bluuebunny/crossref_metadata_2025_split huggingface dataset:
Family building preferences among young women with invasive breast cancer.
Authors: Crown Angelena , Abdo Nadia , Noy Ariela , Chang Cassandra , Gemignani Mary , Goldfarb Shari Beth 
Published: May 2020

e24057 Background: The American Society of Clinical Oncology guidelines recommend discussing the possibility of infertility in cancer patients of childbearing age being treated with gonadotoxic therapies. This prospective study examines the reproductive history and future family building preferences of young women with breast cancer. Methods: This is an Institutional Review Board approved prospective study of women < 45 years of age with non-metastatic invasive breast cancer who completed a questionnaire on reproductive history and family building preferences between April 2013 and December 2019. Questionnaires were administered at initial diagnosis and then annually. Results: Baseline questionnaires were completed by 164 women with a median age of 39 years old (range 20-45); 110 (59%) completed the 1 year follow up survey. Clinicopathologic features and treatment are shown in the table. The majority of women (n = 90, 55%) were parous and many had previous infertility (n = 60, 37%) at time of diagnosis. Most women (n = 87, 53%) wanted additional children or were unsure. Interest in embryo and/or oocyte cryopreservation was common (n = 51, 31%) as was interest in adoption (n = 52, 32%). Of the 110 women who completed the one year follow-up, 39 (35%) saw a reproductive endocrinologist, including 22 (20%) who elected embryo (n = 14) or oocyte (n = 8) cryopreservation. Overall, 88 (80%) women declined fertility preservation. The most common reasons included worrying about delay in cancer treatment (n = 10, 9%), fear of hormonal exposure (n = 7, 6%), and feeling rushed into making a decision (n = 6, 6%). Of 92 women with available data regarding satisfaction with their decision to pursue fertility preservation or not, 84% (n = 77) reported satisfaction whereas 14% (n = 15) reported mixed feelings or regret. Conclusions: Young women with breast cancer expressed a significant interest in family building options. However, pursuit of fertility preservation was uncommon despite a high rate of prior infertility in this cohort of mostly parous women. Decisional satisfaction was common. Further study of factors contributing to patient decision-making regarding fertility preservation and alternative family building options is warranted. Clinical trial information: NCT01788839 . [Table: see text]
Resilience and cognitive symptoms in cancer: An exploratory study.
Authors: Parsons Michael W. , Traeger Lara , Perez Giselle Katiria , Hirschberg April , Park Elyse R. 
Published: May 2020

e24079 Background: One of the most common concerns of cancer survivors is cancer-related cognitive impairment (CRCI), which affects an individual’s ability to return to work, school, or other life activities. The etiology of CRCI is poorly understood. Numerous studies have demonstrated a relationship between emotional distress and cognitive dysfunction, though the core psychological construct underlying this relationship has been elusive. Resilience, defined as the ability to function well despite adversity, reflects individual capacity to manage stress and reduce allostatic load. We hypothesized that low resilience contributes to stress-related cognitive symptoms in cancer survivors, and that improvement in resilience through the Relaxation Response Resiliency Program (3RP), a psychotherapy group that reduces emotional distress, would reduce cognitive symptoms in cancer survivors. Methods: Consistent with prior protocols, adult cancer survivors participated in the 3RP program, a 9-week resiliency mind-body group treatment led by psychologists and/or psychiatrists. Survivors completed measures of cognitive symptoms (Patient Reported Outcome Measure Information System – Cognitive function; PROMIS-Cog) and resilience (Current Experiences Scale; CES) before and after treatment. Pearson correlations evaluated relationships between resilience and cognition. Results: 46 cancer survivors (mean age = 57, 85% female, 94% White, 4% Asian, 2% Black) completed \ CES and PROMIS-Cog at therapy intake, with 41% of subjects reporting significant cognitive impairment at baseline (defined as scores of < 1.0 SD on PROMIS-Cog). There was a significant correlation between these two scales prior to treatment (r = 0.33; p = 0.025), indicating that subjects with lower resilience reported poorer cognition. Thus far, 13 survivors have completed the 8-week therapy program, with 46% of these patients reporting significant cognitive difficulties. The post-treatment correlation between resilience and cognition was nonsignificant (r = 0.19;p = ns). Treatment effects were operationalized by change scores (follow up – baseline) for CES and PROMIS-Cog. The relationship between CES and PROMIS-Cog change scores was positive but not significant with the small sample size (r = 0.35; p = 0.028). Conclusions: This preliminary study suggests that there is a relationship between resilience and cognition in cancer survivors. Improvements in resilience through the 3RP treatment may reduce cognitive symptoms, though further work is needed to determine the significance of this effect.
With a little help from my friends: A multi-disciplinary approach to cancer survivorship.
Authors: Capozza Scott , Harrigan Maura , Brita Javin , Khairallah Angela , Sanft Tara B. 
Published: May 2020

e24082 Background: Long term cancer survivorship care is an integral part of the overall arc of oncology care. There is currently no standard of care for survivorship care beyond dissemination of a Survivorship Care Plan and data evaluating current models is limited. Furthermore, the most current Commission on Cancer recommendations suggest that a multi-disciplinary approach to cancer survivorship will best address the late and long-term side effects that survivors experience1. Methods: A multi-disciplinary adult cancer survivorship clinic at Yale Cancer Center and Yale New Haven Hospital was established in October 2006. This clinic is overseen by a medical oncologist and features the medical expertise of four distinct providers: an advance practice practitioner (such as an APRN or PA), a licensed clinical social worker, an oncology board-certified registered dietitian and an oncology board-certified physical therapist. Survivors meet with each provider for 30 minutes. A follow-up visit is scheduled 2-3 months later to assess the interventions discussed at the first visit and make modifications as necessary. This comprehensive approach allows the providers to address a wide array of late and long-term side effects from cancer treatment, including fear of recurrence, cancer related fatigue and weight management. Beginning with evidence-based research in their respective fields, each provider can create an individualized plan to address these concerns. Results: The National Comprehensive Cancer Network's Distress Thermometer demonstrated an almost 75% decrease in distress in cancer survivors pre- to post initial visit (n = 1,116 patients). Additionally, cancer-related fatigue, as measured by the MD Anderson Brief Fatigue Inventory, decreased by almost 50% from first to second visit (n = 313 patients). Conclusions: This poster is the first to demonstrate the feasibility of implementing a multi-disciplinary cancer survivorship clinic to address the late and long-term side effects of cancer survivors. Further research evaluating the correlation between improved access to long term survivorship care, as well as the health care providers required to provide optimal care in this setting, is needed. 1. American College of Surgeons Comminssion on Cancer, https://www.facs.org/-/media/files/quality-programs/cancer/coc/optimal_resources_for_cancer_care_2020_standards.ashx . Accessed February 10th, 2020.
Cancer-related fatigue (CRF) in breast cancer survivors after treatment: A focus on physical condition.
Authors: Ruiz-Casado Ana , Maximiano Constanza , Mendez Miriam , Alvarez-Bustos Alejandro , De Pedro Cristina G , Mendez Marta , Romero-Elias María , Cebolla Hector , Ramos Javier , Osorio Pablo , Fiuza-Luces Carmen , Nuñez García Beatriz , Cantos Blanca 
Published: May 2020

e24087 Background: Fatigue is one of the most distressing symptoms among breast cancer survivors (BCS) after finishing their treatment. Besides cancer-related factors, fatigue may be influenced by socio-demographic, physical, medical, psychological and behavioural variables. Exercise is recommended to manage CRF. Methods: PH-UEM02 and PH-UEM06 were prospective observational studies in BCS after finishing their treatments. Fatigue was evaluated through the Perform Questionnaire (12-60, being 60 no fatigue). Anthropometry, physical condition (PC) and physical activity (PA) were objectively evaluated. One-mile walk test (MWT), handgrip and sit to stand were used to assess PC. PA was measured by using accelerometers. Clinical data (treatments) were obtained from the clinical record. Socio-economic, diet (PREDIMED questionnaire) and QoL (EORTC QLQ-C30) were reported by BCS. Results: 201 BCS were recruited (age 51±9, BMI 25.9±4, median time from diagnosis 22 months). 73% had been treated with chemo, 66% anthracyclines, 20% trastuzumab, 66% radiotherapy, 81% hormone (24% aromatase inhibitors). Mean PERFORM score (45.6/60). Adherence to Mediterranean diet (9.1/14). EORTC Global score (68.9/100). No association with age, socio-economic or marital status, previous chemo, anthracyclines or radiotherapy, WPA, estimated VO2max, handgrip, sit to stand or PREDIMED score was found. Weight, trastuzumab and MWT time were positively associated with fatigue (<.05). Time from diagnosis, basal and recovery heart rate, global QOL-EORTC were negatively associated. An interesting negative association with nut intake was found (<.05). 42% had a fatigue score (< 45) associated with QOL scores under the normative values for the Spanish population. Conclusions: 1. Prevalence of significant CRF in mid-term BCS is around 40%. Weight was a positive predictor. CRF diminishes along the time and has a strong impact on QoL. 2. Regarding PC/PA, only the time spent in MWT predicted fatigue. Neither WPA, estimated VO2MAX or muscular strength were associated with fatigue. 3. Regarding previous treatments, only trastuzumab was associated with CRF. 4. Interestingly heart rate (both basal and recovery) and nut intake were strongly associated with CRF. 5. More research is warranted in heart rate variability and potential related biomarkers. [Table: see text]
Trastuzumab-induced cardiotoxicity and hypertension among racially and ethnically diverse patients with HER2-positive early-stage breast cancer.
Authors: Chen Monica F. , Manson Daniel K. , Yuan Ariel , Crew Katherine D. 
Published: May 2020

e24092 Background: Trastuzumab improves breast cancer survival but is associated with an increased risk of heart failure. Identifying risk factors associated with trastuzumab induced cardiotoxicity (TIC) would allow for more targeted and intensive screening for at-risk patients. Hypertension is one of the most consistent predictors of TIC. Racial/ethnic minorities are at higher risk of cardiovascular disease but are under-represented in studies of TIC. The objective of this study was to evaluate the relationship between race/ethnicity and risk of TIC among a diverse cohort of patients with HER2-positive early-stage breast cancer. Methods: We conducted a retrospective cohort study of patients treated at Columbia University between 2007 and 2016 for stage I-III breast cancer with adjuvant or neoadjuvant trastuzumab who had at least two echocardiograms. Mild TIC was defined as a ≥10% decline in left ventricular ejection fraction (LVEF); moderate TIC ≥15% decline; severe TIC ≥20% or decline in LVEF to < 50%. Diagnosis of hypertension, average systolic and diastolic blood pressure, and number of hypertension medications was assessed 1- year pre-treatment, during treatment, and 1-year post-treatment. We generated descriptive statistics and used multivariable logistic regression to evaluate demographic and clinical factors associated with TIC. Results: Of 279 patients evaluated, 36.6% were non-Hispanic white, 18.3% non-Hispanic black, 34.8% Hispanic, and 10.4% Asian. The average baseline LVEF was 60% and did not significantly differ between racial/ethnic groups. Mild TIC developed in 33.3% of patients, moderate TIC 18.6%, severe TIC 15.8%, and 14.7% with LVEF decline to < 50%. Patients with hypertension were at increased odds of developing TIC (OR = 2.41, 95% CI = 1.15-3.93; p = 0.02). Prevalence of hypertension was 53% among non-Hispanic white women, 69% non-Hispanic black, 53% Hispanic, and 39% Asian. Incidence of TIC did not differ significantly between racial/ethnic groups. Forty percent of patients with hypertension were not on any medications before initiating trastuzumab. Conclusions: There was no difference in TIC based upon race/ethnicity despite higher rates of hypertension among racial/ethnic minorities compared to non-Hispanic whites. However, a high portion of patients with hypertension were not on any medications before treatment. Increased screening and treatment of hypertension among patients receiving HER2-positive targeted therapy for early-stage breast cancer may be warranted.
The inadequacy of cardiovascular safety reporting in breast cancer clinical trials.
Authors: Hamid Arsalan , Oshunbade Adebamike A. , Kipchumba Rodney K. , Thigpen Samuel Calvin , Hall Michael E. , Butler Javed , Ruckdeschel John C. 
Published: May 2020

e24100 Background: Although some cardiovascular (CV) toxicity is detected in early phase trials of therapeutic agents, most CV toxicities are not appreciated until later phase clinical trials or general clinical practice. The high prevalence of cardiovascular disease (CVD) in the general population warrants study of how later phase oncologic pharmacotherapy clinical trials address eligibility and assess for treatment-related cardiotoxicity. We focused our study on phase 2 and 3 breast cancer trials to limit disease-specific variations. Methods: A methodical Embase search was performed for phase 2 and 3 trials administering breast cancer pharmacotherapy and including > 50 participants. Firstly, we examined CVD as an exclusion criterion. Secondly, we identified what CV safety assessments were reported such as troponin, brain natriuretic peptide (BNP), lipid profile, electrocardiogram (ECG), or CV imaging. Thirdly, we examined whether trials reported adverse CV events. Fischer’s exact test was applied to compare reporting amongst trial characteristics (trial funding source and type of agent administered), and a 2 sided p-value of < 0.05 was considered significant. Results: 50 published articles from 46 separate clinical trials were included. Patients with prevalent CVD were excluded in 67.4% of trials, the most frequently excluded CVD was heart failure/NYHA class > 1 (65.2% of trials). At least one pre or post-treatment CV safety assessment was reported in only 58.7% of trials, most commonly an ECG (52.2% of trials). BNP or troponin assessments were not reported in any trial. Adverse CV events were reported in 82.6% of trials, the most frequently reported event was hypertension (43.5% of trials). CV Safety assessments were more frequently reported in pharmaceutically funded trials compared to non-pharmaceutically funded trials (86.4 vs 10.0%, p < 0.001), and in trials administering targeted/immunotherapy agents compared to those administering only traditional chemotherapy/hormonal therapy (85.2 vs 21.1%, p < 0.001). Conclusions: Later stage breast cancer clinical trials are conducted in populations under-representative of patients with prevalent CVD, a common comorbidity. Trial funding source and type of agent administered impact whether or not CV toxicity is monitored. Despite the frequent exclusion of patients with CVD and poor safety assessment reporting, adverse CV events are frequently encountered and reported. Thus, these trials may underestimate CV toxicity risks for the greater population receiving such agents in clinical practice.
Real-world implementation of serious illness care program (SICP) in cancer care.
Authors: Karim Safiya , Lupichuk Sasha M. , Tan Amy , Sinnarajah Aynharan , Simon Jessica 
Published: May 2020

e24112 Background: The Serious Illness Care Program (SICP) is a system-based intervention, including a conversation guide, which facilitates improved advance care planning (ACP) conversations between clinicians and seriously ill patients. A recent randomized control trial found the program reduced symptoms of depression and anxiety amongst oncology out-patients and improved process outcomes. We implemented the SICP in our center to determine if the effects of this program could be translated into the real world. Methods: Two outpatient oncology clinics implemented the SICP, each over a 16-week period. Patients were identified based on an answer of “no” to the question “would I be surprised if this patient died within the next year?”, or any patient with a diagnosis of metastatic pancreatic cancer, or symptom scores of > 7 on more than three categories of the patient reported outcome dashboard. Physicians were trained on how to conduct the SICP conversation. One patient per week was identified and prepared to have the SICP conversation with the goal of at least 12 conversations in each 16-week period. Rates of SICP conversation documentation on our system’s “ACP and goals of care designation (GCD) Tracking Record” and GCD orders were recorded. Patient satisfaction after each conversation and physician comfort level over time were assessed. Results: 16 patients were identified (8 patients in each 16-week period). One patient was lost to follow-up. Of the remaining 15 patients who had the SICP conversation, 14 (93%) had documentation on the Tracking Record and 8 (53%) had a GCD order. This was a major improvement over baseline rates of documentation (e.g. < 1 % Tracking Record use and 16% GCD for patients with GI cancers). 14 patients completed satisfaction surveys, of which 12 (86%) felt “completely” or “quite a bit” more heard or understood. Physician comfort level increased from 3.6 to 4.8 and from 4.8 to 5 out of 5, respectively over each 16-week period. Conclusions: SICP implementation resulted in high rates of documentation of goals and preferences. Patients felt heard and understood by their healthcare team, and comfort in these conversations improved over time for physicians. The goal number of conversations was not met, but otherwise the SICP was feasible to implement in the real world. Further study is required to identify the appropriate triggers and barriers to routine SICP conversations.
Real-world myeloid growth factor (MGF) prophylaxis patterns in patients receiving chemotherapy at intermediate-risk for febrile neutropenia (FN): A systematic review.
Authors: Wang Weijia , Li Edward C. , Campbell Kim 
Published: May 2020

e24116 Background: Many patients receiving myelosuppressive chemotherapy are at an intermediate risk (10-20%) of developing FN. In this setting, clinical practice guidelines recommend an individualized approach towards MGF prophylaxis based on regimen and patient-specific FN risk factors. The purpose of this review is to summarize and describe the real-world MGF prophylaxis patterns, patient-specific risk factors, and FN outcomes in patients receiving chemotherapy at intermediate risk of FN. Methods: We searched the MEDLINE database (PubMed) for peer-reviewed published articles using the keywords “primary prophylaxis,” “febrile neutropenia,” and “intermediate risk” from 2000-2020. Articles were included if they were cohort or case control studies, and excluded if the data were derived from clinical trials. Studies from outside the United States or where the methods cannot be verified were also excluded. Results: Out of 131 studies identified, 7 met the inclusion/exclusion criteria after review. Most studies included adult cancer patients diagnosed with breast, lung or colorectal cancer receiving chemotherapy identified using public/private insurance claims or electronic medical records. In the 2000s, MGF prophylaxis rates were around 17-22% in patients receiving intermediate-risk regimens; while in 2010s, the prophylaxis rate increased to > 50%. Patient-specific FN risk factors were prevalent, but MGF primary prophylaxis rates among those receiving intermediate risk regimens were generally low (around 24-28%); approximately 25% of patients with > 1 FN risk factor received primary prophylaxis. Primary prophylaxis rates differed by tumor type; breast cancer had the highest rate (~46%), followed by non-small cell lung (~24%), and colorectal (~8%). FN incidence varied among patients with FN risk factors (~7 to 29%) across intermediate risk regimens, and the relative risk of FN (vs. those without risk factors) ranged from 1.1 to 2.2. Conclusions: Although historically low, MGF prophylaxis in patients receiving intermediate risk regimens has been increasing. Patient FN risk factors were widespread and associated with increased FN incidence. Since appropriate primary prophylaxis in patients at intermediate-risk could potentially improve population-based FN-related outcomes, future studies should focus on whether biosimilar MGFs as primary prophylaxis are cost-effective and could better optimize the care reflected in current MGF practice guidelines.
The long and winding road in drug development: Learnings from on-going development of IEPA for chemotherapy-induced myelosuppression.
Authors: Pleimes Dirk , Meyer Michael , Czajkowski Maciej 
Published: May 2020

e24134 Background: An orally bioavailable small molecule IEPA (Imidazolyl Ethanamide Pentandioic Acid) is under development as treatment for chemotherapy-induced myelosuppression (CIM) since 2013. A clinical phase 2a study in epirubicin and cyclophosphamide (CP) treated breast cancer patients demonstrated efficacy of prophylactic (5d pre-CTX) IEPA (100 mg ≈ 1.7 mg/kg/d) in the first but not the second batch of the drug product. After causality due to manufacturing was systematically excluded, the R&D team reassessed the development path and reinitiated non-clinical in vivo studies for efficacy optimization investigating a) the mode of action under different challenge (chemotherapy (CTX); radiation (RX)) b) treatment starting point c) dose d) frequency and e) route of administration to improve reproducibility of efficacy. Methods: The first study assessed hematological recovery over 19 days in mice receiving CTX and treated prophylactically (5 d pre-CTX) or therapeutically (1 h pre-CTX or 24 h post-CTX) with oral IEPA (100 mg/kg, Human Equivalent Dose (HED): 8 mg/kg) either once or twice daily. The second study investigated survival (LD25/30 and 50/30) and hematology in mice exposed to RX in prophylactically (3 d pre-RX) or therapeutically (24 h post-RX) IEPA (50 mg/kg/d) once vs. twice daily, oral vs. intraperitoneal (IP). Results: In mice exposed to CTX (200 mg/kg CP), both prophylactic and therapeutic IEPA treatment accelerated recovery of neutrophils, lymphocytes, and thrombocytes. The time to recovery of white blood cells to the baseline was reduced from 16.8 days to 5.5 days after therapeutic use of IEPA. Dose, treatment start and frequency showed comparable efficacy. In mice exposed to RX (6 Gy, LD50/30), therapeutic IEPA treatment improved survival by 30% (86% IEPA vs. 56% in control). Additionally, accelerated recovery of bone marrow cellularity and reduced body weight loss was observed. Higher doses increased efficacy, while frequency and route of administration of IEPA had limited impact. Conclusions: Two in vivo studies in mice reconfirmed IEPA’s safety and efficacy against both RX-induced mortality and CTX- and RX-induced myelosuppression. While once vs. twice daily and oral vs. IP produced no or only minor improvements, higher doses and therapeutics treatment starting 24 h post-exposure demonstrated reproducible efficacy. Results indicate that increasing the dose to up to 8 mg/kg (based on HED conversion) and starting treatment 24 h post-CTX may improve efficacy in future clinical trials.