Citations

274 Background: The objectives of the formative research were to identify key themes of patient-centered cancer care and determine the best method to collect data to develop the CAHPS Survey for Cancer Care Prototype. This survey seeks to measure aspects of care most important to patients and allow comparisons of those aspects across treatment centers and treatment modalities. Methods: We developed a library of 1,781 items from CAHPS and cancer care surveys. We conducted 14 focus groups with patients (including 2 conducted in Spanish) who had received cancer care in the past 12 months, and 2 focus groups involving family members of cancer patients. We met with 10 experts representing patients and survivors, or who had expertise in quality improvement, oncology, shared decision-making and patient safety to obtain feedback on the development of the survey, potential markets for the instrument, and to assist with overall strategy. Finally, we conducted separate interviews with 5 stakeholder groups representing oncology associations to obtain feedback on focal provider, attribution and sampling. Results: While the focus group results validated findings from the item library, new concepts also emerged, such as the need for having a plan of care. Patients most readily identified with a team of providers, rather than a single provider. The two most important domains to patients were (1) how well the cancer care team communicates with patients and (2) whether the cancer care team keeps patients informed about cancer treatment. Patients were also interested in care coordination, access to information, providers who are up-to-date, and shared decision-making. Stakeholder interviews noted that survey results would be most valuable if presented by treatment modality: medical, radiation, and surgical oncology. Conclusions: These findings suggest that cancer care is best for the patient when providers are knowledgeable and straightforward with medical information, yet can demonstrate empathy and compassion.

134 Background: The CAHPS Survey for Cancer Care Prototype (application for CAHPS trademark in process) represents a significant advancement towards helping cancer care providers understand patients’ experiences of care. Although a number of standard commercial surveys are in use, currently none are available that both (1) capture the aspects of care most important to patients and (2) allow comparisons of those aspects of care across treatment centers and modalities. Methods: We developed a survey instrument that incorporated patient, clinician, and other stakeholder input throughout the development process. The survey measures patients’ perceptions of observable provider behaviors that are indicative of high quality care. Field test data were collected from 1,367 of 2,826 eligible patients (48% response rate) treated with surgery, radiation, or medical oncology from 6 accredited cancer treatment centers across the US. Classical psychometric methods were used to evaluate the measurement properties of composite scales per standard CAHPS methodology. Results: Based on a priori conceptualization, patient and stakeholder input, and empirical analyses, we identified 5 composites measuring shared decision-making, exchanging information about treatment, affective communication, access to care, and patient self-management. A confirmatory factor analysis using structural equation modeling showed an excellent fit (CFI > 0.96; RMSEA < 0.05) between the observed data and the structure for these five composites. Cronbach’s alpha for these composites ranged from 0.71-0.88, discriminant validity was good for all scales, and correlations with overall ratings of cancer care providers were moderate (0.31) to high (0.69). Evaluation of the precision with which the composites distinguish among cancer centers indicated that the measures were reliable; however, a second field test with a greater number and variety of centers will be needed to establish a standard sampling approach and confirm these results. Conclusions: We anticipate wide-spread adoption of this measure by cancer care providers to direct quality improvement efforts due to great interest and involvement in this project on the part of stakeholders.

LBA4 Background: Lapatinib (L) is a HER1-HER2 tyrosine kinase inhibitor. The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial is a randomised, phase III trial comparing 3 oral L-containing regimens with T, each given for 1 year. Methods: From June 2007 to July 2011, 8381 patients (pts) were randomised from 946 sites in 44 countries to receive either L+T, T→L, L, or T. Anti-HER2 therapy was initiated after completing all chemotherapy (N=4613), concurrently with a taxane following anthracycline (N=3337), or concurrently with a non-anthracycline, platinum-containing regimen (N=431). The L arm was closed in Aug 2011 for futility and is not presented. The primary endpoint is invasive disease-free survival (DFS). L+T vs. T is tested for superiority and T→L vs. T is tested for non-inferiority at 1.11 margin. P≤0.025 is required for statistical significance. 850 DFS events in the L+T vs. T comparison would provide 80% power to detect a true hazard ratio (HR) of 0.80 with experiment-wide alpha=0.05. The current analysis was planned to occur either after observing these 850 events or at 4.5 yrs median follow up (MFU). Results: Pt and disease characteristics were well balanced. 40% were node-negative and 57% were hormone receptor positive. Only 555 DFS events for the L+T vs. T comparison were observed at 4.5 years MFU. HR for DFS was 0.84 (97.5% CI, 0.70-1.02; P=0.048; 4-yr DFS%=88% vs. 86%) for L+T vs. T and 0.93 (97.5% CI, 0.76-1.13; non-inferiority P=0.044; 4-yr DFS%=87% vs. 86%) for T→L vs. T. Diarrhoea (75% vs. 20%), rash (55% vs. 20%) and hepatobiliary (23% vs. 16%) adverse events were more frequent in L+T vs. T. Primary cardiac endpoints were infrequent (<1%) in all arms. Conclusions: L+T has lower risk of a DFS event compared with T, and T→L appeared non-inferior to T, but neither finding was statistically significant. The first DFS results of dual HER2 blockade in the adjuvant ALTTO at 4.5 years MFU are unexpected considering the effect shown by doubling the pCR rate with L+T vs. T in the NeoALLTO trial. Follow up continues. Clinical trial information: NCT00490139.

735 Background: In the phase III CORRECT study, regorafenib significantly improved overall survival and progression-free survival (PFS) vs placebo in patients with treatment-refractory mCRC. CONSIGN (NCT01538680) was a large phase IIIb study that included 2872 patients from 25 countries; it was designed to provide continued access to regorafenib for patients with mCRC who failed standard therapy and to further characterize the safety of regorafenib. In CONSIGN, adverse events (AEs) and PFS were consistent with those reported in phase III studies. We present a retrospective subgroup analysis of patients enrolled in CONSIGN in the USA. Methods: Patients with mCRC who progressed on standard therapies and had an ECOG PS 0─1 received regorafenib 160 mg QD for the first 3 weeks of each 4-week cycle. Treatment was continued until disease progression, death, or unacceptable toxicity. The primary endpoint was safety. PFS (per investigator) was the only efficacy variable assessed. Results: A total of 364 patients in the USA were assigned to treatment (all evaluable for safety). The median age was 60 years; 38% and 62% had ECOG PS 0 and 1, respectively. KRAS mutation was present in 59%, KRAS wt in 38%; 74% had ≥ 3 prior regimens for metastatic disease. Median duration of treatment was 2.3 months (range: 0–30). Median PFS (95% CI) was 2.3 (2.0–2.6) months (2.1 months KRAS wt; 2.3 months KRAS mutant). NCI-CTCAE v4.0 grade ≥ 3 AEs occurred in 81% of patients and were considered drug-related in 53% (Table). Grade ≥ 3 hepatobiliary disorders occurred in 2%. Grade ≥ 3 treatment-emergent laboratory toxicities included bilirubin (9%), AST (6%), and ALT (3%). Conclusions: In patients from the USA enrolled in CONSIGN, the safety profile of regorafenib was consistent with that of the overall population and the known safety profile of regorafenib in mCRC. Median PFS was in the range of that reported in phase III trials. Clinical trial information: NCT01538680. [Table: see text]

270 Background: At the 2013 ASCO Quality Symposium, we presented the formative development work and results of the 1st field test of the Cancer CAHPS survey. At that time, we noted next steps in the development and validation of the survey. In this poster/presentation, we will provide updates on these activities. Methods: The Spanish translation was completed in 2013. We conducted interviews with 9 cancer patients in 2014 to identify composite labels that resonated with consumers. We collaborated with diverse cancer care providers (health maintenance organizations, medical foundations, small oncology practices, and comprehensive cancer centers) to identify an approach to sampling patients that could be standardized across settings. With the input of stakeholders, we added additional Shared Decision Making (SDM) and Access to Care questions. Data on the revised survey were collected in a 2nd field test from May 2015 – November 2015. We will analyze these data to assess the feasibility of the sampling approach and confirm the psychometric properties of the survey. We embedded several secondary experiments in the 2nd field test including assessing the effect of language (Spanish vs. English) and mode of administration (mail only vs. web-mail mixed mode) on survey responses. Results: The Spanish-language survey is currently being fielded. Consumers identified “user friendly” composite labels, abbreviated here as Communicates well, SDM, Explains treatment, Supports self-management, Access, Delays, and Claims. We developed a comprehensive sampling approach that relies on billing data to identify cancer patient eligible to receive the survey. Preliminary findings indicate that the standardized sampling approach is feasible. The survey was administered to 3,581 patients across 4 cancer centers (i.e. reporting units) in the 2nd field test. Results of the psychometric analyses and embedded experiments will be completed in December 2015 and available for dissemination in January 2016. Conclusions: The cumulative findings from the 1st and 2nd field tests and other development activities conducted to date will be used to support an application for the CAHPS trademark.

We described physical activity measures and hourly patterns in patients with chronic obstructive pulmonary disease (COPD) after stratification for generic and COPD-specific characteristics and, based on multiple physical activity measures, we identified clusters of patients. In total, 1001 patients with COPD (65% men; age, 67 years; forced expiratory volume in the first second [FEV 1 ], 49% predicted) were studied cross-sectionally. Demographics, anthropometrics, lung function and clinical data were assessed. Daily physical activity measures and hourly patterns were analysed based on data from a multisensor armband. Principal component analysis (PCA) and cluster analysis were applied to physical activity measures to identify clusters. Age, body mass index (BMI), dyspnoea grade and ADO index (including age, dyspnoea and airflow obstruction) were associated with physical activity measures and hourly patterns. Five clusters were identified based on three PCA components, which accounted for 60% of variance of the data. Importantly, couch potatoes (i.e. the most inactive cluster) were characterised by higher BMI, lower FEV 1 , worse dyspnoea and higher ADO index compared to other clusters ( p < 0.05 for all). Daily physical activity measures and hourly patterns are heterogeneous in COPD. Clusters of patients were identified solely based on physical activity data. These findings may be useful to develop interventions aiming to promote physical activity in COPD.

BACKGROUND Extramammary Paget disease (EMPD) is a rare intraepithelial adenocarcinoma occurring mainly in the anogenital region. Traditional management with wide local excision has shown high recurrence rates, thus Mohs micrographic surgery (MMS) has emerged as a promising treatment option. OBJECTIVE To compare long-term outcomes after treatment with MMS or excision for primary EMPD. METHODS AND MATERIALS Retrospective cohort review was conducted for 207 patients with EMPD treated at Mayo Clinic in Rochester, MN, between 1961 and 2012. RESULTS Of the 25 patients treated with MMS, 19 primary tumors were included for outcome analysis, with an estimated 5-year recurrence-free survival rate of 91% (95% confidence interval [CI], 75–100) using Kaplan–Meier curve analysis. Of 158 patients treated with local excision, 124 were included for the analysis, with an estimated 5-year recurrence-free survival rate of 66% (95% CI, 56–78). The hazard ratio (HR) for association of treatment was 0.4 (95% CI, 0.10–1.65; p = .20). Estimated 5-year overall survival rates were 79% for MMS (95% CI, 61–100) and 68% for excision (95% CI, 59–78) (HR, 1.39 [95% CI, 0.69–2.82]; p = .36). CONCLUSION Although treatment of primary EMPD with MMS versus excision did not show statistical difference, MMS demonstrated favorable long-term outcomes and was associated with a higher recurrence-free survival rate.

Abstract Introduction Genetic loci for Alzheimer's disease (AD) have been identified in whites of European ancestry, but the genetic architecture of AD among other populations is less understood. Methods We conducted a transethnic genome‐wide association study (GWAS) for late‐onset AD in Stage 1 sample including whites of European Ancestry, African‐Americans, Japanese, and Israeli‐Arabs assembled by the Alzheimer's Disease Genetics Consortium. Suggestive results from Stage 1 from novel loci were followed up using summarized results in the International Genomics Alzheimer's Project GWAS dataset. Results Genome‐wide significant (GWS) associations in single‐nucleotide polymorphism (SNP)–based tests ( P < 5 × 10 −8 ) were identified for SNPs in PFDN1/HBEGF , USP6NL/ECHDC3 , and BZRAP1‐AS1 and for the interaction of the (apolipoprotein E) APOE ε4 allele with NFIC SNP. We also obtained GWS evidence ( P < 2.7 × 10 −6 ) for gene‐based association in the total sample with a novel locus, TPBG ( P = 1.8 × 10 −6 ). Discussion Our findings highlight the value of transethnic studies for identifying novel AD susceptibility loci.