bluuebunny/crossref_metadata_2025_split huggingface dataset:
Functional impairment on admission and associated symptom burden and health outcomes among hospitalized patients with advanced cancer.
Authors: Lage Daniel E , El-Jawahri Areej , Fuh Charn-Xin , Newcomb Richard , Jackson Vicki , Greer Joseph , Temel Jennifer S. , Nipp Ryan David 
Published: March 2020

11554 Background: Hospitalized patients with cancer often have impaired function, as measured by activities of daily living (ADLs), related to age, comorbidities, and both cancer and treatment-related morbidity. However, the relationship between functional impairment and patients’ symptom burden and clinical outcomes has not been well described. Methods: We prospectively enrolled patients with advanced cancer with unplanned hospitalizations at an academic medical center. Upon admission, nurses assessed patients’ ADLs (mobility, feeding, bathing, dressing, and grooming). We used the Edmonton Symptom Assessment Scale (ESAS) and Patient Health Questionnaire-4 to assess physical and psychological symptoms, comparing symptom burden between patients with and without ADL impairment. We used regression models adjusted for age, sex, education, Charlson comorbidity index, months since advanced cancer diagnosis, and cancer type to assess the relationship between any ADL impairment on admission and hospital length of stay, the composite outcome of death or readmission within 90 days of discharge, and survival. Results: Among 932 patients, 40.2% had at least one ADL impairment. Patients with ADL impairment were older (Mean = 67.2 vs 60.8 years, p < 0.001), had higher Charlson comorbidity index (Mean = 1.1 vs 0.7, p < 0.001), and higher physical symptom burden (ESAS Physical Mean = 35.2 vs 30.9, p < 0.001). Those with ADL impairment were more likely to have moderate to severe constipation (46.7% vs. 36.0%, p < 0.01), pain (74.9% vs. 63.1%, p < 0.01), drowsiness (76.6% vs. 68.3%, p < 0.01), as well as symptoms of depression (38.3% vs. 23.6%, p < 0.01) and anxiety (35.9% vs. 22.4%, p < 0.01). In adjusted models, ADL impairment was associated with longer hospital length of stay (B = 1.30, p < 0.01), higher odds of death or readmission within 90 days (odds ratio = 2.26, p < 0.01), and higher mortality (hazard ratio = 1.73, p < 0.01). Conclusions: Hospitalized patients with advanced cancer who have functional impairment experience a significantly higher symptom burden and worse health outcomes compared to those without functional impairment. These findings highlight the need to assess and address functional impairment among this population to enhance their quality of life and care.
Analysis of financial sustainability of survivorship clinics led by advanced practice providers.
Authors: Rodriguez Maria Alma , Palos Guadalupe R. , Gilmore Katherine Ramsey , Lewis-Patterson Paula A. , Chapman Patricia , Bi Weiqi 
Published: March 2020

11560 Background: Disease specific Survivorship Care Clinics (SCs) have been established within a comprehensive cancer center. Clinics are staffed by Advanced Practice Providers (APPs), Physician Assistants and Advanced Practice Registered Nurses, with experience in the management of each disease type. To determine the sustainability of this model of survivorship care, we analyzed the professional fees’ revenue generated by APPs’ billings for 6 clinics and then compared the APPs’ salaries across all clinics. Methods: A retrospective analysis was conducted of 6 survivorship clinic’s patient volumes and clinic days supported by APPs from 9/1/16-4/30/17. The full FTE salary of the APPs, including benefits were prorated to the time dedicated to each of the SCs. Institutional financial data was used to align professional fees to actual reimbursements received. Salary recovery percentage was calculated as the ratio of reimbursement received to prorated FTE salary. Results: Table shows variation in APPs’ salary commensurate to FTE proportion. Results also indicate there was an average of 99% professional fee recovery. Clinics with an FTE proportion > 0.5 had recovery higher than the anticipated prorated salary, suggesting there is a threshold to maximize efficacy and sustainability. Conclusions: APPs professional fees for care provided to cancer survivors are reimbursable, across disease types or payers, and proportionally supports their salaries. Our findings suggest delivery models based on APPs to manage care of long-term survivors can be self-supporting.[Table: see text]
Return to work after breast cancer: Comprehensive longitudinal analyses of its determinants.
Authors: Dumas Agnes , Luis Ines Maria Vaz Duarte , Bovagnet Thomas , Di Meglio Antonio , El-Mouhebb Mayssam , Pinto Sandrine , Charles Cecile , Dauchy Sarah , Coutant Charles , Cottu Paul H. , Lesur Anne , Lerebours Florence , Tredan Olivier , Vanlemmens Laurence , Levy Christelle , Lemonnier Jerome , Mesleard Christel , Arveux Patrick , Andre Fabrice , Menvielle Gwenn 
Published: March 2020

11564 Background: The interplay between breast cancer (BC) late effects, psychosocial and work-related factors in return to work (RTW) is not well understood. Previous reports were retrospective and did not combine all these features. Methods: We used data of a French prospective cohort study (CANTO, NCT01993498) of stage I-III BC patients (pts) including detailed clinical data of 1,874 pts working at diagnosis (dx) and ≥5 years younger than legal retirement age. The outcome was non-RTW 2 years after dx. Multivariable regressions were conducted to identify correlates of non-RTW. First, we examined the independent effect of treatments, toxicities (Common Toxicity Criteria Adverse Events), and patient reported outcomes (EORTC BR23 and FA12; Hospital Anxiety and Depression Scale) collected shortly after end of primary treatment. Then, in a restricted sample of 1,003 pts with working conditions (WC) information available, we fitted models to account for detailed pre-dx WC including type of contract, working hours, strenuous postures, supportive environment, degree of autonomy and perception of work. All models were adjusted for age, stage, marital status, socioeconomic status and comorbidities. Results: Two years after dx, 21% of pts did not work. Adjusted odds of non-RTW were increased among pts treated with combinations of chemotherapy (CT) and trastuzumab (TR) (e.g. OR of CT-TR = 2.20 [95% CI 1.24-3.88] and OR of CT-TR-hormonotherapy (HT) = 1.72 [1.13-2.63] vs. treated only with CT-HT), who had severe arm morbidity (OR = 1.73 [1.27-2.36] vs. no), severe emotional fatigue (OR = 1.55 [1.03-2.32] vs. no), anxiety (OR = 1.51 [1.02-2.23] vs. no), or depression (OR = 2.23 [1.27-3.94] vs no). In addition, we also found that the odds of non-RTW were increased among pts who had shift working hours (OR = 2.23 [1.32-3.76] vs. no), who did not work in a supportive environment before dx (OR = 2.24 [1.44-3.50] vs. supportive) and who perceived their job as boring (OR = 3.57 [1.71-7.46] vs. not boring). Conclusions: More than 1/5 of pts did not RTW 2 years after dx, with treatment (trastuzumab), clinical, psychological and work-related factors being associated with job reintegration. Multidisciplinary strategies are needed to support BC survivors.
Growth of palliative care (PC) in United States cancer centers: A national survey.
Authors: Hui David , De La Rosa Allison , Chen Joseph , Delgado-Guay Marvin , Heung Yvonne , Liu Diane D. , Hess Kenneth R. , Bruera Eduardo 
Published: March 2020

11601 Background: Outpatient PC facilitates timely referral and improved outcomes for cancer patients. We examined the change in outpatient PC services at US cancer centers over the past decade. Methods: Between April and August 2018, we surveyed all 62 National Cancer Institute designated cancer centers (NCI-CCs) and a random sample of 61 out of 1306 non-NCI-CCs. Two surveys previously used in a national study (Hui et al. JAMA 2010) were sent to each institution: a 22-question executive survey inquired about PC infrastructure and attitudes toward PC and an 82-question PC program leader survey inquired about the PC structures, processes and outcomes in detail. Generalized linear mixed model and logistic regression were used to examine the change in availability of outpatient PC services between 2009 and 2018 among NCI-CCs and non-NCI-CCs, respectively. Results: Among NCI-CCs, 40/62 (65%) executives and 52/61 (85%) program leaders responded. Among non-NCI-CCs, 41/61 (67%) executives and 27/39 (69%) program leaders responded. For NCI-CCs, we observed a significant increase in outpatient PC clinic between 2009 and 2018 (59% v. 95%; OR 13.1, 95% CI 2.6-66.8; P = 0.004) but no significant change in inpatient consultation team (92% v. 90%), PC unit (26% v. 40), nor institute-run hospice (31% v. 18%). For non-NCI-CCs, there was a significant increase in outpatient PC clinics (22% v. 42%; OR 2.51, 95% CI 1.01, 6.26; P = 0.05) and decrease in institute-run hospice (42% v. 22%; P = 0.05) over the past decade but no significant change in inpatient consultation team (56% v. 68%) and PC unit (20% v. 17%). The median (IQR) duration from outpatient referral to death increased from 90 (84, 120) days to 180 (131, 220) days for NCI-CCs and from 41 (28, 54) days to 84 (48, 120) days for non-NCI-CCs, respectively. We also observed significant growth in staffing, service hours, number of referrals, fellowship programs and rotations for oncology fellows, although research activity remains low. Conclusions: Cancer centers reported significant growth in outpatient PC clinics and overall PC infrastructure since 2009. However, major gaps in structures and processes exist, such as the lack of outpatient clinics at non-NCI-CCs, absence of PC units and limited research.
The development of a nomogram to determine the risk for inappropriate opioid use in cancer patients.
Authors: Yennu Sriram J. , Dev Rony , Edwards Tonya , Arthur Joseph Anthony , Lu Zhanni , Erdogan Elif , Malik Jimi S. , Naqvi Syed M. , Wu Jimin , Liu Diane D. , Williams Janet L. , Hui David , Reddy Suresh , Bruera Eduardo 
Published: March 2020

11602 Background: Non-Medical opioid use is a growing crisis. Cancer patients at risk of harmful use of prescribed opioids are frequently underdiagnosed. The aim was to develop a nomogram to predict the probability of occurrence of Inappropriate opioid use that is, presence of SOAPP ≥ 7) among patients receiving outpatient supportive care consultation at a comprehensive cancer center. Methods: 3588 consecutive cancer patients referred to a supportive care clinic from March 1, 2016 to July 15, 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 with spiritual pain and financial distress (ESAS-FS), MEDD (morphine equivalent daily dose), SOAPP-14 (validated questionnaire for assessment of risk of inappropriate opioid use, and CAGE-AID (screening questionnaire for alcoholism/substance use disorder). Patients at with SOAPP+ were defined by SOAPP score ≥7. A nomogram was devised based on the risk factors determined in the multivariate logistic regression model and it can be used to estimate the probability of inappropriate opioid use. Results: Median age was 62yrs. Median ESAS pain item score on consultation was 5, Median ECOG was 2.20.4% were SOAPP+ and 10.1% were CAGE-AID+. SOAPP+ was significantly associated with gender, race, marital status, smoking status, depression, anxiety, financial distress, MEDD and CAGE score. The C-index is 0.8(CI 0.78, 0.82). A nomogram was developed. For example, for a male Hispanic patient, who is married, never smoked, with the following ESAS scores: (depression = 3, anxiety = 3, financial distress = 8), CAGE score of 0, and MEDD of 20, the total score is 9+9+0+0+6+10+26+0+1 = 61. In the nomogram a score of 58 indicates the probability of inappropriate opioid use being 0.1 and a score of 88 indicates the probability of 0.2. Based on the patient’s total score of 61, the probability of his aberrant behavior is between 10% to 20% (close to 10%). Conclusions: A nomogram can predict the risk of inappropriate opioid use in cancer patients.
Effect on pain outcomes in patients treated for painful bone metastases with biopolar RFA: The OPuS One study.
Authors: Bagla Sandeep , Levy Jason , Hopkins Thomas ,   OPuS One Study Investigators
Published: March 2020

11605 Background: To report the preliminary outcomes from the prospective, nonrandomized, multicenter study of the OsteoCool Radiofrequency Ablation system used for the palliative treatment of patients with painful bone metastases (OPuS One Study). Methods: Subjects were prospectively enrolled (NCT03249584) from October 2017 through August 2018. Inclusion criteria were: 2 or less painful target sites involving the thoracolumbar spine, pelvis and/or sacrum, with a worst pain ≥4/10 measured by the Brief Pain Inventory (BPI) within the previous 24 hours. RFA was performed with the OsteoCool device (Medtronic) under imaging guidance and followed by cementoplasty at operator discretion. Subjects were evaluated prior to RFA, at discharge, 3 days, 1 week, and 1-, 3-, 6-, and 12-months. Demographics and disease characteristics were collected at baseline and outcomes were assessed using validated measures. Device-, procedure- and/or therapy-related adverse events (AEs) were collected. Results: At the time of the analysis, 37 subjects at 8 US centers underwent RFA. The mean age was 64 years (range 30-89) and 68% were female. Mean baseline BPI worst pain was 8.6. The most common histology was adenocarcinoma; breast (32%) and lung (24%) were reported as the most common primary cancer. Thirty-one subjects (84%) were treated for lesions involving the thoracolumbar spine, while 6 subjects (16%) were treated for lesions located the pelvis and/or sacrum. All RFA procedures were technically successful. Of the 14 subjects presenting at the 3-month visit, 93% did not undergo radiation therapy at the targeted site(s) between baseline and 3 months. Seventy-four percent (25/34) of subjects at 1 week and 93% (13/14) of subjects at 3 months reported a clinically significant change from baseline in worst pain of ≥ 2 points. One AE, drug hypersensitivity, resolved without intervention. All eleven deaths reported were attributed to the subjects underlying malignancy and not related to RFA. Conclusions: The preliminary results of the OPuS One study show rapid pain improvement at 1 week and sustained long-term relief through 3 months in patients with metastatic bone disease. Clinical trial information: NCT03249584.
Engaging care partners in breast cancer care and communication.
Authors: Aufill Jennifer , Wolff Jennifer L. , Echavarria Diane , Heughan JaAlah-Ai , Lee Kimberley T. , Bantug Elissa Thorner , Levy Howard , Dy Sydney M. , Wolff Antonio C. 
Published: March 2020

11614 Background: Family is often overlooked in cancer care. Little is known about the patient preferences for involving family in communication, whether preferences may be elicited and supported at the point of care, and impact on care quality. Methods: We conducted a two-group pilot randomized controlled trial (NCT03283553) of patients on active treatment for breast cancer and the “care partner” who accompanies them to routine visits (n = 132 dyads). Intervention dyads (n = 69) completed a self-administered checklist to clarify the care partner role, establish a shared visit agenda, and facilitate access to the electronic health record (MyChart) patient portal. Control dyads (n = 63) received usual care. Intervention acceptability and short-term effects were assessed from post-visit surveys and MyChart utilization at 6 weeks. Results: At baseline, most patients (89.4%) but few care partners (1.5%) were registered for MyChart. Most patients (79.4%) wanted their care partner to have access to their records and 39.4% of care partners reported accessing it in the past year using the patient’s account login/password. In completing the checklist, intervention patients and care partners identified an active communication role for the care partner and similar issues for the visit agenda: topics most frequently selected were treatment goals/expectations (75.4% & 66.7%, respectively), symptoms/side effects (73.9% & 62.3%) and chances of cancer recurrence/spread (49.3% & 44.9%). More than 90% of intervention participants reported that completing the checklist was easy, useful, and recommended it to others. At 6 weeks, intervention (vs control) care partners were more likely to be registered for MyChart (75.4 % vs 1.6%; p < 0.001), to have logged in (43.5% vs 0%; p < 0.001) and viewed clinical visit notes (30.4% vs 0%; p < 0.001), but no more likely to have exchanged direct messages with the clinical team (1.5% vs 0%; p = 0.175). No difference in patient MyChart registration, use, or messaging was found at 6 weeks, but intervention patients more often viewed clinical visit notes (50.7% vs 9.5%; p < 0.001). Conclusions: A self-administered patient-family communication intervention affected online practices of patients and cancer care partners. Follow-up continues. Clinical trial information: NCT03283553.
A randomized phase II trial of CX-01 with standard therapy in elderly patients with acute myeloid leukemia (AML).
Authors: Kovacsovics Tibor , Levy Moshe Yair , Cook Rachel J. , Kolitz Jonathan E. , Westervelt Peter , Donnellan William Bruce , Stuart Robert K. , Reagan John Leonard , Tsai Michaela L. , Wieduwilt Matthew Joseph , Maris Michael B. , Stevens Don A. , Yang Jay , Arana-Yi Cecilia , Safah Hana , Marcus Stephen Garrett , Shami Paul J. 
Published: March 2020

7001 Background: Elderly AML patients have poor outcomes irrespective of therapy. CX-01 is a low anticoagulant heparin derivative that retains heparin’s ability to alter the activity of the CXCL12/CXCR4 axis, P-selectin, extracellular histones, and Platelet Factor 4. A pilot study of CX-01 combined with standard therapy for AML led to a complete remission (CR) rate of 92% ( Blood Adv 2:381, 2018). We conducted a randomized, dose-finding study of the same combination in newly diagnosed elderly AML patients. Methods: 76 fit patients older than 59 were randomized to induction with idarubicin and cytarabine on a 7+3 schedule only (Group 1); 7+3 with a lower dose of CX-01 (0.125 mg/kg/hour) (Group 2); or 7+3 with a higher dose of CX-01 (0.25 mg/kg/hour) (Group 3). Patients in CR received consolidation therapy consisting of up to 3 cycles of intermediate dose cytarabine (1000 mg/m2 every 12 hours on Days 1, 3, 5) without or with the same dose of CX-01 for Groups 1, 2, and 3, respectively. CX-01 was given as a continuous infusion after a 4 mg/kg bolus until completion of chemotherapy. Results: 66 of 75 treated patients were evaluable for response. Ten patients were not evaluable due to withdrawal of consent (6 patients), introduction of midostaurin after its approval (3 patients), or death due to hepatic sinusoidal obstructive disease at Day 21 (1 patient in Group 2). We present results for evaluable patients and not on an intent to treat basis. Baseline characteristics were similar across groups. The composite CR rate (CR + CRi) was highest for patients in Group 3 with 89% patients achieving a composite CR as compared to 58% and 50% in Groups 1 and 2, respectively. Kaplan-Meier curves indicated a statistically significant improvement in event free survival (EFS) (P = 0.019) and a non-significant trend (P = 0.10) to improvement in OS in Group 3 as compared to Group 1. Groups 1 and 2 were comparable for EFS and OS. CX-01 was well tolerated without increased incidence of bleeding in Groups 2 and 3. Conclusions: The encouraging CR rate and EFS in elderly fit patients with newly diagnosed AML suggests that CX-01 may potentiate the efficacy of standard AML induction therapy. A randomized study to confirm these findings with the higher dose of CX-01 is warranted. Clinical trial information: NCT02873338.
Randomized phase II study of cladribine with simultaneous or delayed rituximab in patients with untreated hairy cell leukemia.
Authors: Chihara Dai , Arons Evgeny , Stetler-Stevenson Maryalice , Yuan Constance , Zhou Hong , Raffeld Mark , Xi Liqiang , Steinberg Seth M. , Wisch Laura , Feurtado Julie , James-Echenique Lacey , Braylan Raul , Calvo Katherine R. , Maric Irina , Dulau Alina , Kreitman Robert J. 
Published: March 2020

7003 Background: Single-agent purine analog therapy, usually cladribine, has been the standard 1st-line therapy of hairy cell leukemia (HCL) for ~30 years. Relapse is attributed to minimal residual disease (MRD) persisting despite complete remission (CR). Rituximab can clear MRD, but there are no long-term data for how frequently and for how long this happens, or even how frequently MRD remains after cladribine. We therefore conducted a randomized phase II trial of 1st-line cladribine with concurrent vs delayed rituximab. Methods: The primary endpoint was to determine if 8 weekly doses of rituximab (375 mg/m2 iv) begun the same day as 5 daily doses of cladribine (0.15 mg/kg iv) reduce HCL MRD 6 months later compared to cladribine alone. Secondary endpoints included testing delayed rituximab, 8 weekly doses beginning if/when MRD is detected in blood (or if HCL-related cytopenias persist preventing consideration of CR) ≥ 6 months after cladribine. Both groups could receive a 2nd course of rituximab if the same situation recurred ≥ 6 months after starting the 1st course of rituximab. MRD was assessed in blood (PB) and bone marrow (BM) using flow cytometry (FC), consensus PCR, and immunohistochemistry. Results: Sixty-eight patients were randomized 1:1 to concurrent vs delayed arms. At 6 months after cladribine, 97% concurrent vs 24% delayed (p < 0.0001) patients were MRD-free by all tests. 100% concurrent vs 41% delayed patients were MRD-free by all tests except BMA FC (p < 0.0001). At a median follow-up of 87.3 months, delayed rituximab was required by 1 concurrent patient vs 27 courses in 21 delayed patients. MRD-free survival after 1st rituximab was not reached for 34 patients after concurrent rituximab, with 32 still MRD-free after a median of 72 months (94% MRD-free survival), compared to median MRD-free survival 60.1 months after delayed rituximab, with 10 (48%) of 21 remaining MRD-free (p < 0.0001, hazard ratio for concurrent rituximab 0.09). Conclusions: Achievement of MRD-free CR after 1st line cladribine for HCL is greatly enhanced by concurrent rituximab. Use of delayed rather than concurrent rituximab could achieve MRD-free CR but durability was clearly inferior to concurrent rituximab. Longer follow-up will determine if MRD-free survival leads to cures of HCL, increased CR duration, and/or less need for additional therapy. Clinical trial information: NCT00923013.