bluuebunny/crossref_metadata_2025 huggingface dataset:
Undertreated emotional distress in older adults with cancer.
Authors: Kapo Jennifer , Canavan Maureen , Presley Carolyn J , Wang Shi-Yi , Feder Shelli , Sheinfeld Ella , Kent Erin , Davidoff Amy J.
Published: November 2018

165

Background: Depression and anxiety are common among older adults with cancer, and concern about the adequacy of emotional distress management is increasing. We examined receipt of prescription medication (Rx) by older adults with cancer relative to reported activity limitation associated with emotional distress. Methods: Using the 2007-2012 SEER-Medicare Health Outcomes Survey (MHOS) database with a unique linkage to Part D prescription claims, we selected MHOS participants with Part D coverage who were within 5 years of cancer diagnosis. We used claims to identify use of Rx for emotional distress management: anti-depressants, antipsychotics, anxiolytics, and/or sedatives during the 90 days post survey. Participants reported activity limitations (“accomplished less” or “worked less carefully”) within the past 30 days “due to emotional problems.” Limitations were quantified as severe (most/all of the time), moderate (some/little of the time), or none. We used multivariable logistic regression to determine associations of Rx use with degree of activity limitation, controlling for characteristics of cancer, demographics and health status. Results presented are predicted percentages. Results: Reported activity limitation in the study sample (N = 9,105) was 15% severe, 34% moderate, and 52% none. Rx were used by 28% overall, with higher rates for severe (39%) and moderate (33%) compared to no activity limitation (23%), p < .001. Among respondents not using Rx, 13% [32%] reported severe [moderate] activity limitations. Among respondents using Rx, severe [moderate] activity limitation was reported by 20% [39%]. Rx use was lower for male sex, with increasing age, non-white race, with fewer comorbid conditions and without the Part D low-income subsidy. Conclusions: Undertreatment of emotional distress is highly prevalent among older adults with cancer. Many SEER-MHOS respondents reporting moderate or severe activity limitations due to emotional distress did not receive Rx for symptom management, and of those receiving Rx, many still report moderate to severe symptoms. Treatment disparities identified by race/ethnicity, age and sex suggest the need for enhanced emotional distress screening and interventions to reduce treatment barriers.
Clinical and demographic variables of young adult (YA) patients referred to inpatient supportive care.
Authors: Ann-Yi Sujin , Wong Angelique , Wu Jimin , Charone Maira , Baumgartner Karen , Carmack Cindy L. , Castro Debra , Guzman Diana , Joy Manju P , Kuriakose Leela , Madden Kevin , Najera John M , Pangemanan Imelda , Rajani Sabeena Qasim , Raznahan Monica , Stewart Holly A , Tallie Kimmie , Tanco Kimberson Cochien , Zhukovsky Donna S. , Bruera Eduardo
Published: November 2018

168

Background: Literature suggests that YA cancer patients have unique psychosocial issues and more emotional distress compared to older aged patients. Our study aimed to evaluate clinical and demographic factors of YA cancer patients that may impact physical and psychosocial symptom expression. Methods: A retrospective review was conducted on randomly selected patients seen during 2013-2015 of 3 age groups: 18-39 (YA), 40-64, and 65 and older on demographic, medical, psychosocial history, Morphine Equivalent Daily Dose (MEDD), Edmonton Symptom Assessment Scare (ESAS) scores, and Eastern Cooperative Oncology Group (ECOG) scores which are completed at time of initial consultation with the supportive care inpatient mobile team. Results: 896 (YA = 297, 40-64 cohort = 300, 65 and older = 299) patients were reviewed. YA cohort was associated with being female (n = 179 (60%), p = 0.03), more frequently non-white (Black and Hispanic = 124 (42%), p < 0.00), higher ECOG scores (ECOG 0-2 = 83(39%), p < 0.00) more psychiatric history (n = 95(32%), p = 0.00) and worse ESAS sleep scores (median = 6, p = 0.02). The YA cohort also had higher pain expression than the 65 and older cohort (p = .02). The YA group was more likely to have children younger than 18 years old (n = 171(58%), p < 0.00). Patients with children less than 18 years of age reported higher pain expression (median = 6, p = .05), sleep (median = 6, p = 0.01), and financial distress (median = 2, p = 0.02). Conclusions: Contrary to other findings, YA cancer patients did not report higher symptoms or distress when compared to older age cohorts, with the exception of higher insomnia compared to other age cohorts and higher pain expression than the oldest age cohort. YA with young children reported higher level of pain, sleep and financial distress. Our findings suggest that the YA population may benefit from specialized psychosocial services to address their unique social needs, particularly to address concerns related to being parents of young children.
The caregiver perspective: Advancing the understanding of cancer caregiving in the palliative care setting.
Authors: Raymond Martha , Simonetta Margaret-Ann
Published: November 2018

17

Background: 2018 data from the National Cancer Institute’s Surveillance, Epidemiology & End Results (SEER) Program estimates there are 15.5 million cancer survivors in the U.S. Throughout the care continuum, cancer caregivers provide invaluable support which greatly impacts and improves patient quality of life. In the palliative care setting caregiver support is vitally important, but many caregivers struggle to take care of their own needs and are not aware of supportive services. Our study explores the unmet needs of cancer caregivers in the palliative care setting. Methods: Over a two-year time period (2015-2017), our professional facilitator met with cancer caregivers in 32 states hosting nationwide focus groups. Primary goals were reaching caregivers in rural, urban, medically underserved, and community oncology settings to gain perspective from diverse populations. Focus groups were held in person and online via facetime conferencing. Results: 778 caregivers (42% male, 58% female) participated. 92% of caregivers did not feel comfortable defining palliative care nor did they realize the various supportive elements palliative care provides. 76% were extremely anxious during care transitions; 71% feel overwhelmed with daily caregiving tasks; 69% want to help make end of life decisions including advance directives in partnership with their loved one, but did not feel equipped to make tough decisions; 64% report lack of patient/caregiver centered communication with their healthcare team, including guidance on adverse effects and training for medical hands-on tasks. Conclusions: Caregivers in the palliative care setting need additional supportive services, effective interventions, and educational programs to meet their unmet needs. With additional support and awareness, enhanced quality of life for both caregiver and patient is possible. Our conversations with caregivers will continue as we increase palliative care awareness, collaborate with partners, develop meaningful programs, and expand our outreach to help meet the needs of caregivers in the palliative care setting.
Immunotherapy-related toxicities: More common than originally reported?
Authors: Cathcart-Rake Elizabeth Jane , Sangaralingham Lindsey R. , Shah Nilay , Mansfield Aaron Scott
Published: November 2018

184

Background: Population level data regarding incidence of immune-related adverse events (irAE) is lacking. This study evaluated the frequency of irAEs among a large population of patients with non-small cell lung cancer (NSCLC) who received immune checkpoint inhibitors. Methods: Administrative claims data from a large U.S. commercial insurance database (OptumLabs Data Warehouse) were used to retrospectively identify patients with NSCLC who received PD-1 or PD-L1 inhibitors between January 1, 2015 to December 31, 2017. The frequencies of irAEs were reported, identified by having a new medical claim with a corresponding ICD-9 or ICD-10 code during the time period in which the patient was on immunotherapy. Results: Of 2,798 patients with NSCLC (median age at PD-(L)1 initiation: 69 years, interquartile range: 60-75, 1558 male [55.7%], 1240 [44.3%] female), 1,998 (71.4%) received nivolumab, 699 (25.0%) received pembrolizumab, and 101 (3.6%) received atezolizumab. Most patients (1463, 52.3%) received a PD-(L)1 inhibitor as second line therapy; the majority of patients (744) received alkylating agents and antimetabolites prior to receiving PD-(L)1 therapy. See Table 1 for frequencies of irAEs. Conclusions: The current study suggests that the frequencies of some irAEs related to immune checkpoint inhibitor therapies may be higher than those which were reported in the initial trials that led to the FDA approvals for immunotherapies. For example, hypophysitis was noted to occur in 0.6% of patients in the KEYNOTE-024 trial, but was identified in 2.4% of patients in this large cohort. Real world data may refine provider and patient expectations for outcomes beyond what is observed in clinical trials. [Table: see text]
Dry eye after whole brain radiation: Analysis from a prospective study.
Authors: Tobillo Rachel , Pearlstein Kevin A. , Mahbooba Zahra , Moon Dominic Himchan , Shen Colette J. , Marks Lawrence Bruce , Chera Bhishamjit S. , Wang Kyle
Published: November 2018

198

Background: Lacrimal glands (LGs) receive incidental dose of unknown significance in patients undergoing whole brain radiation therapy (WBRT). Median survival following diagnosis of brain metastases is poor, so quality of life is of utmost importance for these patients. We enrolled patients on a prospective observational cohort study with an endpoint of dry eye syndrome, which is not thought to be a toxicity of WBRT. Methods: Patients receiving WBRT for any diagnosis to a total dose of 25 to 40 Gy in 10 to 20 fractions were eligible. Patients received 3D-conformal WBRT using opposed lateral fields covering the skull and C1 or C2 vertebrae. LGs were not prospectively contoured before treatment but were subsequently contoured for dosimetric analysis. Patients completed the single-question Subjective Evaluation of Symptom of Dryness (5-point Likert scale) at baseline, immediately after WBRT (EndRT), 1 month (1M), 3 months (3M), and 6 months (6M). The primary endpoint was change in proportion of patients at 1M experiencing moderate or worse dry eye (defined as symptoms that cause discomfort and interfere with activities). Orbital dose was analyzed as a surrogate for LG dose as LGs were difficult to contour on computed tomography (CT) imaging. Results: 73 enrolled patients were eligible for analysis. There were 69 evaluable patients at EndRT, 55 at 1M, 33 at 3M, and 28 at 6M. Most patients received 30 Gy in 10 fractions. Median bilateral orbit mean dose was 17 Gy. Median bilateral lacrimal mean dose was 25 Gy. Median survival was 8 months. At baseline, 4% of patients had moderate or worse dry eye versus 9% at EndRT, 11% at 1M (1-tailed sign test, p = 0.031), 9% at 3M, and 7% at 6M. No significant relationship was noted between presence of dry eye and CT-contoured lacrimal gland or orbit doses. Conclusions: WBRT appears to cause a small increase in dry eye symptoms. A correlation between dry eye and LG dose was not observed, perhaps due to the overall low rate of toxicity, uncertainty in CT-based contouring of the LGs, set-up variations between planned and delivered doses, and the possibility of non-radiation causes of dry eye. Nonetheless, physicians should be aware of the possible occurrence of dry eye after WBRT, given its potential effects on quality of life.
Changes in symptom burden associated with exposure to outpatient palliative care in an integrated health system.
Authors: Haupt Eric C. , Sharma Ishita , Nguyen Huong Q
Published: November 2018

204

Background: Patients with serious illnesses are often referred to palliative care (PC) for symptom management, advance care planning, and goals-of-care discussions. The purpose of this analysis is to describe the symptom burden (SB) and short-term changes in patients receiving outpatient PC from nine clinics within an integrated health system in Southern California. Methods: We included 3,007 adults with cancer who completed the Edmonton Symptom Assessment System (ESAS) at the start of PC from 1/1/14 - 6/30/18. Patients were identified at baseline as having either a high SB if they scored ≥ 4 on at least two out of nine symptoms or low SB if they did not meet this threshold. We compared baseline socio-demographic and clinical characteristics between high SB and low SB patients. We also examined changes in the ESAS for patients with a follow-up survey at 30 ± 14 days after baseline. Results: Patients with high SB at presentation to PC tended to be younger and had comparable co-morbidities to patients with low SB. Availability of a follow-up ESAS was low but similar between groups (18%). Changes in the ESAS met published minimal clinically important differences (MCID) for the high SB patients whereas low SB patients showed worsening symptoms. Conclusions: We observed similar symptom burden in this community-based oncology patient population as other studies from specialized cancer centers. Greater effort is needed to standardize timing of follow-up assessments and integrating personalized symptom goals.[Table: see text]
FIT: Functional and imaging testing for patients with metastatic cancer.
Authors: Roeland Eric , El-Jawahri Areej , Nelson Sandahl H , Gallivan Andrea , Nipp Ryan David , Horick Nora , Cohen-Arazi Yael , Hagmann Chelsea , Sera Chris , Friedman Sarah , Ma Joseph , Phull Hardeep , Baracos Vickie E
Published: November 2018

208

Background: Despite multiple cancer cachexia (CC) trials evaluating novel agents, the FDA has not approved a single drug to date. One key challenge in CC trials is selection of endpoints. The aim of this study was to explore changes in body composition and associations with functional and patient-reported outcomes (PROs) to clarify CC trial endpoint selection. Methods: We identified metastatic solid tumor cancer patients receiving cancer-directed therapies at a single cancer center (2016-2018). Patients completed all assessments at study enrollment and 3 months from enrollment. We analyzed body composition utilizing cross-sectional computed tomography (CT) scans at the third lumbar vertebra. Functional assessments included the 6-minute walk test (6MWT), Timed Up-and-Go (TUG) test, and Short Physical Performance Battery (SPPB). PROs included the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) and Functional Assessment of Cancer Therapy Fatigue (FACT-F). We examined changes in body composition and functional assessments from enrollment to 3 months using paired t-tests. We utilized linear regression models to assess the relationship between changes in body composition and changes in functional assessment adjusting for age and sex. Results: A total of 57 patients completed baseline assessments; 19 patients did not complete 3-month assessments (5 died, 1 hospice, 13 withdrew). Of the 38 patients with complete data (mean age 61.8 years, 47% female, 71% GI malignancy), 50% received chemotherapy, 16% immunotherapy, and 34% combination therapy. From enrollment to 3 months, we observed an increase in total adipose tissue (16.9±52.4 cm2, 95% CI -33.79-0.63; p = 0.059), but not weight or skeletal muscle. Greater losses in skeletal muscle were associated with greater declines in 6MWT (B = 0.036, p = 0.014) and SBBP (B = 2.444, p = 0.002), but not the TUG. We observed no association with change in weight with all functional outcomes or PROs. Moreover, we found no association with body composition and PROs from enrollment to 3 months. Conclusions: In future CC trials, changes in longitudinal body composition rather than weight should be utilized. Furthermore, changes in skeletal muscle and the 6MWT and/or SBBP may be preferred endpoints.
Perceiving hope from oncologists and prognostic understanding and treatment planning.
Authors: George Login , Derry Heather M , Kurita Keiko , Maciejewski Paul K , Breitbart William , Prigerson Holly Gwen
Published: November 2018

21

Background: Offering hope during prognostic discussions is widely considered essential to the delivery of humane medical care. However, clinicians always offering hope may undermine realism in patients' prognostic understanding and preparation for what lies ahead. We examine how patients’ perceptions of their oncologists as always offering hope, compared to a more tempered sense of hope, relate to prognostic understanding and treatment planning. Methods: Data came from post-scan baseline assessments of an NCI funded multi-site study on prognostic communication among metastatic cancer patients’ refractory to at least one chemotherapy regimen. The analytic sample consisted of 235 participants, who during structured interviews, rated the question, “how often does your oncologist offer hope,” as “always,” “most of the time” or “sometimes.” A binary variable was created comparing participants endorsing “always” to participants endorsing “most of the time” or “sometimes.” Patients also reported on elements of prognostic understanding, DNR order completion, and preference for either life-extending or comfort care. Results: Patients who rated their oncologists as “always” offering hope (62.1%), compared to those who rated “most of the time” or “sometimes” (37.9%), were more likely to have inaccurate prognostic understanding regarding life-expectancy ( OR = 0.40; 95% CI, 0.16, 0.97), and marginally more likely to have a treatment preference that favored life-extending care over comfort care ( OR = 0.61; 95% CI, 0.35, 1.07). A significant moderation effect was seen ( b = -1.43, p = .04) such that accurate understanding of the incurability of their cancer was associated with DNR completion only among patients who perceived more tempered hope from oncologists ( OR = 5.53; 95% CI, 1.80, 17.02), and not among patients who always perceived hope ( OR = 1.32; 95% CI, 0.63, 2.78). Conclusions: Results suggest that the tempering of hope may have benefits, as perceiving oncologists as always offering hope was associated with worse prognostic understanding and lower advance care planning. Future research examining in a more nuanced way the nature of hope offered (e.g., hope for cure vs. symptom management) in longitudinal designs is needed.
Risk of health-related quality-of-life events and pulmonary toxicities in patients with cancer treated with poly adenosine diphosphate ribose polymerase inhibitors: A meta-analysis of seven phase III trials.
Authors: Swarup Sriman , Sultan Anita , Zaw Myo , Yendala Rachana , Han Myat M. , Myat Yin Mon , Yu Nyein Htwe , Panigrahi Kalpana , Thein Kyaw Zin
Published: November 2018

213

Background: Poly adenosine diphosphate ribose polymerase (PARP) enzymes aide in the repair of DNA damage. PARP inhibitors showed synthetic lethality in cancer cells and were utilized in many solid tumors with notable toxicities. Fatigue and pain are the major determinants of health-related quality of life (HRQOL) in cancer patients undergoing chemotherapy. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of HRQOL events and pulmonary toxicities. Methods: MEDLINE, EMBASE databases and meeting abstracts from inception through June 2018 were queried. Phase III RCTs that mention HRQOL events and pulmonary toxicities as adverse effects 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: 3188 patients from 7 phase III RCTs with breast, ovarian, and gastric cancer were eligible. Studies compared olaparib or niraparib or rucaparib versus placebo, olaparib vs single agent chemotherapy, iniparib + gemcitabine / carboplatin (GC) versus GC, veliparib + C versus C and olaparib + paclitaxel versus paclitaxel. The RR of all-grade side effects were as follows: fatigue, 1.26 (95% CI: 1.07 – 1.49, P = 0.006); decreased appetite, 1.42 (95% CI: 1.18 – 1.71, P < 0.001); arthralgia, 1.05 (95% CI: 0.83 – 1.34, P = 0.65); headache, 1.35 (95% CI: 0.99 – 1.84, P = 0.05); cough, 1.75 (95% CI: 1.17 – 2.62, P = 0.006); dyspnea, 1.40 (95% CI: 0.90 – 2.18, P = 0.12); and upper respiratory infections, 1.70 (95% CI: 0.97 – 3.00, P = 0.06). The RR of high-grade side effects were as follows: fatigue, 1.94 (95% CI: 1.24 – 3.04, P = 0.004); arthralgia, 1.37 (95% CI: 0.29 – 6.51, P = 0.68); headache, 1.09 (95% CI: 0.47 – 2.55, P = 0.83); and dyspnea, 1.02 (95% CI: 0.44 – 2.36, P = 0.95). Conclusions: The risk of developing all grades of fatigue as well as any-grade cough and decreased appetite was high in PARP inhibitors group, compared to control arm. Recognizing these toxicities and providing good supportive care is vital in enhancing patients’ quality of life.
A systematic review and meta- analysis of randomized controlled trials to evaluate the risk of hematological toxicities in patients with cancer treated with poly adenosine diphosphate ribose polymerase (PARP) inhibitors.
Authors: Sultan Anita , Swarup Sriman , Zaw Myo , Han Myat M. , Myat Yin Mon , Aung Htay Htay , Zin Myet Mon Mon , Panigrahi Kalpana , Thein Kyaw Zin
Published: November 2018

217

Background: Poly adenosine diphosphate ribose polymerase (PARP) inhibitors have shown to benefit in DNA repair-deficient tumors by enhancing synthetic lethality in cancer cells and are currently employed in many solid tumors. Nevertheless, the risk of hematological toxicities remains significant. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of hematological toxicities. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts from inception through June 2018. Phase III RCTs that mention hematological toxicities as adverse effects were incorporated in the analysis. 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: Seven phase III RCTs with a total of 3,188 patients with breast, ovarian and gastric cancer were eligible. Studies compared olaparib or niraparib or rucaparib versus placebo, olaparib vs single agent chemotherapy, iniparib + gemcitabine / carboplatin (GC) versus GC, veliparib + C versus C and olaparib + paclitaxel vs paclitaxel. The RR of all-grade side effects were as follows: anemia, 2.38 (95% CI: 1.42 – 4.00, p = 0.001); thrombocytopenia, 2.96 (95% CI: 1.37 – 6.40, p = 0.006); neutropenia, 1.47 (95% CI: 1.06 – 2.05, p = 0.02); and leukopenia, 1.08 (95% CI: 0.77 – 1.50, p = 0.63). The RR of high-grade adverse effects were as follows: anemia, 3.63 (95% CI: 1.53 – 8.57, p = 0.003); thrombocytopenia, 2.65 (95% CI: 0.89 – 7.85, p = 0.07); neutropenia, 1.27 (95% CI: 0.87 – 1.86, p = 0.21); and leukopenia, 1.20 (95% CI: 0.90 – 1.58, p = 0.19). Conclusions: Our meta-analysis demonstrated that patients on PARP inhibitors experienced a significant increase in the risk of all grades of anemia with a relative risk of 3.63 for grade 3 and 4 anemia, along with any-grade thrombocytopenia and neutropenia. Proper supportive care is essential, and it will ultimately reduce drug dosing inconsistencies and financial burden among patients undergoing treatment.
The antidiarrheal efficacy of a proprietary amino acid mixture in neuroendocrine tumor (NET) patients.
Authors: Luque Laura , Chauhan Aman , Yu Qian , Miller Rachel C , Weiss Heidi , Siddiqui Fariha , Tarter Zackary , Anthony Lowell Brian
Published: November 2018

218

Background: Gastroenteropancreatic neuroendocrine tumor (GEPNET) incidence has risen 6-fold over past 3 decades. North American Neuroendocrine Tumor Society estimates that over 100,000 GEPNET patients are currently living in the United States. One of the common quality of life limiting symptom seen in GEPNET patient is diarrhea. Diarrhea in these patients could be due to excessive serotonin production, secondary to post-operative short gut syndrome, steatorrhea from somatostatin analogs, bile acid colitis or intestinal bacterial overgrowth. A novel amino acid based oral rehydration solution (enterade) is currently being evaluated in a Phase II clinical trial for antidiarrheal effects in post bone marrow transplant patients (NCT02919670). We conducted a pilot study of enterade in neuroendocrine tumor (NET's) patients with quality of life limiting diarrhea. Methods: Medical records of all the NET patients given enterade to alleviate symptomatic diarrhea were evaluated. Patients were treated at Markey Cancer Center between May 2017-June 2018. Results: Total 69 NETs patients were treated with enterade. Enterade was administered as 8 Oz bottle BID for 1 a week. Antidiarrheal efficacy data was available on 41 patients at the time of abstract submission. 15 patients had small bowel NETs, 5 had bronchial NETs, 1 had colorectal NETs, 3 had NETs of unknown primary, 3 had gastric NETS, 3 had pancreatic NETs and one had high grade neuroendocrine carcinoma of the prostate. Data regarding primary site was unavailable in 10/41 patients. 21 patients had history of prior bowel resection either for primary neuroendocrine tumor resection or debulking. 25 patients were on somatostatin analogs at the time of initiation of enterade. 31 out of 41 patients reported some reduction in diarrhea frequency. 21 out of these 41 patients reported at least a 50% reduction in diarrhea frequency. Conclusions: 75.6% (31/41) neuroendocrine tumor patients reported improvement in diarrhea frequency with enterade. 51.2% (21/41) reported more than 50% reduction in diarrhea frequency. A prospective Phase II study of enterade in neuroendocrine tumor patients with quality of life limiting diarrhea is currently planned.
Risk of gastrointestinal and hepatic toxicities in patients with cancer treated with poly adenosine diphosphate ribose polymerase inhibitors: A meta-analysis of seven phase III trials.
Authors: Zaw Myo , Sultan Anita , Swarup Sriman , Han Myat M. , Myat Yin Mon , Htwe Khaing Khaing , Hein Aung Myo , Yang Tsujung , Thein Kyaw Zin
Published: November 2018

219

Background: Inhibition of poly adenosine diphosphate ribose polymerase (PARP) enzymes terminates an alternative DNA repair pathway, resulting in synthetic lethality in homologous recombination deficient tumors. Many PARP inhibitors have shown to improve survival in many solid tumors with noteworthy safety concerns. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of gastrointestinal (GI) and hepatic toxicities. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts from inception through June 2018. Phase III RCTs that mention GI toxicities and elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) as adverse effects were incorporated in the analysis. 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: 3188 patients from 7 phase III RCTs with breast, ovarian and gastric cancer were eligible. Studies compared olaparib or niraparib or rucaparib versus placebo, olaparib versus single agent chemotherapy, iniparib + gemcitabine / carboplatin (GC) versus GC, veliparib + C versus C and olaparib + paclitaxel versus paclitaxel. The RR of all-grade side effects were as follows: diarrhea, 1.24 (95% CI: 1.08 – 1.42, P = 0.002); nausea, 1.53 (95% CI: 1.16 – 2.02, P = 0.002); vomiting, 1.46 (95% CI: 1.02 – 2.08, P = 0.03); elevated AST, 1.25 (95% CI: 0.58 – 2.67, P = 0.55); and elevated ALT, 1.61 (95% CI: 0.81 – 3.20, P = 0.16). The RR of high-grade side effects were as follows: diarrhea, 1.08 (95% CI: 0.52 – 2.24, P = 0.82); nausea, 1.81 (95% CI: 0.79 – 4.12, P = 0.15); vomiting, 1.99 (95% CI: 1.06 – 3.73, P = 0.03); elevated AST, 1.86 (95% CI: 0.45 – 7.55, P = 0.38); and elevated ALT, 1.33 (95% CI: 0.42 – 4.18, P = 0.62). Conclusions: Our study showed that the risk of developing all grades of vomiting as well as any-grade nausea and diarrhea was high in PARP inhibitors arm, compared to control group. Timely recognition and prompt intervention with good supportive care are entailed.
Nurses’ beliefs and practices regarding intravenous opioid use for breakthrough cancer pain.
Authors: Arthur Joseph Anthony , Reddy Akhila Sunkepally , Smith Uniqua , Hui David , Liu Diane D. , Park Minjeong , Bruera Eduardo
Published: November 2018

222

Background: Faster intravenous (IV) opioid administration speed is associated with increased adverse effects and subsequent increased opioid intake. Infusion rates ≥ 2 minutes are recommended. Data on nurse practices regarding IV opioid administration are limited. We assessed the frequency of nurse-reported speeds of IV opioid bolus infusion in the inpatient oncology units, and nurses’ beliefs and perceptions about opioids in cancer pain management. Methods: A cross-sectional survey among inpatient nurses working in the medical, surgical, intensive care unit (ICU), and emergency department (ED) work areas was conduceted. We defined fast IV opioid bolus infusion speed as < 120 seconds(s). Results: The participant response rate was 60% (731/1234).57%, 55%, and 58% of all nurses administered morphine, hydromorphone, and fentanyl in < 120s.Overall median (IQR) infusion speed of IV morphine, hydromorphone, and fentanyl were 60s (40-120), 90s (45-120), and 60s (30-120) respectively. Correlation between morphine, hydromorphone, and fentanyl infusion speeds were 0.93, 0.90, and 0.90 respectively (p <0 .0001). Median infusion speed of morphine was 55s for ICU nurses, 60s for both surgical unit and emergency department nurses, and 85s for medical unit nurses (p=0.0002). The odds ratio for fast IV opioid infusion was 2.22 for ED nurses (p= 0.027), 2.67 for ICU nurses (p= 0.001), 0.27 and 0.18 for frequent (p=0.003) and very frequent(p=0.001) use a timing device respectively, and 0.86 for hydromorphone infusion compared with morphine (< 0.0001). Fast infusion was also independently associated with perception that suboptimal pain control as the reason for increased patient opioid requests(p=0.009), clinician reluctance to prescribe opioids(p=0.008), lack of psychosocial support services (p= 0.03), and patient’s reluctance to take opiates (p=0.015). Conclusions: More than half the nurses working in the inpatient setting reported administering IV opioids at a faster speed than recommended. Nurses who frequently use a timing device are more likely to infuse at a more optimal speed. Further research is needed to standardize and improve safe intermittent infusion of parenteral opioids.
Outcomes after empiric radiation therapy for leukemic infiltrates of the lung: A single institution experience.
Authors: Byun John , Jabbour Salma , Patel Vimal D. , Parikh Rahul
Published: November 2018

225

Background: Acute leukemias (AL) may present with variable clinical findings, from incidental discovery to respiratory distress or obtundation. However, patients may progress rapidly, requiring emergent treatments including leukophoresis, chemotherapy or radiation. There is little to no data supporting the use of radiation therapy in the setting of presumed lung infiltration. We present the first known case series on the treatment of presumed leukemic lung infiltration with empiric radiation therapy (eRT). Methods: Eleven patients with AL from 2008 – 2018 were identified who were treated with eRT at our center. All patients were on empiric antibiotics, and all were noted to have at least one chest plain film with suspicious infiltrates. The median age was 66 years old (29-77), and five of eleven patients were febrile at the start of radiation. One patient had been intubated prior to radiation delivery. Three of seven patients underwent leukophoresis and six of ten patients received any chemotherapy prior to eRT. Results: The median treatment regimen was 450cGy (range 50 – 1050) in 3 fractions (1 – 7). The median white blood cell (WBC) count prior to radiation therapy was 119.0 x 103 /μL (highest recorded, 1.9 – 317.6), with median blast percentage on manual differential, 88% (3 – 98). All eleven patients had a large reduction in WBC count within the first day of eRT, with median response 48.2% decrease in WBC count (31.7 –99.8; average 57.3%). Ten of ten patients reported subjective improvement in breathing. Conclusions: Empiric radiation therapy is a safe and effective means for rapidly decreasing leukocyte counts and for symptomatic palliation in patients with AL and radiographic chest infiltrates.
An association between tobacco smoking, daily opioid use, pain response and the risk for aberrant opioid use behaviors.
Authors: Yennu Sriram J. , Edwards Tonya , Lu Zhanni , Williams Janet L. , Arthur Joseph Anthony , Reddy Suresh , Bruera Eduardo
Published: November 2018

226

Background: Opioid misuse is a growing crisis. Cancer patients at risk of aberrant drug behaviors are frequently underdiagnosed. Primary aim was to determine the association between current tobacco smoking, daily opioid use, pain response, and risk for aberrant opioid use behaviors (AOB) among patients receiving outpatient supportive care consultation at a comprehensive cancer center. Methods: 1,501 consecutive cancer patients referred to a supportive care clinic from March 1, 2016 to June 6, 2018 were reviewed. Patients were eligible if they had diagnosis of cancer, and were on opioids for pain for at least a week. All patients were assessed using Edmonton Symptom Assessment Scale (ESAS), SOAPP-14 (validated questionnaire for assessment of risk for aberrant opioid use behaviors), and CAGE-AID. Patients with AOB (SOAPP+) were defined by SOAPP score ≥7. Results: Median age was 61yrs. Median ESAS pain item score on consultation was 5. Median ECOG was 2. Never smokers, previous smokers, and current smokers were 54%, 40%, and 6.6% respectively. 16.8% were AOB+ and 10.1% were CAGE-AID+. There was no significant difference in ESAS pain response at first follow-up between AOB+ versus AOB negative. Morphine Equivalent Daily Dose (MEDD) in AOB+ never smokers versus previous smokers versus current smokers was 45 mg versus 60 mg versus 75mg respectively (P=0.03). Table 1 shows that male pts and those with current or previous smoking history, anxiety, and prior alcoholism/illicit drug use are at increased risk of AOB. Conclusions: Male patients and those with history of current or previous smoking history, anxiety, and prior alcoholism/illicit drug use are at increased risk of AOB. [Table: see text]
Family perspectives on prognostic communication in the palliative oncology clinic: "Someone was kind enough to just tell me".
Authors: Craig Kevin , Washington Karla T.
Published: November 2018

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Background: Talking with patients with cancer and their families about the likely course of a disease is commonly cited as one of the most difficult aspects of healthcare delivery, yet palliative care providers routinely engage in such discussions. As such, attention to communication about prognosis in palliative oncology care has increased in recent years. Research and practice wisdom alike have provided important insights into the experiences of providers, patients, and family members who have taken part in discussions about prognosis and, relatedly, goals of care. As a result, we now have a number of highly effective tools at our disposal to enhance prognostic communication in palliative care. Methods: We sought to build on this existing expertise, applying a social ecological perspective to the study of prognostic communication from the family caregiver’s point of view. In this session, we present the findings of an inductive thematic analysis of qualitative data collected as part of randomized clinical trial of a family caregiver intervention in palliative oncology (R21CA191165; Principal Investigator: Author). Results: Findings illustrate how family caregivers ( N = 63) experience discussions about prognosis as one part of a much larger experience with the healthcare system. Themes describe how family caregivers attempt to make sense of seemingly contradictory information, incorporate information from non-provider sources, elicit prognostic information when it is not forthcoming, make their information needs known when they conflict with the patient’s, and use information to plan their future lives. Conclusions: Evidence-informed strategies to improve communication with family caregivers as vital partners in the delivery of palliative oncology care are sorely needed. Clinical trial information: NCT02427490.
Communication of prognostic information between oncologists and patients with advanced lung cancer.
Authors: Babu Dilip Sankar , Gerbino Nicholas , Fiscella Kevin , Shields Cleveland , Griggs Jennifer J. , Epstein Ronald M. , Tejani Mohamedtaki Abdulaziz
Published: November 2018

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Background: A critical domain of patient-provider communication is helping cancer patients understand their prognosis, as well as the efficacy of treatment options. In this qualitative study, we explored the ways oncology providers approached prognostic discussions during initial office visits with patients with metastatic lung cancer. Methods: Transcripts of initial visits between unannounced standardized patients portraying metastatic non-small cell lung cancer and their oncologists were recorded at multiple practice sites in community and academic settings, as part of a large NIH-funded study. Thematic analysis was conducted on a subset of these recorded visits from one study site. In this secondary analysis, three coders (one medical oncologist, one palliative care physician and one research assistant) reviewed transcripts independently to extract quotes related to prognosis, meeting regularly to review selected quotes and to decide on codes. This process repeated until saturation of themes was achieved (n = 15). Results: Discussions of prognosis were found in all 15 transcripts reviewed. Three main themes were identified: (1) Vagueness, in which best-case/worst-case scenarios were presented without an estimate of life expectancy; (2) Statistical Reliance, in which complex statistical data were presented to the patient; and (3) Emotional Support, in which the discussion was infused with emotional reassurance which was contextually appropriate. A fourth identified theme was (4) Minimizing of Supportive Care, as discussions of management options did not always elaborate on best supportive care. Conclusions: Our qualitative analysis of initial office visits among simulated patients with metastatic lung cancer revealed that providers often frame prognostic information in vague terms without a realistic estimate of life expectancy, sometimes give patients complex statistical data, and tend to accompany their discussions with emotional reassurance. Best supportive care is not always fully explained when management options are reviewed. More work is needed to determine optimal ways to convey prognostic and management information during clinic visits for patients with advanced cancer.
Early discussion of patients’ values by oncology nurses.
Authors: Epstein Andrew S. , Chow Kimberly , Anderson Kelley , Okpako Molly , Bernal Camila , Romano Danielle R. , Desai Anjali Varma , Klimek Virginia M. , Rawlins-Duell Robin , Goldberg Jessica , Kramer Dana , Nelson Judith Eve
Published: November 2018

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Background: Optimal advance care planning allows patients to articulate their values as an affirmation of personhood and a touchstone for medical decision-making. Ideally, it occurs when patients are well enough to express themselves thoughtfully, with opportunities for iteration as the clinical situation unfolds. We piloted a novel program of systematic, oncology nurse-led values discussions with patients soon after diagnosis, testing feasibility, and acceptability in high-volume clinics in a dedicated cancer center. Methods: Within an institutional initiative integrating primary and specialist palliative care from diagnosis for all cancer patients regardless of stage or prognosis, specialists trained oncology nurses (90 minutes) to use specific questions ( re living well, hopes, fears, sources of strength, abilities essential for acceptable quality of life) and an empathic communication framework to discuss health-related values with newly-diagnosed patients over two consecutive clinic visits. Nurses summarized discussions on a template for patient verification, oncologist review, and EMR documentation. Documentation was re-reviewed with the patient quarterly (sooner on patient or clinician request). Feasibility and acceptability were evaluated in three clinics for patients with hematologic or gastrointestinal (GI) cancers. Results: Oncology nurses conducted a total of 83 discussions (part 1=38, part 2=29, template review=16) with 15 and 23 newly-diagnosed hematologic and GI cancer patients, respectively. No patient declined participation. Discussions averaged 8 minutes; summaries were reviewed in 4 minutes, and all were verified by patients. Clinic workflow and volume (about 20 patients/clinic day) were maintained. Of 12 patients, all reported feeling comfortable with the process, 92% considered it helpful, 92% would recommend it to others. In structured interviews, patients, families, and clinicians strongly endorsed this process. Conclusions: Early, nurse-led discussions of patient values are feasible and acceptable in high-volume outpatient oncology clinics. Next steps include optimization of EMR accessibility, scalability, and evaluation of impact on other patient-focused and utilization outcomes.
Shared decision-making preferences and pain characterization in patients with cancer.
Authors: Brant Jeannine M. , Stricker Carrie Tompkins , Petok Alison , Sih-Meynier Regina , Wujcik Debra
Published: November 2018

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Background: Cancer pain prevalence is high (52%-77%) with breakthrough pain flares and end-of-dose failure adding to patient suffering and increased health care utilization. Shared decision-making (SDM), incorporating patient-stated preferences, goals, and concerns, can foster comprehensive pain assessment (CPA) and improve pain outcomes. Methods: This study will evaluate SDM and CPA in patients with cancer to manage chronic and breakthrough pain. Eligible patients have pain or are taking opioids to manage chronic cancer pain. Patients complete a tablet-based survey at enrollment to record baseline pain and activity levels, pain flare severity and length, end-of-dose pain, and SDM preferences. Results are presented on an electronic dashboard and the provider and patient collaboratively establish a pain care plan. The effectiveness of SDM on pain outcomes will be measured with the Pain Care Quality Survey. Results: Pain characterization is described for the first 43 patients enrolled, of which 42% (n=18) desire to share decision-making with the provider, while 35% (n=15) prefer to make the final decision after considering provider input. Patients are 57% (n=26) female with a mean age of 56 (range 20-93); baseline mean pain scores were 5.4, and overall distress scores were 5.43, (scale 0-10); 91% had a pain flare in the last seven days with mean severity of 5.53; 72% of flares lasted longer than 30 minutes. All patients had end-of-dose pain. Less than half (42%) have restricted activity and 23% manage self-care but cannot work. Participants reported incident pain associated with certain activity (63%) as well as insidious pain not associated with activity (65%). Enrolled patients selected 143 pain descriptors: burning (16), achy (24), sharp and stabbing (21), pins and needles (15), cramping (14) radiating (14), intermittent (19), and continuous (20). Conclusions: The majority (77%) of patients desire SDM. Although most patients were already taking opioids at presentation, they had moderate pain and distress, frequent flares and end of dose pain, and limitations on activity level due to the pain. Baseline pain characterization with a drill down CPA offers opportunity to use SDM to develop effective pain care plans and measure outcomes. Clinical trial information: NCT03304145.
Impact of a patient and family meeting program for patients with metastatic genitourinary cancer receiving treatment in the ambulatory care setting.
Authors: Ochoa Michele Stayer , Mooney Stefanie , Bergerot Cristiane Decat , Burns Kathleen , Zachariah Finly , Sidhu Rupinder Kaur , Prudhomme-Hunter Jill , Garcia Nellie , Buga Sorin , Dale William , Loscalzo Matthew J. , Pal Sumanta K.
Published: November 2018

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Background: Palliative care in the ICU is recognized as a vital aspect of care delivery but less evidence exists regarding utilization in ambulatory care. Family meetings are considered a relevant strategy to discuss concerns around patients’ illness and treatment. This pilot study sought to describe preliminary results of the Patient and Family Meeting Program (FMP) implemented in October, 2017 in a genitourinary oncologic clinic. Methods: FMP is offered for high-risk patients with ≤ two year prognosis. Program includes: (1) patient identification, (2) orientation, (3) family meeting, and (4) post-meeting follow-up. After identification, social worker orients the patient/family, addresses advance directives, and assesses values regarding care. During the meeting, social worker introduces and elicits understanding of medical situation, physician provides medical information and recommendations, and social worker assists reconciling medical recommendations with patient values. During follow-up, educational materials are provided, referrals are made as indicated, and follow-up meetings are held by request. Results: 51 patients were identified. Most of them were male (69%) with a median age of 68 years, and diagnosed with renal cell carcinoma (47%), prostate cancer (27%), or urothelial cancer (26%). 48 orientations were conducted, and 18 family meetings were held. Hospice was recommended to 16 patients, and 69% were admitted. 6 cases were referred to supportive medicine. Oncologists spent on average 21 minutes with each family. In the inpatient setting, 3 family meetings were requested; all patients were referred to hospice, and 2 were enrolled. Conclusions: Findings indicate the feasibility/benefit of FMP; a high prevalence of patients were referred and enrolled in hospice. Meetings require little extra time for the physician. Also, this program favored better integration between the health care team and patient/family. Results provide support for expanding this program to other specialties. Extending the value of family meetings in ambulatory care is a unique opportunity to enhance essential psychosocial support to oncology patients with greatest need.