PFS was 3 months. Toxicity appears similar to what has been reported on the MPACT trial with the combination. Conclusions: The clinical benefit seen withGem and nab-P in this group of pretreated pancreatic cancer pts suggests that it can be considered as an option. Additionally, prior Gem treatment appears not to decrease Gem and nab-P benefit in this population. Since nab-P monotherapy has modest activity in pre-treated pancreatic cancer pts, our data suggests a positive interaction between Gem and nab-P that may overcome resistance to Gem. [Table: see text]

460 Background: No validated biomarkers exist to direct treatment decisions in PDAC. Decisions regarding tx choices are based on age, organ function, and performance status. Defining predictors of efficacy to F (alone or in combination) or G (alone or in combination) in PDAC are urgently needed. Histologic subtype by immunohistochemistry (IHC); pancreatobiliary type (PB), intestinal type (I), gastric type (Ga) and intestinal/gastric type (I/G); may predict benefit to G or F. Methods: Charts of PDAC pts from 2 institutions from 2007 to 2013 having both pathology specimen and a qualifying tx (FOLFIRINOX, FOLFOX, FOLFIRI, Capecitabine or G or G and nab-paclitaxel) were reviewed. IHC phenotypes were defined by staining >25% CDX2 = I, >25% MUC5 = Ga, >25% CDX2 and MUC5 = I/G, >25% MUC1 = PB. Results: 51 pts were identified. 4 cases had Stage II disease without recurrence after adjuvant tx and were excluded. 5 tumors were PB, 1 I, 3 I/G, 38 Ga. 41 (87%) had Ga or I/G type. Due to lack of statistical power for the other histologic subtypes, response to F or G was only analyzed in the 35 metastatic pts with the Ga subtype. 14 were metastatic at diagnosis. 24 males. Median age 57. 21 Hispanic, 14 Non-Hisp. The PFS for Ga treated with F based tx (>12 m) versus G (~9 m) based tx in the 1st line approached statistical significance (p=0.050). In multivariable analysis with adjustments for clinical stage, ECOG, age at dx, there was a significant lower risk of progression in pts treated with F based tx versus G based tx (HR=0.278, p=0.0315). Conclusions: There was near statistical significance favoring F based tx over G based tx in PDAC Ga subtype (p=0.05). Historically, G has proven superior to F as a single agent but our findings suggest F in combination may be superior to G in combination, at least for the treatment of Ga subtype.

Aim: In a retrospective study of 18 pts with unresectable (UR) or borderline resectable (BR) LAPC, neoadjuvant therapy with FOLFIRINOX with or without subsequent chemoradiation (CCRT) resulted in an R0 resection rate (RR) of 44% (Hosein et al, BMC Cancer 2012). The reported 1-year progression-free survival (PFS) was 83 % and the 1-year overall survival (OS) was 100 %. Toxicity profile was tolerable. In order to confirm these preliminary results, we analyzed a large cohort of pts treated in a similar fashion with mature follow-up. Methods: Between 2008 and 2013, 51 treatment-naive pts with LAPC were treated with first-line FOLFIRINOX with neoadjuvant intent. Pts were categorized as BR or UR using the NCCN criteria. Pts received FOLFIRINOX chemotherapy (at the full dose as described in the ACCORD-11 trial) until maximum response or tolerability, and then underwent surgery if their imaging suggested resectability. Pts then received CCRT if they were still UR or BR after FOLFIRINOX. The end points of this retrospective analysis were OS, PFS, R0 RR and toxicity profile. Results: A total of 429 cycles were given with a median of 8 (range 2-29); 27 (53%) went on to receive CCRT. After a median follow-up of 17 mo (range 2-56), the Kaplan-Meier median OS was 35 mo (95% CI 26-45), the 3-yr OS rate was 42% and the median PFS was 14 mo (95% CI 11 – 16). By imaging criteria, 13 (26%) were converted to resectability and 10 (4 BR and 6 UR) of these had successful R0 resections. Pts who had R0 resections had a significantly longer survival than pts who did not (3-yr OS rate 67% vs 21%, log rank p = 0.042). Grade 1&2/3&4 chemotherapy-related toxicities were neutropenia (39%/20%), neutropenic fever (0%/12%), thrombocytopenia (53%/16%), anemia (63%/10%), fatigue (76%/6%), nausea (57%/4%) vomiting (22%/4%), neuropathy (53%/4%) and diarrhea (37%/10%). Conclusions: FOLFIRINOX followed by chemoradiotherapy is feasible as neoadjuvant therapy in patients with unresectable LAPC. Although the resection rate was only 20%, the median OS of almost 3 years is appreciably longer than historical survival rates for this population. Prospective controlled trials testing this algorithm in LAPC are ongoing. Disclosure: All authors have declared no conflicts of interest.

e15197 Background: Although no prospective data are available for the use of FOLFIRINOX in LAPC, in a retrospective study of 18 pts with UR or BR LAPC, neoadjuvant therapy with FOLFIRINOX with or w...

373 Background: There is no standard chemotherapy regimen for PC patients who have progressed on G and fluoropyrimidine-based therapy. Single agent nab-P had limited activity on a second-line phase II trial in PC. Synergistic preclinical studies with G and taxanes have been reported. Nab-P targets stromal cells and leads to improved delivery of chemotherapy to PC cells. The combination of G + nab-P might be an effective approach in pretreated PC. Methods: A retrospective analysis of advanced refractory PC patients treated from Sep 2010 to Aug 2011 with the combination of G + nab-P was performed at the Sylvester Comprehensive Cancer Center. Patients received G 1000mg/m2 and nab-P 100mg/m2 on D1, 8 and 15 of a 28 day cycle. Treatment response was assessed by review of imaging studies using the RECIST criteria, CA19-9 response and symptomatic improvement. The progression-free survival (PFS) and overall survival (OS) were calculated from time of commencement of G + nab-P until documented progression or death respectively. Results: 10 patients were treated with G + nab-P; 60%, 30% and 10% of patients had received 3, 2 and 1 prior chemotherapy regimen. 90% and 80% received prior G or fluoropyrimidine-based regimen respectively. Therapy was discontinued in one patient following only one dose of G + nab-P (Cycle 1, day 1) due to grade 2 thrombocytopenia. The remaining 9 patients received a median of 4 cycles. Two (22.2%) patients had confirmed PR, 3(33.3%) patients had confirmed stable disease while 4 (44.4%) patients progressed on therapy. The median PFS was 13.7 weeks. The median PFS was 20 weeks in patients with PR or SD and 9.9 weeks in patients with PD. Recurrent malignant ascitis resolved in a patient with peritoneal carcinomatosis. Treatment was well tolerated; grade 3-4 hematologic toxicity included anemia, thrombocytopenia and neutropenia in 2, 1 and 2 patients respectively. 70% of patients required G-CSF support. Non hematologic Grade 3-4 toxicities included fatigue, peripheral neuropathy; nausea and vomiting in 3, 2 and 1 patient respectively. Conclusions: G + nab-P resulted in clinical benefit in half of this group of advanced PC patients who had previously progressed on G and fluoropyrimidine-based regimens.

268 Background: Cholangiocarcinoma is an uncommon malignancy. In addition, only 10-30% of patients are eligible for curative surgical resection due to advanced disease at diagnosis. The role of adjuvant therapy is not yet established. The objective of this analysis is to assess the outcome of patients with cholangiocarcinoma managed with surgery, chemotherapy, radiation, and/or chemo-radiation. Methods: From 1997 to 2007, patients with biliary cancer from the joint tumor registry database at UMH, SCCC, and JHS had their demographics, stage, pathology, treatment (surgical management, adjuvant and palliative therapy) and survival collected. A total of 800 patients with the diagnoses of biliary cancer were reviewed. The site of cancer was the bile duct in 351 patients, gallbladder in 173, and ampulla of vater in 239 patients. Results: Cholangiocarcinoma - adenocarcinoma of the bile duct – in 334 patients of the 351 with bile duct tumors were analyzed. The mean age at diagnosis was 65 (range 26-92) and 55% of patients were male. Stage at presentation was as follows: 22% of patients presented with stage I, 18% with stage II, 21% with stage III, 26% with stage IV, and 13% were unknown. Potentially curative surgical resection was performed in 45% of the patients. 24% received chemotherapy, 20% received radiation, and 14% received chemo-radiation in combination. The overall median survival (MS) of all patients was 13 months - 22, 16, 14, and 10 months for stages I, II, III, and IV respectively. Surgery provided an overall survival benefit for all stages (24 vs. 9 months, p Conclusions: Chemotherapy and chemo-radiation had a positive impact on survival in patients with late stage cholangiocarcinoma. Surgery improved survival in both early and advanced stages. The lack of data on performance status and organ function did not allow factoring these variables in the analysis.

324 Background: 5-flourouracil, leucovorin, irinotecan and oxaliplatin (FOLFIRINOX) is superior to gemcitabine in patients (pts) with advanced PC who have a good performance status (Conroy et al, ACCORD 11 trial, ASCO 2010). After the initial data on FOLFIRINOX were presented at ASCO 2007, we began using it off-protocol as neoadjuvant therapy for LAPC. We report our experience herein. Methods: In this retrospective series, we included pts with unresectable LAPC who received neoadjuvant FOLFIRINOX. The doses were identical to the ACCORD 11 trial, with G-CSF prophylaxis from cycle 1. The primary endpoint was R0 resection rate. Secondary endpoints were overall survival (OS), safety and tolerability. Results: Between 5/2008 and 9/2010, we treated 12 pts with LAPC with neoadjuvant FOLFIRINOX. All pts met consensus criteria for unresectability after multidisciplinary review. The median age was 57.5 years and 9/12 were men. All had ECOG PS of 0 or 1. Two pts received gemcitabine prior to FOLFIRINOX and 10 were treatment-naive. Two pts are still on therapy and 10 completed a median of 6 cycles (range 3-17) and were evaluable; 6 were felt to have converted to resectability by imaging and were taken for surgery. Four had R0 resections (40% of evaluable, 33% of all patients), 1 had R1 resection, and 1 had unresectable disease at laparotomy. To date, 2 pts have died and 10 remain alive with a Kaplan-Meier estimated median OS of 20.7 months (95% CI 18.8-22.6). All 4 pts with R0 resections are alive and disease- free. Grade 3/4 chemotherapy-related toxicities were neutropenia (17%), neutropenic fever (8%) and fatigue (17%). Common grade 1/2 toxicities were neutropenia (42%), anemia (92%), thrombocytopenia (50%), fatigue (92%), nausea (58%), diarrhea (42%) and neuropathy (33%). Two of the 6 surgical pts had significant postoperative complications - 1 with C. Difficile colitis, gastroparesis and a subhepatic collection and another with an infected pancreatic bed collection requiring percutaneous drainage 3 times. Conclusions: FOLFIRINOX is feasible as neoadjuvant therapy in patients with unresectable LAPC, with manageable toxicities. In this small series, the R0 resection rate was at least 33%. A prospective trial is warranted. No significant financial relationships to disclose.

19061 Background: Combination of Gemcitabine and Oxaliplatin (GEMOX) given every 3 weeks was reported to be safe and active in phase II studies in first and second line therapy of NSCLC. The aim of...

15510 Background: Little progress has been made in the treatment of advanced pancreatic cancer (PC). Preclinical data suggest synergism between a platinum + G, and G + C. The combination of G and e...

18157 Background: Single agent gemcitabine is active as second line therapy in NSCLC. Oxaliplatin may be non-cross resistant with the other platinum-containing agents used as first-line therapy in NSCLC. The combination of gemcitabine and oxaliplatin (GEMOX) is synergistic in pre-clinical models. Methods: A phase II, non-randomized trial was designed to assess the efficacy and tolerability of gemcitabine 1,000 mg/m2 over 100 min in combination with oxaliplatin 100 mg/m2 over 2 hours both given on days 1 and 15 of each 28-day cycle. Patients with NSCLC were eligible if they had progressed after first line treatment. Primary endpoint was tumor response rate. Planned sample size is 30 patients over a period of 2 years. Functional Assessment of Cancer Therapy- Lung (FACT-L) v.4 questionaire was used to assess quality of life of patients on therapy. Results: Twenty-two patients have been enrolled. 13 males (59%) and 9 females (41%). 15 Hispanic (68%), 4 Caucasian (18%), and 3 African-American (13%). Median age is 55 yrs. Histologic subtypes are as follows: adenocarcinoma, 12; NSCLC not otherwise specified 7; squamous cell carcinoma, 3. Nine patients had an ECOG performance status (PS) of 0 (41%) and 13 had a PS of 1 (59%). Two patients were never smokers. A total of 56 cycles have been administered (median 2, range 1 to 6). GEMOX as second-line therapy was given to 18 patients (81%), third-line to 4 patients (18%). Two patients died on study from disease progression leading to respiratory and multi-organ failure. The following Grade 3 and 4 adverse events were seen in 2 patients each: fatigue, dyspnea, anemia, and multi-organ failure. Cancer pain was seen in 1 patient. Twenty patients are available for assessment of response. Two patients had a confirmed partial response (10%) and another eight had stable disease (40%). Preliminary results of FACT-L analysis in 19 pts shows improvement in Lung Cancer Subscale (LCS) score in 25% of the patients after 2 cycles of therapy. Conclusions: Combination gemcitabine and oxaliplatin is active and well tolerated as second line treatment for NSCLC. Improvement of LCS score after 2 cycles suggests a clinical benefit that is beyond the observed response rate of 10%. No significant financial relationships to disclose.

15029 Background: Docetaxel and Capecitabine in combination are synergistic in preclinical models. The role of second line chemotherapy in pancreatic cancer is palliative and the role under investigation. Methods: Capecitabine 800 mg/m2 PO bid on days 1–14 in combination with docetaxel 30 mg/m2 IV on days 1 and 8 of each 21-day cycle were given to patients with advanced and metastatic pancreatic cancer previously treated with Gemcitabine. A 3-stage sequential design phase II trial was used with early stopping rules for efficacy at 13 and 26 enrolled patients Results: Twenty-four patients are evaluable for toxicity and evaluable for response. Thirteen are females and 11 male patients. Median age was 65 years. ECOG PS was as follows: PS 0: 2 patients; PS 1: 15 patients; PS 2: 5 patients. Three patients achieved a PR, with a RR of 12.5%. Stable disease for 2 or more cycles was observed in 70.8% of patients (n=17). 45 % (n=11) of patients had a 50% or more decrease in CA 19–9 levels. Treatment was well tolerated with no toxic deaths. Grade III and IV toxicities consisted of fatigue in 4 pts (17%); hand-foot syndrome in 4 patients (17%); diarrhea, anemia and mucositis in 2 patients (9%) and peripheral neuropathy in one patient (4%) Conclusions: The combination of capecitabine and docetaxel is active and well tolerated in pancreatic cancer previously treated with gemcitabine based-therapy. Enrollment continues. [Table: see text]

14111 Background: There is no accepted standard treatment for patients with advanced pancreatic cancer who progress after gemcitabine-based therapy. Capecitabine and docetaxel have single-agent activity in pancreatic cancer and have documented synergy in both pre-clinical models and in the treatment of other solid tumors. Methods: A phase II trial with a 3-stage sequential design was planned to assess the efficacy (primary end-point: response rate) and toxicity of capecitabine 800 mg/m2 PO bid on days 1–14 in combination with docetaxel 30 mg/m2 IV on days 1 and 8 of each 21-day cycle in patients with advanced pancreatic cancer who failed first-line gemcitabine-based chemotherapy. If no responses are observed after 13 patients or less than 3 responses are seen after 26 patients, accrual will stop and the combination deemed ineffective. Results: Eight patients have been enrolled (5 women, 3 men). Median age was 67 years. ECOG PS was as follows: PS 1, three patients; PS 2, five patients. All patients had adequate organ function. A total of 26 cycles have been administered (median: 2 cycles, range 1 to 8). Four patients had stable disease (median duration 9 weeks, range 6 to 24), and 3 had progressed at the time of first evaluation (2 cycles). One patient has not yet completed 2 cycles and is therefore not assessable for radiologic response. Out of 7 patients with an elevated CA 19–9, four had a decrease of 50% or greater while on chemotherapy. Grade 1 or 2 toxicity was seen in 3 patients (diarrhea, 1 patient; fatigue, 2 patients). Grade 3 or 4 toxicity was as follows: fatigue, 2 patients; dehydration, 1 patient; neuropathy, 1 patient. There were no treatment related deaths. Enrollment continues. Efficacy data fulfilling the first stage sequential design should be available at the time of the meeting. Median survival for all patients is currently 13 weeks (range 7–23 weeks) Conclusions: Capecitabine in combination with docetaxel is a well-tolerated regimen in the treatment of patients with pancreatic cancer who have failed prior gemcitabine-based therapy. Four out of 8 patients have had stable disease. Four of 7 patients have had a decrease of 50% or greater in CA 19.9 levels. Enrollment continues. Median survival of 13 weeks underscores the poor prognosis of this patient population. [Table: see text]