Citations

234 Background: Body mass index (BMI) has been reported to determine risk for pancreatic cancer in addition to outcome, as those with higher BMI have decreased survival. Since May 2011, therapy for pancreatic cancer has improved with the addition of FOLFIRINOX. This study looks at overall survival in relation to BMI since the advent of the FOLFIRINOX. Methods: 2,277 patients with pancreatic adenocarcinoma were identified through the Mayo Clinic SPORE pancreatic cancer registry from 2000-14. Usual adult and BMI at time of enrollment were utilized as a binary variable ( < 30, ≥30 kg/m2). These were analyzed for association with survival using Kaplan-Meier curves and Cox proportional hazards regression. Results: For the 2000-11 and 2011-14 groups, stage distribution was 4.4%, 34.7%, 21.6%, 39.2% and 1.2%, 39%, 22.2%, 37.6%, respectively for stage 1-4. Since pancreatic cancer commonly causes weight loss, more patients were in the higher usual adult BMI (34.6%) compared to enrollment (17.1%). For the period 2000-11, 33.8% of patients had a usual adult BMI of 30+ vs 37.8% for the 2011-14 patients. As previously reported, there was a difference in survival by BMI for the period 2000-May 2011, however, this was not seen for the period June 2011-14. Conclusions: Based on this cohort of patients, the previously reported detrimental effect of elevated BMI on survival in pancreatic cancer patients is no longer seen. This corresponds with the time period of improvement in pancreatic cancer treatment with FOLFIRINOX. Further studies should be performed to confirm our findings and to identify the causality of this association. [Table: see text]

Peripheral artery disease (PAD) in the lower extremities often leads to intermittent claudication. In the present study, we proposed a low-dose DCE MRI protocol for quantifying calf muscle perfusion stimulated with plantar flexion and multiple new metrics for interpreting perfusion maps, including the ratio of gastrocnemius over soleus perfusion (G/S; for assessing the vascular redistribution between the two muscles) and muscle perfusion normalized by whole body perfusion (for quantifying the muscle’s active hyperemia). Twenty-eight human subjects participated in this Institutional Review Board-approved study, with 10 healthy subjects ( group A) for assessing interday reproducibility and 8 healthy subjects ( group B) for exploring the relationship between plantar-flexion load and induced muscle perfusion. In a pilot group of five elderly healthy subjects and five patients with PAD ( group C), we proposed a protocol that measured perfusion for a low-intensity exercise and for an exhaustion exercise in a single MRI session. In group A, perfusion estimates for calf muscles were highly reproducible, with correlation coefficients of 0.90–0.93. In group B, gastrocnemius perfusion increased linearly with the exercise workload ( P < 0.05). With the low-intensity exercise, patients with PAD in group C showed substantially lower gastrocnemius perfusion compared with elderly healthy subjects [43.4 (SD 23.5) vs. 106.7 (SD 73.2) ml·min−1·100 g−1]. With exhaustion exercise, G/S [1.0 (SD 0.4)] for patients with PAD was lower than both its low-intensity level [1.9 (SD 1.3)] and the level in elderly healthy subjects [2.7 (SD 2.1)]. In conclusion, the proposed MRI protocol and the new metrics are feasible for quantifying exercise-induced muscle hyperemia, a promising functional test of PAD.NEW & NOTEWORTHY To quantitatively map exercise-induced hyperemia in calf muscles, we proposed a high-resolution MRI method shown to be highly reproducible and sensitive to exercise load. With the use of low contrast, it is feasible to measure calf muscle hyperemia for both low-intensity and exhaustion exercises in a single MRI session. The newly proposed metrics for interpreting perfusion maps are promising for quantifying intermuscle vascular redistribution or a muscle’s active hyperemia.

Background Platinum and etoposide with thoracic radiation followed by prophylactic cranial irradiation constitute the standard treatment for limited‐stage small cell lung cancer (LS‐SCLC). Many patients with LS‐SCLC are elderly with comorbidities. Methods Individual patient data were collected from 11 phase 2 or 3 trials for LS‐SCLC conducted by the National Clinical Trials Network and activated from 1990 to 2010. The primary endpoint was overall survival (OS); the secondary endpoints were progression‐free survival (PFS), the rate of severe adverse events, and off‐treatment reasons. The outcomes were compared for patients 70 years old or older (elderly patients) and patients younger than 70 years (younger patients). Results Individual patient data from 1049 younger patients (81%) and 254 elderly patients (19%) were analyzed. In the multivariate model, elderly patients, in comparison with younger patients, had worse OS (hazard ratio [HR], 1.38; 95% confidence interval [CI], 1.18‐1.63; median OS for elderly patients, 17.8 months; OS for younger patients, 23.5 months) and worse PFS (HR, 1.19; 95% CI, 1.03‐1.39; median PFS for elderly patients, 10.6 months; median PFS for younger patients, 12.3 months). Elderly patients, in comparison with younger patients, experienced more grade 5 adverse events (8% vs 3%; P < .01) and more grade 3 or higher dyspnea (11% vs 7%; P = .03) but less grade 3 or higher esophagitis/dysphagia (14% vs 19%; P = .04) and less grade 3 or higher vomiting (11% vs 17%; P = .01). Elderly patients completed treatment less often, discontinued treatment because of adverse events and patient refusal more frequently, and died during treatment more frequently. Conclusions Elderly patients with LS‐SCLC have worse PFS and OS and more difficulty in tolerating therapy. Future trials should incorporate assessments of elderly patients, novel monitoring of adverse events, and more tolerable radiation and systemic therapies.

175 Background: Biomedical research focused on the experiences of cancer patients in care delivery has progressed remarkably in recent years, including the emergence of Cancer Care Delivery Research (CCDR) within the NCI Community Oncology Research Program (NCORP). CCDR is a relatively new mechanism with the NCORP to support protocols that test questions beyond standard clinical trials for treatment or symptom control interventions. CCDR leverages the NCORP infrastructure to develop and test care delivery interventions in community hospital settings and in settings serving underserved and minority populations. CCDR enables researchers to conduct care delivery studies in critical places and in niche populations. Methods: We will describe our experience coordinating the first Alliance NCORP Research Base Cancer CCDR trial. Our trial – a four arm, cluster-randomized trial of decision aids among sites capable of oversampling minority men with a diagnosis of early stage prostate cancer – was the first CCDR trial in the Alliance NCORP Research Base. We will describe the opportunities and challenges we encountered. Results: We implemented a CCDR protocol even as the oversight for CCDR was being worked out in parallel. Curating partnerships outside of established channels of clinical trials, engaging minority serving institutions, and engaging surgical practices like urology illustrate some of the challenges of implementing a care-delivery trial in a diverse multi-site network. Research staff must learn the art of mitigating the disruption of care delivery research procedures within clinics. Additionally, the researcher’s skills are drawn upon at multiple points— establishing relationships, advocating for flexibility in implementing rules, cheerleading, connecting dots, and directing traffic. Conclusions: Our “lessons learned” presentation will provide an experiential account that will inform aspiring care delivery researchers in their work and describe some of the emerging aspects of the institutional implementation of new initiatives in modern cooperative group research. Our presentation will also inform key stakeholders about how to best facilitate this type of research.

65 Background: We need better methods to understand the social determinants of health and integrate psychosocial and economic sequelae of cancer and its treatment into healthcare delivery for ethnoculturally diverse population. A Patient-Reported Outcomes Quality of Life (PROQOL) instrument has been developed to capture less commonly discussed patient concerns (Personal Relationships, Emotional health, Physical health, Cancer diagnosis and treatment, Money and Care planning) and improve patient-provider communication. We sought to adapt this instrument and pilot it in underserved, ethnically diverse solid tumor and hematological malignancies patients at Maricopa Integrated Health System (MIHS) in Phoenix, AZ. Methods: Two focus groups (FG) were conducted to understand patient perspectives of an adapted Spanish version of PROQOL. This version was then piloted among patients on active cancer treatment. Patients also completed a Linear Analog Scale Assessment (from 1-10) for quality of life (QOL) and its domains (higher scores indicate better QOL). Results: All participants in both FG (11/12 female) were Hispanics, with a median age of 53 years. Participants agreed that the domains covered in the PROQOL represented the most important psychosocial needs in their cancer continuum. No difficulty in understanding the individual domains or questions for delving deeper into each domain was noted. Median age of 34 pilot study participants (74% female) was 48 years, 79% were Hispanic, 10% were African Americans and median household income was $ 43,924 (range 23,002-98,382). 28/34 completed the Spanish version. Most common concerns were ‘Money’ (32%): difficulty paying medical bills and non-medical expenses and ‘Cancer Diagnosis, Treatment and Survivorship’ (32%): type of cancer and treatment concerns. Median overall QOL was 8 (range 3-10). Conclusions: PROQOL is feasible for systematic capture of patient concerns in underserved, ethnic minority cancer patients. A better understanding of these challenges can help design interventions to improve psychosocial and financial outcomes for the vulnerable groups and decrease disparities in care delivery.