bluuebunny/crossref_metadata_2025_split huggingface dataset:
CACHEXIO: Evaluation of body composition changes and immunotherapy in patients with metastatic cancer.
Authors: Roeland Eric , El-Jawahri Areej , Horick Nora , Nelson Sandahl H , Gallivan Andrea , Nipp Ryan David , Cohen-Arazi Yael , Friedman Sarah , Sera Chris , Ma Joseph , Baracos Vickie E , Patel Sandip Pravin , Phull Hardeep 
Published: November 2018

209 Background: Given body composition predicts toxicity for patients receiving cytotoxic chemotherapy, we explored changes in body composition and biomarkers as predictors of immune-related adverse events (irAEs) and health care utilization. Methods: We conducted a longitudinal study of patients with metastatic solid tumor receiving immunotherapy (07/2014-10/2017). Eligible patients had a computed tomography (CT) scan prior to first-line immunotherapy with at least two additional CT scans at three, six or nine months after immunotherapy initiation. We analyzed body composition using cross-sectional CT scans at the third lumbar vertebra. We utilized mixed effect linear regression models to assess longitudinal changes in body composition (weight, skeletal muscle, total adipose). We examined associations of baseline body composition and biomarkers (albumin, neutrophil-lymphocyte ratio (NLR)) with the incidence of irAEs and healthcare utilization (hospitalizations/ED visits) using logistic regression. Results: Of 140 patients treated with immunotherapy, 61 met inclusion criteria. The majority (80%) received prior chemotherapy and the most common malignancies included lung (26%), head and neck (20%), and melanoma (20%). We found that one-third (n=19) experienced an irAE and colitis (53%) was the most common irAE. Patients experienced substantial weight loss over time (B= -1.88, p<0.001) with a decrease both in skeletal muscle (B= -3.08, p=0.001) and total adipose tissue (B =-50.44, p<0.001). We found greater skeletal muscle at baseline was associated with lower risk of health care utilization (OR 0.98, 95% CI: 0.965-0.998, p=0.03). We observed no association with biomarkers and/or body composition variables with irAEs or health care utilization. Conclusions: Patients with metastatic cancer receiving immunotherapy lose weight including skeletal muscle and adipose tissue. Aside from higher baseline skeletal muscle predicting less health care utilization, we did not observe any other associations between body composition changes and irAEs or health care utilization.
Preliminary validation of the Edmonton Symptom Assessment Scale – Acute Leukemia (ESAS-AL) in patients with acute leukemia (AL).
Authors: Tricou Columbe , Mah Kenneth , Malfitano Carmine , Rydall Anne , Schimmer Aaron David , Rodin Gary , Zimmermann Camilla 
Published: November 2018

210 Background: Patients with AL have numerous symptoms resulting from their disease and its treatment. Here we report on a preliminary evaluation of an ESAS version including AL-specific symptoms (ESAS-AL). Methods: Forty-two inpatients with newly-diagnosed AL (31 AML, 11 ALL), receiving induction chemotherapy, completed baseline assessments with the ESAS-AL and the Memorial Symptom Assessment Scale (MSAS) as part of a clinical trial. The ESAS-AL includes the nine usual ESAS symptoms (rated from 0-10), as well as five symptoms reported by patients with AL in a previous longitudinal study: trouble sleeping, mouth sores, diarrhea, constipation, and itching. Correlations between each ESAS symptom and the corresponding MSAS symptom (rated 1-4) were calculated using Spearman’s correlation. Results: The mean age was 52.86 (SD 15.84). Most correlations were moderate to large and were highly significant (Table). Correlations ranged from 0.86 (ESAS-AL/MSAS Itching) to 0.20 (ESAS-AL Anxiety/MSAS Worried). Correlations for 4 physical symptoms specific to ESAS-AL (itching, diarrhea, mouth sores, and constipation) were among the highest (rs>.70). Correlations between ESAS-AL trouble sleeping and MSAS difficulty sleeping and between ESAS-AL anxiety and MSAS worried were lowest (rs<.30). ESAS-anxiety correlated better with MSAS nervous (rs=.61). Conclusions: Well-defined ESAS-AL physical symptoms are highly correlated with equivalent MSAS symptoms, whereas less well-defined symptoms have weaker correlations. These findings provide preliminary support for the validity of the ESAS-AL. Further data collection for larger-scale validation is ongoing. [Table: see text]
A systematic review and combined analysis of phase III trials to evaluate the safety of adjuvant sunitinib in patients with high risk renal cell carcinoma after nephrectomy.
Authors: Quirch Miguel , Thein Kyaw Zin , Ball Somedeb , Adhikari Nimesh , Jones Catherine , D'Cunha Nicholas C. , Awasthi Sanjay , Tijani Lukman Aderoju , Hardwicke Fred L. 
Published: November 2018

214 Background: Sunitinib, an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor, has been approved in adjuvant treatment of high risk renal cell carcinoma (RCC) after nephrectomy despite distinct results among studies, along with notable safety concerns. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of grade 3 and 4 adverse events in patients treated with adjuvant sunitinib. Methods: MEDLINE, EMBASE databases and meeting abstracts from inception through June 2018 were queried. Phase 3 RCTs which utilized adjuvant sunitinib in high risk RCC after nephrectomy were included. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Random effects model was applied. Results: Two phase III RCTs with a total of 1866 patients were eligible. Studies utilized sunitinib versus placebo. The randomization ratio was 1:1 in both ASSURE and S-TRAC studies. The RR of high-grade adverse effects were as follows: hypertension, 4.26 (95% CI: 2.89 – 6.26, p < 0.001); fatigue, 5.40 (95% CI: 3.49 – 8.34; p < 0.001); rash/desquamation, 5.00 (95% CI: 1.59 – 15.68; p = 0.006); hand foot syndrome, 18.68 (95% CI: 5.98 – 58.28, p < 0.001); asthenia, 6.57 (95% CI: 1.005 – 43.04; p = 0.049); diarrhea, 18.08 (95% CI: 6.63 – 49.32; p < 0.001); dyspepsia, 12.68 (95% CI: 2.40 – 66.80, p = 0.003); stomatitis, 29.15 (95% CI: 5.73 – 148.18; p < 0.001); nausea, 19.63 (95% CI: 3.81 – 100.97; p < 0.001); and vomiting, 8.21 (95% CI: 2.21 – 30.51; p = 0.002). Conclusions: The rate of high-grade hypertension, fatigue, asthenia, dermatological toxicities, including hand foot syndrome, and gastrointestinal toxicities were extremely high in patients treated with adjuvant sunitinib, compared to placebo arm. Fatigue, hand foot syndrome and gastrointestinal toxicities significantly contribute to patients’ quality of life and providing good supportive care is warranted.
Hits and misses: A longitudinal examination of congruence between patient-reported quality-of-life concerns in advanced cancer and discussions with oncologists.
Authors: De Sola-Smith Karen Marie , Bell Janice , Tancredi Daniel J , Kravitz Richard L , Duberstein Paul , Epstein Ronald M. , Fenton Joshua J 
Published: November 2018

22 Background: Quality of life (QOL) support is critical to high quality advanced cancer care and is associated with improved patient outcomes, but most patients report unmet supportive care needs. To understand supportive care provision in routine oncology, we examined the agreement, or congruence, between patients’ self-reported symptoms and topics discussed with oncologists over an extended interval of care. Prior research suggests that patient-provider rapport and overall QOL influence discussion of patient concerns, therefore we estimated effects of two predictors of interest: therapeutic alliance between patient and oncologist, and global QOL. Methods: We conducted a secondary analysis of data collected in the VOICE study. Patients with advanced cancer (n=196) completed measures of symptoms (e.g., pain, nausea, emotional concerns) and QOL, as well as an inventory of topics discussed with oncologists over the prior 3 months. Data were collected at quarterly intervals for up to 48 months, resulting in 901 paired reports of patients’ symptoms and discussions with oncologists. We constructed congruence as a multinomial outcome with four discrete categories: congruence (symptom reported/discussed), unaddressed concern (symptom reported/not discussed), surveillance (symptom not reported/discussed), and no supportive care concern (symptom not reported/not discussed). We then estimated effects of global QOL and therapeutic alliance using multi-level logistic regression. Results: Congruence was most common for pain (49.9%), while emotional concerns were most likely to be unaddressed (50.5%). Higher therapeutic alliance with oncologists was associated with lower odds of unaddressed pain (OR 0.94, CI 0.89-1.00) and emotional concerns (OR 0.95, CI 0.91-0.98). Higher global QOL was associated with higher odds of unaddressed emotional concerns (OR 1.11, CI 1.02-1.20). Congruence outcomes were stable over time. Conclusions: Oncologists may improve congruence by strengthening therapeutic alliance, by more consistently discussing emotional concerns, and by prioritizing topics for discussion according to patients’ needs.
Sexual health in young women with metastatic breast cancer: The state of the science.
Authors: Silverman Marissa Rose , Rabow Michael W. 
Published: November 2018

223 Background: The incidence of metastatic breast cancer (MBC) in women under 40 is increasing. Sexual health is a key element of quality of life (QOL) and is impacted by MBC. While those searching the Internet receive primarily anecdotal information, the state of the science around MBC and sexual health for young women appears to be limited. Methods: Four databases were searched for English language articles: PubMed, PsycINFO, Embase, and Sociological Abstracts.Search topics included sexual health, sexual activity, intimacy, gender identity, sexual orientation, body image, and/or intimate partner relationships among young women with MBC. Results: 598 studies were reviewed; 9 met selection criteria. Four studies were included on body image and sexual activity: 2 reported a correlation between young age and poor body image; in a third, no relationship was found for women 30-49; in the fourth, among patients with metastatic or localized disease, women < 45 placed greater importance on body image or changes in sex life than women > 65. Three studies examined sexual health and treatment: a review of hormonal therapies in young patients recommended that sexual side effects be considered; a qualitative study reported on the impact of mastectomy on feelings of femininity and body image; an observational study of patients with locally recurrent or MBC found younger age was associated with greater vaginal dryness and decreased sexual interest/activity. One qualitative study did not find patterns of difference in sexual health needs related to age-patients of all ages and relationship status desired more information. In a study of QOL and MBC, younger age was associated with less sex life satisfaction. Subjects across all studies were primarily white, and sexual activity studied was primarily heterosexual, vaginal sex. Conclusions: The scientific literature on sexual health among young women with MBC is exceedingly limited. Studies that do examine sexual health often exclude those with MBC, do not examine the impact of age, and are focused on heterosexual, white women. Understanding the impact of MBC on young women’s sexual health can inform future care practices for this growing population.
Novel first-in-class small molecule targeting APE1/Ref-1 to prevent and treat chemotherapy-induced peripheral neuropathy (CIPN).
Authors: Kelley Mark R. , Messmann Richard Adam , Fehrenbacher Jill 
Published: November 2018

229 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is an acute and chronic debilitating side effect of a number of chemotherapeutic agents lacking FDA-approved interventions or strategies resulting in dose-limiting neurotoxicity. CIPN can persist following discontinuation of the drug with up to 40% of patients having continued CIPN five years after treatment ends. Thus, CIPN directly affects cancer survivorship, quality of life, and may limit future treatment options if cancer recurs. Although the cellular mechanisms mediating CIPN remain to be determined, several lines of evidence support the notion that DNA damage caused by anticancer therapies could contribute to the neuropathy. Methods: Using an experimental model of isolated sensory neurons in culture, we established a causal relationship between cancer-therapy-induced neurotoxicity and DNA damage and repair. Results: Genetically reducing the activity of APE1 increased the neurotoxicity produced by platin treatment, whereas augmenting the activity of APE1 lessened neurotoxicity. Furthermore, using a targeted small-molecule, APX3330, which increases DNA repair of APE1 in neurons, it lessened neurotoxicity using a variety of endpoints ex vivo; e.g. DNA damage, CGRP release. We will present data using animal models of CIPN demonstrating a protective effect of APX3330 using either cis- or oxaliplatin without diminishing the anti-tumor effect of the platins. A Phase 1 clinical trial for safety/RF2D for APX3330 has completed (NCT03375086). Conclusions: Effective prevention and management of CIPN hinges on understanding its pathophysiology. While multiple causal mechanisms may be at work, we believe that the induction of oxidative DNA damage in sensory neurons is a major cause of CIPN. Thus, enhancement of oxidative DNA damage repair by APX3330 results in reduction of CIPN.
Standardizing goals of care (GoC) documentation for new patients with metastatic disease.
Authors: Kidwai Wajih , Engelking Constance , Pyle Jennifer , Chiang Anne C. 
Published: November 2018

26 Background: Executing GoC discussions is an established national standard, underpins high quality patient-centered cancer care and ensures that patients participate actively in treatment decision-making. Capturing key aspects of those discussions in electronic documentation can be challenging when provider time is limited. This project sought to standardize workflow components to enable provider capacity to meet a GoC standard that ≥75% of patients presenting with metastatic cancer have a GoC discussion by their third visit as evidenced by retrievable documentation (EMR format and location). Methods: Baseline data describing provider: patient GoC interactions with eligible patients was obtained and presented. Providers reached consensus on a consistent timing, location and content for electronic GoC documentation. Patient assessment parameters for identifying patients needing GoC discussions were generated, a procedure outlining documentation expectations and facilitative tools were developed. Clinicians were educated on their roles in the process. A variety of quality improvement tools were utilized in project execution (e.g. focus groups, process mapping, cause-effect diagraming, pareto and control charting). Results: See table. Conclusions: Despite time constraints in a busy practice, the ≥75% target set for retrievable GoC documentation was exceeded within the 9-month project timeframe. Providers improved their documentation with familiarity and experience over time. Compliance with documentation location and use of smart phrases were not fully realized, likely due to the short timeframe for adoption of all elements of project aims. Continued improvement is expected as providers become more comfortable with the process and additional facilitative strategies are further integrated including expanding nursing assessment of patients' GoC needs, dedicating time in scheduling templates, Epic alert builds and utilizing Palliative Care Team assist for patients deemed uncomfortable with GoC discussions.[Table: see text]
Prognostic understanding and barriers to palliative care in patients with metastatic lung cancer on immunotherapy.
Authors: Steffen Laurie , Lycan Thomas , Levine Beverly J , Gabbard Jennifer , Ruiz Jimmy , Grant Stefan C. , Blackstock A. William , Weaver Kathryn E. , Petty William J. 
Published: November 2018

36 Background: Communicating prognosis and integrating palliative care (PC) are challenging yet vital aspects of quality care for patients with metastatic non-small cell lung cancer (NSCLC). These tasks may be more difficult in the setting of immunotherapy, as this modality may offer a durable response but only in 10-20% of patients. Our goal was to identify correlates of prognostic understanding and interest in PC among stage IV NSCLC patients receiving immunotherapy. Methods: We conducted a cross-sectional survey of 60 patients (M age = 62.5 years; SD = 9.3 years; 40% male; 45% ≤ high school degree; 68% ECOG ≤ 1) undergoing immuno- or chemo-immunotherapy for stage IV NSCLC (80% de novo) at an academic medical center. Results: Most patients (73%) reported that knowing their prognosis was very important. Nearly all said the goal of treatment was to help them live longer (98%), feel better (95%), and completely rid them of cancer (85%); 49% thought they were likely to be cured. Only 17% of patients were interested in meeting with PC; 12% had been referred. Those patients with worse performance status (PS; ECOG 2-3) (79% vs. 35%, p = .002) and who had not yet had an appointment to assess treatment response (67% vs. 37%, p = .03) were more likely to believe they would be cured. There were no differences in expectation based on treatment response, time since diagnosis, de novo versus recurrent metastatic disease, or health literacy level. Interest in meeting with PC did not significantly differ based on expectation for cure, though only 13% of those who thought a cure was unlikely were interested in PC compared to 21% who thought a cure was likely. Patients noted multiple barriers to PC, including preference for self-management (58%), lack of provider recommendation (47%), misconceptions (e.g., PC is for people about to die; 45%), and access barriers [e.g., time (36%) and cost (24%)]. Conclusions: Many patients receiving immunotherapy for stage IV NSCLC may expect curative treatment even when they are not actually responding or have poor performance status. Efforts to improve palliative care literacy and use in this population should address PC misconceptions and emphasize its role, including how it can support self-management.
A systematic process to enhance selection of a prepared medical decision maker.
Authors: Zhukovsky Donna S. , Haider Ali , Naqvi Syed Mussadiq Ali Akbar , Joshi Neeraj , Soliman Pamela T. , Mathew Boby , Bodurka Diane C. , Meyer Larissa , Westin Shannon Neville , Frumovitz Michael M. , Archie LaShan , Fenton Shauna L , Williams Janet L. , Boving Valentine G 
Published: November 2018

5 Background: Selecting a prepared medical decision maker (MDM) is an integral component of advance care planning (ACP), an interdisciplinary process supported by prognostic awareness. ASCO’s Quality Initiative recommends providers discuss ACP or advance directives (AD) with all new patients with invasive malignancy (NP) by the third office visit (OV). In this quality improvement project, our goal was to increase documented social work (SW), counseling, and education regarding selection of a prepared MDM to 70% and to increase scanned MPOA in EHR 2x by 3R OV. Methods: All SW received institutional training regarding important elements to include when providing counseling and education regarding selection of a prepared MDM. We collected data from EHR of all NP of five gynecologic oncologist champions, including responses to patient needs survey (PNS), AD questions at first OV and ACP physician/Advanced Practice Provider (MD/APP), and SW ACP notes derived from templates with structured elements. Data were collected during baseline and three intervention cycles (C). C1: coaching RN to ask PNS AD questions from a “culture of yes”, C2: NP viewing brief video about importance of MPOA; C3: providing cards with simple definitions of AD to use with NP. Results are presented for C1-3 versus baseline. Results: Total NP=351 (baseline 133, C1-3 218). Intervention group (IG) patients requested more assistance with AD (15 vs. 5%, p=.005) and wanted more information (16 vs. 8%, p=.02) than baseline. Documented social work ACP notes by the third OV were less frequent in the IG (30 vs. 48%, p=.001); there were fewer documented SW ACP notes in those without scanned MPOA (72 vs. 58% without note, p=.01), and no increase in scanned MPOA (13 vs. 11%, p=.516). Physician documentation of MPOA discussion increased (38 vs. 8%, P.000), but discussion of treatment goals did not (84 vs. 68%, p=.112). Conclusions: Interventions resulted in increased MD/APP discussions of importance of MPOA and NP requests for discussion, but fewer SW ACP discussions. There was no increase in scanned MPOA. Current processes reach only a minority of NP and do not effectively engage NP in selecting a prepared MDM. More proactive approaches systematically incorporating ACP discussions into care in an iterative manner are needed.
Process measures of palliative and end-of-life care among young adults who died from cancer.
Authors: Poort Hanneke , Zupanc Sophia , Wright Alexi A. , Lindvall Charlotta 
Published: November 2018

54 Background: Timely delivery of palliative and end-of-life care (EOL) are essential components of high-quality cancer care. To date, however, few studies have examined process measures for EOL care in young adult (YA; ages 18-35 years) cancer decedents. Methods: We conducted a retrospective study using medical records of YA decedents who received cancer treatment at an academic cancer center between Jan. 1, 2012 and June 13, 2018. We used natural language processing (NLP) with validated key words to identify documentation of four process measures – palliative care involvement, and discussions of goals of care, code status, and hospice – from documented clinical encounters in the medical record within 6 months of death. Results: During this period 146/2,878 (5.1%) YA patients had a recorded death date and a first note at least 31 days prior to death. In this decedent cohort, the mean age was 28.2 years (SD=4.4) and 58.9% were men. The most common diagnoses were brain cancer (33.6%), sarcoma (19.9%), and breast cancer (12.3%). The 146 patients accrued 26,441 clinical notes during the last 6 months of life (median=116.5 notes, IQR 37.0-222.0). Using NLP, we identified that 68.5% of the 146 YAs had at least one process measure documented in the last 6 months of life, including: 54.1% palliative care involvement; 56.8% discussions of goals of care; 47.3% discussions of code status; and 51.4% discussions of hospice. On average, palliative care was documented 7.5 times (range 0-75); goals of care 6.1 times (range 0-43), code status 1.9 times (range 0-12), and hospice 8.1 times (range 0-67). Late documentation of process measures (defined as first recorded within 30 days of death) included: hospice (45.3%), code status (30.3%), palliative care (20.8%), and goals of care (9.6%). Notably, in 31.5% of YAs, we did not detect documentation of any process measures prior to death. Conclusions: In this cohort of YA cancer decedents, nearly one-third of YAs did not have documentation of any process measures, highlighting the importance of efforts to improve EOL care communication with this young population.