bluuebunny/crossref_metadata_2025 huggingface dataset:
Exploring the barriers and facilitators to the acceptability of donor human milk in eastern Uganda – a qualitative study
Authors: Magowan Sarah , Burgoine Kathy , Ogara Collin , Ditai James , Gladstone Melissa
Published: April 2020

Background

Human milk is the best nutrition for all infants. When the mother’s own milk is not available, the World Health Organization recommends the use of donated human milk and milk banking for neonates born prematurely or with medical problems.

Donor human milk is rarely available in low-resource settings where both the rates of preterm birth and neonatal mortality are highest. The potential to reduce neonatal mortality through use of donated human milk is one that is yet to be fully explored in the African setting. For the introduction of any new health intervention to be successful, determining the barriers and facilitators to its acceptability is a vital first step. There are limited studies on this in sub-Saharan Africa.

Methods

This qualitative study used focus group discussions and in-depth interviews to explore the potential barriers and facilitators to utilizing donated human milk for neonates in a hospital setting in eastern Uganda from the perspectives of caregivers (parents, grandparents) and healthcare workers.

Results

Six focus group discussions involving 28 caregivers were conducted in a hospital setting in eastern Uganda. Four in-depth interviews were then also held with healthcare staff. Lack of knowledge of donated human milk emerged with discussants, and the barriers relating to transmission of infection (HIV) and poor hygiene. Common reasons which facilitated its acceptability were; a general knowledge and recognition that human milk is better than formula milk and a strong belief by caregivers in healthcare workers providing knowledgeable and safe care. Healthcare workers were supportive of introducing donor human milk but perceived a need for community and hospital education programs to enable this to be facilitated and scaled up.

Conclusions

This study shows that donor human milk can be acceptable to the caregivers of vulnerable babies in hospital settings in Uganda. Lack of awareness of donor human milk, its benefits and the methods of screening, acquisition and storage of donor milk are all barriers that could be addressed through improved education. This study advocates for national policies and programs that build capacity for effective and sustainable donor milk banking.
Sex-specific associations with cerebrospinal fluid biomarkers in dementia with Lewy bodies
Authors: van de Beek M. , Babapour Mofrad R. , van Steenoven I. , Vanderstichele H. , Scheltens P. , Teunissen C. E. , Lemstra A. W. , van der Flier W. M.
Published: April 2020

Background

Dementia with Lewy bodies (DLB) is more prevalent in men than in women. In addition, post-mortem studies found sex differences in underlying pathology. It remains unclear whether these differences are also present antemortem in in vivo biomarkers, and whether sex differences translate to variability in clinical manifestation. The objective of this study was to evaluate sex differences in cerebrospinal fluid (CSF) biomarker concentrations (i.e., alpha-synuclein (α-syn), amyloid β1-42 (Aβ42), total tau (Tau), phosphorylated tau at threonine 181 (pTau)) and clinical characteristics in DLB.

Methods

We included 223 DLB patients from the Amsterdam Dementia Cohort, of which 39 were women (17%, age 70 ± 6, MMSE 21 ± 6) and 184 men (83%, age 68 ± 7, MMSE 23 ± 4). Sex differences in CSF biomarker concentrations (i.e., α-syn, Aβ42, Tau, and pTau) were evaluated using age-corrected general linear models (GLM). In addition, we analyzed sex differences in core clinical features (i.e., visual hallucinations, parkinsonism, cognitive fluctuations, and REM sleep behavior disorder (RBD) and cognitive test scores using age- and education-adjusted GLM.

Results

Women had lower CSF α-syn levels (F 1429 ± 164 vs M 1831 ± 60, p = 0.02) and CSF Aβ42 levels (F 712 ± 39 vs M 821 ± 18, p = 0.01) compared to men. There were no sex differences for (p) Tau concentrations (p > 0.05). Clinically, women were older, had a shorter duration of complaints (F 2 ± 1 vs M 4 ± 3, p < 0.001), more frequent hallucinations (58% vs 38%, p = 0.02), and scored lower on MMSE and a fluency task (MMSE, p = 0.02; animal fluency, p = 0.006). Men and women did not differ on fluctuations, RBD, parkinsonism, or other cognitive tests.

Conclusions

Women had lower Aβ42 and α-syn levels than men, alongside a shorter duration of complaints. Moreover, at the time of diagnosis, women had lower cognitive test scores and more frequent hallucinations. Based on our findings, one could hypothesize that women have a more aggressive disease course in DLB compared to men. Future research should investigate whether women and men with DLB might benefit from sex-specific treatment strategies.
Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy
Authors: Langlois Alexandra , Lavergne Marie-Hélène , Leroux Hélène , Killer Kerstin , Azzano Pauline , Paradis Louis , Samaan Kathryn , Lacombe-Barrios Jonathan , Eiwegger Thomas , Upton Julia , Sussman Gordon , Poder Thomas , Mâsse Benoît , Des Roches Anne , Bégin Philippe
Published: April 2020

Background

Previous proof-of-concept studies have shown that a short course of omalizumab can safely accelerate the oral immunotherapy schedule for multiple allergens simultaneously. Considering the high cost of medication, the dose-related efficacy of omalizumab at decreasing the duration of oral immunotherapy up-dosing phase must be objectively quantified before cost–benefit analyses can be performed. The primary objective of this trial will be to compare the efficacy of 2 omalizumab dosages to placebo at decreasing time-to-maintenance dose during a symptom-driven multi-food OIT protocol.

Methods

A total of 90 participants aged 6 to 25 with multiple food allergies (3 or more) will be enrolled at four sites in Canada. Participants will be randomized to: (A) Omalizumab 8 mg/kg per month (n = 36); (B) Omalizumab 16 mg/kg per month (n = 36); or (C) Placebo (n = 18). Study drug will be administered at full dosage for 12 weeks, then progressively tapered at 50% dosage (8 mg/kg vs 4 mg/kg vs placebo) for 4 weeks and at 25% dosage (4 mg/kg vs 2 mg/kg vs placebo) for another 4 weeks. After a pre-treatment period of 8 weeks, participants will undergo an initial food escalation (IFE) to an OIT mix containing 3 allergens and start daily home dosing with biweekly increases until a target daily maintenance of 1500 mg protein is achieved. The amount escalated at each visit will vary based on treatment tolerance according to a standardized up-dosing algorithm. Participants will be followed for at least 12 months following the initial food escalation. The primary endpoint will be time from IFE to the target maintenance dose of 1500 mg protein. Time-to-event analytic methods, including the log-rank test, will be used to compare the 3 arms.

Discussion

This trial uses a novel pragmatic approach to compare OIT with omalizumab to OIT without omalizumab in a blinded manner, which allows to single out the effect of this anti-IgE medication on treatment effectiveness speed without the recourse to predetermined schedules. The innovative patient-centered up-dosing algorithm allows to maximise treatment effectiveness speed without compromising patient safety, regardless of whether the patient is on omalizumab or not. This study will also provide novel prospective data to inform on the optimal and most cost-effective dosage for this indication.

Trial registration ClinicalTrials.gov, NCT04045301, Registered 5 August 2019,https://clinicaltrials.gov/ct2/show/NCT04045301
Melioidosis after a long silence in Sri Lanka: an environmental hazard and dilemma in diagnosis, with recovery and longitudinal follow-up for 13 years: a case report
Authors: Pathirage Manoji M. K. , Kularatne Senanayake A. M. , Weerakoon Kosala G.
Published: April 2020

Background

Melioidosis is a potentially fatal bacterial infection caused by Burkholderia pseudomallei. The existence of melioidosis in Sri Lanka was once unheard of, and entertaining it as a diagnosis in clinical practice was extremely rare.

Case presentation

In this case report, we describe the clinical, epidemiological, and longitudinal follow-up data of a 58-year-old previously healthy Sinhalese woman who presented to our hospital with protracted febrile illness of 5 weeks’ duration, later developing multiple abscesses at different sites of the body. There was a significant delay in confirming the diagnosis of melioidosis by isolating B. pseudomallei from blood and pus cultures. The patient recovered fully with a prolonged course of antibiotics and has remained in good health over the last 13 years without recurrence. Despite being immunocompetent, she had contracted the infection by a brief contact with mud soil in a footpath.

Conclusions

A high index of clinical suspicion along with laboratory support is needed to confirm the diagnosis of melioidosis. Treatment with sensitive antibiotics over a long duration is needed, and longitudinal follow-up is essential to detect recurrences. This case raised awareness and created renewed interest in studies of melioidosis in Sri Lanka.
A Filon-like integration strategy for calculating exact exchange in periodic boundary conditions: a plane-wave DFT implementation
Authors: Bylaska Eric J , Waters Kevin , Hermes Eric D , Zádor Judit , Rosso Kevin M
Published: April 2020

An efficient and accurate approach for calculating exact exchange and other two-electron integrals has been developed for periodic electronic structure methods. Traditional approaches used for integrating over the Brillouin zone in band structure calculations, e.g. trapezoidal or Monkhorst-Pack, are not accurate enough for two-electron integrals. This is because their integrands contain multiple singularities over the double integration of the Brillouin zone, which with simple integration methods lead to very inaccurate results. A common approach to this problem has been to replace the Coulomb interaction with a screened Coulomb interaction that removes singularities from the integrands in the two-electron integrals, albeit at the inelegance of having to introduce a screening factor which must precomputed or guessed. Instead of introducing screened Coulomb interactions in an ad hoc way, the method developed in this work derives an effective screened potential using a Filon-like integration approach that is based only on the lattice parameters. This approach overcomes the limitations of traditionally defined screened Coulomb interactions for calculating two-electron integrals, and makes chemistry many-body calculations tractable in periodic boundary conditions. This method has been applied to several systems for which conventional DFT methods do not work well, including the reaction pathways for the addition of H2 to phenol and Au$_{20}^{-}$20− nanoparticle, and the electron transfer of a charge trapped state in the Fe(II) containing mica, annite.
Phase I trial of dacarbazine and bortezomib in melanoma and soft tissue sarcoma
Authors: Roberts J. D. , Ernstoff M. S. , Birdsell C.
Published: April 2020

18008

Background: Dacarbazine (D) has modest single agent activity against melanoma and soft tissue sarcomas. NFκB is a transcription factor that in general promotes cell survival and antagonizes apoptosis. In melanoma NFκB is constitutively activated and increases further in response to D. Bortezomib (B) is a prosteasome inhibitor that down-regulates NFκB. In tissue culture and xenograft melanoma models B potentiates anticancer effects of D and the related agent temozolomide. Methods: The primary objective is to identify recommended phase II doses for D+B administered weekly. Patients with advanced melanoma or sarcoma are enrolled in a traditional ‘3+3‘ dose escalation format. Results: Recommended phase II doses will be at least D 250 mg/m2 and B 1.6 mg/m2, and dose escalation continues. Treatment has been generally well tolerated with known D and B toxicities. Among 8 melanoma patients there is 1 partial response (PR), 1 with stable disease on treatment 15 weeks, 6 with progressive disease (PD) 6, 7, 8, 8, 13, and 13 weeks. Among 5 sarcoma patients there is 1 PR and 4 with PD 4, 8, 16, and 24 wks. Conclusions: At full dose B and moderate dose D for this schedule, D+B is feasible and generally well-tolerated. Activity beyond that of D alone is not apparent to date, but several or all patients have been treated at less than maximum tolerated doses.

[Table: see text]
Long-term disease-free survival (LTDFS) after biochemotherapy (BioCT) for stage IV melanoma: The experience of the Hospital Sírio-Libanês, Brazil
Authors: William W. N. , Schmerling R. A. , Belfort F. A. , Fonseca H. E. , Buzaid A. C.
Published: April 2020

18013

Background: A small subset of patients with metastatic melanoma treated with BioCT may experience LTDFS. Methods: We retrospectively reviewed all patients with stage IV melanoma and a follow-up of at least 12 months (mo) who received BioCT between 1/1998 -1/2005 under the supervision of one of the co-authors (ACB). Treatment consisted of two 3-week-cycles of cisplatin 25 mg/m2 IV D1–3, vinblastine 2 mg/m2 IV D1–3, dacarbazine 800 mg/m2 IV D1, IL-2 9 MIU/m2 IVCI D1–4, and interferon alpha-2b (IFN) 5 MIU SC D1–5. Responding patients received up to 4 additional cycles, depending on tolerance. Metastasectomy was performed for residual disease at the discretion of the attending physician. Results: A total of 57 pts (36 men, median age 45 years, median follow-up 50 months) received 190 cycles of BioCT (median 3 cycles/pt). No deaths occurred during treatment. To date, 48 pts (84%) have recurred and 41 pts (72%) have died. Median time to progression and overall survival were 8 and 17 mo, respectively. Response rates using RECIST: CR 19%, PR 32%, for an overall response rate of 51%. LTDFS, defined as pts alive and recurrence-free at 24+ mo after BioCT, was observed in 8 of the 57 pts treated (29+, 30+, 51+, 58+, 69+, 71+, 80+, and 97+ mo). 4 of the 8 pts were rendered disease-free by surgery following BioCT (2 CR, 1 PR and 1 SD; 3 with viable melanoma at pathology and 1 with pathologic CR). The remaining 4 pts achieved CR and LTDFS with BioCT alone (see Table for clinical characteristics). Conclusions: LTDFS can be achieved in approximately 7% of pts with stage IV melanoma treated with BioCT alone. Although small, this subset of pts justifies the use of BioCT for young and highly selected pts. Further studies such as gene profiling designed to better identify individuals who could potentially benefit most from BioCT are clearly warranted.

[Table: see text]

No significant financial relationships to disclose.
Tuning formulation of multipeptide vaccination for melanoma patients at high risk of relapse
Authors: Baurain J. , Van Baren N. , Marchand M. , Humblet Y. , Machiels J. , Coulie P. G.
Published: April 2020

18014

Background: Vaccination with MAGE peptides is followed by tumor regression in 10–20% of metastatic melanoma patients with detectable disease, mostly those with only SC or lymph node metastases. Anti-vaccine cytolytic T lymphocyte (CTL) responses have been observed in about 50% of the regressor patients, suggesting that these vaccines were poorly immunogenic. Recent reports have documented convincing CTL responses in patients vaccinated with peptides administered in a water-in-oil emulsion with Montanide, a clinical grade incomplete Freund’s adjuvant. After SC injection, this vaccine stimulates a local inflammation which could help to the recruitment of peptide presenting cells. Considering the absence of an effective treatment to prevent relapses of cutaneous melanoma, we applied this vaccination modality in an adjuvant setting. Methods and Results: We vaccinated 14 HLA-A2 melanoma patients with no evidence of disease but at high risk of relapse, with 4 antigenic peptides (MAGE-3.A2, NA17.A2, Tyrosinase.A2 and gp100.A2) emulsified in Montanide ISA51. Seven patients received 5 vaccinations, every 3 weeks, consisting of 4 injections of 900 μg of one peptide and 1 ml Montanide. Seven other patients received the same vaccines but with 300 μg of each peptide. Toxicity was limited to grade II, at the injection sites. Two thirds of the patients mounted a CTL response to peptide gp100.A2, and 50% to peptide NA17.A2. The lower doses of peptides were as immunogenic as the higher. Conclusions: These encouraging results indicate that this simple vaccination modality is not toxic and clearly immunogenic. We wish to formally assess the role of the immunological adjuvant Montanide in these CTL responses by vaccinating a third group of patients with the same 4 antigenic peptides without Montanide. We will also vaccinate with a mix of the 4 peptides and Montanide all injected at one site, as this will reduce the number of injections and could facilitate immunological helper effects of each peptide on the others. Finally, depending on the immunological results obtained with these two additional cohorts of patients, the best modality will be used in a larger study to evaluate clinical efficacy.

No significant financial relationships to disclose.
American Cancer Society (ACS) clinical trial matching service (CTMS)
Authors: Gansler T. , Sharpe K. , Demler C. , Eyre H.
Published: April 2020

18501

Background: The low prevalence of clinical trial participation limits progress in clinical research and practice. ACS assists individuals in finding trials appropriate to their medical and personal situation. Methods: The ACS call center and website provide access to a comprehensive cancer clinical trial database and matching software platform licensed from EmergingMed. This report outlines characteristics and outcomes of constituents who met initial eligibility criteria and requested further information for at least one trial after entering data on their diagnosis and prior treatment. Results: Among 4525 CTMS constituents during 2004–5, 58% were patients, 40% were their relatives and 2% were friends. 62% entered data via the call center, the rest used www.cancer.org (although for quality assurance reasons, all must speak with a call center specialist before receiving trial site contact information). They requested protocols for a median of 6 trials (range 1 to 75); most often requesting information on trials for lung cancer (16.4%), breast cancer (11.4%), colorectal cancer (7.3%), prostate cancer (7.0%), and melanoma (5.2%). Likelihood of trial enrollment varied by cancer type (χ2, p < 0.0001) and was highest with kidney cancer (10.7%), melanoma (7.8%), multiple myeloma (4.4%), head & neck cancer (4.4%), and leukemia (3.8%). We studied several common cancer types in greater detail. For example, in analysis of data from 2004, non-small cell lung cancer patients requesting trial information had more advanced disease than typical patients in the National Cancer Database (χ2, p < 0.001). Enrollment rates for patients with stage I-IIIA and IIIB-IV were 0% and 3.7% (NS), respectively; rates for those with ECOG performance 0–1 and >1 were 4.8% and 0.0% (χ2, p < 0.05). Conclusions: The ACS CTMS can substantially augment participation in clinical trials among patients not recruited into trials by their oncologists.

No significant financial relationships to disclose.
Influence of the level of subjective distress of healthcare professionals on the perception of symptom intensity reported by patients with terminal cancer
Authors: Zloklikovits S. , Ladinek V. , Andritsch E. , Greimel A. , Pilgram E. H. , Strohscheer I. , Verebes J. , Springer-Schlegl I. , Stoger H. , Samonigg H.
Published: April 2020

18503

Background: In palliative cancer care, effective symptom management requires knowledge of the factors influencing the accuracy of assessment by other raters. The aim of this study is to describe differences in symptom severity ratings between patients and their professional caregivers depending on the subjective level of distress of the proxy raters. Methods: A total of 50 patients with advanced cancer admitted to the palliative care unit of the University Hospital Graz, Austria participated in the study. Socio-demographic data, different physical, psychological and functional disorders as well as pain were assessed within the first three days after admission to the ward. Symptoms were rated independently by the patients themselves, their treating physicians as well as nurses using a modified standardized Symptom List for Quality Assurance in Palliative Care (MIDOS) drafted by the Working Group on the Core Documentation for Palliative Care Units in Germany and the psychological subscale of the Memorial Symptom Assessment Scale (MSAS-PSYCH). The Distress Thermometer (DT), a one item self-report measure, was completed by the different raters. Results: Statistical analyses were computed on individual symptoms (Mann-Whitney-U-Test) as well as different sum-scores for pain, physical/functional symptoms and psychological symptoms (ANOVAs). The preliminary results concerning the sum-scores showed that nurses significantly underestimated the intensity of patients’ pain (p = .005) and physical/functional symptoms (p = .022) whereas physicians agreed with the patients self-assessments. Both physicians and nurses scored psychological items (MSAS) more severe than the patients with significant higher scores for the physicians’ ratings (p = .015). In addition, comparisons between congruent and non-congruent rater dyads were analysed in relation to caregivers’ distress. Significant differences were found only for the pain sum-score, where nurses in the non-congruent dyads had significantly higher distress levels than nurses in the congruent dyads (p = .014). Conclusions: The findings indicate that at least the perception of pain of terminally-ill patients depends on healthcare professionals’ distress.

No significant financial relationships to disclose.
Relationship between biological and self-reported measures of stress among informal caregivers of patients with prostate cancer
Authors: Witt W. P. , Pickard S. , Kuzel T. , McDade T. , Perry S. , Hung S. , Zagory J. , Lin H. , Costello S. , Colella K. , Bennett C. L.
Published: April 2020

18506

Background: Informal caregivers of prostate cancer patients often experience chronic psychological stress that may adversely impact their physical and mental health, and their ability to care for their families and the patient. This study aims to determine the association between perceived and biological stress among informal caregivers of prostate cancer patients. Methods: A total of 24 informal caregivers of prostate cancer patients were recruited from both the Jesse Brown VA Center (Lakeside and Westside, Chicago) and the Robert H. Lurie Comprehensive Cancer Center at Northwestern University. Caregivers completed self-reported measures of stress, somatization, life events, burden, health status (SF-36) and mental health. Capillary blood spot samples from caregivers were used to examine two measures of biological stress, Epstein-Barr virus antibody titer and C-reactive protein. Results: Informal caregivers had a mean age of 63 years and were mostly female and spouses of patients with prostate cancer. Many had preexisting co-morbidities, including 45.8% with hypertension, 45.8% with arthritis, and 33.3% with diabetes. Nearly 30% had been hospitalized in the last 12 months. 33.3% of caregivers experienced at least one major life event in the last year and 62.5% had symptoms of somatization illness. Caregivers with symptoms of somatization illness had higher mean Epstein-Barr antibody titers as compared with those without symptoms (Mean EBV antibody titer: 198.3 versus 141.8, respectively (p < 0.05)). Caregiver-reported measures were not correlated with C-reactive protein levels. Caregivers with higher levels of strain perceived more stress in their lives (p < 0.05), but showed relatively high self-esteem (mean = 30.6, SD = 2.8, on a 7–35 scale). Conclusions: These preliminary findings suggest that informal caregivers who report symptoms of somatization illness exhibit signs of relative suppression of the cell-mediated immune processes as a result of the reactivation of the Epstein-Barr virus. Final analyses will be conducted that control for potential confounders and will further elucidate if caregiver stress is associated with suppression of the immune system.

No significant financial relationships to disclose.
The palliative care network as a model of continuity of care in oncologic departments
Authors: Tassinari D. , Poggi B. , Fabbri A. , Massa L. , Nicoletti S. , Pecci A. , Ricci G. , Raffaeli W.
Published: April 2020

18518

Background: Although medical oncology and palliative care are often distant dimensions in the treatment of patients with cancer, it is a common notion that an integration could improve the outcome in a comprehensive assistance to the patient. Methods: To create a Palliative Care Network (PCN) in our Department, we promote the creation of a multidisciplinary team (MT) with oncologists (2), palliativists (1), psychologists (1), social workers (2) and nurses (3) with the aim of favouring the continuity of care along all the phases of the disease. The MT gathers the competences of the oncologic and palliative care units, and is coordinated by the responsible of the supportive and palliative care unit of the district. All the patients were evaluated before entering into the project and classified in three levels with different care burden. In all the patients admitted to the PCN a palliative support is planned since the early phases of metastatic disease. The palliative care project are weekly updated by the MT. The outcomes of the PCN are evaluated every six months for activity and annually for efficacy. Results: 4589 patients have been admitted in 2003–2005 period (419 in Hospice). 2441 (53.2%), 1533 (33.4%) and 615 (13.4%) patients were classified respectively in the three increasing severity levels, and an “intensive” palliative approach was needed in 2547 (55.5%) patients. The main problems referred by the patients or their families were symptoms control, pain control, the need of psychological or social support, the need of a continuity of care along the terminal phases of the disease. Preliminary data seem to suggest a positive impact of the shared approach against the symptoms of advanced or terminal disease, and an interesting level of satisfaction by patients and caregivers seems to be confirmed in a preliminary assessment. Conclusions: The continuity of care is considered an index of the quality of care and an integrated model of palliative care should be elaborated in every oncologic district; oncologic departments seem to represent the ideal dimension where favouring an integration between medical oncology and palliative care and every effort should be made to realize this kind of integration.

No significant financial relationships to disclose.
Intrathecal drug delivery versus comprehensive medical management as it may impact inpatient length of stay, readmission, and inpatient cost of care
Authors: Isaacs J. D. , Stearns L. J. , Poling W. H. , Milton D. , Nasternak J. , Romano C.
Published: April 2020

18520

Background: Long lengths of stay (LOS) and high readmission rates partly explain the high medical costs of treating cancer patients. Uncontrolled pain is the number two reason for hospital readmission. Aggressive measures and treatment strategies for relieving intractable cancer pain can require the implantation and management of intrathecal (IT) drug delivery systems. The objective was to examine LOS, episodes of readmission, intensive care (ICU) stays, and discharge status among patients treated with IT versus comprehensive medical management (CMM) for pain. Methods: Retrospective case-control medical record review methods were employed. Sixty-three randomly selected cancer patients who received an IT were matched on gender, age group, and primary diagnosis to 63 who did not. Results: The total LOS for the 63 non-IT patients was 567 days. The total LOS for the 63 IT patients was 301 days. The mean LOS among the non-IT patients was 9 days. The mean LOS among the IT patients was 4.7 days. Total LOS for the non-IT patients was statistically significantly higher. Among the 63 non-IT patients 94 total inpatient episodes were experienced. Among the 63 IT patients 68 total inpatient episodes were experienced. The likelihood of a non-IT patient readmitting was nine-fold higher than the IT patients and statistically significantly different. The total Intensive Care Unit (ICU) days for the 63 non-IT patients were 60 days. The total ICU days for the 63 IT patients were 30 days. The total ICU for the non-IT patients was not statistically significantly higher. The likelihood of a non-IT patient expiring while an inpatient was fourteen-fold higher than the IT patients and was statistically significantly different. The average cost per episode was 22% higher among the IT group versus the non-IT group. Conclusions: The implantable IT system for pain management among cancer patients experiencing intractable pain may be a significant influence on patient LOS, readmission, and ICU episodes even though it represents a 22% increase in average inpatient costs per episode. Controlled studies examining these hospital indicators as primary outcomes for these patients by evaluating the IT drug delivery system as compared to CMM are warranted.

No significant financial relationships to disclose.
Lymphedema is common among post-operative cancer survivors
Authors: Cormier J. N. , Davidson L. , Xing Y. , Evans W. J. , Armer J. M.
Published: April 2020

18524

Background: Lymphedema (LE) is associated with the surgical treatment of a number of tumors and is a serious long-term condition with significant medical, economic, and quality of life consequences. Early detection and management are critical to preventing LE progression and complications. We examined the literature to ascertain the incidence and identify factors associated with an increased postoperative risk for LE. Methods: We systematically reviewed the oncology literature (1972–2005) to identify studies that examined postoperative LE. Data pertaining to the type of malignancy, the surgical procedure performed, the criteria used to define LE, and the median follow-up time were extracted. The incidence of LE was summarized using weighted averages. Results: We identified a total of 122 reports of postoperative LE (N = 24,095 patients), which were broken down by cancer type as follows: breast cancer (n = 45), melanoma (n = 31), gynecologic (GYN) malignancies (n = 30), genitourinary (GU) malignancies (prostate n = 6, penile n = 6, bladder n = 2), and sarcoma (n = 2). When only prospective studies (n = 74, 61%) were considered, the incidence of LE following axillary node dissection (AND) in patients with breast cancer was 19% compared with 8% following AND for melanoma. The incidence of lower extremity LE following inguinofemoral and/or pelvic lymph node dissection for melanoma was 30% compared with 24%, 14%, and 20% for GYN malignancies, GU malignancies and sarcomas. The relative risk of postoperative lower extremity LE increased two-fold in patients who received radiation therapy. Methods of measuring LE included extremity circumference (n = 17 studies) with various defined thresholds (>1 cm [n = 8], >2 cm [n = 7], and >3 cm [n = 2]). Fourteen studies used volume measurements, while the remainder used an ad hoc clinical grading method. The lowest incidence of LE was seen in studies with the shortest follow-up. Conclusions: LE is a common condition resulting from the surgical treatment of a number of different malignancies. To enhance the quality of postoperative care in cancer survivors, objective LE measurement and symptom assessment should be part of standard practice during both early and long-term follow-up.

No significant financial relationships to disclose.
Hub colonization of central line catheters in children with cancer
Authors: Norville R. , Horvath B. , Lee D. , Hyde A. , Gregurich M. , Hilburn J. , Starke J. , Versalovic J. , Mueller B. , Hockenberry M.
Published: April 2020

18530

Background: Central venous catheter (CVC) hub sites provide bacterial access to the blood stream through migration along the external and internal surfaces of the catheter. Hub colonization rates vary from 29–38% in the adult literature. While pediatric studies were not found, one study reported the incidence of blood stream infections in neonates to be 30 times higher in catheters with hub colonization compared to catheter hubs that were not colonized. The purpose of this descriptive study was to obtain baseline cultures of CVC hubs to determine the incidence of colonization. Methods: Fifty-one catheter hub cultures were obtained from a convenience sample of 27 children with cancer. The mean age of the patients was 8.2 years (range 0.5–16.2 years); 77% were diagnosed with leukemia and 23% with solid tumors. Cultures were obtained by swabbing the threaded area of the catheter hub after removing the injection cap. A semi-quantitative culture for bacteria and fungus was obtained using standard laboratory procedures by a microbiologist. This study was conducted in a large urban hospital in the Southwest. Results: Fifty-seven percent of the hubs were culture positive. Of those positive cultures, 69%, 24%, 10% and 7% were colonized with 2, 3, 4 and 5 organisms, respectively. The most common organism cultured was coagulase negative staphylococcus. The only significant risk factor for this population was previous central venous catheter infections (p = 0.025). Sixty-nine percent of the lines were tunneled catheters. Central venous catheters were in place on an average of 75.3 days but this was not a factor in the colonization rate. Conclusions: The majority (57%) of the 51 central venous catheter hubs cultured were colonized with at least one organism. This study is the first to evaluate the rate of central venous catheter hub colonization in children with cancer. These findings support the need for more stringent guidelines for central venous catheter care. Further research evaluating the relationship between hub colonization and subsequent blood stream infection is needed.

No significant financial relationships to disclose.
Darbepoetin alfa improves quality of life in cancer patients undergoing radiation, final results of a multicenter, open study
Authors: Antonadou D. , Varveris P. , Karageorgis P. , Papadopoulos V. , Georgakopoulos G. , Kyprianou C. , Panousaki A. , Athanasiou H. , Beroukas C. , Skarlatos J. , Misailidou D.
Published: April 2020

18531

Background: Anaemia is a poor prognostic factor for patients undergoing radiotherapy (XRT) and has been associated with decreased response to treatment. Darbepoetin alfa has been proven effective in treating anaemia and in improving QoL. The purpose of this study was to assess the efficacy, safety and the impact on QoL of darbepoetin alfa in these pts. Methods: Patients with Hb level 10–12 g/dl, PS ECOG <2, and life expectancy >6 mos were administered darbepoetin alfa SC 150 mcg once weekly during the 6 wk course of conventional XRT (2 Gy/5 days/week). All pts received iron supplem. Blood transfusion was given for Hb <9 g/dl. Complete blood counts, serum iron, folate, B12, ferritin, serum LDH, bilirubin and reticulocyte count were measured weekly. The primary study endpoints were changes in Hb level during XRT, number of transfusions and evaluation of QoL. Results: Between Mar 2002 and Feb 2004, 140 pts were entered, 116 were evaluable. Mean Hb at baseline was 10.95 ± 1.76. There was a significant increase (17.1%) in mean Hb levels from 2nd wks onwards with the peak value at wk 10 from XRT initiation. Hb significantly increased to 12.03 ± 2.39 (p < 0.001), 12.63 ± 2.10 (p < 0.001) and 12.96 ± 2.33 (p < 0.001) at 3,6 and 10 wks, respectively. Blood transfusion was necessary in 3 pts (2.6%). None of the pts experienced serious adverse events. There was a significant difference in physical well being score between Hb levels (p = .016) regardless the period of time (p = .17). Pts with high Hb levels had higher functional well being scores (p = .002) regardless time for the interaction (p = .24).There was a significant difference in mean fatigue score between Hb levels (p=.019) and a significant time by group interaction (p = .03).Pts with high Hb levels tend to have a higher social well being score than those with lower Hb (p = .08) while the differences were similar over time (p = .89).Those with Hb ≤ 12 g/dL had a tendency for increased emotional scores at 6 wks (p = .07) while the differences were similar over time (p = .138). Conclusion: Hb levels were significantly increased from baseline, irrespective of tumour localisation and stage. This increase reached the maximum value during wk 10 and remained significant 2 mos post XRT. QoL was significantly improved in these pts.

No significant financial relationships to disclose.
Spirituality correlates positively with higher quality of life and negatively with depression in a sample of low income brazilian cancer patients
Authors: Del Giglio A. , Ramos E. , Bensi C. G. , Centofanti G. , Frankfurt S. , Garcia A. , Tannuous N. G.
Published: April 2020

18534

Background: Brazil has a multicultural mostly poor population with many different kinds of religious affiliations. Since cultural, psychological, spiritual and social factors may influence the quality of life (QOL) of cancer patients, we wanted to evaluate spirituality and its relation to depression and the QOL in a sanple of these patients. Methods: We surveyed 72 adult cancer patients through three questionnaires: a general one, the FACIT-Sp QOL questionnaire, as well as the Beck depression inventory, all of them already validated in Portuguese. From the FACIT-Sp questionnaire we obtained also the general quality of life (FACT-G) score. We evaluated correlations between variables with Chisquare, Fisher and ANOVA tests. Since multiple univariate correlations were assessed in this study, we considered significant only p values equal or bellow 0.005. We employed multiple regression analysis to evaluate if depression and spirituality would independently correlate with QOL. Results: We included 72 patients. The mean age was 52 years, 63.9% were female, 58.3% were married, 20.8% were regularly employed, and 59.7% had studied up to elementary school only. For most patients (66, 2%) their religious faith was the most important factor that helped them to cope with their disease. We found no statistical correlations between the scores of the questionnaire FACIT-Sp and any of the demographic variables. We observed significant correlations between higher scores of spirituality (ANOVA p < 0.001) with the absence of depression. Likewise higher scores of QOL (ANOVA p < 0.001) correlated with lack of depression. By multiple regression analysis both the spirituality dominion of the FACIT-Sp and the Beck depression inventory score correlated independently and significantly with general QOL measured by the FACT-G questionnaire’s score (p = 0.025 and p = 0.004, respectively). Conclusions: Despite the small sample size of our study, it was possible to show that religion is highly regarded by our patients and that it may influence their quality of life independently from depression. Furthermore, spirituality may also be a protective factor against depression. Therefore, physicians respect and encourage their religious practices.

No significant financial relationships to disclose.
Long term analysis of recurrences in patients treated by multimodality approach for local treatment of early rectal cancer—Liverpool’s Experience
Authors: Sun Myint A. , Elam F. , McDonald A. , Hershman M. J.
Published: April 2020

18539

Background: Local treatment of early rectal cancer with curative intent is highly controversial. Three years ago, we reported our results in 100 patients treated by multimodality approach. We have updated our results and analyse the pattern of recurrences in155 patients treated up to 2005 Methods: From Jan 1992 to Jan 2005, local treatment was offered to 155 patients with low rectal carcinoma. The majority of patients were elderly with the mean age of 76 years( range 33–101). There were 87 males and 68 females. 109 had surgery; TEM (79 patients) and TAR(30 patients). Forty six patients had radical radiotherapy alone.Locally treated patients were followed up regularly with DRE and sigmoidoscopy. CT and MRI scans were done at 0,12 and 24 months. Results: Local recurrence only occured in 13 patients (8.3%). Four patients had local and distant recurrence (2.5%). Overall local recurrence occured in 17 patients (10.8 %). Salvage surgery was carried out in 11 patients(10 APER and 1 local excision). Two had retreatment with Papillon. A total of 13 patients had salvage treatments (76.5%). At median follow-up of 40 months (range 12–168) only 72.7% of patients were still alive. Five patients (3.2%) developed distant metastases only and one had nodal recurrence. Cancer specific survival was 96% and colostomy free survival was 93%. Conclusions: Local treatment of early rectal cancer is a complex issue that needs to be address and discuss. As ageing populationis likely to increased in the next decade demands on local treatment will increase. It is important to balance the benefits of radical surgery in terms of lower local recurrence against increase mortality and morbidity from such procedures especially in elderly patients, versus slightly higher local recurrences and much lower mortality and morbidity from conservative treatments such as TEM and Papillon contact radical radiotherapy. Our study has shown that local treatment is safe and effective treatment for elderly patients with medical co morbidity. In our experience, salvage surgery can be offered for recurrences in the majority of patients but long term close follow-up is necessary. A careful case selection and multimodality treatment is essential for successful out come.

No significant financial relationships to disclose.
Antithrombotic prophylaxis (AP) and catether-related infections in cancer patients (pts) carrying central venous devices (CVD): An observational study
Authors: Fagnani D. , Franchi R. , Porta C. , Giordano M. , Scanni A. , Bertolini A. , Duro M. , Ardizzoia A. , Filipazzi V. , Cimminiello C.
Published: April 2020

18550

Background: Recent data underline the possibility to reduce catheter-related infections in cancer pts having placed a central line by using low-dose heparin. Here we report the results of an observational prospective study aimed at recording management and outcome, including infective complications, of pts affected by solid tumors undergoing a CVD placement. Methods: The study was named “Registro CVD-POLO NORD” and involved 18 centers of oncology in Lombardia (Italy). Starting from January 2003 and with an accrual period of 30 months, 1418 pts entered the study and their data were recorded. Both bloodstream infections and local infections of the subcutaneous pocket were considered as catheter-related infections. Results: On September 2005, 1253 pts had a follow-up of at least 4 months, the median follow-up period being 6 months. Of them, 424 subjects (34%) received a continuous AP consisting mainly of very low-dose warfarin. CVD-related infections occurred in 46 pts (3.6%, 95 CI 2.6%–4.7%). In the table the frequency of infective complications is reported according to type of cancer, stage of disease, treatment with chemotherapy (CT) and administration of AP. The use of central venous catheter (CVC) and peripherally inserted central catheter (PICC) as well as CT were significantly more associated with infections. On the contrary, low-dose warfarin appeared to be protective. No difference was found as regard to the primary tumor site. There were no major bleeding complications among subjects receiving AP. Conclusions: Confirmatory of previous reports, our data underscore the increased risk of infections related to the use of certain devices and CT administration. The role of fibrin deposition in favouring bacterial colonization of CVD seems to be confirmed by the protective effect of low-dose warfarin which represents a feasible way to obtain a long-term reduction of catheter-related infections.

[Table: see text]

No significant financial relationships to disclose.
A randomized prospective open labeled study of oral amoxicillin-clavulanate with intravenous ceftriaxone and amikacin in low risk febrile neutropenia
Authors: Dominic J. F. , Kumar L. , Kochupillai V. , Raina V. , Sharma A. , Bakshi S. , Seth T. , Kapil A.
Published: April 2020

18551

Background: Empiric oral antibiotic administration is a treatment option in low risk febrile neutropenia. Methods: Low risk febrile neutropenia patients (expected neutropenic duration <7 days with no comorbid features) between 15 and 75 years of age were randomized to receive either oral amoxicillin-clavulanate 625 mg twice daily and levofloxacin 500 mg once daily or intravenous (i.v.) ceftriaxone 2 g and amikacin 15 mg/kg once daily. Most patients were treated on out patient basis. The primary end point was response to therapy- defervescence of fever within 72 hours with improvement in any clinical manifestation of infection and no recurrence of fever for 48 hours without use of antipyretics. Use of growth factors was not permitted except in treatment failure. The study was cleared by the institute ethics committee. Results: Sixty four episodes in 53 patients were evaluable, 33 in the i.v. group and 31 in the oral antibiotics group. The underlying diagnosis was bone and soft tissue sarcomas in 32 episodes, hematological cancers in 22 and other solid cancers in 10. The groups were equally matched for age (median 25 years in the i.v. arm and 19 years in the oral arm), gender, type of cancer, baseline absolute neutrophil count (median 200/μL in both arms) and duration of neutropenia (5 days and 4 days in the i.v. and oral groups respectively). A focus of infection was identified clinically in 15% of episodes and microbiologically in 11% of episodes; 57% of which were gram positive organisms and the rest gram negative. Seventy two percent (95% confidence interval 58% to 88%) in the i.v. arm and 77% (95% confidence interval 63% to 92%) in the oral arm responded to therapy. The only serious toxicity was one episode of convulsions in the i.v. group. All treatment failures received second line i.v. antibiotics. There was no mortality in either group. Comparing the two groups for equivalence (assuming a 25% difference between the two arms as unequal) the two groups were found to be equivalent with a power of 59% (p = 0.03). Conclusion: Oral antibiotics have comparable efficacy as intravenous antibiotics in the management of low risk febrile neutropenia.

No significant financial relationships to disclose.