bluuebunny/crossref_metadata_2025_split huggingface dataset:
Correlation of psychological distress with quality of life and efficacy of immune checkpoint inhibitors in patients with newly diagnosed stage IIIB-IV NSCLC.
Authors: Wu Fang , Hu Chunhong , Li Yizheng , Zeng Yue , Liu Junqi , Liu Xiaohan , Ma Fang , Qiu Zhenhua , Deng Chao 
Published: June 2022

12001 Background: Psychological distress is common among cancer patients and leads to activation of the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system (SNS) and continuous production of distress hormones, which may contribute to a highly immunosuppressive tumor microenvironment (TME). Meanwhile, preclinical studies have shown that psychological distress could undermine cancer therapies. Therefore, we investigate the prevalence of psychological distress in non-small-cell lung cancer (NSCLC) patients, identify its impact on quality of life (QoL) and efficacy of immune checkpoint inhibitors (ICIs), and explore the possible neuro-endocrinological mechanisms. Methods: Patients with newly diagnosed stage ⅢB-Ⅳ NSCLC received ICIs as first-line treatment were included. The assessments of psychological distress including depression and anxiety symptoms were measured using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), respectively. The QoL was measured by Short Form Health Survey 36 (SF-36). Stress hormones including serum cortisol, adrenocorticotropic hormone (ACTH), plasma epinephrine (Epi), and norepinephrine (NE) were determined by ELISA kit before treatment. Objective response rates (ORR) and Median progression-free (PFS) were estimated using the Chi-square test, Kaplan-Meier, and Cox regression method. Results: 77 NSCLC patients with a mean age of 60.9 years were enrolled. Stage distribution included 50 (64.9%) stage ⅢB/C and 27 (35.1%) stage Ⅳ. 44(57.1%) patients were present psychological distress. Psychological distress was associated with poorer QoL (P<0.001). The median follow-up time was 16.2 months. Compared with non-psychological distress patients, psychological distress patients had a significant lower ORR (35.9% vs 63.64%; P=0.033) and shorter PFS (median 12.63 vs 14.60 months; 95% CI: 0.36 to 1.98; P=0.026). Moreover, psychological distress was the only independent predictor for PFS (HR:2.71, 95%CI: 1.06～6.90; P=0.037) in multivariate Cox regression analyses. The patients with psychological distress had higher levels of serum cortisol ( P=0.040) and plasma Epi ( P=0.023). Additionally, the serum cortisol ( P=0.043) and plasma Epi ( P=0.025) concentrations were associated with inferior ICIs response. Conclusions: Psychological distress is common within stage ⅢB-Ⅳ NSCLC patients. Patients with psychological distress are associated with worse QoL and inferior outcomes to ICIs and discover the potential mechanisms of neuro-endocrinological hormones in resistance to ICIs therapy.
Open-labeled placebo for the treatment of cancer-related-fatigue in patients with advanced cancer: Results of a randomized controlled trial.
Authors: Yennu Sriram , Azhar Ahsan , Lu Zhanni , Rodriguez Ashley , Arechiga Adrienne , Guerra-Sanchez Maria , Stanton Penny A , Andersen Clark , Urbauer Diana L. , Bruera Eduardo 
Published: June 2022

12006 Background: Despite the high frequency of cancer related fatigue (CRF) in patients with advanced cancer (PAdC), there are no effective pharmacological treatments. Our group previously found that the placebo response was 56% among PAdC participating in CRF trials. There are no clinical trials using open label placebo for CRF in PAdC. The purpose of this study was to determine the effects of open labeled placebo (OLP) compared to waitlist control (WLC) in reducing CRF in PAdC using Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F). Methods: In this randomized controlled trial, PAdC with fatigue ≥ 4/10 on ESAS were randomized to OLP one tablet twice a day or WLC for seven days (primary end point). After week 1 in patients of both arms received placebo for 3 weeks. Changes in FACIT-F from baseline to Day 8 (primary outcome), and changes after 21 days of placebo in both arms were assessed. Secondary outcomes included quality of life (QOL)[FACT-G], fatigue dimensions(MFSI-SF), depression(CES-D), and Fatigue cluster(ESAS fatigue, pain, and depression). Results: 82/90(91%) patients were evaluable. The adherence to placebo [mean%(SD)], was 93.6(18.6), and 88.1(20.2) at Day 8 and Day 29 respectively in OLP arm, and 89.9 (73) at Day 29 in WLC arm. The mean(SD) FACIT-F change at day 8 was 6.6 (7.6) after OLP, 2.1 (9.4) after WLC (p = 0.016). On days 15 and 29, when all patients received OLP, there was significant improvement of CRF but not difference between arms. FACT-G Total Score, FACT-G EWB, ESAS Fatigue, and Fatigue cluster score, all showed significant evidence of reduced CRF in the OLP arm on Day 8 of the study (p = 0.002, 0.030, 0.029, and 0.044, respectively). There was no significant difference in adverse events between the two groups. Conclusions: Open labeled placebo was efficacious in reducing CRF, fatigue cluster, and QOL in fatigued advanced cancer patients at the end of one week. The improvement in fatigue was maintained for 4 weeks. Further studies of this intervention are justified. Clinical trial information: NCT03927885.
Strategies for implementing an ePRO-based symptom management program (eSyM) across six cancer centers.
Authors: Hassett Michael J. , Cronin Christine , McCleary Nadine Jackson , Bian Jessica J , Wong Sandra L. , Hazard-Jenkins Hannah W. , Dias Samira , Johnson Julie , Schrag Deborah , Dizon Don S. , Osarogiagbon Raymond U. ,   eSyM Project Managers Author Group
Published: June 2022

12017 Background: Electronic patient-reported outcome (ePRO)-based symptom management can improve cancer care outcomes. However, implementation is challenging as it requires 1) tremendous technical resources to integrate ePROs into the electronic health record (EHR), 2) substantial buy-in from clinicians and patients, 3) between visit symptom management, and 4) institutional investment to support engagement. Methods: The SIMPRO Consortium developed and deployed eSyM, an EHR-integrated ePRO-based symptom management program for medical oncology and surgery patients, at 6 cancer centers between September 2019-March 2022. Site teams document new and changes to implementation strategies monthly using REDCap (data collection is ongoing). Strategies are itemized using the Expert Recommendations for Implementation Change (ERIC) list and mapped to the Consolidated Framework for Implementation Research (CFIR) list of barriers. The SIMPRO Coordinating Center (Dana-Farber) reviews all ERIC-CFIR classifications for consistency. Results: To date, 162 distinct strategies have been documented. On average, sites have implemented 23 strategies, 5 preparing for go-live and 18 remaining active beyond go-live. Preparation of clinical staff, training, and routine program evaluation are consistent high impact strategies. Other adaptive strategies have varied across sites, including various approaches to patient and provider engagement. Foundational strategies have been deployed by the coordinating center to support the multi-center initiative. Conclusions: Methodical deployment using theory-based implementation strategies may foster adoption of novel health care delivery systems by patients, clinicians, and institutions. Attention to the specific high-value strategies identified by the SIMPRO Consortium could support similar ePRO deployment at other institutions. [Table: see text]
Vitamin D insufficiency as a peripheral neuropathy risk factor in white and black patients in SWOG 0221.
Authors: Chen Ciao-Sin Chelsea , Zirpoli Gary , McCann Susan , Barlow William E. , Budd George Thomas , Pusztai Lajos , Hortobagyi Gabriel N. , Godwin Andrew K. , Thompson Alastair Mark , Ambrosone Christine B. , Stringer Kathleen A , Hertz Daniel Louis 
Published: June 2022

12023 Background: Peripheral neuropathy (PN) is a treatment-limiting toxicity of paclitaxel. Black patients have higher rates of PN and vitamin D insufficiency, and our prior work suggests vitamin D insufficiency increases risk of paclitaxel-induced PN. The objective of this study was to validate that patients with vitamin D insufficiency have higher risk of paclitaxel-induced PN and investigate whether this explains racial disparities in PN risk. Methods: This retrospective validation study was conducted in the phase III SWOG 0221 (NCT00070564) trial comparing paclitaxel-containing chemotherapy regimens for early-stage breast cancer. Pre-treatment 25-hydroxy-vitamin D was quantified in cryopreserved serum. Males and patients who received less than a third of the paclitaxel treatment were excluded. The association between vitamin D insufficiency (≤20 ng/mL) and grade 3+ sensory PN was tested via logistic regression and then adjusted for self-reported race, age, paclitaxel schedule (QW vs Q2W), and body mass index. Results: Of the 1,116 female patients in the analysis, 169 (15.1%) experienced PN and 376 (33.7%) had vitamin D insufficiency. Vitamin D insufficiency was associated with higher PN risk (19.4% vs 13.0%, OR = 1.62, p = 0.005, Data Table). The association was borderline significant (OR = 1.44, p = 0.056) after adjustment for black race (OR = 2.41, p = 0.001), paclitaxel schedule (OR = 2.22, p < 0.001), and age (OR = 1.03, p = 0.005). Compared with white patients (n = 943), black patients (n = 99) had more prevalent vitamin D insufficiency (77.8% vs 28.6%, OR = 8.72, p < 0.001) and increased PN risk (29.3% vs 13.5%, OR = 2.66, p < 0.001); adjusting for vitamin D insufficiency decreased but did not eliminate the higher PN risk in black patients (OR = 2.23, p = 0.002). Conclusions: Vitamin D insufficiency increases risk of paclitaxel-induced PN and partially explains the higher risk of PN in black patients. Prospective trials are needed to test whether vitamin D supplementation lessens PN and reduces disparities in treatment outcomes. [Table: see text]
The impact of primary palliative care on advance care planning in advanced cancer.
Authors: Cohen Michael , Althouse Andrew , Chu Edward , Resick Judith , Rosenzweig Margaret Q. , Smith Kenneth , White Douglas B. , Schenker Yael 
Published: June 2022

12030 Background: Palliative care specialists are experts in conducting advance care planning (ACP), but are a limited resource. We sought to determine the impact of a nurse-led primary palliative care intervention on ACP completion among patients with advanced cancer. Methods: We performed a secondary analysis of a cluster randomized controlled trial looking at the impact of nurse-based primary palliative care at community cancer centers. In the parent trial, patients with advanced cancer received either monthly primary palliative care visits with trained nurses within their cancer center or usual care. Nurses in the intervention arm received special training in addressing symptom management and ACP. ACP uptake was assessed at enrollment and 3 months later via validated questionnaire in the forms of an end-of-life conversation (EOLC) with one’s oncologist or completion of an advance directive (AD). The present analyses were restricted to patients without ACP at baseline. Multivariable logistic regression tested differences in ACP uptake by treatment arm when adjusting for age, religious importance, education, time with current oncologist, and ECOG. Results: Of 672 patients enrolled, 182/336 in the intervention arm and 196/336 in usual care lacked an EOLC at baseline and completed three-month assessments. Of those, 82/182 (45.1%) in the intervention arm and 29/196 (14.8%) in the usual care arm reported having an EOLC at three months (Table). Similarly, 111/336 in the intervention arm and 105/336 in usual care lacked an AD at baseline and completed the three-month assessments. Of those, 48/111 (43.2%) in the intervention arm and 19/105 (18.1%) in usual care completed an AD over the study period (Table). For both types of ACP, the treatment effect suggested increased uptake of new ACP in the intervention arm after controlling for variables known to be associated with ACP (Table) Conclusions: Nurse-led primary palliative care increased the uptake of ACP among patients with advanced cancer. Training oncology nurses embedded within community cancer centers may represent a feasible mechanism to improve access to primary palliative care and uptake of advance care planning. Clinical trial information: NCT02712229. [Table: see text]
Quality of end-of-life care for patients with multiple myeloma: A 12-year analysis of a population-based cohort.
Authors: Mohyuddin Ghulam Rehman , Sinnarajah Aynharan , Gayowsky Anastasia , Chan Kelvin K. , Seow Hsien , Mian Hira 
Published: June 2022

12031 Background: Despite treatment advances, multiple myeloma (MM) remains a significant source of morbidity and mortality. The end of life for patients with MM has not previously been examined within the context of a population-based cohort in a publicly funded health system. Methods: We retrospectively analyzed patients with death attributable to MM between 2006-2018 using ICES linked databases in the public health care system in Ontario, Canada. Aggressive care was defined as two or more emergency department visits in the last 30 days before death, at least two new hospitalizations within 30 days of death, or an ICU admission within 30 days of death. Supportive care was defined as physician house call 2 weeks before death, or a palliative nursing or personal support visit at home in last 30 days before death. Multivariable logistic regression models were used to assess for factors predisposing to aggressive or supportive care. Patients were stratified based on receipt of autologous stem cell transplant (ASCT). Results: In total, 5095 patients were included (Table). Overall, 23.2% of patients received chemotherapy in last two weeks of life and 55.6% of patients died in the hospital. Most patients were admitted to hospital within the last 30 days of life (73.4%:ASCT cohort, 61.4%:non-ASCT cohort). A minority received aggressive care at end of life (28.3%:ASCT cohort, 20.4%:non-ASCT cohort), and a majority received supportive care at end of life (65.4%:ASCT cohort, 61.5%:non-ASCT cohort). Multivariate regression models showed that patients ≥ 80 years (compared to 60-69) were less likely to receive aggressive care (OR=0.54, 95% CI=0.42-0.68), and those with residence in smaller size community of < 10,000 were more likely to receive aggressive care (OR=1.89, 95% CI=1.5-2.4). Supportive care was significantly less likely to be received by patients (OR=0.72, 95% CI= 0.59 to 0.88) and more likely to be received by patients aged 18-49 (OR=1.9, 95% CI=1.2-3.1). Neighbourhoods with lowest income quintiles (OR=0.65, 95% CI=0.53-0.78) were less likely to receive supportive care. When trended over time, patients receiving supportive care at end of life increased (56.0% in 2006 to 70.3% in 2018). Conclusions: We demonstrate that despite improvements over time, a substantial number of patients with MM experience aggressive care and hospitalizations at the end of life. Despite this being a publicly funded system, disparities in end-of-life care based on age, income and area of residence are present.[Table: see text]
Nurse navigator–initiated geriatric assessments in hematology/oncology clinics.
Authors: Shaia John L. , Liu Raymond , Sun Hongxin , Kolevska Tatjana , Kotak Dinesh , Belohlav Kate , Williams Grant Richard , Arora Amit 
Published: June 2022

12051 Background: As the number of older adults with cancer continues to grow, there is an urgent and unmet need to implement geriatric assessments and toxicity screening tools (G8 and CARG toxicity tool) for patients 65 and older with a cancer diagnosis in real-world settings. Studies of these tools show completion rates of 20-35% when administered by a physician. To determine if nurse navigators could increase completion rates, we implemented a pilot in seven community cancer centers within an integrated health system. Methods: A pilot project of G8 and CARG toxicity tool implementation was completed at seven community cancer centers from May 1,2021 to December 31,2021 in patients age ≥ 65 years, with solid or malignant hematologic cancer diagnosis. G8 was administered at seven sites and CARG was assessed in addition to G8 on solid tumor patients undergoing chemotherapy at four of the seven sites. Referrals to nutrition, audiology, physical therapy, psychiatry, and neurology were sent by nurse navigators based on assessment results. Results: The total number of eligible patients for G8 was 1372, with 1082 (78.9 %) successfully completing assessment, and the total number of eligible patients for CARG toxicity tool was 563 with 516 (91.6%) successfully completing assessment. The median age of patients completing assessment was 74 years old (range 65-100) and 52% were female. The cohort included Asian / Pacific Islanders (23%), Black (15%), Hispanic White (8%), and Non-Hispanic Whites (51%). Most common cancers included genitourinary cancer (18%), breast cancer (17%), upper GI cancer (15%), and thoracic cancer (13%). The assessments resulted in referrals to multiple services including nutrition (193 referrals), audiology (30), physical therapy (18), psychiatry (5), and neurology (5). Conclusions: Nurse navigators can successfully implement G8 and CARG toxicity tool in hematology-oncology clinics in a broad range of cancer types at a high rate with resultant referrals to multiple supportive services in real-world settings.
Lymphedema therapy referral is associated with improved understanding of lymphedema prevention among breast cancer survivors.
Authors: Klugman Madelyn , Patil Sujata , Finik Jackie , Kuo Ting-Ting , Eberle Carolyn E. , Pinkhasov Alexandr M. , Gillis Theresa , Gany Francesca , Blinder Victoria Susana 
Published: June 2022

12069 Background: Lymphedema is common among breast cancer survivors (BCS) and negatively affects quality of life. There are modifiable factors to reduce lymphedema risk and exacerbation; it is unknown how aware survivors are of these factors. We hypothesized referral to lymphedema therapy (LT) to be associated with improved lymphedema knowledge. Methods: BCS were approached during follow-up visits at an NCI-designated cancer center between 2014-2015 and asked to complete an anonymous survey. Eligibility criteria: age ≥18, English-speaking, > 6 months post-surgery, no cancer recurrence, no prior or subsequent second cancer. Surveys included 10 true/false questions to assess beliefs of common lymphedema misconceptions and questions about sociodemographics, cancer treatment, and prior LT referral. Charts were reviewed to determine history of axillary lymph node dissection (ALND) or sentinel node biopsy (SLNB). Multivariable logistic regression assessed the relationship between prior LT referral and correctly answering questions about lymphedema misconceptions. Results: Of 209 participants, 67% identified as non-Latinx white, 13% Black, 10% Latinx and 8% Asian. 53 (25%) had been referred to LT. Those who had SLNB were less frequently referred to LT [15 (14%)] than those who had ALND [38 (39%)]. There were 5 lymphedema knowledge questions with < 80% correct responses (Table). Those previously referred to LT more often correctly answered the questions about weight gain and using the arm on an airplane than those not referred (chi-2: p <0.01 and p < 0.01), but they were less likely to answer correctly about carrying > 10 lbs or strenuous activity at work (p < 0.01 and p = 0.02, respectively) (Table). These associations remained in multivariable analyses, other than strenuous work activity (Table). Conclusions: We identified several misconceptions regarding lymphedema among BCS. LT referral is a potential opportunity to debunk common misunderstandings regarding lymphedema risk reduction; providers should have a low threshold to refer patients. Lymphedema therapists teach progressive exercise strategies, which may have inadvertently caused participants to think they should avoid carrying objects > 10 lbs.[Table: see text]
Time for paying attention to fluoropyrimidine-associated cardiotoxicity: A pooled data analysis for epidemiology based on 60537 cases.
Authors: Lu Yajie , Long Zuoyao , Pan Wei , Deng Shi-Zhou , Dou Qiong-Yi , Wang Xiang-Xu , Wang Zhen , Zhang Hong-Mei 
Published: June 2022

12071 Background: With the rise of cardio-oncology discipline, treatment-related cardiotoxicity has become a growing concern. However, fluoropyrimidine induced cardiotoxicity has been underestimated for a long time. The aim of this study was to comprehensively investigate the incidence and profiles of the cardiotoxicity associated with fluoropyrimidine using a pooled data meta-analysis. Methods: A systematic literature review was performed using PubMed, Embase, Medline, Web of Science, Cochrane library databases and clinical trials on studies published between the establishment of each database and March 31, 2021, investigating fluoropyrimidine associated cardiotoxicity (FAC). The main outcome was pooled incidence of FAC, and the secondary outcome were specific treatment-related cardiac AEs. Random-effects or fixed-effects modeling was used for analyses according to the heterogeneity assessed by Cochran’s Q test. Subgroup analysis and meta-regression were conducted to explore the source of heterogeneity, and the incidence of FAC was compared among different clinical characteristics. The protocol was registered in PROSPERO (No. CRD42021282155). Results: Two hundred and six studies involving 60537 patients were included in this meta-analysis, covering 31 countries or regions in the world. The pooled incidence of FAC was 5.18% (95% CI 4.32%-6.10%) for all grade and 1.5% (95% CI 1.09%-1.96%) for grade 3 or higher. A total of 0.29% of patients died from severe cardiotoxicity. Cardiac ischemia and arrhythmia were the two most common cardiac AEs, occurring in 2.31% (95% CI 1.70%-3.00%) and 1.69% (95% CI 1.08%-2.42%) of patients, respectively. ECG alterations occurred in 5.85% (95% CI 3.4%-8.9%) of patients, indicating asymptomatic ECG alterations in a subset of the population. The incidence of cardiotoxicity varied among different regions, gender, cancer types and treatment regimens. Studies conducted in Asia outlined a significant higher pooled incidence of FAC than in Europe (χ2 = 4.47, p = 0.03) and America (χ2 = 4.49, p = 0.03). Female population had a lower pooled incidence than general population (χ2 = 9.90, p= 0.01). The highest pooled incidence was observed in esophagus cancer (10.53%, 95% CI 5.8%-16.35%), and the lowest occurred in breast cancer (3.66%, 95% CI 2.4%-5.12%). In addition, combination therapy, high cumulative dose, anthracycline addition, and pre-existing cardiac disorder significantly increased the risk of FAC ( p< 0.05). No obvious publication bias was detected by funnel plots and Egger’s test (p < 0.05), and the stability of our results was confirmed by the sensitivity analysis. Conclusions: FAC is not a rare condition during treatment containing fluoropyrimidines. Our results provide comprehensive global data on epidemiology of FAC, potentially representing an important reference on cancer management in clinical practice.