bluuebunny/crossref_metadata_2025_split huggingface dataset:
caBIG: Proof of concept platform for personalized cancer care
Authors: Buetow K. 
Published: August 2020

e20712 Background: Numerous factors including enhanced understanding of the molecular basis of disease and the availability of sophisticated information technology are catalyzing a “rapid learning healthcare system,” where knowledge obtained from clinical outcomes can drive research discoveries that can be can be brought rapidly to the bedside. Benefits from such an iterative process may include earlier detection, more efficient drug discovery and development, and individualized patient care leading to better clinical outcomes. Methods: The National Cancer Institute (NCI) identified the need for an informatics initiative in recognition of the growing clinical and economic burden of cancer; the transformation of research catalyzed by multiple genomics technologies that were generating massive amounts of data; and recognition that the “essential unity” of research and clinical care had powerful potential to improve the outcomes of all cancers, as it had done in the field of pediatric oncology. In response, NCI pioneered caBIG (cancer Biomedical Informatics Grid), a network of interconnected data, individuals, and organizations, designed to share data and knowledge, simplify collaboration, and speed research. Results: caBIG is being deployed and used in numerous research and clinical facilities, including almost 60 NCI-designated cancer centers and the NCI's National Community Cancer Center Program (NCCCP). This widespread implementation provides the framework for collaborative research projects and data sharing that will accelerate basic and clinical research and improve clinical care. Programs enabled by caBIG technologies are included in the table . Conclusions: The benefits of an interconnected cancer community will multiply as the collective knowledge and expertise of its members is harnessed and their findings are shared. Researchers and clinicians must be fully aware of opportunities to connect data, individuals and institutions to achieve their goals. [Table: see text] No significant financial relationships to disclose.
Cancer in pregnancy: Trends and research
Authors: McKain L. F. , Albano J. D. , Desai M. 
Published: August 2020

e20720 Background: Treatment advances for some cancers have allowed reproductive opportunities that would not have otherwise been possible. Optimal cancer treatment in pregnancy balances maternal needs with concerns for the developing fetus, often relying upon case report and retrospective study data which are subject to confounding factors. Study objectives were to estimate trends in cancer incidence during pregnancy and to describe current research methodology. Methods: The number and rate of pregnancies affected by cancer in 1990 and 2004 were estimated by applying age-specific incidence data from the Surveillance, Epidemiology, and End Results Program to pregnancy data from the National Center for Health Statistics for women 15–44 years. In addition, public trials registries were searched for actively enrolling studies related to “cancer in pregnancy.” Investigators were contacted for detail regarding methodology and descriptive statistics tabulated. Results: The incidence of cancer complicated pregnancies has increased overall between 1990 and 2004 from 1/1,560 to 1/1,180 pregnancies, and individually for breast, melanoma, and thyroid cancers. Seven studies actively enrolling pregnant patients with cancer were identified. Six studies are observational registries, two of which prospectively study specific drug therapies. Three enroll patients receiving care at single institutions whereas the others allow open-enrollment. Three studies focus on breast cancer during pregnancy including the only interventional study. Both maternal and pediatric outcomes are of interest. Conclusions: The shift in the distribution of pregnancies towards older women coupled with an overall increased incidence of cancer puts more women at risk of having a pregnancy complicated by cancer. Current studies are few and dominated by observational registries which maximize the eligible study population through open enrollment. Registries can efficiently provide outcome and follow-up data for this special population but have limited ability to assess effectiveness of specific treatment regimens. Oncologists must recognize the trend in the incidence of cancer in pregnancy and become stakeholders in the process of contributing to ongoing research by engaging their patients in existing studies and initiating new projects. [Table: see text]
Phase II trial comparing darbepoetin alfa every 3-week versus weekly epoetin alfa for the treatment of chemotherapy-induced anemia
Authors: Hassan M. A. , Sleem M. M. 
Published: August 2020

e20724 Background: Anemia is common in patients receiving chemotherapy and may adversely affect health-related quality of life. Erthyrpiotic factors darbepoetin alfa (DA) and epoetin alfa (EA) are currently approved for the treatment of anemia in patients with nonmyeloid malignancies who receive chemotherapy. Methods: Forty patients with a diagnosis of nonmyeloid malignancy with 8 weeks of planned chemotherapy, age 18 years, and anemia (hemoglobin 10 g/dL). 20 patients received DA 500 μg every three weeks (Q3W) and the others 20 patients received EA 40,000 units every week (QW) for up to 18 weeks. Treatment was hold at week 6 for nonresponse, which was defined as failure to achieve a hemoglobin increment of at least 2 g/dL above the baseline measurement. Efficacy was assessed by the incidence of RBC transfusion. Results: Forty patients with a diagnosis of nonmyeloid malignancy, the median age was 49 years and 52 years for DA and EA groups respectively, The majority of patients had solid tumors: Common cancer types for (DA - EA) groups were gastrointestinal (8 -5), breast (3–6), lung (3–3), soft tissue sarcoma (2–1), genitourinary (2–1), non-Hodgkin's lymphoma (1–1), multiple myeloma (1–1), Hodgkin's lymphoma (0–1), and metastatic with unknown primary in (1–0) respectively . 75% 0f the patients in both group achieved the target hemoglobin level. Transfusion incidence from week 6 to the end of the treatment phase (the primary end point) was required in 5 patients (25%) in both groups. The side effects reported in this study were thromboembolic in two patients in both groups 10%. Nausea, diarrhea and neutropnia were 25%, 15% and 10% for DA group respectively compare to 20%, 10%, and 15% in AE group respectively. Conclusions: This study demonstrates comparable efficacy and safety of DA 500 μg every three weeks (Q3W) and EA40, 000 units every week (QW). No significant financial relationships to disclose.
Erythropoiesis-stimulating agents for cancer patients: Increasingly restrictive guidelines and policies in the United States and Europe
Authors: Samaras A. T. , Lai S. Y. , Kim B. , West D. P. , McKoy J. M. , Henke M. , Silver S. M. , Bennett C. L. 
Published: August 2020

e20725 Background: Erythropoiesis stimulating agents (ESAs) have transformed the treatment of cancer-associated anemia worldwide. However, recent reports of venous thromboembolism (VTE), tumor progression, and mortality risks associated with ESA administration to cancer patients have resulted in reassessments of the safety and appropriate usage of these agents. The present study investigated the disparate factors that contributed to the transformation of ESA policies. Methods: We reviewed meta-analyses, advisory committee recommendations, manufacturer label revisions, clinical guidelines, reimbursement policies from the Centers for Medicare and Medicaid Services (CMS), updated clinical guidelines, and ESA usage trends. Results: See Table . Conclusions: The risks and benefits of ESAs for cancer patients have been reassessed, resulting in increasingly restrictive guidelines and labels in the U.S. and Europe. In response to the 2008 ESA labeling change mandated by the U.S. Food and Drug Administration (FDA), the European advisory committee, Committee for Medicinal Products for Human Use (CHMP), convened to reassess the risk-benefit profile of ESAs and determined that for patients with reasonably long life expectancies, the benefits of ESAs do not outweigh the risks. Additionally, the U.S. National Comprehensive Cancer Network (NCCN) revised clinical guidelines in accordance with the FDA labeling change. Therefore, FDA actions combined with the CMS reimbursement policy have provided the impetus for increasingly restrictive use of ESAs. [Table: see text] [Table: see text]
Cardiac anthracycline risk: Prognostic value of troponin I (TnI) and B-natriuretic peptide (BNP)
Authors: Bertolini A. S. , Croce A. , Fusco O. , Berardi E. , Malugani F. , Fiumanò M. , Deligiannis P. , Menatti E. 
Published: August 2020

e20726 Background: In patients with cancer who are undergoing to high-dose chemotherapy (HDC), even minimal elevation of TnI is associated with late left ventricular dysfunction. A TnI increase soon after HDC is a strong predictor of poor cardiological outcome. BNP elevation seems to have same prognostic value. Patients treated by standard Anthracycline-based chemotherapy (ADM-CT) doses could not have benefit from TnI/BNP evaluation; on the contrary the method could adsorb too much resources and may not be rational. Methods: To evaluate cardio toxicity trend we studied TnI and BNP in plasma samples of 28 breast cancer pts (female, adjuvant setting, mean age 50), treated with ADM-CT. The samples were detected before (a) one hour (b) and ten days (c) after each course. TnI was considered positive for values ≥ 0.044 ng/mL; BNP for values ≥ 100pg/mL .Comparison between TnI and BNP values were made with the ANOVA method. A probability value < 0.05 was considered statistically significant. Each patient was followed also with LVEF (basal & 3 months after). Results: At present we observed 135 events, mean TnI: (a) 0,00672, (b) 0,006512, (c) 0,005791; BNP (a) 33.8, (b) 36.4, (c) 35.2. We performed 405 detections for both tests; costs: 8.707$ BNP, 10.327$ TnI. No significant difference in test values has been observed between the different time periods. We can't indicate a trend referring to therapy or a particular time period. No patients had LVEF variation. Conclusions: TnI and BNP release pattern after ADM-CT doesn't identify patients at different risk of cardiac events. The program appears useful for HDC treatments, while in normal chemotherapy the data are ongoing and expensive. No significant financial relationships to disclose.
Evaluation of neurological symptoms in oncologic patients at the emergency department
Authors: Ferrer A. , López D. , Vidal M. , Tobeña M. , Serrano S. , Pajares I. , Millastre E. , Ruiz-Echarri M. , Lambea J. , Tres A. 
Published: August 2020

e20728 Background: Neurological symptoms in cancer patients are common and some of them represent a potentially serious situation. They are a frequent cause of complaint at the Emergency Department (ED). The aim of the study is to describe the profile of cancer patient who consult at ED for neurological symptoms, their diagnosis and management. Methods: From October 2007 to October 2008, all cancer patients treated at the ED of our hospital were prospectively collected. The reasons for consultation, diagnosis and clinical management are described. Results: A total of 560 cancer patients were enrolled. Of them, 61 patients (11%) consulted for a neurologic symptom: 50 of these patients (82%) were stage IV disease and 30 (49,2%) were receiving chemotherapy treatment. Of the total of patients, 14 (23%) had lung cancer; 10 patients (16%) had colorectal cancer; and 8 patients (13%) had primary central nervous system tumor. Most frequent causes of complaint were: low level of consciousness, 13 patients (21%); mobility deficit, 12 patients (19%); syncope, 9 patients (15%) and comitial crisis, 6 patients (10%). Of the patients who consulted for a neurological symptom, 52% of cases (32 patients) the cause was a structural lesion of central nervous system. Tumor progression was the diagnosis made in 27 patients (44,3%), in 14 patients (23%) the diagnosis was a metabolic alteration. A 69% of patients (42 patients) required hospitalization, 26% was discharged (16 patients) and 5% (3 patients) needed to be under observation during at least 24 hours. Conclusions: Neurological symptom is a frequent cause of complaint at ED for cancer patients. especially in patients in advanced stages. The most frequent diagnosis made because of these symptoms is tumor progression. Metabolic alterations are also an important diagnosis because of their frequency and because they can be solved by medical treatment. Most patients who consult for neurological symptoms need hospitalization. No significant financial relationships to disclose.
Systematic review of toxicities of lineage-specific hematopoietic growth factors toxicities: Implications for biosimilar erythropoietins, thromopoietic receptor agonists, and continuous erythropoietin receptor agonists
Authors: Polish A. , Samaras A. T. , McKoy J. M. , West D. P. , Trifilio S. M. , Tallman J. , Talman M. S. , Bennett C. L. 
Published: August 2020

e20733 Background: Erythropoiesis stimulating agents (ESAs) and the granulocyte and granulocyte macrophage colony stimulating factors (G-CSF/GM-CSF) have been widely used for the past two decades. Recently, thrombopoietin receptor agonists, romiplostim and eltrombopag, biosimilar erythropoietins, and a continuous erythropoietin receptor agonist were licensed. Although lineage specific hematopoietic growth factors play important roles in the treatment of cancer and chronic kidney disease, recent basic and clinical research studies have identified toxicities. Herein, we compared toxicities of ESAs, thrombopoietins and G-CSF/CSFs and the implications of these findings. Methods: Meta-analyses, reviews, clinical guidelines, and FDA transcripts for G-CSF, GM-CSF, and ESAs were reviewed. For MGDF, romiplostim, and eltrombopag, clinical trial reports, reviews, and FDA transcripts were reviewed. The study period was 2000 to 2008. Results: See Table . Conclusions: Commonalities in toxicities exist across lineage specific hematopoietic growth factors. Delayed recognition of adverse effects with ESAs and G-CSF highlights the importance of anticipating toxicities with biosimilars and thrombopoietin receptor agonists. [Table: see text] No significant financial relationships to disclose.
Methadone rotation and initiation in outpatient cancer pain
Authors: Moura G. L. , Padilha S. , Vianna K. , Giublin M. 
Published: August 2020

e20734 Background: Methadone is an effective mu opioid agonist. Delta receptor affinity, monoamine reuptake inhibition an antagonism in N-methyl-D-aspartate receptor have been described. Because of itst long half-life and lack of standart conversion ratio outpatient use is chalinging. Methods: Retrospective review of consecutive medical reports were performed from 2002 to 2007. Patients with methadone as exclusive drug for the first two months were selected. A total of 143 patients were analyzed. Symptoms, toxicities, clinical caraceristics rotation e neuropatic pain were acessed. Results: 89 (62.2%) were female, 54 (37.7%) were male, all patients had solid tumors and were under palliative care only. 52 (36.6%) had neuropathic pain. Median age was 67 years. Median pain score at baseline was 7. After four follow-up with intervals of four days in average, 78% patients had score zero. At the end of two months we found a median (range) of 18 follow-ups performed. 127 (88.8%) patients had score zero. The remaining patients were rotated to other opioid. Neuropathic pain was improved in 36 (73%) of patients only with methadone. 16 (17%) had to use adjuvant drugs. Mean methadone dose was 10mg/day at baseline and 20mg/day at the end of two months.Sedation, obstipation and neurologic symptoms were mild and no major complication was observed. Conclusions: Methadone as initial opioid opyion showed excelent and safe response rates. Its capacity of blocking NMDA receptors may explain the high rate control for neuropathic pain. This finding was not observed in others studies. The low cost, lack of active metabolites, good tolerance in older patents and the finding in neuropathic pain should be better explored in well prospective randomized future clinical trials. No significant financial relationships to disclose.
Prevention of stomal complications
Authors: Phadke M. V. 
Published: August 2020

e20745 Background: Ileostomy/Colostomy operations are associated with a high rate of infections and complications resulting in increased morbidity, mortality and litigation. Pathogenesis of each complication and role of Nature was observed. Technique of stomal maturation was modified. Surgeon must maintain control over the stoma at all times. Primary maturation of stoma is unnecessary and potentially harmful. Opening stomal lumen in O.R. is unscientific and allows bacteria to contaminate stomal and main wounds. Methods: Concept was evolved by serendipity in April 1986. Since then it has been used on all patients requiring an Ileostomy or Colostomy. Bacterial migration is prevented by keeping the lumen obstructed. Iatrogenic obstruction of small/large intestine has no deleterious effect on post-operative course. Obstructed bowel is brought out of opening at proposed site of stoma. Mesenteric corner of obstructed stoma is always above the skin. Anti-mesenteric surface is pulled out till the anti-mesenteric corner becomes the apex of a conical stoma. Serosa is sutured to a round opening in the rectus sheath. Stoma is covered by an appliance with a transparent pouch. Peristalsis starts in about 48–72 hours. When obstructed stoma bulges, it is opened with electrocautery as a minor bedside procedure. Diet is started. Peristalsis pushes mucosal cuff which protrudes, everts and auto-grafts over angiogenesis. This is based on Delayed-Primary (DP) wound healing. Mucosal cuff comes in contact with dermis of skin opening at stomal site completing Self-Maturation (SM). During SM, mucosal tube separates from serosal tube. Peristalsis continues to exert its effect on serosal tube but not on mucosal tube. Lumen of stoma remains concentric. Results: 65 Colostomies and 15 Ileostomies were performed using DPSM technique. Infection and complications were prevented. Minor complications were handled easily. Patient satisfaction was excellent. Conclusions: Primary maturation of stoma is unnecessary and potentially harmful and should be replaced by DPSM. It can be performed in all types of stoma construction, end or loop, temporary or permanent. It prevents infection and complications in all patients. No significant financial relationships to disclose.
Prevention of peristomal skin excoriation
Authors: Phadke M. V. 
Published: August 2020

e20746 Background: Purpose of this paper is to prevent the peristomal skin excoriations. So far there has not been any permanent solution for this complication. Approximately 45% of patients with stoma suffer from this problem and are told to learn to live with it. It is important to understand the pathogenesis of any complication before a solution can be found. The excoriation results from digestion of the epithelium by enzymes in the mucus flowing out of the stoma. The liquid contents of the feces, because of their physical property, run along the mesenteric border of the intestine which is shorter than the anti-mesenteric border. This is complicated by bacterial contamination present in feces. It is essential to have intact mucosa all around the stoma. Skin is less resistant to bacterial invasion when compared with mucosa. When peristalsis starts, it tends to pull the mesenteric corner of the stoma inside the peritoneal cavity. This will continue till the mesenteric corner comes to the skin level. At this point there is no mucosa to protect and the liquid intestinal contents, instead of dropping in the bag leak over the skin and start digesting the epithelium. To change the mechanics of peristalsis, it is necessary to separate the mucosal (inner) tube from the serous (outer) tube. Once this is achieved, the peristalsis affects only the serous tube and has no effect on the mucus tube which forms the lumen of the stoma. This results in a 360 degree mucosal protection of the stoma. Methods: Delayed-Primary Self-Maturation a technique of constructing stoma described by Phadke was utilized in constructing all ileostomies and colostomies. Primary maturation of stoma is avoided. The stoma is left obstructed with staples. It is opened with electro-cautery only after good peristalsis has returned. The opening is at the anti-mesenteric corner. Mucosal cuff protrudes and is pushed by peristalsis. It everts and debrides the eschar of serositis, exposing the granulation tissue. The cuff rolls out and auto-grafts over the granulation tissue. The margins of the cuff come in contact with dermis of the opening in skin and complete the maturation process. Results: 63 Colostomies and 17 Ileostomies were constructed using this technique. All complications were prevented. Conclusions: DPSM technique will prevent peristomal skin excoriations and all other complications. No significant financial relationships to disclose.
Efficacy and safety of administration of gemcitabine and docetaxel with radiation therapy in patients with high-grade soft tissue sarcoma
Authors: Raval G. G. , Govindarajan R. 
Published: August 2020

e21503 Background: Neo-adjuvant therapy of soft tissue sarcoma is not standardized. Anthracyclines (A) improve disease free and overall survival in high grade extremity soft tissue sarcomas measuring more than 5 cm. A and ifosfamide (I) therapy require inpatient administration and is associated with significant toxicities when administered in combination with RT. G in combination with D has been shown to prolong progression free and overall survival in patients with advanced or metastatic STS after progression on A and I, and in patients unable to receive the combination. The safety of administration of G with radiation is not known. We evaluated the safety of neo-adjuvant G and D in combination with RT in patients with STS. Methods: Retrospective analysis of subjects with high grade STS treated with RT and neo-adjuvant chemotherapy with G and D was conducted. G 600mg/m2 was administered on days 1 and 8 along with D 75 mg/m2 on day 8 for a total of 3 cycles. 2200 cGY RT was administered in 11 daily fractions between cycles 1 and 2 and between cycles 2 and 3. 72 hour gap was given between RT and chemotherapy. Chemotherapy was administered on outpatient basis. Efficacy was evaluated by the extent of tumor necrosis at the time of surgery. Safety was evaluated by the presence of complications following chemotherapy. Results: GD + R was administered to 12 patients in the neo-adjuvant setting. 11 of them were evaluable for response. 10 of the 11 patients had evidence of tumor necrosis at the time of surgery. 1 patient had poor response. 3 of 11 patients had neutropenia complicating neo-adjuvant chemotherapy. 4 patients required hospital admission post chemotherapy. 3 for neutopenic fever, and 1 for fever, chills and pneumonia without neutropenia. Conclusions: Gemcitabine and taxotere combination with radiation therapy can be administered safely on outpatient basis with minimal toxicity. Further safety and efficacy evaluation of this therapy will need to be confirmed in a prospective phase II study. No significant financial relationships to disclose.