bluuebunny/crossref_metadata_2025_split huggingface dataset:
Final results of a large, community-based, prospective study evaluating the impact of first and subsequent cycle pegfilgrastim on neutropenic events in patients receiving myelosuppressive chemotherapy
Authors: Ozer H. , Mirtsching B. , Rader M. , Ding B. , Truscinski D. , Dreiling L. 
Published: April 2020

8569 Background: Neutropenia is the major dose-limiting complication of myelosuppressive chemotherapy (CT). The Awareness of Neutropenia in CT (ANC) Study Group has prospectively documented cycle 1 febrile neutropenia (FN) in 8% of patients (pts) receiving CT with or without growth factor support in community practice. Our study was conducted to assess the impact of first and subsequent cycle pegfilgrastim use on neutropenic events in pts receiving CT in community practice. Interim data were previously reported (Ozer ASCO 2005). Methods: Pts ≥18 years with cancers other than leukemia or MDS were eligible, including pts with major comorbidities. Key exclusion criteria of this open-label study were weekly CT or concurrent radiotherapy (RT). Pts were to receive pegfilgrastim 6 mg ∼24 hours after CT (min 4 cycles planned). Primary endpoints were neutropenic hospitalization and CT dose delays and reductions; additionally, FN (absolute neutrophil count <1×109/L with temperature ≥38.2oC) was measured. Results: 319 centers enrolled 2,249 pts (2,500 planned); 2,112 patients who received CT and pegfilgrastim after proper consent were included in final analyses. Most pts were women (75%). Major tumor types included: breast (46%), lung (16%), and ovarian (8%) cancers, and lymphoma (18%). 36% of pts were ≥65 years (mean age [SD]: 59 [12.8]), 55% had stage 3/4 or extensive disease, 23% received prior CT, 17% received prior RT, and 27% had a significant comorbidity. Neutropenic complications occurred infrequently (table). FN was experienced by 3.6% (95% CL: 2.8, 4.5) of pts in cycle 1 and in 6.3% (5.3, 7.5) in all cycles. Serious adverse events were consistent with toxicities observed in pts receiving CT. Conclusions: Pts treated in community practice receiving pegfilgrastim in every cycle of myelosuppressive CT experienced a low incidence of neutropenic complications and alterations in CT dose and schedule due to neutropenia. [Table: see text] [Table: see text]
Survival prediction in terminally ill cancer patients by clinical estimates, laboratory and psychometric tests
Authors: Gripp S. , Moeller S. , Willers R. 
Published: April 2020

8578 Background: To improve general survival estimates in advanced cancer pat. we studied physicians’ clinical estimates, the impact of emotional disorders (anxiety and depression), and laboratory tests in palliative patients. Methods: From 12/03 to 7/04 patients with advanced cancer referred to radiation oncology for palliative treatment were invited to participate in this prospective cohort study. Pat. with adjuvant or curative treatment intent were not considered. The life span was independently estimated by two physicians and the institutional tumor board according to 3 categories (<1, 1–6, and >6 months). Agreement of survival predictions was analyzed with contingency tables and kappa statistics. Primary tumor, metastatic spread, performance status, pain, dyspnoea, weight loss, nausea, fatigue, serum enzymes (AP, LDH), function parameters (creatinine, bilirubin, CRP), and blood count (WBC, RBC) were also studied. Emotional disorders were measured using a validated psychometric self-assessment scale (Hospital Anxiety and Depression Scale, HADS). Life table analysis with log-rank test and stepwise Cox regression analysis with univariate significant variables were performed. Results: 216 pat. were enrolled and followed for at least 6 months. 580 prognoses were obtained. 94% (204) had complete blood tests. HADS questionnaires were completed by 71% (154). Survival was <1 mo in 15% (33), 1–6 mo in 36% (78), and >6 mo in 49% (105).Survival prediction was poor (kappa= 0.33) and consistently too optimistic (test of symmetry, p<0.0001). In life table analysis primary tumor (hazard ratio 2.0), brain metastases, performance status (HR 1.9), dyspnoea (HR 2.0), nausea (HR 2.0), LDH (HR 1.9), WBC (HR 2.1), fatigue, anxiety and depression (HADS) were highly significant (p< 0.0002). Conclusions: Physicians generally overestimated survival of advanced cancer patients emphasizing the need of objective prognostic models. Even short-term survival estimates (< 1 mo.) were unreliable. Combined objective variables may improve survival prediction. Psychometric tests are promising candidates to be incorporated in more accurate prognostic models. No significant financial relationships to disclose.
Results of a longitudinal survey on quality of life (QoL) in 935 patients with supradiaphragmatic early stage Hodgkin lymphoma (HL) enrolled in the EORTC-GELA H8 trial (# 20931)
Authors: Heutte N. , Mounier N. , Flechtner H. , Mellink A. M. , Meerwaldt J. H. , Fermé C. , Eghbali H. , Henry-Amar M. 
Published: April 2020

8582 Background: To study the change in posttreatment QoL and fatigue in patients with supradiaphragmatic early stage HL. Methods: QoL assessment was made using the EORTC QLQ-C30 core questionnaire and fatigue was assessed using the MFI-20 questionnaire. Questionnaires were given immediately after treatment completion and every 6 months thereafter for at least a period of 5 years. Mixed models (Med Decis Making 2003;3:54–66) were used to assess statistically reliable changes of the variables tested with time because they allow unequal number of assessments per patients. Variables tested were the 7 functioning scales and the fatigue scale of the QLQ-C30 questionnaire, the 5 MFI-20 fatigue scales, and time using 6 time periods: 0–6, 7–14, 15–21, 22–32, 33–47, ≥48 months following the end of treatment. The impact of gender, age (<30, 30–49, ≥50 years), treatment (mantle-field irradiation, subtotal nodal irradiation (STNI), 3, 4 or 6 MOPP-ABV and involved-field irradiation or 4 MOPP-ABV and STNI) and treatment-related acute grade 3–4 toxicity was also tested. Patients were censored at relapse when occurred. Results: Of the 1577 patients enrolled in the trial (1993–1998), 935 (59%, median follow-up 7 years) participated for a total of 3,227 assessments. Main clinical characteristics did not differ between patients with missing QoL forms and those with complete data. There were no significant differences in disease-free survival between treatment arms. Significant (P<0.001) improvement with time was observed for all QoL and fatigue variables tested. Overall, young age and male sex significantly (P<0.01) correlated with improvement in all QLQ-C30 dimensions except cognitive functioning. Treatment duration ≥6 months had a significant (P<0.005) negative impact on global QoL. Age≥30 years and treatment duration ≥2 months negatively (P<0.05) influenced MFI-20 variable changes. Previous toxicity and age ≥30 years altered mental fatigue and motivation. Conclusions: QoL data from the reintegration process of patients into normal life during the first follow-up years show substantial limitations. The impact of treatment is limited. Fatigue remains of great concern in these patients. No significant financial relationships to disclose.
Stress, immunity, and cervical cancer: Psychoneuroimmunologic (PNI) results of a randomized telephone counseling intervention
Authors: Nelson E. L. , Wenzel L. B. , Osann K. , Monk B. J. , Dogan-Ates A. , Chantana N. , Reina-Patton A. A. , Chicz-Demet A. , Dupont N. , Laust A. K. 
Published: April 2020

8585 Background: The association between counseling benefit and improved cancer patient survival is controversial. If such an association exists, it requires biological control of tumor growth, with the immune system as the most likely effector arm. It is widely held that for anti-tumor immunity a T helper type 1 (Th1) immune response is more advantageous, by supporting antigen-specific cytotoxicity, than a T helper type 2 (Th2). The purpose of this study was to test potential QOL, neuroendocrine and immune benefits obtained from psychosocial telephone counseling (PTC). Methods: Fifty cervical cancer patients were randomized to PTC or usual care. QOL and biological specimens were collected at baseline (3–15 months post diagnosis), and four months post-enrollment, Time 2. QOL was assessed by the FACT-Cx. Saliva was collected for the evaluation of cortisol and DHEA. Blood was collected for evaluation of selected neuroendocrine and immune parameters. We defined a Th1:Th2 ratio based upon cytokine precursor frequency determined from ELISpot assays for interferon (IFN) gamma and interleukin-(IL-) 5 performed using anti-CD3 and anti-CD28 lymphocyte stimulation. Results: We demonstrated a significant improvement in overall QOL from baseline to Time 2 for PTC participants compared to the control population (absolute difference 8.15, p=0.05). We observed longitudinal changes, up to 15 fold, in the Th1:Th2 ratio. Improvement in QOL was significantly associated with an increased Th1 immune system bias and conversely a decline in QOL with a more pronounced Th2 bias, p= 0.0097 two tailed Fisher’s exact T test and Spearman Correlation Coefficient r= 0.6368 (p= 0.0002, two tailed). Evaluation of association between QOL and the neuroendocrine parameters, salivary cortisol and DHEA, demonstrated the predicted trends, but did not reach statistical significance. Conclusions: PTC can improve QOL for cervical cancer survivors. Importantly, we have shown for the first time that changes in QOL are significantly associated with a shift of immune system Th1:Th2 stance. This provides support for a biobehavioral model, which identifies potential mechanisms by which interventions that lead to improvement in QOL could also result in improved clinical outcomes. No significant financial relationships to disclose.
Symptom clusters in newly-diagnosed brain tumor patients
Authors: Gleason J. , Case D. , Rapp S. , Ip E. , Naughton M. , Butler J. , McMullen K. , Stieber V. , Saconn P. , Shaw E. 
Published: April 2020

8587 Background: A symptom cluster is 2 or more co-occurring symptoms. Patients with brain tumors experience disease and treatment-related symptoms that impact their health-related quality of life (QOL). Identifying symptom clusters will facilitate treatment and improve QOL outcomes. Methods: 66 patients were enrolled in a phase III, placebo-controlled, double-blind, prospective randomized clinical trial assessing the effect of prophylactic d-methylphenidate (d-MPH) on QOL in newly diagnosed brain tumor patients receiving brain radiation therapy (RT). Inclusion criteria were: age ≥ 13 years, primary or metastatic brain tumor, partial or whole brain RT with a total dose of ≥ 2,500 cGy in ≥ 10 fractions, KPS ≥ 70, and life expectancy ≥ 3 months. Patients received d-MPH 5–15 mg BID (or placebo) starting week 1 of RT and continuing for 8 weeks post-RT. QOL data were collected at baseline, the end of RT, and 4, 8, and 12 weeks following RT using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) and the Center for Epidemiologic Studies Depression Scale (CES-D). Symptom data were analyzed using exploratory factor analysis, multi-dimensional scaling (MDS), and cluster analysis. Results: The study failed to show a treatment effect for d-MPH (Butler J et al, Int J Radiat Oncol Biol Physics 63 [Supp1]:80, 2005).Thus, both d-MPH and placebo patients were analyzed together. 58 and 48 patients were analyzed at baseline and the end of RT, respectively. Two symptom clusters were identified using exploratory factor analysis and supported by MDS and cluster analysis: an expressive language cluster including difficulty reading, writing, and finding the right words, and a mood cluster including feeling sad, anxious, and having depressed mood. Conclusions: Two symptom clusters were identified in patients undergoing brain RT: an expressive language cluster and a mood cluster. This suggests that interventions that target both cognitive function and mood should be utilized. Further research on symptom clusters in cancer patients is needed. This study was supported by NCI grant 1 U10 CA81851. No significant financial relationships to disclose.
The relationship between older cancer survivors’ reports of depression, anxiety and pain to health providers’ findings and mortality
Authors: Seo P. H. , Sloane R. , Ingram S. S. , Misra D. , Clipp E. C. , Montana G. S. , Cohen H. J. 
Published: April 2020

8597 Background: Older cancer survivors may experience psychological distress due to their cancer experience and aging health. This study aimed to compare primary care and specialty providers’ inquiries of pain, depression and anxiety to older cancer survivors’ questionnaire responses. Methods: 153 patients seen in oncology clinics at the Veterans Affairs Medical Center (Durham, NC) from November 1999 until April 2000 completed the Hospital Anxiety and Depression Scale and a pain thermometer questionnaire. Blinded chart review examined health provider inquiries of pain, anxiety and depression. Cox proportional hazards survival analyses were performed on subjective pain, anxiety and depression with comorbidities and Karnofsky performance status (KPS) added in controlled models. Results: Patients were on average aged 68, had 5.4 comorbidities, 87.4% KPS, and were 3.1 years from a cancer diagnosis. Health providers missed 17 of 94 patients with significant levels of self-reported pain (sensitivity 0.82). Although 28 (20.6%) and 33 (25.8%) patients screened positively for depression and anxiety respectively, providers asked 7 patients about anxiety (sensitivity 0.15) and 16 patients about depression (sensitivity 0.25). The overall three year mortality was 37.9%. Pain was not associated with mortality. Patients screening for depression [HR 2.03 (95% CI: 1.03, 4.01)] and anxiety [HR 2.02 (95% CI: 1.01, 4.04)] had lower 3 year survival. KPS and comorbidities diminished these effects. Conclusions: In older cancer survivors, anxiety and depression may have an association with mortality. To improve detection, oncology and primary care providers should routinely inquire about mood and aim to intervene with pharmacologic or supportive treatments. No significant financial relationships to disclose.
The development of a prediction tool for chemotherapy-induced anemia in patients with advanced non-small cell lung cancer (NSCLC) palliative receiving chemotherapy
Authors: Vincent M. , Dranitsaris G. , Clemons M. , Verma S. , Lau C. , Gascon P. , Van Belle S. , Ludwig H. 
Published: April 2020

8600 Background: Anemia remains a common complication in patients with advanced NSCLC on palliative chemotherapy. Many oncologists believe that anemia is unpredictable, acting on a low hemoglobin value once the patient is anemic (i.e. reactively). However, patient care could be substantially improved if severe anemia could be accurately predicted by validated mathematical models. The development and validation of our cycle-based prediction model for severe anemia (hemoglobin ≤ 100 g/L) is described. Methods: Data on 536 European patients receiving palliative chemotherapy was prospectively collected as part of the European Cancer Anemia Survey (Ludwig et al, 2004), including information on clinical and biochemistry parameters that could potentially be associated with anemia. The sample was randomly divided into a 2/3 model derivation and 1/3 validation sample. Multivariable logistic regression techniques were applied for the initial model. A risk scoring system based on regression parameters was created, from 0 to 15. Finally a receiver operating characteristic curve (ROC) analysis was undertaken to measure predictive accuracy of the validation sample. Results: Precycle hemoglobin, low body surface area, advanced age, poor performance status, recurrent/persistent disease and platinum or gemcitabine-based chemotherapy were identified as being important predictors for severe anemia. The ROC analysis on the derivation and internal validation datasets had areas under the ROC curve of 0.80 (95%CI: 0.74 - 0.85) and 0.86 (95%CI: 0.83 - 0.89). A risk score of ≥ 8 to < 10 was identified as being the optimal cut-off to maximize sensitivity (83.1%) and specificity (67.8%) of the prediction tool. Patients with a score of ≥ 8 would be considered at high risk for developing severe anemia following a particular cycle of chemotherapy. Conclusions: This study outlines the development of an accurate anemia prediction tool for NSCLC patients receiving chemotherapy. The application and planned continued refinement of this prediction tool will be an important source of patient specific risk information for the practicing oncologist and can enhance patient care by utilizing anemia therapies earlier and pro-actively. [Table: see text]
Screening for unmet psycho-social needs in cancer care
Authors: Doebbeling C. , Losee L. , Powers J. , Johns S. , Connor J. 
Published: April 2020

8633 Background: Persons receiving cancer care are at risk for undiagnosed depression, but the burden of anxiety symptoms and social work needs is not well described. The objectives of the clinical intervention were: 1) to describe the burden of depression, anxiety and social distress; and 2) to determine whether an unmet need for psycho-social services existed in a sample of cancer patients at a university cancer center with an active psycho-social referral program. Methods: We developed a survey composed of the Memorial Distress Thermometer (MDT), specific social work needs, and the depression and anxiety modules from the Patient Health Questionnaire (PHQ). The clinical survey was administered to a convenience sample presenting for either referral visits or ongoing cancer treatment at the Indiana University Cancer Center for a four month period. Patient request for services, indicated need, and standardized threshold scores were used to determine need for referral (MDT ≥ 4; PHQ depression ≥ 10; PHQ anxiety ≥ 10). Descriptive statistics were calculated. Results: 184 patients (70% male) completed the survey. One-third of those screened met criteria for social work referral. 78% reported at least some distress (mean score 3.6) on the MDT, with 46% (n=81) scoring 4 or above. Social work needs included helping children cope with parental illness (11%), pharmaceutical expenses (11%), insurance assistance (6%), discussing illness with spouse (6%), and lodging during treatment (5%). Mental health distress was common. 34% met criteria for referral to psychological or psychiatric services. The mean PHQ depression score was 4.7, with moderate to severe depression (score ≥ 10) in 13%. Symptoms of generalized anxiety were also common, with a mean score of (5.0) and 11% scoring ≥ 10. Conclusions: In persons receiving cancer care, previously unknown distress, social work needs, depression, and anxiety were common. The burden of symptoms resulted in a markedly increased need for psycho-social services. These data reflect upon the significant need for regular screening and integration of psycho-social services with cancer treatment. No significant financial relationships to disclose.
Postpartum Thyroiditis in Women With Euthyroid and Hypothyroid Hashimoto’s Thyroiditis Antedating Pregnancy
Authors: Moleti Mariacarla , Mauro Maria Di , Alibrandi Angela , Vita Roberto , Benvenga Salvatore , Vermiglio Francesco 
Published: April 2020

Abstract

Context
Postpartum thyroiditis (PPT) is defined as the occurrence of de novo autoimmune thyroid disease accompanied by thyroid dysfunction in the first year postpartum. However, hormonal changes resembling the typical pattern of PPT have been reported to occur even in women with pregestational Hashimoto’s thyroiditis (HT) on levothyroxine (LT4).

Objective
To evaluate the risk of PPT in women with HT antedating pregnancy.

Design/Setting
Retrospective chart review of pregnant women with HT antedating pregnancy seen in a university hospital (2008-2017), who were followed from preconception up to 1 year after delivery.

Patients
167 women preconceptionally diagnosed with HT and classified as hypothyroid HT (hypo-HT; n = 98) or euthyroid HT (eu-HT; n = 69), according to their thyroid status at the time of diagnosis.

Outcome Measures
PPT occurrence and associated clinical characteristics/risk factors.

Results
PPT occurred in 65/167 women, with a rate statistically greater in the eu-HT than in the hypo-HT group (68.1% vs 18.4%; odds ratio [OR] 9.49, 95% confidence interval [CI] 4.62-19.49). Most of the women experiencing PPT in both groups were euthyroid at the time of first-trimester evaluation (39/47 eu-HT [83%] and 16/18 hypo-HT [88.9%]). Multivariate regression analysis showed eu-HT group and first-trimester euthyroidism to be positively associated with PPT occurrence (ORs 10.71 and 3.89, respectively).

Conclusion
PPT may occur in hypo-HT women on LT4 therapy, although significantly less frequently than in eu-HT women. The 4-fold higher risk of PPT in HT women maintaining euthyroidism at first -trimester of gestation suggests that the risk of PPT could be related to the amount of unaffected thyroid tissue.
Evolving Evidence of Diabetic Ketoacidosis in Patients Taking Sodium-Glucose Cotransporter 2 Inhibitors
Authors: Fleming Nicola , Hamblin Peter Shane , Story David , Ekinci Elif I 
Published: April 2020

Abstract

Introduction
Sodium glucose cotransporter 2 inhibitors (SGLT2i) have emerged as an important class of blood glucose–lowering medications, due to cardiovascular, metabolic, and renal benefits. However, there is a small but significant risk of diabetic ketoacidosis (DKA) associated with their use.

Methods
A literature search was conducted in Ovid MEDLINE and Embase to July 2019 using variants on the key search terms sodium-glucose cotransporter 2, diabetic ketoacidosis, and type 2 diabetes. A broad spectrum of evidence was incorporated to facilitate a comprehensive narrative review. Further sources were identified through hand searching of reference lists.

Discussion
Although cardiovascular outcome trials demonstrated mixed evidence of SGLT2i associated DKA, increasing evidence from case reports and cohort studies has identified an increased risk. SGLT2i use is associated with a ketotic state caused by an increased glucagon:insulin ratio and stimulated by factors including stress-induced hormonal changes, insufficient insulin, decreased glucose, increased ketone resorption, and hypovolemia. Atypical presentations of DKA with lower-than-expected blood glucose levels are possible with SGLT2i use, so clinical and biochemical monitoring is vital for early identification and management. DKA risk is particularly increased with precipitating factors, therefore optimization of risk factors is vital. Recommendations for perioperative and sick day management of patients taking SGLT2i have been suggested based on available evidence.

Conclusion
SGLT2i are an excellent class of drug in the physician’s toolkit for managing type 2 diabetes. However, both clinicians and patients must be aware of the potential for DKA and the need for increased monitoring, both clinically and biochemically, when potential precipitating factors are present. In acutely unwell patients, these medications should be withheld to reduce the risk of DKA.