bluuebunny/crossref_metadata_2025 huggingface dataset:
Potential pitfalls of binary reporting metrics using a QOPI end-of-life (EOL) sample.
Authors: Barysauskas Constance , Dalby Carole Kathleen , Catalano Paul J. , Jacobson Joseph O.
Published: February 2017

261

Background: Practice accountability through measurement is emergent in the United States. The National Quality Forum has adopted several EOL metrics as national standards. Care at EOL is highly variable due to patient and family preference, symptom management, and psychosocial care. We hypothesize binary measures with fixed cut-points limit the understanding of EOL practice thus reducing opportunities for care improvement. Methods: We previously demonstrated limitations of the QOPI sampling methodology among all patients at Dana-Farber Cancer Institute Satellites following the QOPI sampling strategy between July 1, 2012 and December 31, 2012. Using the same population, we examined the distribution of chemotherapy administration in the last two weeks of life. We compared our QOPI EOL data (A) with simulated scenarios modeled via log-normal distributions (B, C, D, E). The binary metric was held constant at the observed proportion to illustrate potential variability in other statistical metrics. Results: A total of 193 patients received chemotherapy before death. Chemotherapy administration in the last two weeks of life was measured at 11%, with a mean of 84 days (inter-quartile range, IQR: 92 days). Different distributions were generated by varying the mean and SD as demonstrated in the table below. Conclusions: As our simulated scenarios show, practices disseminating the same binary metric may stem from very different distributions. We have identified two limitations of binary reporting metrics with fixed cut-points. First, binary metrics risk misrepresenting actual delivered care as substantially different practice patterns can result in the same binary result. Second, binary metrics greatly limit the ability to learn from actual practice patterns. Quality improvement projects may be wrongly prioritized based on the national standards and project focus may be misaligned with practice need. EOL care is multifaceted and nuanced; binary metrics are convenient, but may be misleading to practice accountability and limit opportunities for practice improvement. [Table: see text]
Formative research on patient experiences with cancer care.
Authors: Frentzel Elizabeth , Cowans Tamika , Egginton Jason , Evensen Christian , Keller San , Yost Kathleen J. , Sangl Judith , Arora Neeraj K. , Garfinkel Steven
Published: February 2017

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.
Sex and funding trends in phase 3 oncology trials registered with clinicaltrials.gov.
Authors: Moloci Nicholas M. , Yee Sarah , Tomczyk David , Sun Gordon
Published: February 2017

295

Background: Women have been historically underrepresented as authors of clinical research, which may obscure important scientific interpretations and perspectives. We examined whether primary investigator sex was associated with funding sources of registered phase 3 oncology trials. Methods: We searched ClinicalTrials.gov, identifying completed phase 3 oncology trials registered from 1/1/2005 to 12/31/2010. The first investigator sex and nationality, funding source, and cancer type were collected. Bivariate associations between first investigator and funding source were analyzed with chi-square tests. Temporal trends were analyzed using the Cochran Armitage test. Results: Of 1,365 trials, 882 listed an individual as first investigator and were eligible for analysis; 195 (22.1%) listed a woman as first investigator. From 2005 to 2010 the proportion of women as first investigator across all funding sources did not change significantly (p for trend >.05). The proportion of breast and gynecological cancer trials led by women was significantly higher than the proportion led by men (29.3% of all trials led by women vs. 17.8% of all trials led by men, p<.001). In contrast, the proportions of prostate cancer trials led by women and men were similar (7.7% vs. 6.8%, p>.05). The National Institutes of Health (NIH) funded 95 trials with 32.6% led by women. Private industry funded 305 trials with 19.3% led by women. Of 659 trials funded by other sources such as universities and community-based organizations, 22.6% were led by women. The proportion of women leading industry trials increased from 11.3% to 27.3% (p for trend=.02), while the proportion of women leading trials by the NIH or other sources remained stagnant (p for trend>.05). However, the odds of a woman leading a trial funded by the NIH were 1.84 (95% confidence interval: 1.16-2.92) times greater than the odds for a man (15.9% vs. 9.3%). Conclusions: Women may be underrepresented as lead investigators of oncologic clinical trials, though they do appear to lead a substantial number of breast and gynecologic cancer trials. Primary investigator sex was associated with both funding source and cancer type.
Oncology comanagement agreements (CMA) and quality improvement.
Authors: Haggstrom David , Boustani Malaz , Azar Jose Maroun , Greenspan Andrew , Goe Holly , Cripe Larry Dean
Published: February 2017

55

Background: At Indiana University Health, an integrated health care delivery system, an Oncology CMA was implemented in 2013 to provide a framework for engagement between administrators and physicians to improve the value of oncology care. Methods: A collaborative process was used to establish shared goals, measures for performance, and set target goals. For efficiency goals, a system redesign approach was taken. Project teams were organized to develop and implement strategies to achieve goals. Experts in implementation science consulted with individual project teams. Financial incentives were distributed across projects. Final performance measures were assessed across the oncology service line. Results: See Table. Conclusions: Overall, the Oncology CMA positively affected the value of care provided by medical oncologists. The level of physician engagement was variable, although clinical and financial benefits accrued to all members of the practice. Based upon the positive contribution of implementation scientists the CMA in 2014 was modified to create greater support for the design, implementation, and assessment of project goals and plans, It is anticipated that future years will include an institutionalized core of implementation scientists and a steering committee to oversee an ongoing discussion of goals and resource allocation. [Table: see text]
How does parental status influence preferences for cancer treatment and palliative care?
Authors: Check Devon , Park Eliza , Reeder-Hayes Katherine Elizabeth , Mayer Deborah , Deal Allison Mary , Yopp Justin , Rosenstein Donald , Hanson Laura
Published: February 2017

65

Background: When patients with metastatic cancer have dependent children, they may be less likely to acknowledge the terminal nature of their illness and more willing to accept toxic treatments for small improvements in survival, compared to patients without children. Our mixed methods study sought to clarify the role of parental concerns in treatment decision-making. Methods: We recruited 63 patients with metastatic cancer who have children <18 to complete measures of physical and social wellbeing. 47 (75%) also participated in a semi-structured interview, which included questions about whether parental status influences patients’ decisions about anti-cancer treatment and whether patients would consider using palliative care, including hospice. We used univariable logistic regression to examine the relationship between patient and family characteristics and 3 outcomes: 1) influence of parental status on treatment decision-making, 2) interest in palliative care, and 3) interest in hospice. We used participants’ qualitative comments to describe the context for their preferences. Results: Average patient age was 44; average number of children was 2, and average child age was 13. 70% of patients reported that being a parent influences their treatment decisions. 64% cited parental status as motivation for life-extending treatment. 15% prioritized preserving parental functioning. Half of patients said they would consider using palliative care, and 57% said they would consider using hospice. Reasons for disinterest in palliative care and hospice included concerns about being perceived as giving up and children’s exposure to death at home. Parents with older children (OR 0.85, p=0.03), and those with increased social support (OR 0.96, p=0.05) had lower odds of reporting an influence of parental status on treatment decisions. Children’s age (OR 0.85, p=0.02) and low performance status (OR 4.3, p=0.02) were associated with palliative care interest. Conclusions: Parental concerns may influence treatment decision-making for metastatic cancer patients with children. Information about parental concerns may help oncologists to align treatment with patients’ priorities.
Program development through compilation of patient self-reported symptom burden.
Authors: Denny Diane , Bosch Brandon , Alston Kayla , Markman Maurie
Published: February 2017

78

Background: Cancer Treatment Centers of America, (CTCA) is a national network of five hospitals that specialize in the treatment of patients fighting complex or advanced-stage cancer. The Symptom Inventory Tool (SIT) is an assessment tool that captures the patients’ perceived symptom burden for real time clinical intervention and provides longitudinal data to demonstrate how effectively we meet our patient’s needs, from the point of no intervention (baseline) and every 21 days or greater. The SIT is comprised of 27 questions utilizing the MD Anderson Symptom Inventory tool, a validated assessment instrument with 8 questions added and a free text box by CTCA. The SIT became an integral part of patient care at CTCA in September 2012. Methods: A multidisciplinary team convened to evaluate how best to deliver the SIT data to facility leadership to assist with program development. The data needed to perform each calculation was obtained using analytical software that interfaces the database, electronic health record, and cancer registry. A Quality Research Associate prepares the operational summary providing a monthly update for the leadership at each facility with data included for the previous month, cumulatively for the facility, and cumulatively for the network. Results: The summary includes mean time to complete an assessment, assessments by timeframe (i.e. baseline, 2nd, 3rd assessments, etc.), gender and age percentages, and patients categorized by cancer type. The top three average scoring symptoms and interference issues by baseline, 2nd, and 3rd assessment are highlighted along with the top areas of improvement and diminishment in score defined by a change of 2 or more points reflecting clinical relevance. The top areas scored at 8 or greater that improved and the top areas where patients continued to score at 8 or greater on return are presented to focus upon the most severe needs. Graphs and tables are accompanied by explanation. Conclusions: In addition to consistency in presentation of the data across centers, the SIT operational summary provides visibility and insight on key emerging trends. Meaningful discussion of programmatic opportunities for focus on the most problematic and severe symptom by patient group has occurred.
ASCO research program quality assessment tool: Basics for a quality community-based research site.
Authors: Hurley Patricia A. , Smith Renee Yvonne , Robert Nicholas J.
Published: February 2017

97

Background: In 2008, ASCO published a statement to identify minimum standards and exemplary attributes of clinical trial sites. Recommendations were made to assist with the development and implementation of high-quality research programs. Based on feedback from an ASCO needs assessment survey, ASCO’s Community Research Forum (CRF) sought to develop a tool to help community-based research sites exceed the minimum standards of conducting clinical research, and to identify important components for an internal quality assurance program. Methods: A tool was developed to incorporate elements of ASCO publications on minimal standards and exemplary attributes of research sites. The tool was designed to assist community-based research sites with the development and implementation of an internal quality assurance program. A checklist was also developed to help sites easily conduct an assessment of their program. Community-based researchers provided feedback on the tool’s content and utilization. Feedback was incorporated and the tool was released for widespread use in March 2014. Results: The tool was very well received by reviewers. All reviewers indicated that the level of detail of the tool was sufficient; 94% indicated that it presented realistic expectations, in terms of resources required to implement; and 81% indicated that it would be valuable for conducting a quality assessment of their research program. As of July 2014, the tool was downloaded by over 150 practices from 8 different countries and early feedback continued to be favorable, particularly from small and/or new research programs. Conclusions: Many community-based research programs do not have the resources to support an effective quality assurance program and rely heavily on external audits. The ASCO Research Program Quality Assessment Tool provides self-directed continual process improvement to help community-based research sites create an internal quality assurance program and exceed minimum standards of conducting clinical research. The CRF will learn more from users of the tool about the quality of research programs and processes, and key quality metrics. The tool is available for download at www.asco.org/communityresearchforum.
Frequency and characteristics of cancer-related drowsiness (CRD or excessive daytime sleepiness) in patients with advanced cancer: Results of a prospective survey at a tertiary cancer center.
Authors: Yennu Sriram , Balachandran Dave , Pedraza Sandra L. , Berg Elyssa A , Chisholm Gary B. , Reddy Akhila Sunkepally , Williams Janet L. , Bruera Eduardo
Published: February 2017

131

Background: CRD is extremely distressing but treatable symptom to the advanced cancer patients (ACP). There are limited studies to evaluate the frequency and characteristics of CRD. The aim of this study was to identify the frequency, and factors associated with severity of CRD. Secondary aim was to determine the screening performance Edmonton Symptom Assessment Scale (ESAS)-drowsiness item against the Epworth Sleepiness Scale (ESS). Methods: We prospectively assessed 180 consecutive ACP at a tertiary cancer hospital. After obtaining signed consent, the patients completed ESAS, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI); ESS (≥10 diagnostic of CRD), Hospital Anxiety Depression Scale (HADS), STOP-Bang Screening Scale (SBS), and Screening tool for RLS. We determined epidemiological performance, spearman correlations, regression analysis, receiver operated characteristics of CRD. Results: Of the180 patients assessed, 51% were female, CRD was found in 50% ACP, median scores(IQR) ESS: 11(7-14); ESAS- drowsiness item was 5 (2-6); PSQI was 8(5-11); ISI (13 (5-19); SBS 3(2-4); HADS-D 6(3-10). Sleep apnea was found in 61%; and RLS in 38%. ESAS-D was associated with other ESAS items[r, p-value] Sleep (0.38, < 0.0001); pain (0.3, < 0.0001); fatigue(0.51, < 0.0001); depression(0.39, < 0.0001); anxiety(0.44, < 0.0001); shortness of breath(0.32, < 0.0001); anorexia(0.36, < 0.0001), FWB(0.41, < 0.0001), and ESS (0.24, 0.001), Opioid dose [MEDD] (0.19, 0.01). Multivariate analysis found no independent predictors except ISI (OR 2.35; 0.036), ESAS Fatigue (OR 9.08, <0.0001), ESAS Anxiety (3.0, 0.009); feeling of well-being (OR 2.27, p=0.04). An ESAS- drowsiness cut-off score of ≥ 3(of 10) resulted in a sensitivity and specificity of 81% and 32% and of 70% and 44% in the training and validation samples, respectively. Conclusions: Clinically significant CRD was associated with increased fatigue, anxiety, sleep disturbance and worse feeling of well-being. These symptoms should be routinely assessed and treated in ACP with CRD. ESAS-drowsiness score of ≥3 of 10 is most useful for screening CRD.
Sequencing the genome of hope.
Authors: Ferguson Anna K. , Lipson Evan J.
Published: February 2017

234

Background: Hope is widely regarded as essential to the emotional health of cancer pts, yet remains under-studied. We sought to explore the concept of hope and develop a teaching module to educate providers about the importance of hope in optimizing oncology care. Methods: We audio recorded interviews with oncology patients. Questions focused on what hope means, the role it plays in their ability to manage their illness, and ways in which they felt oncology providers could engender hope and positively impact their experience. We also interviewed oncology providers, including physicians, nurses, and social workers. Questions focused on the role they feel hope plays for their pts, whether or not they have received training in how to discuss hope, and tools they use to discuss hope with their pts. Common themes were extracted to form the backbone of a webcast-style teaching module. Results: A total of 24 volunteers were enrolled in an IRB approved protocol. One half of the subjects were pts and the other half were oncology providers (n = 6 physicians, 3 nurses, 3 social workers). Hope emerged as an important element to good quality of life in 12/12 (100%) pts.. The overwhelming majority (11/12, 92%) further expressed that feeling “well cared for” as well as receiving clear, honest information about their disease greatly increased their hopefulness. Hope also was recognized as essential to pts’ wellness and ability to manage their illness by all 12 (100%) of the providers. Although all providers recognized hope as essential to their pts, only the social workers reported that they had received some level of training in how to discuss hope, while the physicians and nurses felt that they had received little to no training. All providers expressed desire to contribute positively to their pts’ sense of hope. Conclusions: Both pts and providers view hope as a vital element in how oncology pts manage their illness. This point of connection between providers and their pts offers a mechanism to enhance the care of patients and impact their overall experience with cancer, yet most providers have little to no training in how to discuss hope. Development of an education module is underway to help increase awareness of the importance of hope and teach providers strategies to better engage with their pts on the subject of hope.
A retrospective analysis evaluating the benefit of early palliative care for patients with advanced pancreatic adenocarcinoma.
Authors: Quintin Julia , Bennouna Jaafar , Senellart Hélène , Hiret Sandrine , Barbarot Veronique
Published: February 2017

30

Background: Patients with advanced pancreatic carcinoma exhibit from the diagnosis and beyond severe clinical symptoms dominated by pain and weight loss, hampering quality of life. A recent study in metastatic lung cancer have shown a clear advantage of early palliative care in both quality of life and mood (Temel JS, et al. N Engl J Med 2010;363:733-42). Methods: Based on these data, we conducted a monocentric retrospective study including patients with advanced pancreatic cancer newly diagnosed and treated according with standard guidelines. The aim of this study was to determine the contribution of early palliative care visits (with supportive care physicians) on disease control symptoms, quality of life and overall survival. Results: From January 2006 to December 2010, 157 patients, PS 0, 1 or 2, with newly diagnosis of advanced pancreatic cancer were retrospectively enrolled. 126 patients (80.3 %) received at least one chemotherapy line. Out of 157 patients, 64 (40.7%) were seen in our palliative care department. Demographic patient characteristics between the two groups were well balanced; palliative care versus non palliative care: median age, 66.2 vs 66.7 years; PS 0,1 51 (79.5 %) vs 73 (79.7 %) ; male 34 (53.1 %) vs 47 (50.5 %) ; metastatic disease 39 (60.9%) vs 51 (54.8 %). Patients in the palliative care group showed more clinical symptoms at diagnosis, especially pain (73.4% patients in palliative care group versus 50.5%; p=0.004). They received less aggressive care at the end of their life: interruption of chemotherapy earlier (1.7 months before death versus 1.2 months) and less number of chemotherapy cycles in the month before death (22.7% versus 43.5%, p=0.042). However, no significant difference was observed for overall survival between both groups: 7.5 months in palliative care group versus 6.9 months (p=0.99). Conclusions: This study underlines the need of a multidisciplinary approach in advanced pancreatic cancer, promoting palliative care started initially at the diagnosis. It deserves to be completed by a largest prospective randomized study including a quality of life analysis.
Delirium rate and risk factors in palliative oncology outpatients and associated caregiver coping.
Authors: Livermore Sarah Deur , Xavier Marin Feldman
Published: February 2017

46

Background: Delirium causes suffering and undermines important palliative goals of care at end of life. Prior evaluation of outpatient delirium rate was 14% among demented elders. It is hypothesized that frail, palliative oncology outpatients have high rates of missed delirium. Improved knowledge and screening can improve patient outcomes through treatment in the home. This study examined the prevalence rate and risk factors for delirium among palliative care outpatients, and identified caregiver coping strategies associated with the episode. Methods: This was a descriptive, correlational study using a convenience sample of patient/caregiver dyads at an urban cancer center based on Rigney's Allopathic Load in Delirium Model. Oncology patient participants consented to a chart review for demographic risk factors. Caregivers of patients with a life-limiting illness were asked to complete two surveys at the time of their usual visit. The Family Administered Confusion Assessment Method, FAM-CAM scale reflected upon the patient's behavior over the past month using 12 simple yes/no questions. Risk factors such as age, gender, marital status, medications and diagnosis were correlated with delirium. The Folkman Lazarus Ways of Coping compared coping styles. Results: The rate of delirium among palliative care outpatients in this sample of 52 patient/caregiver dyads was 27%. The results suggested that opioid use slightly increases the odds for an episode of delirium, and approaches significance (r(50) =.270, p =.052). The majority of caregiver participants reported positive coping styles, however positive reappraisal and emotion-focused coping mechanism were more common in caregivers with a cognitively intact patient. Problem-focused coping was more common if the patient screened positive for delirium (m =.22, SD =.073). Conclusions: Oncology clinicians must screen for delirium in order to improve quality of care, especially among those on palliative chemotherapy.
Effect of early palliative care on depression and survival in patients with advanced cancer.
Authors: Prescott Anna Tekla , Hull Jay , Dionne-Odom J Nicholas , Lyons Kathleen , Tosteson Tor , Li Zhigang , Li Zhongze , Dragnev Konstantin H. , Bakitas Marie
Published: February 2017

5

Background: We previously demonstrated improved depression and survival in advanced cancer patients participating in two palliative care (PC) RCTs: ENABLE II (EII; N=322) compared intervention vs. usual care, and ENABLE III (EIII; N=207) compared immediate vs. delayed intervention. The interventions were identical, except in EIII, the intervention included support for family caregivers and the delayed group began the intervention 12 weeks after enrollment. Both EII and EIII included an in-person PC consultation, weekly phone sessions facilitated by a nurse coach, and monthly follow-up calls. The Center for Epidemiologic Studies-Depression (CES-D) scale was collected at baseline and every 6 weeks until death or study completion. Our aim was to examine the moderating effects of baseline depression on the intervention effect and on survival outcomes in both RCTs. Methods: After combining data from the two RCTs the sample consisted of 529 patients. We conducted Cox proportional hazard analyses to examine the effect of the intervention (as a time-varying covariate) and baseline depression scores on subsequent survival. Results: The intervention significantly reduced mortality risk in this sample (Hazard Ratio [HR]= 0.78, CI: 0.63-0.98, p=.029). Adding baseline CES-D scores and the interaction of the intervention and CES-D scores as predictor variables yielded a significant interaction (HR= 0.97, p =.035) that remained after controlling for cancer type. Following this analysis, patients were classified as clinically depressed (baseline CES-D 16) or not, and Cox analyses were conducted using the intervention as the sole predictor within each depression group. Receiving the intervention significantly reduced mortality risk among clinically depressed patients (HR = 0.65, CI: 0.44-0.95, p =.029), but not among non-depressed patients (HR = 0.89, CI: 0.65-1.21, p >.45). Conclusions: The ENABLE intervention improved survival in this combined sample of advanced cancer patients. The intervention effect on survival was moderated by baseline depression levels, such that patients who were depressed at baseline and received the intervention had a longer survival compared with non-depressed intervention patients.
Impact of early palliative care consultation on inpatient length of stay and discharge disposition among oncology patients.
Authors: Dhakal Ajay , Shrestha Suvash , Homel Peter , Popp Beth
Published: February 2017

53

Background: As palliative care develops as a medical subspecialty, studies are needed to assess its impact on patient care. Studies examining the effect of inpatient palliative care consult (PCC) on the admission length of stay (LOS) for non-ICU patients have failed to demonstrate consistent results. Also, there is a paucity of data on the effect of PCC on discharge disposition. The objective of this study is to examine the effect of early PCC on the length of stay and discharge disposition among cancer patients discharged alive. Methods: A retrospective review of oncology inpatients (pts) from January 2011 to Jan 2014 of whom 307 had PCC (PC group) and 305 pts did not have PCC (NC group). Visits less than 4 days, those ending with in-hospital deaths and those with PCC called more than 3 days into the admission were excluded. Groups were randomly matched based on All Patient Refined Diagnosis Related Group (APR DRG) Severity of Illness scores. Median LOS was compared with the Mann Whitney test. Pts coming from home without services (certified home health agency, advanced illness management, hospice, skilled nursing facility, or rehabilitation center) and discharged with services were considered favorable dispositions; any discharge without services was considered unfavorable disposition; all other dispositions considered neutral. Chi Square test was used to analyze discharge disposition. Results: The demographic profiles of 2 groups were similar in age, race, religion, marital status, insurance and living condition; females were more likely to get PCC (60 % vs 44 %, p<0.001). Median (minimum, maximum) LOS for PC group was longer by 1 day: 8 (4, 76) days vs 7 (4, 251) days for NC group (p=0.003). PC group was more likely to receive a favorable discharge disposition (45 % vs 36 %); less likely to receive unfavorable discharge (13 % vs 28 %, overall p < 0.001). Neutral dispositions were similar (41% vs 35 %). Conclusions: Oncology pts with PCC have 1 day longer LOS compared to those without it but are more likely to get a favorable discharge disposition. This may favorably impact readmission rates, which we hope to study in the future.
Early integration of palliative care in patients with pancreatic cancer: A retrospective study for quality improvement.
Authors: Grenon Nina N.
Published: February 2017

72

Background: Many patients with pancreatic cancer receive palliative care only at the end of life despite the fact that the course of illness is plagued with physical, emotional symptoms and existential distress. There is strong evidence that combining palliative care with standard cancer treatment improves quality of life for those patients with in metastatic cancer and in some cases can help extend survival. Early incorporation of palliative care for patients with incurable cancer is an important focus for quality improvement. Methods: The purpose of this quality improvement study was to describe quality indicators for palliative care, and discover when palliative care was introduced during the course of illness in patients with pancreatic cancer. Domains of palliative care identified by the National Consensus Project and the National Quality Framework, provided the framework for this study. A retrospective medical record review of patients with pancreatic cancer treated at the Dana-Farber Cancer Institute (DFCI) between January 2009 to December 2011 was conducted. Time variables relevant to disease course, and palliative care referrals were collected. Other key variables included: the reason for, and frequency and timing of, palliative care discussions. Results: Medical records from 150 DFCI patients were reviewed in which the mean length of care from first visit to last note (typically death) was 414 days (SD=347). 52 (35%) records included documentation of a palliative care discussion and the majority of those occurred at the time of disease progression. Prognosis discussions were documented after a mean 177 (SD=285) days and a palliative care consult was made on average at day 343 (SD=301). Of those consults, the large majority (82%) were requested for symptom management. Conclusions: Despite evidence and standards of care that support early palliative care discussions and subsequent referrals for palliative care consults, these findings suggest such events occurred late in the trajectory and care of patients with pancreatic cancer. Future quality work and training will address provider and health system variables that can promote discussions and consults.
Oncogeriatrics joint consultations: When pharmacists improve patients' management together with oncogeriatrics physician.
Authors: Rey Jean-Baptiste , Parent Damien , Perin Stephane
Published: February 2017

79

Background: Elderly patients often have several diseases and therefore polymedicated. Comorbidities and treatments may interfere with management of oncological patients. Methods: The objectives of this project are 1) to ensure a proper understanding of patients regarding their treatment, 2) to perform a pharmaceutical analysis of patients’ prescription, 3) to propose changes to the patients’ doctors (general practitioners and physicians of the Institute) to prevent and reduce adverse drug events. The project combines medical and pharmaceutical expertise around the patient to optimize their care coordinated with the action of a "disease professional” and a "drug professional " with a particularly vulnerable population. Results: Since the project began, more than 100 patients benefited from these joint consultations, thus establishing a network between the Institute and the general practionners supporting our patients. Optimization of drug treatment and reduction of iatrogenic events avoids the complications and hospitalizations extensions and / or re-hospitalization. The pharmaceutical intervention documented in the medical records of patients (explaining terms of the intervention) and the transmission of the report to "pharmaceutical consultation" to physician 1) improves the management of patients (reduction potential iatrogenic events – e.g. risk of falling by orthostatic hypotension) and 2) allows the referring physician to optimize patient care. Conclusions: Launched in 2010, the project entered its fourth year of existence and continues.
A phase II study of capecitabine, carboplatin, and bevacizumab for metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma.
Authors: Kunz Pamela L. , Nandoskar Prachi , Koontz Michael Zach , Ji Hanlee , Ford James M. , Balise Raymond R. , Kamaya Aya , Rubin Daniel , Fisher George A.
Published: February 2017

115

Background: Gastroesophageal junction (GEJ) and gastric adenocarcinomas constitute a major health problem worldwide. In the United States, the incidence of adenocarcinoma of the esophagus, GEJ and gastric cardia is rising rapidly. Chemotherapy for metastatic disease improves survival and quality of life when compared to best supportive care. The addition of bevacizumab to chemotherapy in a large, randomized, multinational study showed conflicting results. Methods: Patients (pts) with biopsy proven metastatic or unresectable GEJ and gastric adenocarcinomas received bevacizumab 15 mg/kg IV and carboplatin AUC 6 IV on day 1 and capecitabine 850 mg/m2twice daily by mouth on days 1-14 on a 21-day cycle. Pts with stable disease (SD) or partial response (PR) were allowed to continue therapy with bevacizumab with or without capecitabine. Primary endpoints were progression free survival (PFS) and toxicity; secondary endpoints were overall survival (OS) and response rate by RECIST. Results: Between April 2009 and April 2013, a total of 35 pts were enrolled. At present, 29 patients are off treatment and 6 are still actively receiving treatment. 29 pts are available for response assessment, 6 patients came off study prior to their first tumor assessment. Baseline characteristics are: M:F = 25:10; median age = 58 years (range 25-81); primary site = GEJ (17) and gastric (18); degree of differentiation = well (3), moderate (12), poor/signet ring (18), and unknown (2); race = White Non-Hispanic (24), White Hispanic (6), and Asian (5). The 1-year PFS is 21% and median PFS is 8.5 months. Median OS is 14.3 months. Best response by RECIST is as follows: PR in 17 pts (49%), SD in 6 pts (17%), and progressive disease (PD) in 6 pts (17%). The treatment was well-tolerated with toxicities as expected. Conclusions: The combination of capecitabine, carboplatin and bevacizumab in metastatic or unresectable unresectable GEJ and gastric adenocarcinomas is well tolerated and shows promising response rates, though did not meet the primary endpoint of PFS. Clinical trial information: NCT00780494.
Risk factors for surgical complications after D2 gastrectomy following neoadjuvant chemotherapy for gastric cancer.
Authors: Yoshikawa Takaki , Aoyama Toru , Hayashi Tsutomu , Tanabe Kazuaki , Nishikawa Kazuhiro , Ito Yuichi , Cho Haruhiko , Morita Satoshi , Miyashita Yumi , Tsuburaya Akira , Sakamoto Junichi
Published: February 2017

164

Background: The feasibility and safety of D2 surgery following neoadjuvant chemotherapy (NAC) has not yet been fully evaluated in patients with gastric cancer. Moreover, the risk factors for surgical complications after D2 gastrectomy following NAC are also unknown. The aim of the present study was to identify risk factors for postoperative complications after D2 surgery following NAC. Methods: This study was conducted as an exploratory analysis of a prospective randomized phase II trial of NAC. This randomized phase II trial compared two and four courses of neoadjuvant S-1/cisplatin (SC) and paclitaxel/cisplatin (PC) using a two-by-two factorial design for locally advanced gastric cancer. Sample size was set at 60 to 80 to achieve 10% improvement of 3-year OS by four courses or by PC with approximately 80% probability of the correct selection. The surgical complications were assessed and classified according to the Clavien-Dindo classification. The uni- and multivariate logistic regression analyses were performed to identify risk factors for morbidities. Results: Among the 83 patients who were registered in the phase II trial, 69 patients received NAC and D2 gastrectomy. Postoperative complications were identified in 18 patients, and the overall morbidity rate was 26.1%. The results of the univariate and multivariate analyses of various factors potentially affecting the overall surgical morbidity identified a creatinine clearance (CCr) < 60ml/min (P = 0.016) as the sole significant independent risk factor for overall morbidity. The incidence of pancreatic fistula was significantly higher in the patients with a low CCr than in those with a high CCr. Conclusions: A low CCr was found to be a significant risk factor for surgical complications associated with D2 gastrectomy after NAC. Careful attention is therefore required for these patients. Clinical trial information: UMIN000002595.
Outcome of chemoradiotherapy followed by surgery for locally advanced T4 thoracic esophageal squamous cell carcinoma.
Authors: Akutsu Yasunori , Kono Tsuguaki , Uesato Masaya , Hoshino Isamu , Murakami Kentaro , Matsubara Hisahiro
Published: February 2017

170

Background: Chemoradiotherapy (CRT) is a standard modality for locally advanced esophageal squamous cell carcinoma (ESCC). The outcome of CRT with/without following surgery for locally advanced ESCC was demonstrated. Methods: 1,235 new ESCC patients from 2001 to 2012 were obtained. From these, locally advanced thoracic ESCC was selected. If the patients showed resectability with down-staging after CRT, a subsequent surgery was performed. For the remaining cases, an additional CRT was prescribed, following by a re-evaluation for surgery. If down-staging and resectability were achieved, the patients underwent surgery. In the surgery group, pathologic effectiveness in the primary tumor and lymph nodes was observed and survivals both in surgery and non-surgery group were calculated. Results: From 1,235 new ESCC patients, 153 patients (12.4%) were of locally advanced thoracic ESCC. Among these, 28 patients (18.3%) showed finally down-staging of the primary tumor and could undergo following surgery. 12 patients (7.8%) could obtain down-staging and underwent surgery (surgery H group). In total, 40 patients (26.1%) could undergo surgery (surgery group). The rate of residual tumor in the primary tumor was detected in 32 cases (80%). The 5-year overall survival was 33.0% in the surgery group and 10.0% in the non-surgery group (P=0.002). The 5-year cause-specific survival was 65.0% in the surgery group and 18.1% in the non-surgery group (P=0.002). Conclusions: CRT for locally advanced thoracic ESCC is the standard modality and following surgery have benefits. However, the outcome is not satisfactory and further improvements of treatments for such cases are requested.
EVOLVE-1: Phase 3 study of everolimus for advanced HCC that progressed during or after sorafenib.
Authors: Zhu Andrew X. , Kudo Masatoshi , Assenat Eric , Cattan Stéphane , Kang Yoon-Koo , Lim Ho Yeong , Poon Ronnie Tung Ping , Blanc Jean-Frédéric , Vogel Arndt , Chen Chao-Long , Dorval Etienne , Peck-Radosavljevic Markus , Santoro Armando , Daniele Bruno , Furuse Junji , Jappe Annette , Perraud Kevin , Anak Ozlem , Sellami Dalila B. , Chen Li-Tzong
Published: February 2017

172

Background: No effective treatment options exist for advanced HCC following sorafenib failure. Preliminary data suggest everolimus may provide benefit after sorafenib. EVOLVE-1 (NCT01035229) assessed the efficacy and safety of everolimus for advanced HCC after sorafenib failure. Methods: Pts aged ≥18 y with BCLC stage B or C HCC and Child-Pugh A liver function whose disease progressed during or after sorafenib or who were sorafenib intolerant were randomized 2:1 to everolimus 7.5 mg/d or placebo. All pts received best supportive care. Randomization was stratified by region (Asia v rest of world) and macrovascular invasion (yes v no). Study drug was given continuously until disease progression or intolerable toxicity. CT/MRI was performed every 6 wk. Primary endpoint was OS. Secondary endpoints were TTP, disease control rate (DCR; percentage of pts with best overall response of CR, PR, or SD per RECIST 1.0), and safety. Final analysis was performed when 454 deaths occurred. Results: 546 pts from 18 countries enrolled from Apr 2010 to Mar 2012 (everolimus = 362, placebo = 184). Baseline characteristics were balanced between arms; median age was 66.0 y, 84.8% of pts were male, 86.3% had BCLC stage C disease, 16.7% were from Asia, 32.8% had macrovascular invasion, and 74.0% had extrahepatic disease. Prior sorafenib was discontinued for disease progression in 80.8% of pts and intolerance in 19.0%. Median OS was 7.56 mo with everolimus and 7.33 mo with placebo (HR 1.05; 95% CI 0.86-1.27; P = .675). Median TTP was 2.96 mo and 2.60 mo, respectively (HR 0.93; 95% CI 0.75-1.15). DCR was 56.1% and 45.1%, respectively (P = .010). The most common grade 3/4 AEs with everolimus (v placebo) were anemia (7.8% v 3.3%), asthenia (7.8% v 5.5%), decreased appetite (6.1% v 0.5%), and hepatitis B viral load increase or reappearance (6.1% v 4.4%). No pts experienced HCV flare. HBV reactivation was experienced by 39 pts (29 everolimus, 10 placebo); all cases were asymptomatic, but 3 everolimus recipients discontinued therapy. Conclusions: Everolimus did not improve OS in pts with advanced HCC whose disease progressed on or after sorafenib or who were sorafenib intolerant. The safety profile was consistent with that previously observed with everolimus. Clinical trial information: NCT01035229.
Randomized controlled trial of irinotecan drug-eluting beads with simultaneous FOLFOX and bevacizamab for patients with unresectable colorectal liver-limited metastasis.
Authors: Martin Robert C. G. , Scoggins Charles R. , Rilling William S. , Schreeder Marshall T. , Kauh John S. , Strasberg Steven M. , Crocenzi Todd S. , Redman Rebecca , Sharma Vivek R.
Published: February 2017

174

Background: Reports have demonstrated the activity of combining both Irinotecan and Oxaliplatin into a FOLFOXIRI therapy. An option to gain similar benefits and less toxicity to FOLFOXIRI would be to administer the irinotecan through an hepatic arterial apporach. The aim of this study was to assess the maximal response and adverse event rates of Irinotecan Drug Eluting Beads (DEBIRI) with FOLFOX and Bevacizumab (Bev) as a first line treatment for unresectable colorectal liver metastasis (CLMs). Methods: Metachronous and Synchronous CLMs were randomly assigned to mFOLFOX6/Bev or mFOLFOX6, Bev and DEBIRI (FOLFOXDEBIRI). Primary end point was optimal response rates and adverse events. Secondary endpoints were patients (pts) converted to resection and survival. Results: The intention-to-treat population comprised 70 pts, 40 pts randomly assigned to the FOLFOXDEBIRI arm and 30 pts to FOLFOX/Bev arm. Both were similar with synchronous disease (50% vs. 36%), extent liver involvement (35% vs. 31%), but greater percentage in the FOLFOXDEBIRI arm of ECOG 1/2 (57% vs. 31%), p=0.04) and extra-hepatic disease (51% vs. 36%, p=0.02). Median number of chemotherapy cycles was similar in both arms of 8, with a similar Grade 3/4 adverse event rate of 54% FOLFOXDEBIRI and 46% FOLFOX/Bev arm. The overall response rate was significantly greater in the FOLFOXDEBIRI arm vs. FOLFOX/BEV at 2 mons (78% vs. 54%), 4 mons (95% vs. 70%) and 6 mons (76% vs. 60%, p=0.03). Significantly greater downsizing to resection in the FOLFOXDEBIRI arm vs. FOLFOX/Bev (35% vs. 16%, p=0.05), with an improved median progression free survival (15.3 mons vs. 7.6 mons). Overall improvement in hepatic specific progression free survival was seen in the treatment arm (12.8 mons vs. 10.5 mons). Conclusions: Simultaneous mFOLFOX6 with bevacizumab and hepatic arterial irinotecan drug eluting beads is safe, without causing chemotherapy delivery delays and without increasing chemotherapy toxicity. Simultaneous FOLFOXDEBIRI leads to improved overall response rates, improved hepatic progression free survival, and more durable overall progression free survival in patients downsized to resection. Clinical trial information: NCT00932438.